Pertussis Vaccine in Healthy Pregnant Women
Public ClinicalTrials.gov record NCT00707148. 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.
Official title
Safety and Immunogenicity of Tdap Vaccine in Healthy Pregnant Women, Safety in Their Neonates, and Effect of Maternal Immunization on Infant Immune Responses to DTaP Vaccine
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00707148
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 80 participants
Conditions and interventions
Conditions
Interventions
- Placebo Drug
- Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed Biological
Drug · Biological
Eligibility (public fields only)
- Age range
- Up to 45 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2008
- Primary completion
- Apr 30, 2012
- Completion
- Apr 30, 2012
- Last update posted
- Jul 24, 2014
2009 – 2012
United States locations
- U.S. sites
- 4
- U.S. states
- 3
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Duke University Medical Center - Duke Perinatal Clinic | Durham | North Carolina | 27705 | — |
| Baylor College of Medicine - Molecular Virology and Microbiology | Houston | Texas | 77030-3411 | — |
| Group Health Research Institute - Seattle | Seattle | Washington | 98101-1466 | — |
| Seattle Children's Hospital - Infectious Diseases | Seattle | Washington | 98105-3901 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00707148, 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 Jul 24, 2014 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00707148 live on ClinicalTrials.gov.