NCT00546572

Study Evaluating The Safety, Tolerability And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)

A Phase 3, Randomized, Active-Controlled, Modified Double-Blind Trial, Evaluating The Safety, Tolerability And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) Compared To A 23-Valent Pneumococcal Polysaccharide (23vPS) Vaccine in Ambulatory Elderly Individuals Aged 70 Years And Older Who Received One Dose of 23vPS At Least 5 Years Prior To Study Enrollment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 938 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 70 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety, tolerability and immunogenicity of study vaccines 13vPnC and 23vPS in older, healthy subjects who have previously received a dose of 23vPS at least 5 years ago. It will also evaluate the safety, tolerability and immunogenicity to a dose of 13vPnC 1 year after the initial dose of study vaccine.

Conditions

• Pneumococcal Infections

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	23vPS	0.5-mL dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5-mL dose 13vPnC will be administered into the deltoid muscle at year 1

Timeline

• Start date: 2007-11-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2007-10-19
• Last updated: 2011-07-14
• Results posted: 2011-05-30

Locations

58 sites across 2 countries: United States, Sweden