At a glance
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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
In Brief
A Phase 3 clinical trial evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC), 23-valent Pneumococcal Polysaccharide Vaccine (23vPS), and 1 other intervention for HIV Infections and Pneumococcal Infections. Completed, enrolled 303 participants across 11 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
13vPnC; 3 vaccinations given at approximately 1 month intervals at visits 1-3
23vPS; 1 vaccination given at visit 4 (approximately 1 month after visit 3)
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).
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.