NCT01446289

Immune Response Induced by a Vaccine Against Group B Streptococcus and Safety in Pregnant Women and Their Offsprings

A Phase II Randomized, Observer-Blind, Multi-Center, Controlled Study of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Novartis · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The study investigated the immune response induced by the Group B streptococcus vaccine in healthy pregnant women. In addition, the study investigated the amount of vaccine induced antibodies which were transferred to the newborn.

Conditions

• Streptococcal Infection
• Gram-positive Bacterial Infection
• Bacterial Infection

Interventions

Type	Name	Description
BIOLOGICAL	Group B Streptococcus Trivalent Vaccine	Pregnant women who received one injection of Group B Streptococcus Trivalent Vaccine administered intramuscularly.
BIOLOGICAL	Placebo	Pregnant women who received one injection of saline solution administered intramuscularly.

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-04-01
• Completion: 2013-10-01
• First posted: 2011-10-05
• Last updated: 2014-09-08
• Results posted: 2014-09-08

Locations

5 sites across 2 countries: Belgium, Canada