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NCT00707148 · ClinicalTrials.gov registry record · Phase 1
Pertussis Vaccine in Healthy Pregnant Women
A Phase 1 study of Diphtheria and Tetanus, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
- 4
- Study locations
NCT00707148 is a Phase 1 study of Diphtheria and Tetanus that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 80 participants, below the 1,861-participant average among 15 other Diphtheria trials with a reported enrollment target (96% lower). The trial reports 4 study locations across 3 states.
The verdict
NCT00707148, a Phase 1 study of Diphtheria and Tetanus, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of this study is to look at the safety and immunogenicity of a combination vaccine that includes tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap). The study will be conducted in 48 pregnant women and 32 non-pregnant women. Safety of the newborn infant and the effect of the mother's vaccination on the infants' immune responses prior to vaccinating infants with another combination vaccine to protect against diphtheria, tetanus, and pertussis will be evaluated. Participants will be 18-45 years old. Pregnant volunteers will be 30-32 weeks pregnant and at a low risk for pregnancy complications. Pregnant volunteers will receive 2 injections (1 vaccine and 1 placebo, inactive substance); non-pregnant volunteers will receive 1 injection of vaccine. Blood samples will be collected from the mother and infant, along with the baby's growth measurements. Participation for mother infant pairs is about 15 months and about 7 months for non-pregnant women.
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed
Study Locations (4)
Washington
- Group Health Research Institute - Seattle - Seattle
- Seattle Children's Hospital - Infectious Diseases - Seattle
North Carolina
- Duke University Medical Center - Duke Perinatal Clinic - Durham
Texas
- Baylor College of Medicine - Molecular Virology and Microbiology - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2009-01 |
| Est. Completion | 2012-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00707148
The ClinicalTrials.gov registry entry for NCT00707148 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,861-participant average among 15 other Diphtheria trials with a reported enrollment target (96% 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 3 conditions, with Diphtheria appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00707148 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Washington, North Carolina, Texas.
Frequently Asked Questions
What is clinical trial NCT00707148 about?
NCT00707148 is a clinical study titled "Pertussis Vaccine in Healthy Pregnant Women". The purpose of this study is to look at the safety and immunogenicity of a combination vaccine that includes tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap). The study will be conducted in 48 pregnant women and 32 non-pregnant women. Safety of the newborn infant and the eff...
What is the current status of trial NCT00707148?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2009-01. Estimated completion is 2012-05.
What conditions does trial NCT00707148 study?
This clinical trial studies the following conditions: Diphtheria, Tetanus, Pertussis.
What interventions are being tested in trial NCT00707148?
The interventions under investigation include: Placebo (DRUG), Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (BIOLOGICAL).
Who is sponsoring clinical trial NCT00707148?
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 NCT00707148 being conducted?
This trial has 4 study locations across North Carolina, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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