NCT00574548

Study Evaluating the Safety, Tolerability and Immunogenicity of 13vPnC as a 2-Dose Regimen or With 23vPS

A Phase 3, Randomized, Active-Controlled, Modified Double-blind Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine When Administered Over 12 Months Either as a 2-Dose Regimen or With 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Adults 60 to 64 Years of Age Who Are Naive to 23vPS

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 720 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 60 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to compare the safety, tolerability and immunologic response to a dose of 23vPS or 13vPnC given one year after either 13vPnC or 23vPS in subjects that have never received a previous dose of 23vPS.

Conditions

• Pneumococcal Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	13 valent Pneumococcal Conjugate Vaccine	0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1
BIOLOGICAL	13 valent Pneumococcal Conjugate Vaccine	0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and 0.5 ml dose 23vPS at year 1
BIOLOGICAL	13 valent Pneumococcal Conjugate Vaccine	0.5 ml dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5 ml dose 13vPnC at year 1
BIOLOGICAL	23-valent Pneumococcal Polysaccharide Vaccine	0.5 ml dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5 ml dose 13vPnC at year 1
BIOLOGICAL	23-valent Pneumococcal Polysaccharide Vaccine	0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and 0.5 ml dose 23vPS at year 1

Timeline

• Start date: 2007-11-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2007-12-17
• Last updated: 2011-07-22
• Results posted: 2011-05-09

Locations

6 sites across 1 country: United States