NCT00963235

Safety & Immunogenicity of 13vPnC in HIV-Infected Subjects Aged 18 or Older Who Were Previously Immunized With 23vPS

A Phase 3, Open-label, Single-Arm Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 3 Doses of 13vPnC Vaccine in HIV-Infected Subjects 18 Years of Age or Older Who Have Been Previously Immunized With 23vPS Vaccine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 331 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will evaluate the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) in HIV-infected subjects 18 years of age or older who have been previously immunized with at least one dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). All subjects will receive 3 doses of 13vPnC, with each study vaccine dose given approximately 6 months apart.

Conditions

• HIV Infections
• Pneumococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	13-valent pneumococcal conjugate vaccine	Three doses of 13vPnC given 6 months apart.
PROCEDURE	Blood draw	Six blood draws pre-vaccination and 1 month post-vaccination, doses 1-3.

Timeline

• Start date: 2009-11-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2009-08-21
• Last updated: 2013-06-10
• Results posted: 2013-06-10

Locations

15 sites across 1 country: United States