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Pertussis Vaccine in Healthy Pregnant Women
NCT00707148 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00707148 reports 4 study locations spanning 3 distinct geographic areas — top geographies include Washington, North Carolina, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00707148?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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