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Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings

Bacterial Infections Clinical Trial

Official title:
A Phase II Open-Label, Multi-Center Study of a Group B Streptococcus Vaccine in HIV Positive and HIV Negative Pregnant Women

Clinical Trial Summary

The study compared the magnitude of the antibody response and safety of a GBS Trivalent Vaccine in HIV positive and HIV negative pregnant women and their offspring. In addition the study investigated the maternal to fetal transfer of antibodies induced by the investigational vaccine.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01412801
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 2
Start date September 2011
Completion date December 2012
View Details
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