NCT00500357

Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects

A Phase 3, Open-Label, Single-Arm Trial Evaluating the Safety, Tolerability, and Immunogenicity of a Subsequent Dose of 13-valent Pneumococcal Conjugate Vaccine Administered to One Group of Individuals Who Participated in Study 6115A1-500

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

This is a follow-up study to the core study NCT00269672 (6115A1-500). This study will further evaluate the safety, tolerability, and immunogenicity of 13-valent pneumococcal conjugate vaccine (13vPnC) when administered to subjects who have already received one dose of 13vPnC, and one dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) one year later. This study will determine if a subsequent dose of 13vPnC one year later results in similar or greater immune response (body's ability to protect against disease) than that measured after the initial dose of 13vPnC.

Conditions

• Vaccines, Pneumococcal Conjugate Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	13-valent Pneumococcal Conjugate Vaccine	1 dose 13vPnC

Timeline

• Start date: 2007-11-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2007-07-12
• Last updated: 2011-04-19
• Results posted: 2011-02-17

Locations

16 sites across 1 country: South Africa