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TDAP Safety in Pregnant Women

NCT02209623 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 375

Last updated 2017-12-20

No results posted yet for this study

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.

Conditions

  • Pertussis

Interventions

BIOLOGICAL

TDAP

Sponsors & Collaborators

Principal Investigators

  • Kathryn M Edwards, MD · Vanderbilt Medical Center

  • Geeta K Swamy, MD · Duke Medical Center

  • Karen R Broder, MD · Centers for Disease Control and Prevention

  • Kimberly B Fortner, MD · Vanderbilt University

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-05-31
Completion
2017-12-18

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT02209623 on ClinicalTrials.gov