CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 55 enrolled
Drug / intervention
Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum phosphatebiological
Likely dose
Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum phosphate 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01711645
NCT01711645Phase 4Completed
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Phase IV, Open Label Trial to Evaluate Immunogenicity of Tdap Vaccine in Post-Partum Women to Optimize Vaccination Schedule for Women Who May Have a Subsequent Child

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Oct 22, 2012·Updated May 5, 2017

In Brief

A Phase 4 clinical trial evaluating Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum phosphate for Diphtheria and 2 related conditions. Completed, enrolled 55 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiphtheria, Pertussis, Tetanus
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 22, 2012
Enrollment StartOct 26, 2012
Primary CompletionAug 28, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 13.7 years ago

Interventions

Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum phosphatebiological

55 postpartum subjects receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed).