Wyeth Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

Phase 3 Completed 269 enrolled Wyeth is now a wholly owned subsidiary of Pfizer

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of manufacturing scale 13-valent pneumococcal conjugate (13vPnC) vaccine compared to pilot scale 13vPnC in healthy infants when given with routine pediatric vaccines.

Timeline

Start: 2007-06
Primary completion: 2008-09
Completion: 2008-09

Publications

Gadzinowski J, Albrecht P, Hasiec B, Konior R, Dziduch J, Witor A, Mellelieu T, Tansey SP, Jones T, Sarkozy D, Emini EA, Gruber WC, Scott DA. Phase 3 trial evaluating the immunogenicity, safety, and tolerability of manufacturing scale 13-valent pneumococcal conjugate vaccine. Vaccine. 2011 Apr 5;29(16):2947-55. doi: 10.1016/j.vaccine.2011.02.002. Epub 2011 Feb 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Prevnar 13	Vaccine	—	—

Indications

No indication recorded.