CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1,363 enrolled
Drug / intervention
Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1 +5 morebiological
Likely dose
Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2 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/NCT02587520
NCT02587520Phase 2Completed
CompareCT.gov

Safety and Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (SP0173) in Healthy Adolescents, Adults, and Older Adults

Sanofi Pasteur, a Sanofi Company·interventional·Posted Oct 27, 2015·Updated Mar 23, 2022

In Brief

A Phase 2 clinical trial evaluating Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1, Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2, and 4 other interventions for Tetanus and 3 related conditions. Completed, enrolled 1,363 participants across 20 sites.

Detailed Summary

This was a dose and formulation ranging study to assess the safety and immunogenicity of SP0173 in healthy adolescents, adults, and older adults in the United States (US). Primary Objective * To describe the safety profile of each SP0173 investigational formulation. Observational Objective: * To describe the immunogenicity of each SP0173 investigational formulation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTetanus, Diphtheria, Pertussis, Whooping Cough
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 27, 2015
Enrollment StartOct 22, 2015
Primary CompletionFeb 21, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.7 years ago

Interventions

Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1biological

0.5 milliliter (mL), Intramuscular

Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2biological

0.5 mL, Intramuscular

Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3biological

0.5 mL, Intramuscular

Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4biological

0.5 mL, Intramuscular

Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbedbiological

0.5 mL, Intramuscular

Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccinebiological

0.5 mL, Intramuscular