Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02270944 | Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyophilized Formulation of Group B Streptococcus Trivalent Vaccine | PHASE2 | COMPLETED | 1,053 | — | — | Nov 20, 2014 | Sep 22, 2015 | Dec 5, 2019 | 9 | United States, Belgium +1 |
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...