drugset / Trial / NCT01445743

Immunogenicity and Safety of an Acellular DPT Vaccine During Pregnancy

NCT01445743

Phase 2 Completed 204 enrolled Hospital Universitario Dr. Jose E. Gonzalez
RandomizedParallel-groupDouble-blindPrevention

Summary

That is a double-blind randomized trial with parallel control to demonstrate the safety and immunogenicity of acellular Tdap vaccine in pregnant mexican women. The general objective is to determine the safety and immunogenicity of acellular Tdap vaccine. The experimental group will receive acellular Tdap vaccine and the control group will receive a placebo consisting of saline 0.9% Sodium Chloride solution, randomly assigned, which will be administered by the same route (intramuscular) and at the same dose (0.5 ml) that the vaccine.

Timeline

Start
2011-09
Primary completion
2012-08
Completion
2014-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Adacel Vaccine 0.5 ml Intramuscular

Indications