drugset / Trial / NCT01445743
Immunogenicity and Safety of an Acellular DPT Vaccine During Pregnancy
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Adacel | Vaccine | 0.5 ml | Intramuscular |