CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 43 enrolled
Drug / intervention
(ADACEL®): Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussisbiological
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/NCT01689324
NCT01689324Phase 2Completed
CompareCT.gov

Immunogenicity and Safety of the Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (SP306) as a Booster in Japanese Adolescents

Sanofi Pasteur, a Sanofi Company·interventional·Posted Sep 21, 2012·Updated Feb 21, 2014

In Brief

A Phase 2 clinical trial evaluating (ADACEL®): Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis for Pertussis and 2 related conditions. Completed, enrolled 43 participants across 3 sites.

Detailed Summary

This study is designed to assess the immunogenicity and safety of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (ADACEL®, Tdap vaccine) as a booster dose in adolescents in Japan. Primary Objective: * To assess the immunogenicity of Tdap (SP306) when administered as a single dose in Japanese adolescents Secondary Objective: * To assess the safety of Tdap vaccine when administered as a single dose in Japanese adolescents.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPertussis, Tetanus, Diphtheria
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 21, 2012
Enrollment StartSep 1, 2012
Primary CompletionNov 1, 2012
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 13.8 years ago

Interventions

(ADACEL®): Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussisbiological

0.5 mL, Intramuscular