NCT00368966

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

A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Spain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 619 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 42 Days – 98 Days
• Healthy volunteers: Accepted

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 pediatric vaccinations in Spain.

Conditions

• Vaccines, Pneumococcal

Interventions

Type	Name	Description
BIOLOGICAL	13-valent Pneumococcal Conjugate Vaccine
BIOLOGICAL	7-valent Pneumococcal Conjugate Vaccine

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2006-08-29
• Last updated: 2012-08-16
• Results posted: 2012-08-16

Locations

41 sites across 1 country: Spain