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Monovalent GBS-CRM glycoconjugate vaccine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Monovalent GBS-CRM glycoconjugate vaccine | BIOLOGICAL | 1 dose of GBS conjugate vaccine |
| Placebo | BIOLOGICAL | 1 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 Monovalent GBS-CRM glycoconjugate vaccine is an investigational vaccine developed by Novartis AG for the prevention of invasive Group B Streptococcus (GBS) disease. It is a glycoconjugate vaccine that combines a GBS polysaccharide antigen with a CRM carrier protein. It was studied in healthy women aged 18 to 40 years.
The Monovalent GBS-CRM glycoconjugate vaccine is being developed for the prevention of invasive Group B Streptococcus (GBS) disease. GBS can cause serious infections, and vaccination aims to induce protective immune responses. The clinical program studied the vaccine in healthy adult women, a population relevant to maternal immunization strategies.
Novartis AG, which trades under the ticker NVS, is the developer of the Monovalent GBS-CRM glycoconjugate vaccine. The company sponsored the Phase 1 clinical trial evaluating the vaccine in healthy women aged 18 to 40 years in Switzerland.
The Monovalent GBS-CRM glycoconjugate vaccine is in Phase 1 development. Its only recorded clinical trial, NCT00657683, was a Phase 1 study that has been completed. The vaccine is investigational and has not been approved by the FDA for any indication.
The Monovalent GBS-CRM glycoconjugate vaccine was evaluated in one clinical trial, NCT00657683. This completed Phase 1 study was a randomized, single-blind, placebo-controlled, single-center trial that enrolled 65 healthy women aged 18 to 40 years in Switzerland to assess safety and immunogenicity.