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NCT00013871 · ClinicalTrials.gov registry record · NA

Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs

A NA study of HIV Infections and Hepatitis B, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
NA
Development phase
300
Enrollment target
20
Study locations

NCT00013871 is a NA study of HIV Infections and Hepatitis B that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 300 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (33% lower). The trial reports 20 study locations across 10 states.

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The verdict

NCT00013871, a NA study of HIV Infections and Hepatitis B, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
NA
Development phase
300 participants
Enrollment target
20
Study locations

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

HIV Infections Hepatitis B Pertussis Pneumococcal Infections Measles

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

FieldValue
Enrollment Target 300 participants
Est. Completion 2004-11
Phase NA

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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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, categorized as NA. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (33% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

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.

NCT00013871 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Connecticut.

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.

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).

Who is sponsoring clinical trial NCT00013871?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

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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