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Seroprevalence of Bordetella Pertussis Antibodies and Anti-pertussis Antibody Response After a Single Dose of Tdap in Pregnant Thai Women

NCT03498300 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2020-03-24

Study results available
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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.

Conditions

  • Pertussis
  • Pregnancy Related

Interventions

BIOLOGICAL

Tdap vaccine

A single dose of Tdap vaccine at GA 27 - 36 weeks

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Nalat Sompagdee, MD · Mahidol University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-09
Primary Completion
2019-04-13
Completion
2019-04-13
FDA Drug
Yes

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03498300 on ClinicalTrials.gov