A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008)

Summary

This study is designed to evaluate the safety, tolerability, and immunogenicity of two different lots of V114 in healthy infants 6 to 12 weeks (\>=42 days to \<=90 days) of age. The primary hypothesis of the study is that the proportion of participants receiving V114 who have serotype specific IgG \>=0.35 mcg/mL for each of pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F at 1 month after Dose 3 is non-inferior to that for recipients of Prevnar 13™.

Timeline

Start

2017-03-21

Primary completion

2018-10-04

Completion

2018-10-04

Publications

• Platt HL, Greenberg D, Tapiero B, Clifford RA, Klein NP, Hurley DC, Shekar T, Li J, Hurtado K, Su SC, Nolan KM, Acosta CJ, McFetridge RD, Bickham K, Musey LK; V114-008 Study Group. A Phase II Trial of Safety, Tolerability and Immunogenicity of V114, a 15-Valent Pneumococcal Conjugate Vaccine, Compared With 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants. Pediatr Infect Dis J. 2020 Aug;39(8):763-770. doi: 10.1097/INF.0000000000002765.

Drugs

Indications