Study Evaluating the Safety, Tolerability and Immunogenicity of 13vPnC as a 2-Dose Regimen or With 23vPS

Phase 3 Completed 720 enrolled Wyeth is now a wholly owned subsidiary of Pfizer

RandomizedCrossoverTriple-blindPrevention

Summary

The objective of this study is to compare the safety, tolerability and immunologic response to a dose of 23vPS or 13vPnC given one year after either 13vPnC or 23vPS in subjects that have never received a previous dose of 23vPS.

Timeline

Start: 2007-11
Primary completion: 2010-02
Completion: 2010-02

Publications

Greenberg RN, Gurtman A, Frenck RW, Strout C, Jansen KU, Trammel J, Scott DA, Emini EA, Gruber WC, Schmoele-Thoma B. Sequential administration of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine-naive adults 60-64 years of age. Vaccine. 2014 Apr 25;32(20):2364-74. doi: 10.1016/j.vaccine.2014.02.002. Epub 2014 Mar 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pneumovax 23	Vaccine	0.5 ml	Intramuscular
Subject	Prevnar 13	Vaccine	0.5 ml	Intramuscular

Indications

No indication recorded.