Group B Streptococcus (GBS) Disease
Conditions
Keywords
Group B streptococcus, GBS, Vaccine
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.
Interventions
BIOLOGICALGroup B streptococcus (GBS) vaccine
No vaccine will be administered in this study. Only one study visit is required. Subjects will return to the clinic for a single visit at 24 months (± 3 months) after the last injection administered in the V98P1 study.
Sponsors
Novartis Vaccines
Novartis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 42 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Switzerland
Outcome results
None listed