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A Phase 3b, open-label study to evaluate the non-inferiority of the immune response and to evaluate the safety of the RSVPreF3 OA investigational vaccine in adults 18-49 years of age at increased risk of respiratory syncytial virus disease, compared to older adults ≥60 years of age.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510190-34-00
Acronym
222253
Enrollment
70
Registered
2024-05-24
Start date
2024-06-04
Completion date
2025-03-13
Last updated
2025-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Syncytial Virus Infections

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

GlaxoSmithKline Biologicals
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026