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

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.

Inclusion Criteria:

• Human immunodeficiency virus (HIV)-infected subjects aged 6 years or older
• Viral load < 50,000 copies/mL and CD4+ T cell count >= 200/uL within 6 months before study vaccination
• Receiving stable highly active antiretroviral therapy (HAART) or not currently receiving any antiretroviral therapy
• No previous vaccination with a pneumococcal vaccine
• Subject or parent/legal guardian able to complete an electronic diary

Exclusion Criteria:

• Acquired immune deficiency syndrome (AIDS) at time of enrollment
• Current illicit substance and/or alcohol abuse
• History of active chronic viral hepatitis
• Previous anaphylactic reaction to a vaccine or vaccine-related component
• Serious chronic disorders including metastatic malignancy and end-stage renal disease