Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02209623
Study type Observational
Source Vanderbilt University Medical Center
Contact
Status Completed
Phase N/A
Start date May 2014
Completion date December 18, 2017

See also
  Status Clinical Trial Phase
Not yet recruiting NCT04056728 - A Phase IV Study to Assess the Safety of EupentaTM Inj Phase 4
Completed NCT02453048 - Study of BPZE1 (High Dose) Nasal Live Attenuated B. Pertussis Vaccine Phase 1
Completed NCT01917357 - A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject Phase 3
Completed NCT02526394 - Pertussis and Meningitis C Concomitant Vaccination in Adolescents Phase 4
Completed NCT01689324 - Study of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (ADACEL®) as a Booster in Adolescents Phase 1/Phase 2
Completed NCT01214889 - Study of PENTAXIM™ Vaccine Versus TETRAXIM™ Vaccine Given With ACTHIB™ Vaccine in South Korean Infants. Phase 3
Completed NCT00804284 - Database Surveillance Safety Study of PENTACEL® Vaccine N/A
Completed NCT00514709 - Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants Phase 3
Completed NCT00534833 - Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™ Phase 3
Completed NCT00524732 - Assessment of the Reactogenicity of ADACEL® (TdcP Vaccine) in Children and Adolescents 7 to 19 Years of Age N/A
Completed NCT00772369 - Retrospective Survey of Safety of Fourth Dose Pentacel® in Children Phase 4
Completed NCT01457495 - Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly Phase 2
Completed NCT01267058 - Booster Study of Combined Diphtheria-tetanus-acellular Pertussis Vaccine in Healthy Adults Phase 3
Completed NCT00004800 - Phase III Randomized, Double-Blind, Placebo-Controlled Study of Acellular and Whole-Cell Pertussis Vaccines Phase 3
Completed NCT02858440 - A Study to Assess the Immunogenicity and Safety of GSK Biologicals' Infanrix-IPV/Hib Vaccine Administered as a Three-dose Vaccination Course at 3, 4.5 and 6 Months of Age and a Booster Dose at 18 Months of Age in Healthy Infants in Russia Phase 3
Recruiting NCT04023929 - Sources of COmplement in Meningococcal and Pertussis Serum Bactericidal Antibody Assays
Completed NCT02946190 - The PertADO Geneva Trial Phase 2
Completed NCT03541499 - Safety and Immunogenicity of Intranasal BPZE1 Vaccination in Healthy Adults Phase 2
Completed NCT02587520 - Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed in Healthy Subjects Phase 1/Phase 2
Completed NCT04589312 - Maternal Pertussis Wholecell Responses Phase 2