CompletedPhase 1

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

Switzerland130 participantsStarted 2008-02

Plain-language 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.

Who can participate

Age range18 Years – 40 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

To evaluate the safety and tolerability of an intramuscular GBS conjugate vaccine

Timeframe: 1 month

Trial details

NCT IDNCT00645346

SponsorNovartis Vaccines

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-05

View on ClinicalTrials.gov More Invasive Group B Streptococcus (GBS) Disease trials