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GBS glycoconjugate vaccine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Subjects will receive either 5, 10 or 20 mcg of the vaccine |
| 2 | PLACEBO_COMPARATOR | Subjects will receive placebo control |
| Name | Type | Description |
|---|---|---|
| GBS glycoconjugate vaccine | BIOLOGICAL | Study subjects will receive either GBS conjugate vaccine or placebo. Total study size is 65. Study subjects will be followed for a total of 12 months after their last vaccination. |
| Placebo | BIOLOGICAL | Subjects will receive one dose of placebo |
Inclusion Criteria: * healthy females 18 through 40 years of age; * have provided written informed consent after the nature of the study has been explained; * are available for all visits scheduled for the study (i.e. are not planning to leave the area before the end of the study period); * are in ...
The GBS glycoconjugate vaccine is an investigational vaccine being developed for the prevention of invasive Group B Streptococcus (GBS) disease. It is designed to be administered to healthy women aged 18 to 40 years, as evaluated in a Phase 1 clinical trial.
The GBS glycoconjugate vaccine is being developed by Novartis AG, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The vaccine is currently in clinical development for the prevention of invasive Group B Streptococcus disease.
The GBS glycoconjugate vaccine is in Phase 1 clinical development. It is an investigational vaccine, meaning it has not been approved by regulatory authorities and is still undergoing clinical evaluation for safety and immunogenicity.
The GBS glycoconjugate vaccine has been evaluated in one completed Phase 1 clinical trial, identified as NCT00645346. This trial was a randomized, single-blind, placebo-controlled study conducted in Switzerland, enrolling 130 healthy women aged 18 to 40 years to assess the safety and immunogenicity of a dose range of the vaccine.
The GBS glycoconjugate vaccine is classified as a monoclonal antibody modality in the development pipeline. However, as a vaccine, it is designed to elicit an immune response against Group B Streptococcus, and the trial data provided does not specify the exact mechanism of action.