Status:
COMPLETED
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
Lead Sponsor:
Pfizer
Conditions:
HIV Infections
Pneumococcal Infections
Eligibility:
All Genders
6+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
303 Patients enrolled
Trial Details
Trial ID
NCT00962780
Start Date
March 1 2010
End Date
April 1 2013
Last Update
November 17 2014
Active Locations (11)
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1
Pfizer Investigational Site
Bucharest, Romania, 021105
2
Pfizer Investigational Site
Bucharest, Romania, 030303
3
Pfizer Investigational Site
Constanța, Romania, 900709
4
Pfizer Investigational Site
Johannesburg, Gauteng, South Africa, 2013