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Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs
NCT00013871 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to determine if 2 doses of Pneumococcal Conjugate Vaccine (PCV) followed by 1 dose of Pneumococcal Polysaccharide Vaccine (PPV) in HIV-infected children on anti-HIV therapy is helpful and safe in fighting pneumococcal infections in this group of children. This study will also look at the protection provided by childhood vaccination against measles, pertussis, and hepatitis B virus. Pneumococcal infections are the most common AIDS-related infection in HIV-infected children. PCV may help reduce the chances of HIV-infected children getting pneumococcal infections. This study will look at whether pneumococcal vaccines are safe and effective in HIV-infected children receiving HAART. It will look at whether HIV-infected children are protected by childhood vaccines received previously and if more doses are safe and improve protection.
Conditions Studied
Interventions
- BIOLOGICAL Hepatitis B Vaccine (Recombinant)
- BIOLOGICAL Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed
- BIOLOGICAL Measles-Mumps-Rubella Vaccine (Live)
- BIOLOGICAL Pneumococcal Vaccine, Polyvalent (23-valent)
- BIOLOGICAL Pneumococcal Conjugate Vaccine, Heptavalent
Study Locations (20)
California
- Long Beach Memorial Med. Ctr., Miller Children's Hosp. — Long Beach
- Usc La Nichd Crs — Los Angeles
- Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. — Oakland
- UCSD Mother-Child-Adolescent Program CRS — San Diego
- UCSF Pediatric AIDS CRS — San Francisco
Florida
- South Florida CDTC Ft Lauderdale NICHD CRS — Fort Lauderdale
- Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy — Gainesville
- Univ. of Florida Jacksonville NICHD CRS — Jacksonville
- Univ. of Miami Ped. Perinatal HIV/AIDS CRS — Miami
Connecticut
- Connecticut Children's Med. Ctr. — Hartford
- Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease — New Haven
Illinois
- Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease — Chicago
- Chicago Children's CRS — Chicago
Maryland
- Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology — Baltimore
- Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases — Baltimore
Alabama
- UAB, Dept. of Ped., Div. of Infectious Diseases — Birmingham
Colorado
- Univ. of Colorado Denver NICHD CRS — Aurora
District of Columbia
- Children's National Med. Ctr. Washington DC NICHD CRS — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Est. Completion | 2004-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00013871
The ClinicalTrials.gov registry entry for NCT00013871 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with HIV Infections appearing as the primary indexed condition, and to 5 interventions — of which Hepatitis B Vaccine (Recombinant) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00013871 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00013871 about?
NCT00013871 is a clinical study titled "Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs". The purpose of this study is to determine if 2 doses of Pneumococcal Conjugate Vaccine (PCV) followed by 1 dose of Pneumococcal Polysaccharide Vaccine (PPV) in HIV-infected children on anti-HIV therapy is helpful and safe in fighting pneumococcal infections in this group of children. This study will...
What is the current status of trial NCT00013871?
This trial is currently completed. It is a NA study. The enrollment target is 300 participants. Estimated completion is 2004-11.
What conditions does trial NCT00013871 study?
This clinical trial studies the following conditions: HIV Infections, Hepatitis B, Pertussis, Pneumococcal Infections, Measles. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00013871?
The interventions under investigation include: Hepatitis B Vaccine (Recombinant) (BIOLOGICAL), Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed (BIOLOGICAL), Measles-Mumps-Rubella Vaccine (Live) (BIOLOGICAL), Pneumococcal Vaccine, Polyvalent (23-valent) (BIOLOGICAL), Pneumococcal Conjugate Vaccine, Heptavalent (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00013871?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00013871 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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