Safety and Tolerability Study for the Pneumococcal Conjugate Vaccine V114 Versus Prevnar™ (V114-001)

Summary

This study is being conducted to evaluate the safety, tolerability, and immunogenicity of 15-valent pneumococcal conjugate vaccine (V114) compared to Prevnar™ in healthy adults and toddlers.

Timeline

Start

2009-09-25

Primary completion

2010-04-16

Completion

2011-01-05

Publications

• Results Sobanjo-ter Meulen A, Vesikari T, Malacaman EA, Shapiro SA, Dallas MJ, Hoover PA, McFetridge R, Stek JE, Marchese RD, Hartzel J, Watson WJ, Musey LK. Safety, tolerability and immunogenicity of 15-valent pneumococcal conjugate vaccine in toddlers previously vaccinated with 7-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2015 Feb;34(2):186-94. doi: 10.1097/INF.0000000000000516.
• McFetridge R, Meulen AS, Folkerth SD, Hoekstra JA, Dallas M, Hoover PA, Marchese RD, Zacholski DM, Watson WJ, Stek JE, Hartzel JS, Musey LK. Safety, tolerability, and immunogenicity of 15-valent pneumococcal conjugate vaccine in healthy adults. Vaccine. 2015 Jun 4;33(24):2793-9. doi: 10.1016/j.vaccine.2015.04.025. Epub 2015 Apr 23.

Drugs

Indications