Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT 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-...