A Randomized, Consistency Study Comparing Immunogenicity and Safety of 2 Vaccines Against Measles, Mumps and Rubella (MMR) Administered to Children 12–15 Months of Age

Abstract

Background. In the US, a combination vaccine against MMR was first licensed in 1971 and is supplied by one manufacturer (Merck & Co., Inc.). GSK Vaccines is developing an MMR vaccine for US licensure (GSK‐MMR). This study evaluated: consistency of 3 lots of GSK‐MMR; immunogenic non‐inferiority of pooled lots of GSK‐MMR to Merck & Co., Inc.'s MMR vaccine (MRK‐MMR); and acceptable immune response and safety of GSK‐MMR. Methods. In this phase IIIA, controlled, multi‐country, observer‐blind study (NCT01702428), healthy children 12‐15 months of age were randomized (3:1) to receive 1 of 3 lots of GSK‐MMR or MRK‐MMR, along with hepatitis Avaccine and varicella vaccine (all children) and pneumococcal 13‐valent conjugate vaccine (US children only). Antibodies against MMR antigens were measured by ELISA. Primary objectives: lot consistency in terms of seroresponse rates (SRR; met if 2‐sided 95% CI of the difference in SRR is within [‐5%; 5%]) and antibody geometric mean concentrations (GMCs; met if 2‐sided 95% CI of ratio is within [0.67; 1.5]); non‐inferiority of 3 pooled lots of GSK‐MMR to MRK‐MMR (met if the lower limit [LL] of 2‐sided 95% CI of difference in SRR [GSK‐MMR ‐ MRK‐MMR] is ≥‐5% and of GMC ratio [GSK‐MMR / MRK‐MMR] is ≥0.67); and acceptable immune responses (met if LL of 95% CI of SRR [pooled GSK‐MMR lots] is ≥90%). Solicited injection site and general symptoms were recorded for 4 and 43 days post‐vaccination, respectively; fever was also analyzed during days 5‐12 post‐vaccination. Results. A total of 5003 children were enrolled and received GSK‐MMR lot 1 (n = 1239); GSK‐MMR lot 2 (n = 1232); GSK‐MMR lot 3 (n = 1243) or MRK‐MMR (n = 1289). At day 42 post‐vaccination, all GSK‐MMR lots met criteria for consistency, non‐inferiority of pooled GSK‐MMR lots compared with MRK‐MMR was confirmed for all antigens, and acceptable immune responses were demonstrated (Table). Solicited symptoms occurred at a similar frequency in recipients of GSK‐MMR and MRK‐MMR (pain: 25.9% versus 28.1%, redness: 24.5% versus 25.2% and swelling: 8.9% versus 10.7%, respectively; fever: 19.7% versus 18.2%, grade 3 fever: 1.4% versus 1.1%, respectively, during days 5‐12 post‐vaccination). Conclusion. Immune responses to GSK‐MMR were non‐inferior to MRK‐MMR, with a similar safety profile. (Table Presented).