Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Adenovirus serotype 26-based respiratory syncytial virus. preF · 1 trial · 2 indications
Number of participants with first occurrence of RT-PCR-confirmed RSV mediated LRTD according to protocol defined criteria were reported. A participant was considered to have RT-PCR-confirmed RSV-mediated LRTD if the following criteria were met: new onset or worsening from baseline of 3 or more of the symptoms as captured on the respiratory infection intensity and impact questionnaire (RiiQ, version 2) at the same assessment time point: cough, short of breath, coughing up phlegm (sputum), and wheezing and confirmation of RSV by RT-PCR in one or more of the nasal swabs, or in the sputum sample. RiiQ symptom scale was a 13-item questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The total LRTD symptom score was calculated as the mean of the 4 lower respiratory scores (cough, short of breath, coughing up phlegm \[sputum\] and wheezing).
| Arm | Type | Description |
|---|---|---|
| Group 1: Respiratory Syncytial Virus (RSV) vaccine | EXPERIMENTAL | All participants in the active group will receive a single dose intramuscular (IM) injection of study vaccine on Day 1. |
| Group 2: Placebo | PLACEBO_COMPARATOR | All participants in the placebo group will receive a single IM injection of matching placebo on Day 1. |
| Name | Type | Description |
|---|---|---|
| Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF | BIOLOGICAL | Participants will receive a single IM injection of an RSV vaccine. |
| Placebo | BIOLOGICAL | Participants will receive a single IM injection of matching placebo. |
Inclusion Criteria: * Must be able to work with smartphones/tablets/computers * From the time of vaccination through 3 months after vaccination, participant agrees not to donate blood * Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator d...