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NCT00133445 · ClinicalTrials.gov registry record · Phase 2
Pentavalent DTaP-Hep B-IPV
A Phase 2 study of Hepatitis B and Diphtheria, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT00133445: Completed Phase 2 study of Hepatitis B and Diphtheria, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00133445 is a Phase 2 study of Hepatitis B and Diphtheria that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 5 participants, below the 1,628-participant average among 32 other Hepatitis B trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00133445, a Phase 2 study of Hepatitis B and Diphtheria, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the safety of administering a combination vaccine (DTaP-HepB-IPV; Pediarix™) to infants at birth, 2 and 6 months compared to the administration of a HepB vaccine at birth and the same combination vaccine at 2, 4, and 6 months of age. Additionally, researchers will assess the body's antibody response (proteins produced by the body's immune system that help fight infections) following each vaccine dose. The study will enroll 5 healthy newborns, ages 0-5 days. Participants will be involved in study related procedures for up to 288 days, including blood sample collection and 5 study visits.
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL DTaP-Hep B-IPV Vaccine
- BIOLOGICAL Monovalent Hep B Vaccine
Study Locations (1)
California
- UCLA Center For Vaccine Research - Torrance
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2005-12 |
| Est. Completion | 2006-08 |
| Phase | Phase 2 |
What the finished NCT00133445 record still lists
NCT00133445 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 1,628-participant average among 32 other Hepatitis B trials with a reported enrollment target (100% lower).
The record links to 5 conditions, with Hepatitis B appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT00133445 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00133445 about?
NCT00133445 is a clinical study titled "Pentavalent DTaP-Hep B-IPV". The purpose of this study is to evaluate the safety of administering a combination vaccine (DTaP-HepB-IPV; Pediarix™) to infants at birth, 2 and 6 months compared to the administration of a HepB vaccine at birth and the same combination vaccine at 2, 4, and 6 months of age. Additionally, researchers...
What is the current status of trial NCT00133445?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2005-12. Estimated completion is 2006-08.
What conditions does trial NCT00133445 study?
This clinical trial studies the following conditions: Hepatitis B, Diphtheria, Tetanus, Pertussis, Poliomyelitis.
What interventions are being tested in trial NCT00133445?
The interventions under investigation include: Placebo (DRUG), DTaP-Hep B-IPV Vaccine (BIOLOGICAL), Monovalent Hep B Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00133445?
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 NCT00133445 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatitis B
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00133445's enrollment target sits among peer trials
5 33rd of 32 the lowest of 32 other Hepatitis B trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatitis B trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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