Trials / Completed
CompletedNCT03498300
Seroprevalence of Bordetella Pertussis Antibodies and Anti-pertussis Antibody Response After a Single Dose of Tdap in Pregnant Thai Women
Seroprevalence of Bordetella Pertussis Antibodies and Anti-pertussis Antibody Response After a Single Dose of Reduced-antigen, Combined Diphtheria, Tetanus, and Acellular Pertussis Vaccine (Tdap) in Pregnant Thai Women
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 129 (actual)
- Sponsor
- Mahidol University · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This study evaluated the seroprevalence of Bordetella pertussis antibodies and anti-pertussis antibody response after a single dose of reduced-antigen, combined diphtheria, tetanus, and acellular pertussis vaccine (Tdap) in pregnant Thai women. All seronegative participants received Tdap, while seropositive participants were equally randomized into 2 groups. Half of seropositive participants received Tdap and the other half received tetanus-diphtheria (Td) as standard protocol.
Detailed description
The primary objective of this study was to determine the seroprevalence of anti-pertussis toxin antibodies (anti-PT IgG) among pregnant Thai women. The secondary objectives were to evaluate antibody response after Tdap vaccination between seronegative and seropositive participants and to compare the different antibody titers at delivery among seropositive participants who received Tdap to those who received tetanus-diphtheria vaccine (Td). The sample size calculation was based on the primary objective. Randomized clinical trial was performed for the latter secondary objective.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Tdap vaccine | A single dose of Tdap vaccine at GA 27 - 36 weeks |
Timeline
- Start date
- 2018-05-09
- Primary completion
- 2019-04-13
- Completion
- 2019-04-13
- First posted
- 2018-04-13
- Last updated
- 2020-03-24
- Results posted
- 2020-03-24
Locations
1 site across 1 country: Thailand
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03498300. Inclusion in this directory is not an endorsement.