NCT00384059

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 the United Kingdom

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 286 (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 paediatric vaccines in the United Kingdom.

Conditions

• Vaccines, Pneumococcal

Interventions

Type	Name	Description
BIOLOGICAL	13-valent Pneumococcal Conjugate Vaccine	Single 0.5 mL dose given at 2, 3, 4, and 12 months of age
BIOLOGICAL	7vPnC	Single 0.5 mL dose given at 2, 3, 4 and 12 months of age
BIOLOGICAL	Pediacel	concommitant vaccine, both at arm 1 and at arm 2, at 2 months, 3 months and 4 months of age
BIOLOGICAL	NeisVac-C	concomittant vaccine, both at arm 1 and at arm 2, at 2 months and 4 months of age
BIOLOGICAL	Menitorix	concomitant vaccine, both at arm 1 and at arm 2, at 12 months of age

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2006-10-04
• Last updated: 2013-01-24
• Results posted: 2012-08-15

Locations

11 sites across 1 country: United Kingdom