Clinical Trials Logo

Clinical Trial Summary

Monitoring immune response and longevity in serum and milk after Tdap administration to postpartum women. The clinical trial will involve women (aged 18 - 45 years) who have just delivered full-term infants (greater than or equal to 37 completed weeks of gestation) at Vanderbilt University Medical Center. The enrollment period will be fifteen months. The duration is over two years of observation.


Clinical Trial Description

This is a single site, prospective study involving only one intervention, receipt of a single 0.5 mL intramuscular (IM) dose of Adacel (Tetanus toxoid, reduced diphtheria toxoid and acellular Pertussis) vaccine, among 55 healthy post partum women. The purpose of the study is to examine the immune responses and subsequent decline in serum and breast milk antibody titers over two years of observation. The clinical trial will involve women (aged 18 - 45 years) who have just delivered full-term infants (greater than or equal to 37 completed weeks of gestation) at Vanderbilt University Medical Center. One particular population at Vanderbilt to target will be the "centering prenatal care group" that has breastfeeding rates as high as 75 percent at hospital discharge and maintained at 20 percent at 6 months. The enrollment period will be fifteen months. The subjects, staff assessing subjects, and laboratory personnel will be aware of receipt of the vaccine. Since only a single vaccine product is being utilized, there is no blinding needed of the subjects or staff. ;


Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT01711645
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Active, not recruiting
Phase Phase 4
Start date October 2012
Completion date October 2015

See also
  Status Clinical Trial Phase
Completed NCT00352963 - Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age). Phase 3
Not yet recruiting NCT04056728 - A Phase IV Study to Assess the Safety of EupentaTM Inj Phase 4
Completed NCT00753649 - Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants Phase 4
Completed NCT02538211 - The Role of the Intestinal Microbiome in Enteric and Systemic Vaccine Immune Responses N/A
Completed NCT01917357 - A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject Phase 3
Completed NCT01689324 - Study of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (ADACEL®) as a Booster in Adolescents Phase 1/Phase 2
Completed NCT01444781 - Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants Phase 3
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 NCT00534833 - Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™ Phase 3
Completed NCT00514709 - Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants Phase 3
Completed NCT00379977 - Study to Assess the Safety & Reactogenicity of GSK Biologicals' DTPa/Hib Vaccine When Given at 3, 4 and 5 Months of Age Phase 3
Completed NCT00772369 - Retrospective Survey of Safety of Fourth Dose Pentacel® in Children Phase 4
Completed NCT00879827 - Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants Phase 3
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 NCT02853929 - Evaluation of Immunogenicity and Safety of a Booster Dose of Infanrix Hexa™ in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery Phase 4
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 NCT06049940 - Safety and Immunogenicity of Tetanus Vaccine, Adsorbed in 18~44 Years Old Population Phase 3
Completed NCT00385255 - Immunogenicity, Safety of GSKs Tdap Vaccine Boostrix When Coadministered With GSKs Influenza Vaccine Fluarix in Adults Phase 3