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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

Marshall, Gary S ; Senders, Shelly D ; Shepard, Julie ; Twiggs, Jerry D ; Gardner, Julie ; Hille, Darcy ; Hartzel, Jonathan ; Valenzuela, Rowan ; Stek, Jon E ; Helmond, Frans A

Human vaccines & immunotherapeutics, 02 August 2016, Vol.12(8), pp.2188-2196 [Periódico revisado por pares]

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  • Título:
    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: Marshall, Gary S ; Senders, Shelly D ; Shepard, Julie ; Twiggs, Jerry D ; Gardner, Julie ; Hille, Darcy ; Hartzel, Jonathan ; Valenzuela, Rowan ; Stek, Jon E ; Helmond, Frans A
  • Assuntos: Mmrv ; Immunogenicity ; Measles ; Mumps ; Rubella ; Safety ; Varicella ; Chickenpox -- Prevention & Control ; Chickenpox Vaccine -- Adverse Effects ; Measles -- Prevention & Control ; Measles-Mumps-Rubella Vaccine -- Adverse Effects ; Mumps -- Prevention & Control ; Rubella -- Prevention & Control
  • É parte de: Human vaccines & immunotherapeutics, 02 August 2016, Vol.12(8), pp.2188-2196
  • Descrição: 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 (MMRV) 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 MMRV 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 MMRV 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 MMRV. Febrile seizures occurred at similar rates in both groups during the first 42 d after each vaccine dose. MMRV is non-inferior to MMRV and represents an important advancement in maintaining an adequate supply of vaccines against these diseases.
  • Idioma: Inglês

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