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

NCT01446289 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2014-09-08

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Novartis Vaccines

    collaborator INDUSTRY

  • Novartis

    lead INDUSTRY

Principal Investigators

  • Novartis Vaccines · Novartis Vaccines

  • Gilbert Donders, Prof. · Regional Hospital Heilig Hart, Tienen, Belgium

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-04-30
Completion
2013-10-31

Countries

  • Belgium
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01446289 on ClinicalTrials.gov