NCT00962780

Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in HIV-Infected Subjects 6 Years of Age or Older Who Are Naive to Pneumococcal Vaccine

A Phase 3, Open-label, Single-Arm Trial to Evaluate the Safety, Tolerability and Immunogenicity of 2 and 3 Doses of 13vPnC in HIV-Infected Subjects 6 Years of Age and Older Who Have Not Been Previously Immunized With Pneumococcal Vaccine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 303 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 6 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 6 years of age or older who have not been previously immunized with a pneumococcal vaccine. All subjects will receive 3 doses of 13vPnC and 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), with each dose given approximately 1 month apart.

Conditions

• HIV Infections
• Pneumococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	13-valent Pneumococcal Conjugate Vaccine (13vPnC)	13vPnC; 3 vaccinations given at approximately 1 month intervals at visits 1-3
BIOLOGICAL	23-valent Pneumococcal Polysaccharide Vaccine (23vPS)	23vPS; 1 vaccination given at visit 4 (approximately 1 month after visit 3)
PROCEDURE	Blood draw	Blood draw; 5 blood draws approximately 1 month apart taken prior to vaccination at visits 1-4 and visit 5 (approximately 1 month after visit 4).
PROCEDURE	Blood draw	1 or 2 blood draws for CD4+ T cell count and HIV viral load at least 6 weeks apart, if subject does not have 2 CD4+ T cell counts and HIV viral load counts within 6 months before visit 1.

Timeline

• Start date: 2010-03-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2009-08-20
• Last updated: 2014-11-17
• Results posted: 2014-11-17

Locations

11 sites across 2 countries: Romania, South Africa