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
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
The purpose of this study is:
Inclusion Criteria:
Exclusion Criteria:
Medical Conditions:
Prior/Concomitant Therapy:
• Use of any investigational or non-registered product other than the study vaccine during the period beginning 30 days before the first dose of study vaccine, or planned use during the study period. • Previous vaccination with an RSV vaccine (investigational or licensed vaccine) and/or planned administration of an RSV vaccine during the study period other than the RSVPreF3 OA vaccine administered during the RSV OA=ADJ-006 study.
Prior/Concurrent Clinical Study Experience:
• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product.
Other Exclusion Criteria:
Specific exclusion criteria for Crossover group:
• Planned or administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after study intervention administration, with the exception of COVID vaccines which can be administered up to 14 days before or from 14 days after study vaccination. Inactivated seasonal influenza vaccines can be co-administered or administered at any time.
Specific exclusion criteria for RSV_PreS4, RSV_PreS5 and RSV_1Dose groups:
Kluisbergen, 9690, Belgium
London-Ontario, Ontario N5W 6A2, Canada
Negrar Verona, 37024, Italy
Pessione - Chieri to, 10023, Italy
RM Pharmamexico CITY, 03100, Mexico
Grafton Auckland, 1010, New Zealand
Hawke's Bay, 4122, New Zealand
Kapiti, 5032, New Zealand
StPetersburg, 191119, Russia
StPetersburg, 196143, Russia
Ekurhuleni, 1459, South Africa
Bucheon-si Kyunggi-do 14584, 14584, South Korea
Kangwon-do, 26426, South Korea
Suwon Gyeonggi-do, 442-723, South Korea
Bradford on Avon Wiltsh, BA15 1DQ, United Kingdom
Lancashire, PR7 7NA, United Kingdom