A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants
Public ClinicalTrials.gov record NCT00000829. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To assess whether HIV-infected infants who receive a heptavalent pneumococcal conjugate vaccine have more local reactions at the site of injection and systemic reactions than placebo subjects. To assess whether this vaccine is more immunogenic than placebo following the third vaccination. Children with HIV infection are at increased risk for invasive pneumococcal infection, particularly bacteremia. A large proportion of pneumococcal disease is caused by a limited number of serotypes. The maximum number of pneumococcal serotypes that can be included in a new conjugate vaccine is felt to be limited by the amount of carrier protein. A heptavalent pneumococcal conjugate vaccine has been developed that consists of pneumococcal capsular saccharides from serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F bound to a diphtheria toxin mutant carrier protein.
Study identification
- NCT ID
- NCT00000829
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 60 participants
Conditions and interventions
Conditions
Interventions
- Pneumococcal Vaccine, Polyvalent (23-valent) Biological
- Pneumococcal Conjugate Vaccine, Heptavalent Biological
- Placebo Biological
Biological
Eligibility (public fields only)
- Age range
- 2 Months to 6 Months
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Not listed
- Primary completion
- Not listed
- Completion
- Oct 1999 (Actual)
- Last update posted
- Oct 28, 2021
Ends 1999
United States locations
- U.S. sites
- 31
- U.S. states
- 14
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Usc La Nichd Crs | Los Angeles | California | 90033 | — |
| Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. | Oakland | California | 946091809 | — |
| UCSD Maternal, Child, and Adolescent HIV CRS | San Diego | California | 920930672 | — |
| San Francisco Gen. Hosp. | San Francisco | California | 94110 | — |
| UCSF Pediatric AIDS CRS | San Francisco | California | 941430105 | — |
| Univ. of Florida Jacksonville NICHD CRS | Jacksonville | Florida | 32209 | — |
| Univ. of Miami Ped. Perinatal HIV/AIDS CRS | Miami | Florida | 33161 | — |
| Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases | Atlanta | Georgia | 30306 | — |
| Cook County Hosp. | Chicago | Illinois | 60612 | — |
| Chicago Children's CRS | Chicago | Illinois | 606143394 | — |
| Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease | Chicago | Illinois | 606371470 | — |
| Tulane/LSU Maternal/Child CRS | New Orleans | Louisiana | 701122699 | — |
| Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology | Baltimore | Maryland | 21201 | — |
| Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases | Baltimore | Maryland | 212874933 | — |
| HMS - Children's Hosp. Boston, Div. of Infectious Diseases | Boston | Massachusetts | 021155724 | — |
| Children's Hospital of Michigan NICHD CRS | Detroit | Michigan | 48201 | — |
| UMDNJ - Robert Wood Johnson | New Brunswick | New Jersey | 089030019 | — |
| NJ Med. School CRS | Newark | New Jersey | 071072198 | — |
| North Shore-Long Island Jewish Health System, Dept. of Peds. | Great Neck | New York | 11021 | — |
| NYU Med. Ctr., Dept. of Medicine | New York | New York | 10016 | — |
| Columbia IMPAACT CRS | New York | New York | 10032 | — |
| Incarnation Children's Ctr. | New York | New York | 10032 | — |
| Harlem Hosp. Ctr. NY NICHD CRS | New York | New York | 10037 | — |
| Strong Memorial Hospital Rochester NY NICHD CRS | Rochester | New York | — | — |
| SUNY Stony Brook NICHD CRS | Stony Brook | New York | 117948111 | — |
| SUNY Upstate Med. Univ., Dept. of Peds. | Syracuse | New York | 13210 | — |
| Bronx-Lebanon Hosp. IMPAACT CRS | The Bronx | New York | 10457 | — |
| DUMC Ped. CRS | Durham | North Carolina | 277103499 | — |
| The Children's Hosp. of Philadelphia IMPAACT CRS | Philadelphia | Pennsylvania | 191044318 | — |
| Texas Children's Hosp. CRS | Houston | Texas | 77030 | — |
| UW School of Medicine - CHRMC | Seattle | Washington | 981050371 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00000829, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 28, 2021 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00000829 live on ClinicalTrials.gov.