An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study (RSV OA=ADJ=012)

Full name

A Phase 3b, Randomized, Open Label, Multicountry, 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

NCT Number

NCT06534892

Geography

Non-US

Locations

Australia, Belgium, Canada, Estonia, Finland, Germany, Italy, Japan, Mexico, New Zealand, Poland, Russia, South Africa, South Korea, Spain, United Kingdom, United States

Primary Endpoints

RSV-A neutralizing titers expressed as Geometric mean titers (GMTs) in RSV_PreS4 group at Day 1
RSV-A neutralizing titers expressed as GMTs in RSV_PreS4 group at Day 31
RSV-B neutralizing titers expressed as GMTs in RSV_PreS4 group at Day 1
RSV-B neutralizing titers expressed as GMTs in RSV_PreS4 group at Day 31
RSV-A neutralizing titers expressed as Mean geometric increase (MGI) in RSV_PreS4 group. From Day 1 to Day 31
RSV-B neutralizing titers expressed as MGI in RSV_PreS4 group. From Day 1 to Day 31
Percentage of participants with RSV-A neutralizing titers greater than or equal to (>) cut-off in RSV_PreS4 group at Day 1
Percentage of participants with RSV-A neutralizing titers > cut-off in RSV_PreS4 group at Day 31
Percentage of participants with RSV-B neutralizing titers >cut-off in RSV_PreS4 group at Day 1
Percentage of participants with RSV-B neutralizing titers >cut-off in RSV_PreS4 group at Day 31
Percentage of participants with seroresponse rate (SRR) for RSV-A neutralizing titers in RSV_PreS4 group. At Day 31
Percentage of participants with SRR for RSV-B neutralizing titers in RSV_PreS4 group. At Day 31
RSV-A neutralizing titers expressed as GMT in RSV_PreS5 group at Day 1
RSV-A neutralizing titers expressed as GMT in RSV_PreS5 group at Month 12
RSV-A neutralizing titers expressed as GMT in RSV_PreS5 group at Month 13
RSV-A neutralizing titers expressed as GMT in RSV_PreS5 group at Month 24
RSV-B neutralizing titers expressed as GMTs in RSV_PreS5 group at Day 1
RSV-B neutralizing titers expressed as GMTs in RSV_PreS5 group at Month 12
RSV-B neutralizing titers expressed as GMTs in RSV_PreS5 group at Month 13
RSV-B neutralizing titers expressed as GMTs in RSV_PreS5 group at Month 24
RSV-A neutralizing titers expressed as MGI in RSV_PreS5 group from Month 12 to Month 13
RSV-A neutralizing titers expressed as MGI in RSV_PreS5 group from Month 12 to Month 24
RSV-B neutralizing titers expressed as MGI in RSV_PreS5 group from Month 12 to Month 13
RSV-B neutralizing titers expressed as MGI in RSV_PreS5 group from Month 12 to Month 24
Percentage of participants with RSV-A neutralizing titers >cut-off in RSV_PreS5 group at Day 1
Percentage of participants with RSV-A neutralizing titers >cut-off in RSV_PreS5 group at Month 12
Percentage of participants with RSV-A neutralizing titers >cut-off in RSV_PreS5 group at Month 13
Percentage of participants with RSV-A neutralizing titers >cut-off in RSV_PreS5 group at Month 24
Percentage of participants with RSV-B neutralizing titers >cut-off in RSV_PreS5 group at Day 1
Percentage of participants with RSV-B neutralizing titers >cut-off in RSV_PreS5 group at Month 12
Percentage of participants with RSV-B neutralizing titers >cut-off in RSV_PreS5 group at Month 13
Percentage of participants with RSV-B neutralizing titers >cut-off in RSV_PreS5 group at Month 24
Percentage of participants with seroresponse rate (SRR) for RSV-A neutralizing titers in RSV_PreS5 group. At Month 13
Percentage of participants with SRR for RSV-B neutralizing titers in RSV_PreS5 group. At Month 13

Order

Disease

RSV Disease

Version

AAFP/FMX 2025

Phase

Status

Recruiting