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

• Immune responses after 2 and 3 doses of 13vPnC as measured by serotype-specific immunoglobulin G (IgG) geometric mean fold rises (GMFRs) in all subjects. [ Time Frame: 1 month after 3 doses of 13vPnC (approx. 3 months) ] [ Designated as safety issue: No ]
• Safety of 13vPnC measured by local reactions, systemic events. [ Time Frame: 14 days post-vaccination, doses 1- 3 ] [ Designated as safety issue: Yes ]
• Safety of 13vPnC measured by adverse events. [ Time Frame: Ongoing through study ] [ Designated as safety issue: Yes ]

• Immune responses after each dose of study vaccine as measured by IgG in all subjects. [ Time Frame: 1 month post-vaccination, doses 1-4 ] [ Designated as safety issue: No ]
• Immune responses after each dose of study vaccine as measured by IgG in the pediatric & adult subgroups. [ Time Frame: 1 month post-vaccination, doses 1-4 ] [ Designated as safety issue: No ]
• Immune responses after each dose of study vaccine as measured by opsonophagocytic activity in all subjects. [ Time Frame: 1 month post-vaccination, doses 1-4 ] [ Designated as safety issue: No ]
• Immune responses after each dose of study vaccine as measured by opsonophagocytic activity in the pediatric & adult subgroups. [ Time Frame: 1 month post-vaccination, doses 1-4 ] [ Designated as safety issue: No ]

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.

• HIV Infections
• Pneumococcal Infections

• Biological: 13-valent Pneumococcal Conjugate Vaccine (13vPnC)
  13vPnC; 3 vaccinations given at approximately 1 month intervals at visits 1-3
  Other Name: 13-valent Pneumococcal Conjugate Vaccine (13vPnC)
• Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)
  23vPS; 1 vaccination given at visit 4 (approximately 1 month after visit 3)
  Other Name: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)
• 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).
  Other Name: Blood draw
• 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.
  Other Name: Screening blood draw(s)

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