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Safety and Immunogenicity of a Group B Streptococcus Vaccine in Healthy Women | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Safety and Immunogenicity of a Group B Streptococcus Vaccine in Healthy Women

A Phase Ib Randomized, Observer-Blind, Controlled, Single Center, Dose-Ranging Study of a Group B Streptococcus Vaccine in Healthy Women 18-40 Years of Age

NCT01150123•Novartis Vaccines

View on ClinicalTrials.gov

Summary

This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine.

Eligibility

Age

18 - 40 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy females 18-40 years of age inclusive.

Exclusion Criteria

•Individuals who are pregnant or nursing.
•Individuals who have had a previous immunization with a vaccine containing streptococcus antigens or any vaccine within 30 days of enrollment through 30 days of study completion.
•Individuals with a history of severe allergic reactions after previous vaccination
•Individuals with designated blood tests that are not within normal range

Locations (1)

Ghent, Belgium

Key Dates

Start Date

May 1, 2010

Primary Completion Date

November 1, 2011

Completion Date

October 1, 2012

Last Updated

May 15, 2017

Enrollment

678

ACTUAL participants

Conditions

Group B Streptococcus

Interventions

Group B streptococcus (GBS) vaccine- low dose

BIOLOGICAL

Group B streptococcus (GBS) vaccine- High dose

BIOLOGICAL

Placebo- Saline

BIOLOGICAL

Preparing for Maternal GBS Vaccine Trials in Africa

NCT06833957

Group B StreptococcusInvasive Bacterial Diseases (IBD)+1 more

View study

TERMINATED

A Follow up Study of Group B Streptococcus (GBS)-NN/NN2 Vaccine in Healthy Volunteers

NCT06280157

Group B Streptococcus Infection

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 15, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Immunogenicity of a Group B Streptococcus Vaccine in Healthy Women

Inclusion Criteria

Exclusion Criteria

Preparing for Maternal GBS Vaccine Trials in Africa

A Follow up Study of Group B Streptococcus (GBS)-NN/NN2 Vaccine in Healthy Volunteers

Rapid Detection of Group B Strep- 35-37 Week Study

Membrane Sweeping in Group B Streptococcus (GBS) Positive Patients

A Phase I, Randomized, Single-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of a Dose Range of Glycoconjugate Antigen Vaccine of Group B Streptococcus in Healthy Women 18- 40 Years of Age