Safety and immunogenicity of an upper-range release titer measles-mumps-rubella vaccine in children vaccinated at 12 to 15 months of age: a phase III, randomized study.

ABSTRACT: The titer of live attenuated viral vaccines, such as MMR vaccines, varies between batches and over the shelf-life of a batch, with the highest titer expected at batch release. As higher titers may theoretically lead to increased reactogenicity, we compared the safety profile of an upper-range release titer MMR-RIT lot with commercial MMR II lots in a phase III, randomized, controlled study (NCT02184572). We vaccinated 1736 children with MMR-RIT (N = 1164) or MMR II (N = 572), both administered as first doses with varicella, hepatitis A, and pneumococcal conjugate vaccines at 12-15 months of age. The incidence of fever 5-12 days post-vaccination was comparable following MMR-RIT and MMR II vaccination: 4.2% vs 3.1% (difference: 1.1%) for fever > 39.0°C and 18.2% vs 17.1% (difference: 1.1%) f

SUBMITTER: MMR-162 Study Group 

PROVIDER: S-EPMC6343620 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature