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Safety of a 2-dose regimen of a combined measles, mumps, rubella and varicella live vaccine manufactured with recombinant human albumin.

Abstract

BACKGROUND
ProQuad, a vaccine containing antigens from M-M-RVAXPRO (measles, mumps and rubella vaccine) and VARIVAX (varicella vaccine), is indicated for simultaneous vaccination against measles, mumps, rubella and varicella (MMRV) in individuals from 12 months of age. To eliminate blood-derived products of human origin from the manufacturing process of the MMRV vaccine, recombinant human albumin was selected as a replacement for human serum albumin.
METHODS
This open-label, multicenter clinical trial (clinicaltrials.gov identifier NCT00560755) was designed to describe the safety profile of a 2-dose schedule of the MMRV vaccine at a 1-month interval in healthy children aged 12-22 months.
RESULTS
In total, 3388 children received at least 1 dose of the MMRV vaccine. Overall, 3376 (99.65%) children were included in the post-dose 1 safety analysis and 3342 (98.64%) in the post-dose 2 safety analysis. After doses 1 and 2, the frequencies of children experiencing solicited injection-site reactions (post-dose 1: erythema 14.31%; swelling 5.57% and pain 10.31%; post-dose 2: erythema 30.46%; swelling 13.23% and pain 11.49%), rashes of interest (post-dose 1: 11.4%; post-dose 2: 2.78%), vaccine-related nonserious systemic adverse events (post-dose 1: 34.86%; post-dose 2: 13.4%) and temperature ≥39.4 °C (post-dose 1: 25.24%; post-dose 2: 12.06%) were consistent with those observed in previous studies of the MMRV vaccine manufactured with human serum albumin. Neither serious allergic-type adverse events nor anaphylactic reactions were reported.
CONCLUSION
The results confirm the good safety profiles of MMRV and of measles, mumps and rubella vaccines manufactured with recombinant human albumin.

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  • Publisher Full Text

    • Authors

    Rüger G, Gabutti G, Rümke H, Rombo L, Bernaola E, Diez-Domingo J, Martinon-Torres F, Høgh B, Konstantopoulos A, Fiquet A, Thomas S, Eymin C, Baudin M

    Institution

    Kinder-Jugendarztpraxis, Wildeshausen, Germany.

    Source

    The Pediatric infectious disease journal 31:11 2012 Nov pg 1166-72

    MeSH

    Albumins
    Chickenpox Vaccine
    Humans
    Immunization Schedule
    Infant
    Measles-Mumps-Rubella Vaccine
    Recombinant Proteins
    Vaccines, Combined

    Pub Type(s)

    Clinical Trial
    Journal Article
    Multicenter Study
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    22772170