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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT00645346•Novartis Vaccines

View on ClinicalTrials.gov

Summary

The goals of the proposed study are to evaluate the safety, tolerability and immunogenicity of a GBS vaccine. Previous studies suggest that immune responses against GBS can protect humans from infection.

Eligibility

Age

18 - 40 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•healthy females 18 through 40 years of age;
•have provided written informed consent after the nature of the study has been explained;
•are available for all visits scheduled for the study (i.e. are not planning to leave the area before the end of the study period);
•are in good health as determined by: medical history ,physical assessment

Exclusion Criteria

•unwilling or unable to give written informed consent to participate in the study;
•pregnant (serum pregnancy test)
•unwilling to use acceptable birth control from screening and until at least 3 months after the final immunization
•nursing (breastfeeding) mothers

Locations (1)

Institute for Pharmacokinetic and Analytical Studies I.P.A.S.

Ligornetto, Ligornetto, Switzerland

Key Dates

Start Date

February 1, 2008

Primary Completion Date

May 1, 2009

Completion Date

July 1, 2009

Last Updated

December 8, 2011

Enrollment

130

ACTUAL participants

Conditions

Invasive Group B Streptococcus (GBS) Disease

Interventions

GBS glycoconjugate vaccine

BIOLOGICAL

Placebo

BIOLOGICAL