Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HZ/su VACCINE · 1 trial · 1 indication
Describe local reactions (redness, swelling, and pain at the injection site) within 7 days following each study intervention administration recorded by participants in an electronic diary (e-diary).
Describe systemic events (fatigue, headache, vomiting, nausea, diarrhea, muscle pain, and joint pain) within 7 days following each study intervention administration recorded by participants in an electronic diary (e-diary).
Describe AEs occurring through 1 month after each study intervention administration
Describe SAEs occurring through 4 months after the first study intervention administration.
| Arm | Type | Description |
|---|---|---|
| Coadministration Group | OTHER | * Visit 1 (Day 1): RSVpreF + HZ/su dose 1 * Visit 3 (Month 2): HZ/su dose 2 |
| Sequential Administration Group | OTHER | * Visit 1 (Day 1): HZ/su dose 1 * Visit 2 (Month 1): RSVpreF * Visit 3 (Month 2): HZ/su dose 2 |
| Name | Type | Description |
|---|---|---|
| RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE | BIOLOGICAL | Intramuscular injection |
| HZ/su VACCINE | BIOLOGICAL | intramuscular injection |
Inclusion Criteria • Male and female participants 50 years of age and older who are healthy or with stable chronic medical conditions Exclusion Criteria * Current clinically suspected or polymerase chain reaction (PCR)-confirmed ongoing episode of HZ and/or history of clinically suspected or PCR-...
HZ/su VACCINE is an investigational vaccine being studied for use in adults to prevent Respiratory Syncytial Virus (RSV). It is a monoclonal antibody modality and is currently in Phase 3 clinical development. The vaccine is being evaluated for safety and immunogenicity when coadministered with a herpes zoster vaccine.
HZ/su VACCINE is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in adult populations.
HZ/su VACCINE is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. A Phase 3 clinical trial has been completed to evaluate its safety and immunogenicity when coadministered with a herpes zoster vaccine in adults.
HZ/su VACCINE has one completed Phase 3 clinical trial registered under NCT06890416. The study evaluated the safety and immunogenicity of RSVpreF coadministered with a herpes zoster vaccine in adults aged 50 years and older. The trial enrolled 526 participants in the United States and Puerto Rico.
HZ/su VACCINE is associated with the investigational vaccine candidate RSVpreF, which is being studied for the prevention of Respiratory Syncytial Virus (RSV). The Phase 3 clinical trial NCT06890416 evaluates RSVpreF coadministered with a herpes zoster vaccine, and HZ/su VACCINE refers to this vaccine candidate.