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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
130
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.
Subjects will receive one dose of placebo
Institute for Pharmacokinetic and Analytical Studies I.P.A.S.
Ligornetto, Ligornetto, Switzerland
To evaluate the safety and tolerability of an intramuscular GBS conjugate vaccine
Time frame: 1 month
To study the magnitude and durability of GBS-specific antibody responses over 12 months.
Time frame: 12 months
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