CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 40 enrolled
Drug / intervention
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap +1 morebiological
Likely dose
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap 0.5 mLfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01933776
NCT01933776Phase 1Completed
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Clinical Safety Study of the Tdap Combined Vaccine (ADACEL™) as a Booster Dose in Healthy Adults and Children in China

Sanofi Pasteur, a Sanofi Company·interventional·Posted Sep 2, 2013·Updated Mar 7, 2016

In Brief

A Phase 1 clinical trial evaluating Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap for Diphtheria and 2 related conditions. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The aim of the study is to assess the safety profile of ADACEL vaccine in a small number of participants in China. Primary objective: * To describe the safety in terms of occurrence of serious adverse reactions and grade 3 adverse reactions after administration of Sanofi Pasteur's Tdap vaccine (ADACEL) given as a single dose in 20 adults and 20 children. Secondary objective: * To describe the full reactogenicity profile after administration of sanofi pasteur's Tdap vaccine (ADACEL) given as a single dose in 20 adults and 20 children.

Study Details

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

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 2, 2013
Enrollment StartAug 1, 2013
Primary CompletionNov 1, 2013
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 12.8 years ago

Interventions

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdapbiological

0.5 mL, Intramuscular (IM)

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdapbiological

0.5 mL, Intramuscular (IM)