Testing of the liquid and lyophilized formulation of a vaccine on non-pregnant women that are 18 to 40 years old to asess its safety and the protection it gives from blood poisoning caused by a bacterium

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Extrait

Immunogenicity Objectives To demonstrate the equivalence of the liquid GBS trivalent vaccine formulation to the lyophilized GBS trivalent vaccine formulation for serotypes Ia, Ib, and III, when administered to healthy non-pregnant women, as measured by Geometric Mean Concentrations (GMCs) at 30 days (Day 31) after a single vaccination. Safety Objectives To evaluate the safety and tolerability of a single dose of liquid and lyophilized GBS trivalent vaccine formulations when administered to healthy non-pregnant women aged 18-40 years, inclusive.

Critère d'inclusion

Healthy person immune response to Group B Streptococcus polysaccharide capsule antigens

Liens

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Kusajili – Centralise les essais cliniques mondiaux

Testing of the liquid and lyophilized formulation of a vaccine on non-pregnant women that are 18 to 40 years old to asess its safety and the protection it gives from blood poisoning caused by a bacte...