Concomitant administration of a liquid formulation of human rotavirus vaccine (porcine circovirus-free) with routine childhood vaccines in infants in the United States: Results from a phase 3, randomized trial
| Autor: | Joshua Fuller, Paul Wisman, Martin Levinson, Anthony Pruitt, Gary S. Marshall, Laurent Sigg, Regine Bataille, Luke Anschutz, Rogelio Amisola, Donald Hurley, Stephen Russell, Sean Livingston, John A. Fling, Julie Shepard, Shelly Senders, Paola Pirrotta, Mary Tipton, Michael Povey, Martin Schear, Alan Garscadden, James Hedrick, Dan Bi, Edward Zissman, Matthew Cornish, William Johnston, Armando Acevedo, Michael Leonardi, Remon Abu-Elyazeed, Leentje Moerman, Earl Franklin, David J. Hurley, Aarti Kulshrestha, Joseph B. Domachowske, Ana Ugarte, James D. Campbell, Peter E. Silas, Walter Rok, Nicola P. Klein, Tina Singh, Alvin Gabrielsen, Giancarlo Guido |
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| Rok vydání: | 2020 |
| Předmět: |
Serotype
Circovirus Rotavirus medicine.disease_cause complex mixtures Pneumococcal conjugate vaccine 03 medical and health sciences 0302 clinical medicine stomatognathic system 030225 pediatrics medicine Humans Hepatitis B Vaccines Single-Blind Method 030212 general & internal medicine Vaccines Combined Adverse effect Child Diphtheria-Tetanus-Pertussis Vaccine Haemophilus Vaccines Vaccines Conjugate General Veterinary General Immunology and Microbiology Tetanus business.industry Immunogenicity Poliovirus Diphtheria Public Health Environmental and Occupational Health Rotavirus Vaccines virus diseases Infant Hepatitis B medicine.disease Antibodies Bacterial United States Poliovirus Vaccine Inactivated Infectious Diseases Immunology Molecular Medicine business medicine.drug |
| Zdroj: | Vaccine. 39(10) |
| ISSN: | 1873-2518 |
| Popis: | Background In response to the detection of porcine circovirus type 1 (PCV-1) in the human rotavirus vaccine (HRV), a PCV-free HRV (no detection of PCV-1 and PCV-2 according to the detection limit of tests used) was developed. Liquid (Liq) PCV-free HRV previously showed immunogenicity and safety profiles comparable to lyophilized (Lyo) HRV. Methods This was a phase 3a, randomized, single-blind study (NCT03207750) conducted in the United States. Healthy infants aged 6–12 weeks received 2 doses (0, 2 months) of either Liq PCV-free HRV or Lyo HRV with routine vaccines (0, 2, 4 months): diphtheria-tetanus-acellular pertussis, hepatitis B and inactivated poliovirus combination vaccine (DTaP-HBV-IPV), monovalent tetanus toxoid-conjugated vaccine against Haemophilus influenzae type b (Hib-TT), and 13-valent pneumococcal conjugate vaccine. Co-primary objectives were: (i) to assess non-inferiority of immune responses to routine vaccine antigens 1 month post-dose 3 following co-administration with Liq PCV-free HRV compared to Lyo HRV; (ii) to rule out a 10% decrease in seroresponse to pertussis antigens after dose 3. Other objectives were to evaluate immunogenicity and safety of HRV vaccines. Results Of 1272 vaccinated infants, 990 (489 in Liq PCV-free HRV and 501 in Lyo HRV group) were included in the per-protocol set. All statistical criteria were met, thus co-primary objectives were demonstrated. Seroprotection/seropositivity rates in both groups were high: 100% for diphtheria/tetanus, ≥99.3% for HBV, ≥99.8% for polio, ≥99.8% for each pertussis antigen, ≥90.8% for all pneumococcal serotypes except serotype 3 (≥69.1%), and ≥ 97.4% for Hib. Most infants seroconverted for anti-RV antibodies (76.3% of Liq PCV-free HRV and 78.9% of Lyo HRV recipients). Geometric mean concentrations/titers were comparable between groups. Incidences of adverse events and serious adverse events were similar between groups. Conclusion Routine pediatric vaccines co-administered with Liq PCV-free HRV showed non-inferior immune responses and similar safety profiles to those following co-administration with Lyo HRV. |
| Databáze: | OpenAIRE |
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