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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 developed by Novartis AG for the prevention of invasive Group B Streptococcus (GBS) disease. It is a glycoconjugate antigen vaccine designed to be given to healthy women 18 to 40 years of age. It remains in Phase 1 clinical development.
The GBS glycoconjugate vaccine is being studied to prevent invasive Group B Streptococcus (GBS) disease. The Phase 1 trial enrolled healthy women aged 18 to 40 years, a population relevant to preventing GBS disease. It is investigational and has not been approved for use.
Novartis AG, which trades under the ticker NVS, is the developer of the GBS glycoconjugate vaccine. The company sponsored the Phase 1 clinical trial of the vaccine in Switzerland. Novartis AG is the sole developer named for this asset.
The GBS glycoconjugate vaccine is in Phase 1 clinical development. Its only recorded trial, NCT00645346, was a Phase 1 study that has been completed. The vaccine is investigational and has not been approved by the FDA or any other regulator.
The GBS glycoconjugate vaccine has been studied in one Phase 1 trial, NCT00645346, titled a Phase I, Randomized, Single-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of a Dose Range of Glycoconjugate Antigen Vaccine of Group B Streptococcus in Healthy Women 18-40 Years of Age. It enrolled 130 participants in Switzerland and is completed.
Yes. The Phase 1 trial NCT00645346 was a randomized, single-blind, placebo-controlled study. It enrolled 130 healthy women aged 18 to 40 years at a single center in Switzerland and evaluated the safety and immunogenicity of a dose range of the glycoconjugate antigen vaccine. The trial is completed.