Status:
COMPLETED
Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non Pregnant and Pregnant Women 18-40 Years of Age
Lead Sponsor:
Novartis Vaccines
Conditions:
Streptococcal Infections
Eligibility:
FEMALE
18-40 years
Phase:
PHASE1
PHASE2
Brief Summary
This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine at one dose in healthy non pregnant women and then in three different doses in healthy pregnant women.
Eligibility Criteria
Inclusion
- Group 1 (Non Pregnant Women): Healthy females 18-40 years of age inclusive.
- Group 2 (Healthy Pregnant Women): Healthy pregnant women 18-40 yrs of age (between 28-35 weeks gestation)
Exclusion
- Group 1 (Non Pregnant Women): Pregnant or nursing; History of severe allergy to previous vaccines; Known HIV positive
- Group 2 (Healthy Pregnant Women): History of severe allergy to previous vaccines; Known HIV positive
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT01193920
Start Date
October 1 2010
End Date
December 1 2012
Last Update
August 22 2014
Active Locations (1)
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1
Chris Hani Baragwanath Hospital
Chris Hani Rd, Soweto, Johannesburg, South Africa