A Study to Assess the Persistence of a GBS Antibody in Women Previously Immunized With a GBS Vaccine
Phase 1
Completed
- Conditions
- Group B Streptococcus (GBS) Disease
- Interventions
- Biological: Group B streptococcus (GBS) vaccine
- Registration Number
- NCT01052935
- Lead Sponsor
- Novartis
- Brief Summary
This study looks at the body's immune responses to a GBS vaccine 2 years after the orginal vaccine(s) were given in the V98P1 study. Blood will be drawn and evaluated for GBS antibody levels.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 50
Inclusion Criteria
- Individuals who have given written consent.
- Individuals who participated in V98P1 and received the complete schedule of vaccinations.
Exclusion Criteria
- Individuals who have not given written consent.
- Subjects who did not receive the complete schedule of vaccination in V98P1.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 Group B streptococcus (GBS) vaccine This is a phlebotomy study.
- Primary Outcome Measures
Name Time Method Antibody (Ab) response data at 24-months after the last injection given in study V98P1 GMCs, GMRs and associated 95% confidence intervals will also be determined 24- months post last injection from V98P1
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Institute for Pharmacokinetic and Analytical Studies
🇨🇭Via Mastri, 36, CH - 6853 Ligornetto, Switzerland