Invasive Group B Streptococcus (GBS) Disease
Conditions
Keywords
GBS
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 infection.
Interventions
BIOLOGICALGBS glycoconjugate vaccine
Study subjects will receive either GBS conjugate vaccine or placebo. Total study size is 65. Study subjects will be followed for a total of 12 months after their last vaccination.
BIOLOGICALPlacebo
Subjects will receive one dose of placebo
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of an intramuscular GBS conjugate vaccine | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| To study the magnitude and durability of GBS-specific antibody responses over 12 months. | 12 months |
Countries
Switzerland
Outcome results
None listed