Respiratory Syncytial Virus Infections
Conditions
Brief summary
RSV_PreS4 group: - RSV-A and RSV-B neutralizing titers before revaccination (pre-Season 4, Day 1) and 30 days post-revaccination (Day 31) - Fold increase in RSV-A and RSV-B neutralizing titers from Day 1 to Day 31 - RSV-A and RSV-B neutralizing titers ≥cut-off at Day 1 and Day 31 - Participant having a ≥4-fold increase in neutralizing titers (Day 31 over Day 1), "RSV_PreS5 group: - RSV-A and RSV-B neutralizing titers before revaccination (pre-Season 4 and pre-Season 5), 30 days post-revaccination and at pre-Season 6 - Fold increase in RSV-A and RSV-B neutralizing titers from pre-Season 5 to Day 31 and pre-Season 6 - RSV-A and RSV-B neutralizing titers ≥cut-off at pre-Season 4, pre-Season 5, Day 31 and pre-Season 6 - Participant having a ≥4-fold increase in neutralizing titers (Day 31 over pre-Season 5)"
Detailed description
"RSV_1dose group: - RSV-A and RSV-B Neutralizing titers at pre-Season 4, pre-Season 5 and pre-Season 6 - RSV-A and RSV-B Neutralizing titers ≥cut-off at pre-Season 4, pre-Season 5 and pre-Season 6 ", "All participants: - Occurrence of unsolicited AEs with an onset during the 30-day follow-up period after vaccination (i.e., the day of vaccination and 29 subsequent days) - Occurrence of all SAEs/pIMDs from the day of vaccination up to 6 months after vaccination - Occurrence of SAEs/pIMDs related to study vaccination from Day 1 up to study end - Occurrence of fatal SAEs from Day 1 up to study end"
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RSV_PreS4 group: - RSV-A and RSV-B neutralizing titers before revaccination (pre-Season 4, Day 1) and 30 days post-revaccination (Day 31) - Fold increase in RSV-A and RSV-B neutralizing titers from Day 1 to Day 31 - RSV-A and RSV-B neutralizing titers ≥cut-off at Day 1 and Day 31 - Participant having a ≥4-fold increase in neutralizing titers (Day 31 over Day 1), "RSV_PreS5 group: - RSV-A and RSV-B neutralizing titers before revaccination (pre-Season 4 and pre-Season 5), 30 days post-revaccination and at pre-Season 6 - Fold increase in RSV-A and RSV-B neutralizing titers from pre-Season 5 to Day 31 and pre-Season 6 - RSV-A and RSV-B neutralizing titers ≥cut-off at pre-Season 4, pre-Season 5, Day 31 and pre-Season 6 - Participant having a ≥4-fold increase in neutralizing titers (Day 31 over pre-Season 5)" | — |
Secondary
| Measure | Time frame |
|---|---|
| "RSV_1dose group: - RSV-A and RSV-B Neutralizing titers at pre-Season 4, pre-Season 5 and pre-Season 6 - RSV-A and RSV-B Neutralizing titers ≥cut-off at pre-Season 4, pre-Season 5 and pre-Season 6 ", "All participants: - Occurrence of unsolicited AEs with an onset during the 30-day follow-up period after vaccination (i.e., the day of vaccination and 29 subsequent days) - Occurrence of all SAEs/pIMDs from the day of vaccination up to 6 months after vaccination - Occurrence of SAEs/pIMDs related to study vaccination from Day 1 up to study end - Occurrence of fatal SAEs from Day 1 up to study end" | — |
Countries
Belgium, Estonia, Finland, Germany, Italy, Poland, Spain