NCT00366340

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

A Phase 3, Randomized, Active-Controlled, Double-blind Trial of the Safety, Tolerability, and Immunologic Non-Inferiority of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 7-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Germany.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 604 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 56 Days – 112 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 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.

Conditions

• Vaccines, Pneumococcal

Interventions

Type	Name	Description
BIOLOGICAL	13-valent pneumococcal conjugate vaccine	Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age
BIOLOGICAL	7-valent pneumococcal conjugate vaccine	Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2006-08-21
• Last updated: 2012-08-08
• Results posted: 2012-08-08

Locations

51 sites across 1 country: Germany