Early Phase 1
N=42
Seroprevalence of Bordetella Pertussis Antibodies and Anti-pertussis Antibody Response After a Single Dose of Tdap in Pregnant Thai Women
Pertussis · Pregnancy Related
Bottom Line
View on ClinicalTrials.gov: NCT03498300 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: The Seroprevalence of Anti-pertussis Toxin Antibodies (Anti-PT IgG) in Pregnant Thai Women — 43 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Tdap vaccine (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Mahidol University
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Seroprevalence of Anti-pertussis Toxin Antibodies (Anti-PT IgG) in Pregnant Thai Women |
43 | — |
| SECONDARY Change From Baseline in Anti-pertussis Toxin Immunoglobulin G Levels Among Seropositive Participants Who Received Tdap to Those Who Received Td |
42; -7.4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Thai pregnant women age at least 18 years
- No known underlying disease
- Singleton pregnancy without maternal or fetal complications
- Gestational age not more than 20 weeks at the time of recruitment
- Desired for delivery at Siriraj Hospital
Exclusion Criteria
- Pregnant women who have any contraindication to Tdap vaccine including
- History of serious allergic reaction to any components of Tdap vaccine
- History of seizure or coma after receiving Tdap vaccine in childhood
- Having an underlying disease involving central nervous system (e.g., epilepsy, Guillain-Barré syndrome)
- History of serious reactions after receiving Tdap vaccine (e.g., severe pain, severe swelling at the injection site)
- Recently had Tdap vaccine injection
- Denied for Tdap vaccine injection
Data sourced from ClinicalTrials.gov (NCT03498300). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.