Status:
COMPLETED
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
Lead Sponsor:
Novartis Vaccines
Conditions:
Invasive Group B Streptococcus (GBS) Disease
Eligibility:
FEMALE
18-40 years
Phase:
PHASE1
Brief 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 infecti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00645346
Start Date
February 1 2008
End Date
July 1 2009
Last Update
December 8 2011
Active Locations (1)
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1
Institute for Pharmacokinetic and Analytical Studies I.P.A.S.
Ligornetto, Ligornetto, Switzerland, 6853