Status:
COMPLETED
Safety and Immunogenicity of a Group B Streptococcus Vaccine in Healthy Women
Lead Sponsor:
Novartis Vaccines
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Group B Streptococcus
Eligibility:
FEMALE
18-40 years
Phase:
PHASE1
Brief Summary
This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine.
Eligibility Criteria
Inclusion
- Healthy females 18-40 years of age inclusive.
Exclusion
- Individuals who are pregnant or nursing.
- Individuals who have had a previous immunization with a vaccine containing streptococcus antigens or any vaccine within 30 days of enrollment through 30 days of study completion.
- Individuals with a history of severe allergic reactions after previous vaccination
- Individuals with designated blood tests that are not within normal range
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
678 Patients enrolled
Trial Details
Trial ID
NCT01150123
Start Date
May 1 2010
End Date
October 1 2012
Last Update
May 15 2017
Active Locations (1)
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1
Ghent, Belgium