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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...
GBS Vaccine is an investigational vaccine being developed for the prevention of infections caused by Group B Streptococcus. It is being studied in healthy female volunteers aged 18 years and older. The vaccine is currently in Phase 2 clinical development and is not yet approved for use.
GBS Vaccine is being developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the safety and immunogenicity of the vaccine in healthy adult female participants.
GBS Vaccine is currently in Phase 2 clinical development. It has completed one Phase 2 clinical trial with a total enrollment of 1053 participants. The vaccine is investigational and has not been approved by regulatory authorities for commercial use.
GBS Vaccine has been studied in a completed Phase 2 clinical trial with the identifier NCT02270944. This trial evaluated the safety and immunogenicity of the liquid and lyophilized formulations of the Group B Streptococcus trivalent vaccine in healthy female volunteers aged 18 years and older.
Yes, GBS Vaccine is also known as the Group B Streptococcus Trivalent Vaccine. The clinical trial NCT02270944 evaluated both the liquid and lyophilized formulations of this trivalent vaccine, which is designed to protect against infections caused by Group B Streptococcus.