Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Infants

Phase 3 Completed 605 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 a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in Italy.

Timeline

Start: 2006-10
Primary completion: 2008-07
Completion: 2008-07

Publications

Rodgers GL, Esposito S, Principi N, Gutierrez-Brito M, Diez-Domingo J, Pollard AJ, Snape MD, Martinon-Torres F, Gruber WC, Patterson S, Thompson A, Gurtman A, Paradiso P, Scott DA. Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule. Vaccine. 2013 Oct 1;31(42):4765-74. doi: 10.1016/j.vaccine.2013.08.009. Epub 2013 Aug 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Prevnar 13	Vaccine	0.5 ml	—

Indications

No indication recorded.