Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00133445
The ClinicalTrials.gov registry entry for NCT00133445 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,628-participant average among 32 other Hepatitis B trials with a reported enrollment target (100% 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 Hepatitis B appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT00133445 reports 1 study location spanning 1 distinct geographic area - top geographies include 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.
-
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
RECRUITING · Phase 2
-
Liver Cancer Disparities in American Indian and Alaska Native Persons
RECRUITING · Phase 2
-
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
ACTIVE NOT RECRUITING · Phase 2
-
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
ACTIVE NOT RECRUITING · Phase 2
-
Study of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants With Both Chronic Hepatitis B and HIV
ACTIVE NOT RECRUITING · Phase 2
-
Study of Adding Entecavir to Current Lamivudine Therapy in HIV and HBV Co-Infected Patients
COMPLETED · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.