CompletedPhase 1

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

Switzerland65 participantsStarted 2007-12

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

See this in plain English?

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, clinical judgment of the investigator 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. Safety will be assessed by measuring the incidence of local and systemic reactogenicity, adverse events and serious adverse events.

Timeframe: 1 month

Trial details

NCT IDNCT00657683

SponsorNovartis Vaccines

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-04

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