Clinical Trial: TDAP Safety in Pregnant Women

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Clinical Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine (Tdap) Safety in Pregnant Women

Brief Summary:

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.

Detailed Summary: This is an observational study of both pregnant and non-pregnant women. Vaccine administration in the pregnant population will be part of routine care. Vaccine administration in the non-pregnant women will be provided as either routine care or as part of the study. Pregnant women at ≥ 20 weeks 0 days gestation who have not received Tdap during the current pregnancy will be enrolled, with prioritized emphasis on enrolling pregnant women who have received Tdap prior to the current pregnancy in order to attempt to address the question of closely-spaced repeated dosing. Detailed data will be collected from study participants on prior Tdap/Td/TT receipt. The non-pregnant women will consist of both Tdap naïve and those who have received Tdap previously. With Day 0 serving as the day of vaccination, participants will be followed through Day 7 for symptoms of reactogenicity. For Primary Objective 1, symptoms of reactogenicity occurring from Day 0 -7 will be compared between pregnant and non-pregnant women. For Objective 2, pregnant women will be followed through delivery for collection of pregnancy outcome data. Pregnancy outcomes among study participants will be compared with historical outcomes from summary data from both Vanderbilt and Duke. In addition, follow-up will be conducted for infants born to mothers who received Tdap during pregnancy to assess health outcomes and growth parameters through 6 months of life.
Sponsor: Vanderbilt University

Current Primary Outcome:

• 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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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

Original Secondary Outcome:

• 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 vaccination ]
  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: 7 days post vaccination ]
  To describe health outcomes and growth parameters through 6 months of life among infants born to women who received Tdap during pregnancy

Information By: Vanderbilt University Medical Center

Dates:
Date Received: July 28, 2014
Date Started: May 2014
Date Completion: December 31, 2017
Last Updated: February 16, 2017
Last Verified: February 2017