Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Adjuvanted RSVPreF3 vaccine · 1 trial · 1 indication
RSV-A neutralizing titers are given as GMTs and are expressed as Estimated Dilution 60 (ED60). GMT is calculated by taking the anti-log of the mean of the log titer transformations.
RSV-B neutralizing titers are given as group GMTs and are expressed as ED60. GMT is calculated by taking the anti-log of the mean of the log titer transformations.
MGI is defined as the geometric mean of the within participant ratios of two timepoints (ie., ratio of titers observed at Visit 1 over titers observed 30 days post last dose in the RSV OA=ADJ-023 parent study).
MGI is defined as the geometric mean of the within participant ratios of two timepoints (ie., ratio of titers observed at Visit 1 over titers observed 30 days post last dose in the RSV OA=ADJ-023 parent study).
RSV-A neutralizing titers are given as GMTs and are expressed as ED60. GMT is calculated by taking the anti-log of the mean of the log titer transformations.
| Arm | Type | Description |
|---|---|---|
| IC Revaccination Group | EXPERIMENTAL | Lung or kidney transplant recipients undergoing chronic immunosuppressive therapy who received 1 and 2 doses of the adjuvanted RSVPreF3 vaccine (IC\_1 and IC\_2 groups respectively) in the RSV OA=ADJ-023 parent study will receive a revaccination dose of adjuvanted RSVPreF3 vaccine at Visit 1 (Day 1) in the current study. |
| Name | Type | Description |
|---|---|---|
| Adjuvanted RSVPreF3 vaccine | BIOLOGICAL | 1 dose of adjuvanted RSVPreF3 vaccine administered intramuscularly at Visit 1 (Day 1). |
Inclusion Criteria: * Participants of the RSV OA=ADJ-023 study from the Per Protocol Set (Visit 3 for participants in IC\_1 and Visit 4 for participants in IC\_2 group), who received either 1 or 2 doses of the adjuvanted RSVPreF3 vaccine and for whom the immunogenicity data are available. * Partici...
The Adjuvanted RSVPreF3 vaccine is being studied for use in Respiratory Syncytial Virus (RSV) infections. It is an investigational vaccine in Phase 2 clinical development, evaluated in adults 18 years and older who received lung or kidney transplants, to assess immune response persistence and safety following revaccination.
The Adjuvanted RSVPreF3 vaccine is developed by GSK plc, traded on the stock exchange under the ticker GSK. The company is conducting a Phase 2 clinical trial to evaluate the vaccine's immune response and safety in adult transplant recipients.
The Adjuvanted RSVPreF3 vaccine is in Phase 2 clinical development. It is an investigational vaccine, not yet approved, and is being studied in a single active clinical trial that is not currently recruiting participants.
The Adjuvanted RSVPreF3 vaccine is being evaluated in clinical trial NCT07092865, a Phase 2 study assessing persistence of immune response and safety following revaccination in adults 18 years and older who received lung or kidney transplant. The trial is active but not recruiting, with 168 participants enrolled.
The Adjuvanted RSVPreF3 vaccine is designed to target the respiratory syncytial virus (RSV) by eliciting an immune response against the RSV fusion protein (F protein) in its prefusion conformation. The vaccine includes an adjuvant to enhance the immune response, though specific details of the mechanism are not fully disclosed.
The Adjuvanted RSVPreF3 vaccine is a specific investigational vaccine developed by GSK. It is not the same as other RSV vaccines, as it is formulated with an adjuvant and targets the prefusion F protein. Its unique composition and clinical evaluation in transplant recipients distinguish it from other RSV vaccine candidates.