Respiratory Syncytial Virus Infections
Conditions
Brief summary
"• RSV-A neutralizing titers expressed as GMT ratio (RSV-OA over RSV-A-AIR) at 1 month (Day 31) after study intervention administration. • Seroresponse in RSV-A neutralizing titers from Day 1 to Day 31.", "• RSV-B neutralizing titers expressed as GMT ratio (RSV-OA over RSV-A-AIR) at 1 month (Day 31) after study intervention administration. • Seroresponse in RSV-B neutralizing titers from Day 1 to Day 31. "
Detailed description
"• Occurrence of each solicited administration site event with onset within 4 days after dosing • Occurrence of each solicited systemic event with onset within 4 days after study intervention administration • Occurrence of unsolicited AEs within 30 days after study intervention administration • Occurrence of all SAEs (including fatal and related SAEs) and AESIs after study intervention administration (Day 1) up to study end (Month 6). ", "• RSV-A and RSV-B neutralizing titers, at pre-study intervention administration and 1 month and 6 months after study intervention administration. "
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| "• RSV-A neutralizing titers expressed as GMT ratio (RSV-OA over RSV-A-AIR) at 1 month (Day 31) after study intervention administration. • Seroresponse in RSV-A neutralizing titers from Day 1 to Day 31.", "• RSV-B neutralizing titers expressed as GMT ratio (RSV-OA over RSV-A-AIR) at 1 month (Day 31) after study intervention administration. • Seroresponse in RSV-B neutralizing titers from Day 1 to Day 31. " | — |
Secondary
| Measure | Time frame |
|---|---|
| "• Occurrence of each solicited administration site event with onset within 4 days after dosing • Occurrence of each solicited systemic event with onset within 4 days after study intervention administration • Occurrence of unsolicited AEs within 30 days after study intervention administration • Occurrence of all SAEs (including fatal and related SAEs) and AESIs after study intervention administration (Day 1) up to study end (Month 6). ", "• RSV-A and RSV-B neutralizing titers, at pre-study intervention administration and 1 month and 6 months after study intervention administration. " | — |
Countries
Germany