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GBS Vaccine · 1 trial · 2 indications
To evaluate serotype-specific Ia GBS serum IgG antibody levels (anti-Ia) in healthy non-pregnant women when administered with the liquid GBS trivalent vaccine formulation or the lyophilized GBS trivalent vaccine formulation. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).
To evaluate serotype-specific III GBS serum IgG antibody levels (anti-III) in healthy non-pregnant women when administered with the liquid GBS trivalent vaccine formulation or the lyophilized GBS trivalent vaccine formulation. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).
To evaluate serotype-specific Ib GBS serum IgG antibody levels (anti-Ib) in healthy non-pregnant women when administered with the liquid GBS trivalent vaccine formulation or the lyophilized GBS trivalent vaccine formulation. Geometric mean concentrations (GMCs) were measured and expressed in micrograms per milliliter (μg/mL). As the singleton ELISA was no longer in use at the time of serotype Ib testing, results were obtained using multiplex immunoassay.
| Arm | Type | Description |
|---|---|---|
| Liquid GBS trivalent vaccine | EXPERIMENTAL | Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine |
| Lyophilized GBS trivalent vaccine | ACTIVE_COMPARATOR | Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine |
| Name | Type | Description |
|---|---|---|
| GBS Vaccine | BIOLOGICAL | Liquid formulation of a vaccine containing polysaccharide capsules from serotypes Ia, Ib, and III of the Group B Streptococcus |
Inclusion Criteria: 1. Healthy females 18-40 years of age, inclusive. 2. Individuals who have given written consent after the nature of the study has been explained according to local regulatory requirements. 3. Individuals in good health as determined by the outcome of medical history, physical ex...
The GBS vaccine is an investigational vaccine developed by GSK plc for streptococcal infections, specifically Group B Streptococcus. It is a trivalent vaccine designed to prevent infections caused by this bacterium. It is currently in Phase 2 clinical development and has not been approved by any regulatory agency.
The GBS vaccine is being developed for the prevention of streptococcal infections, specifically those caused by Group B Streptococcus. It is intended for use in adult women, as the completed Phase 2 trial enrolled healthy female volunteers aged 18 years and older.
The GBS vaccine is being developed by GSK plc, which trades under the ticker symbol GSK. GSK is the sponsor of the clinical trial evaluating the vaccine.
The GBS vaccine is in Phase 2 clinical development. One Phase 2 trial has been completed, and no active trials are currently listed. The vaccine is investigational and has not been approved for any indication.
The GBS vaccine has been evaluated in one completed Phase 2 clinical trial, NCT02270944. This randomized, double-blind, active-controlled study enrolled 1,053 healthy female volunteers aged 18 years and older across the United States, Belgium, and Czechia to assess the safety and immunogenicity of liquid and lyophilized formulations of the Group B Streptococcus trivalent vaccine.