Tento výsledek nelze pro nepřihlášené uživatele zobrazit.
K zobrazení výsledku je třeba se přihlásit.

Integrating CMC Document Preparation into the Development Process for Vaccine INDs.

Autor: Hagen, Anna¹, Aunins, Anne¹, Howson, Laura¹, Janus, Tracy¹, LeGrow, Kathleen¹, Robinett, Robin¹, Thornton, Rachel¹, Sitrin, Robert¹ anna_hagen@merck.com

Publikováno v: BioPharm International. Sep2003, Vol. 16 Issue 9, p56. 6p.

Evaluation of mRNA-1273 Vaccine in Children 6 Months to 5 Years of Age.

Autor: Anderson EJ; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Creech CB; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Berthaud V; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Piramzadian A; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Johnson KA; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Zervos M; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Garner F; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Griffin C; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Palanpurwala K; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Turner M; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Gerber J; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Bennett RL; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Ali K; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Ampajwala M; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Berman G; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Nayak J; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Chronis C; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Rizzardi B; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Muller WJ; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Smith CA; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Fuchs G; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Hsia D; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Tomassini JE; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., DeLucia D; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Reuter C; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Kuter B; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Zhao X; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Deng W; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Zhou H; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Ramirez Schrempp D; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Hautzinger K; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Girard B; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Slobod K; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., McPhee R; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Pajon R; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Aunins A; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Das R; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Miller JM; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.)., Schnyder Ghamloush S; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; OnSite Clinical Solutions, Charlotte, NC (A.P.); the Henry Ford Health System, Detroit (M.Z.); Pi-Coor Clinical Research, Burke, VA (F.G.); the Lynn Health Science Institute, Oklahoma City (C.G.); the Cyfair Clinical Research Center (K.P.) and the Texas Center for Drug Development (K.A.), Houston, and ACRC Trials, Frisco (M.A.) - all in Texas; Velocity Clinical Research, Meridian, ID (M.T.); Children's Hospital of Philadelphia Clinical Research Partners, Philadelphia (J.G.); Clinical Research Partners, Richmond, VA (R.L.B.); Clinical Research Institute, Minneapolis (G.B.); the University of Rochester Medical Center, Rochester (J.N.), and Certified Research Associates, Cortland (C.A.S.) - both in New York; Pediatric, Infant, and Adolescent Medicine, Ventura, CA (C.C.); Velocity Clinical Research, West Jordan, UT (B.R.); Ann and Robert H. Lurie Children's Hospital, Chicago (W.J.M.); the University of Kentucky, Lexington (G.F.); the Pennington Biomedical Research Center, Baton Rouge, LA (D.H.); and Moderna, Cambridge, MA (J.E.T., D.D., C.R., B.K., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., A.A., R.D., J.M.M., S.S.G.).

Publikováno v: The New England journal of medicine [N Engl J Med] 2022 Nov 03; Vol. 387 (18), pp. 1673-1687. Date of Electronic Publication: 2022 Oct 19.