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A phase 3b, randomized, open label, multi-country, multi-center, extension and crossover vaccination study to evaluate the immunogenicity and safety of different revaccination schedules and persistence of a single dose of the RSVPreF3 OA vaccine in adults aged 60 years and above who participated in the RSV OA=ADJ-006 study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509762-38-00
Acronym
222090
Enrollment
4918
Registered
2024-06-06
Start date
2024-08-01
Completion date
Unknown
Last updated
2025-12-17

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_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

GlaxoSmithKline Biologicals
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

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