NCT00574795

Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Infants

A Phase 3, Open-Label Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Japan

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 193 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 2 Months – 6 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in infants of Japanese descent.

Conditions

• Vaccines, Pneumococcal Conjugate Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	13vPnC	"First dose during 2 to 6 months of age Second dose at least 28 days after the first dose Third dose at least 28 days after the second dose Forth dose during 12 to 15 months of age"

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2007-12-17
• Last updated: 2012-08-08
• Results posted: 2012-08-08

Locations

24 sites across 1 country: Japan