drugset / Trial / NCT01412801

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

NCT01412801 ↗

Phase 2 Completed 270 enrolled Novartis Vaccines
Non-randomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2011-09
Primary completion
2012-10
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Group B streptococcus vaccine Vaccine 5 ug Intramuscular