Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

Phase 3 Completed 500 enrolled Wyeth is now a wholly owned subsidiary of Pfizer

RandomizedParallel-groupDouble-blindPrevention

Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine manufactured with Polysorbate 80 compared to a 13-valent pneumococcal conjugate (13vPnC) manufactured without Polysorbate 80 when given concomitantly with routine paediatric vaccinations.

Timeline

Start: 2006-11
Primary completion: 2008-06
Completion: 2008-06

Publications

Gadzinowski J, Tansey SP, Wysocki J, Kopinska E, Majda-Stanislawska E, Czajka H, Korbal P, Pietrzyk JJ, Baker SA, Giardina PC, Gruber WC, Emini EA, Scott DA. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine manufactured with and without polysorbate 80 given to healthy infants at 2, 3, 4 and 12 months of age. Pediatr Infect Dis J. 2015 Feb;34(2):180-5. doi: 10.1097/INF.0000000000000511.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Prevnar 13	Vaccine	—	—

Indications

No indication recorded.