TDAP Safety in Pregnant Women (Tdap)
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|ClinicalTrials.gov Identifier: NCT02209623|
Recruitment Status : Completed
First Posted : August 6, 2014
Last Update Posted : December 20, 2017
The purpose of this observational study is to evaluate the safety of Tetanus Toxoid Reduced Diphtheria, Toxoid, and Acelluar Pertussis Vaccine (Tdap) in pregnant women at ≥ 20 weeks 0 days gestation receiving Tdap as part of standard practice. Prior Tdap/Td/TT history will be verified by medical record review when possible. There will be an emphasis on enrolling women who have received Tdap before the current pregnancy, to the greatest extent possible. Non-pregnant women who are receiving their initial Tdap will also be recruited.
Injection-site (local) and systemic reaction data will be assessed on the vaccination day and during the 7 days following vaccination using either identical web-based or paper diaries, depending on the preference of the study participant.
Pregnant women will be followed until delivery with comprehensive obstetric and neonatal outcomes obtained from review of the electronic medical record.
|Condition or disease||Intervention/treatment|
|Study Type :||Observational|
|Actual Enrollment :||375 participants|
|Official Title:||Clinical Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine (Tdap) Safety in Pregnant Women|
|Actual Study Start Date :||May 2014|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||December 18, 2017|
|Pregnant Women receiving TDAP||
- Rates of injection-site and systemic reactions post Tdap administration. [ Time Frame: 7 days post administration ]Rates of injection-site and systemic reactions after Tdap in pregnant women versus non-pregnant women will be compared.
- Rates of preterm and small for gestational age (SGA) births in women who received Tdap prenatally [ Time Frame: 7 days post delivery ]Rates of preterm and small for gestational age (SGA) births in women who received Tdap prenatally will be evaluated by review of the hospital delivery record following delivery.
- Differences in injection-site and systemic reactions in pregnant women who received Tdap before the current pregnancy versus women who are receiving their first Tdap dose [ Time Frame: 7 days post vaccination ]Differences in injection-site and systemic reactions in pregnant women who received Tdap before the current pregnancy versus women who are receiving their first Tdap dose will be explored.
- Rates of additional obstetrical and infant outcomes in pregnant women receiving Tdap [ Time Frame: 7 days post delivery ]To assess rates of additional obstetrical and infant outcomes in pregnant women receiving Tdap including, but not limited to, maternal or fetal death, placental abruption, postpartum hemorrhage, pregnancy related hypertension, gestational diabetes
- Health outcomes and growth parameters among infants born to women who received Tdap during pregnancy [ Time Frame: 6 months post delivery ]To describe health outcomes and growth parameters through 6 months of life among infants born to women who received Tdap during pregnancy
- Measurement of serum cytokines before and after severe, local and systemic reactions [ Time Frame: 28 days post vaccination ]Levels of cytokines will also be compared across groups (pregnant vs. non-pregnant women)
- Measurement of serum antibody levels to pertussis toxin, filamentous hemagglutinin, pertactin, fimbria and diphtheria and tetanus toxins [ Time Frame: 28 days post vaccination ]Antibody responses pre and post-vaccination will be compared between pregnant and non-pregnant women to each pertussis vaccine antigen
Biospecimen Retention: Samples Without DNA
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): NCT02209623
|United States, North Carolina|
|Duke University Dept of ObGyn, Division of Maternal-Fetal Medicine|
|Durham, North Carolina, United States, 27705|
|United States, Tennessee|
|Vanderbilt Medical Center, Vaccine Research Program|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Kathryn M Edwards, MD||Vanderbilt Medical Center|
|Principal Investigator:||Geeta K Swamy, MD||Duke Medical Center|
|Principal Investigator:||Karen R Broder, MD||Centers for Disease Control and Prevention|
|Principal Investigator:||Kimberly B Fortner, MD||Vanderbilt University|