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

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ClinicalTrials.gov Identifier: NCT03498300
Recruitment Status : Completed
First Posted : April 13, 2018
Results First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Nalat Sompagdee, Mahidol University

Brief 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.


Condition or disease Intervention/treatment Phase
Pertussis Pregnancy Related Biological: Tdap vaccine Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : May 9, 2018
Actual Primary Completion Date : April 13, 2019
Actual Study Completion Date : April 13, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental
A single dose of Tdap vaccine at GA 27 - 36 weeks
Biological: Tdap vaccine
A single dose of Tdap vaccine at GA 27 - 36 weeks

No Intervention: Active comparator
dT vaccine as standard protocol



Primary Outcome Measures :
  1. The Seroprevalence of Anti-pertussis Toxin Antibodies (Anti-PT IgG) in Pregnant Thai Women [ Time Frame: Four months ]

    Percentage of participants who were seropositive for anti-pertussis toxin antibodies (anti-PT IgG).

    The overall number of 129 participants is greater than the number of 42 participants include in the Particiant Flow Module because it was the sample size calculated based on the primary objective, which was the seroprevalence of anti-pertussis antibodies in pregnant Thai women. Randomized clinical trial on 42 seropositive participants was performed for one of the secondary objectives, which was to compare the different anti-PT IgG at delivery among seropositive participants who received Tdap to those who received Td.



Secondary Outcome Measures :
  1. Change From Baseline in Anti-pertussis Toxin Immunoglobulin G Levels Among Seropositive Participants Who Received Tdap to Those Who Received Td [ Time Frame: Eight months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

    1. History of serious allergic reaction to any components of Tdap vaccine
    2. History of seizure or coma after receiving Tdap vaccine in childhood
    3. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498300


Locations
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Thailand
Nalat Sompagdee
Bangkok Noi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Nalat Sompagdee, MD Mahidol University
  Study Documents (Full-Text)

Documents provided by Nalat Sompagdee, Mahidol University:

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Responsible Party: Nalat Sompagdee, Principal Investigator, Mahidol University
ClinicalTrials.gov Identifier: NCT03498300    
Other Study ID Numbers: SI 089/2018
First Posted: April 13, 2018    Key Record Dates
Results First Posted: March 24, 2020
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Vaccines
Antibodies
Immunologic Factors
Physiological Effects of Drugs