A double blind, randomized, active controlled study to assess the safety, tolerability and immunogenicity of measles, mumps rubella, and varicella vaccine (MMRV) manufactured using an alternative process
| Autor: | Shelly Senders, Jerry D. Twiggs, Jonathan Hartzel, Rowan Valenzuela, Frans A. Helmond, Gary S. Marshall, Darcy A. Hille, Jon E. Stek, Julie L. Gardner, Julie Shepard |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Male
Mumps measles rubella Varicella vaccine Drug-Related Side Effects and Adverse Reactions viruses Immunology Antibodies Viral Rubella Measles Virus Double blind Chickenpox Vaccine 03 medical and health sciences 0302 clinical medicine Chickenpox Double-Blind Method 030225 pediatrics medicine Immunology and Allergy Humans 030212 general & internal medicine Vaccines Combined Mumps Pharmacology integumentary system business.industry Immunogenicity virus diseases Infant Safety tolerability medicine.disease Virology Research Papers United States Female business Measles-Mumps-Rubella Vaccine |
| Popis: | Vaccination against measles, mumps, rubella, and varicella is recommended for all children in the US. Limitations manufacturing Oka/Merck strain varicella-zoster virus have hampered the availability of the combination vaccine (MMRV) against these 4 viruses, which drove the need to investigate an alternative manufacturing process. Healthy children 12-to-23 months of age at 71 US sites were randomized (1:1) to receive MMRV manufactured using an alternative process (MMRVAMP) or the currently licensed MMRV. Subjects received 2 0.5 mL doses 3 months apart. Sera were collected before and 6 weeks after Dose-1. Adverse experiences (AEs) were collected for 42 d after each dose and serious AEs and events of special interest for 180 d after Dose-2. Overall, 706 subjects were randomized to MMRVAMP and 706 to MMRV and 698 and 702 received at least 1 dose of study vaccine, respectively. The risk difference in response rates and geometric mean concentrations of antibody to measles, mumps, rubella, and varicella viruses 6 weeks after Dose-1 met non-inferiority criteria for MMRVAMP versus, MMRV. Response rates met acceptability criteria for each virus, and the seroconversion rate to varicella-zoster virus was 99.5% in both groups. Vaccine-related AEs were mostly mild-to-moderate in intensity and somewhat more common after MMRVAMP. Febrile seizures occurred at similar rates in both groups during the first 42 d after each vaccine dose. MMRVAMP is non-inferior to MMRV and represents an important advancement in maintaining an adequate supply of vaccines against these diseases. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|