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

Phase 3 Completed 604 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 7-valent pneumococcal conjugate (Prevenar/Prevenar®, 7vPnC), when given concomitantly with Infanrix hexa at 2, 3, 4, months (infant series) and at 11-12 months of age (toddler dose) in Germany.

Timeline

Start: 2006-10
Primary completion: 2008-08
Completion: 2008-08

Publications

Gimenez-Sanchez F, Kieninger DM, Kueper K, Martinon-Torres F, Bernaola E, Diez-Domingo J, Steul K, Juergens C, Gurtman A, Giardina P, Liang JZ, Gruber WC, Emini EA, Scott DA; 501 and 006 study groups. Immunogenicity of a combination vaccine containing diphtheria toxoid, tetanus toxoid, three-component acellular pertussis, hepatitis B, inactivated polio virus, and Haemophilus influenzae type b when given concomitantly with 13-valent pneumococcal conjugate vaccine. Vaccine. 2011 Aug 11;29(35):6042-8. doi: 10.1016/j.vaccine.2011.06.026. Epub 2011 Jun 23.

Drugs

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

Indications

No indication recorded.