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
65
1 dose of GBS conjugate vaccine
1 dose of placebo
Institute for Pharmacokinetic and Analytical Studies, I.P.A.S. S.A.
Ligornetto, Switzerland
To evaluate the safety and tolerability of an intramuscular GBS conjugate vaccine. Safety will be assessed by measuring the incidence of local and systemic reactogenicity, adverse events and serious adverse events.
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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