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Hum Vaccin Immunother. 2016 Aug 2;12(8):2188-2196. Epub 2016 May 5.

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.

Author information

1
a University of Louisville School of Medicine , Louisville , KY , USA.
2
b Senders Pediatrics , Cleveland , OH , USA.
3
c Ohio Pediatric Research , Dayton , OH , USA.
4
d Dixie Pediatrics , St. George , UT , USA.
5
e Merck & Co., Inc. , Kenilworth , NJ , USA.
6
f Covance Inc. , Princeton , NJ , USA.

Abstract

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.

KEYWORDS:

MMRV; immunogenicity; measles; mumps; rubella; safety; varicella

PMID:
27149048
PMCID:
PMC4994724
DOI:
10.1080/21645515.2016.1165374
[Indexed for MEDLINE]
Free PMC Article

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