CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 30 enrolled
Drug / intervention
Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)biological
Likely dose
Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis) 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/NCT01040052
NCT01040052Phase 3Completed

A Bridging Study to Assess the Safety of the Vaccine Adacel® in a Clinical Trial

Sanofi Pasteur, a Sanofi Company·interventional·Posted Dec 25, 2009·Updated May 16, 2016

In Brief

A Phase 3 clinical trial evaluating Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis) for Diphtheria and 2 related conditions. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The objective of this study is to describe the safety of Adacel® vaccination in adults subjects in Vietnam. This study is conducted in accordance with Vietnamese regulation in support to Adacel® registration. Primary objective: To monitor the adverse effects of the vaccine ADACEL® from day 0 to day 30 after immunization.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesVietnam
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 25, 2009
Enrollment StartDec 1, 2009
Primary CompletionFeb 1, 2010
Study CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 16.5 years ago

Interventions

Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)biological

0.5 mL, Intramuscular