Back to resultsSeroprevalence of Bordetella Pertussis Antibodies and Anti-pertussis Antibody Response After a Single Dose of Tdap in Pregnant Thai Women
Primary Purpose
Pertussis, Pregnancy Related
Status
Completed
Phase
Early Phase 1
Locations
Thailand
Study Type
Interventional
Intervention
Tdap vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Pertussis
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
Sites / Locations
- Nalat Sompagdee
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental
Active comparator
Arm Description
A single dose of Tdap vaccine at GA 27 - 36 weeks
dT vaccine as standard protocol
Outcomes
Primary Outcome Measures
The Seroprevalence of Anti-pertussis Toxin Antibodies (Anti-PT IgG) in Pregnant Thai Women
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
Change From Baseline in Anti-pertussis Toxin Immunoglobulin G Levels Among Seropositive Participants Who Received Tdap to Those Who Received Td
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03498300
Brief Title
Seroprevalence of Bordetella Pertussis Antibodies and Anti-pertussis Antibody Response After a Single Dose of Tdap in Pregnant Thai Women
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 9, 2018 (Actual)
Primary Completion Date
April 13, 2019 (Actual)
Study Completion Date
April 13, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
4. Oversight
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
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pertussis, Pregnancy Related
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
A single dose of Tdap vaccine at GA 27 - 36 weeks
Arm Title
Active comparator
Arm Type
No Intervention
Arm Description
dT vaccine as standard protocol
Intervention Type
Biological
Intervention Name(s)
Tdap vaccine
Intervention Description
A single dose of Tdap vaccine at GA 27 - 36 weeks
Primary Outcome Measure Information:
Title
The Seroprevalence of Anti-pertussis Toxin Antibodies (Anti-PT IgG) in Pregnant Thai Women
Description
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.
Time Frame
Four months
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nalat Sompagdee, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nalat Sompagdee
City
Bangkok Noi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Seroprevalence of Bordetella Pertussis Antibodies and Anti-pertussis Antibody Response After a Single Dose of Tdap in Pregnant Thai Women
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