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

Pfizer

Status and phase

Completed

Phase 3

Conditions

Pneumococcal Infections

HIV Infections

Treatments

Procedure: Blood draw

Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)

Biological: 13-valent Pneumococcal Conjugate Vaccine (13vPnC)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00962780

B1851021

6115A1-3002

Details and patient eligibility

About

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.

Enrollment

303 patients

Sex

All

Ages

6+ years old

Volunteers

No Healthy Volunteers

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