drugset / Trial / NCT02587520

Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed in Healthy Subjects

NCT02587520

Phase 1/2 Completed 1363 enrolled Sanofi Pasteur, a Sanofi Company
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2015-10-22
Primary completion
2017-02-21
Completion
2017-02-21

Drugs

EvaluationDrugModalityDoseRoute
Comparator Adacel Vaccine 0.5 ml Intramuscular
Comparator Boostrix Vaccine 0.5 ml Intramuscular
Subject tetanus toxoid Vaccine 0.5 ml Intramuscular