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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Streptococcal Infections
• Gram-Positive Bacterial Infections
• Bacterial Infections

Interventions

Type	Name	Description
BIOLOGICAL	Group B streptococcus vaccine	Subjects receive one dose of 5 μg of each of the 3 glycoconjugates present in the Group B streptococcus vaccine.

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-10-01
• Completion: 2012-12-01
• First posted: 2011-08-09
• Last updated: 2014-09-12
• Results posted: 2014-09-12

Locations

2 sites across 2 countries: Malawi, South Africa