Safety of a Two-Dose Regimen of a Combined Measles, Mumps, Rubella and Varicella Live Vaccine Manufactured with Recombinant Human Albumin.

摘要

AbstractBACKGROUND: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 (rHA) was selected as a replacement for human serum albumin (HSA).METHODS:This open-label, multicentre clinical trial (clinicaltrials.gov identifier NCT00560755) was designed to describe the safety profile of a two-dose schedule of the MMRV vaccine at a 1-month interval in healthy children aged 12-22 months.RESULTS:In total, 3,388 children received at least one dose of the MMRV vaccine. Overall, 3,376 (99.65%) children were included in the post-Dose 1 safety analysis, and 3,342 (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%; pain 10.31%; Post-Dose 2: erythema 30.46%; swelling 13.23%; pain 11.49%), rashes of interest (Post-Dose 1: 11.4%; Post-Dose 2: 2.78%), vaccine-related non-serious 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 HSA. Neither serious allergic-type adverse events nor anaphylactic reactions were reported.CONCLUSION:The results confirm the good safety profiles of MMRV and of MMR vaccines manufactured with rHA.