title: 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.
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 MMRVAMPand 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 MMRVAMPversus, 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. MMRVAMPis non-inferior to MMRV and represents an important advancement in maintaining an adequate supply of vaccines against these diseases.
authors.affiliation: a University of Louisville School of Medicine , Louisville , KY , USA.
authors.forename: Gary S
authors.initials: GS
authors.lastname: Marshall
authors.affiliation: b Senders Pediatrics , Cleveland , OH , USA.
authors.forename: Shelly D
authors.initials: SD
authors.lastname: Senders
authors.affiliation: c Ohio Pediatric Research , Dayton , OH , USA.
authors.forename: Julie
authors.initials: J
authors.lastname: Shepard
authors.affiliation: d Dixie Pediatrics , St. George , UT , USA.
authors.forename: Jerry D
authors.initials: JD
authors.lastname: Twiggs
authors.affiliation: e Merck & Co., Inc. , Kenilworth , NJ , USA.
authors.forename: Julie
authors.initials: J
authors.lastname: Gardner
authors.affiliation: e Merck & Co., Inc. , Kenilworth , NJ , USA.
authors.forename: Darcy
authors.initials: D
authors.lastname: Hille
authors.affiliation: e Merck & Co., Inc. , Kenilworth , NJ , USA.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Hartzel
authors.affiliation: f Covance Inc. , Princeton , NJ , USA.
authors.forename: Rowan
authors.initials: R
authors.lastname: Valenzuela
authors.affiliation: e Merck & Co., Inc. , Kenilworth , NJ , USA.
authors.forename: Jon E
authors.initials: JE
authors.lastname: Stek
authors.affiliation: e Merck & Co., Inc. , Kenilworth , NJ , USA.
authors.forename: Frans A
authors.initials: FA
authors.lastname: Helmond
mesh_terms: D000914:Antibodies, Viral / Q000097:blood; D002644:Chickenpox / Q000517:prevention & control*; D019433:Chickenpox Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008457:Measles / Q000517:prevention & control*; D022542:Measles-Mumps-Rubella Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D009107:Mumps / Q000517:prevention & control*; D012409:Rubella / Q000517:prevention & control*; D014481:United States; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000914:Antibodies, Viral; D019433:Chickenpox Vaccine; D022542:Measles-Mumps-Rubella Vaccine; D017778:Vaccines, Combined; C050102:measles, mumps, rubella, varicella vaccine
keywords: MMRV; immunogenicity; measles; mumps; rubella; safety; varicella