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
NCT Number: NCT06534892
Acronym: RSV OA=ADJ=012
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Respiratory Syncytial Virus Infections
Interventions: BIOLOGICAL: RSVPreF3 OA vaccine
Sponsor: GlaxoSmithKline
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-01
Completion Date: 2026-09-30
Locations: GSK Investigational Site, Birmingham, Alabama, 35205, United States|GSK Investigational Site, Birmingham, Alabama, 35211, United States|GSK Investigational Site, Huntsville, Alabama, 35802, United States|GSK Investigational Site, Phoenix, Arizona, 85306, United States|GSK Investigational Site, Tucson, Arizona, 85741, United States|GSK Investigational Site, Cerritos, California, 90703, United States|GSK Investigational Site, Coral Gables, Florida, 33134, United States|GSK Investigational Site, Fort Myers, Florida, 33912, United States|GSK Investigational Site, Jacksonville, Florida, 32205, United States|GSK Investigational Site, Lake City, Florida, 32055, United States|GSK Investigational Site, Melbourne, Florida, 32934, United States|GSK Investigational Site, Miami, Florida, 33174, United States|GSK Investigational Site, Orlando, Florida, 32806, United States|GSK Investigational Site, Pinellas Park, Florida, 33781, United States|GSK Investigational Site, The Villages, Florida, 32162, United States|GSK Investigational Site, West Palm Beach, Florida, 33409, United States|GSK Investigational Site, Atlanta, Georgia, 30328, United States|GSK Investigational Site, Savannah, Georgia, 31406, United States|GSK Investigational Site, Chicago, Illinois, 60602, United States|GSK Investigational Site, Evansville, Indiana, 47714, United States|GSK Investigational Site, Mishawaka, Indiana, 46544, United States|GSK Investigational Site, El Dorado, Kansas, 67042, United States|GSK Investigational Site, Newton, Kansas, 67114, United States|GSK Investigational Site, Wichita, Kansas, 67205, United States|GSK Investigational Site, Wichita, Kansas, 67207, United States|GSK Investigational Site, Lexington, Kentucky, 40509, United States|GSK Investigational Site, Rockville, Maryland, 20854, United States|GSK Investigational Site, Richfield, Minnesota, 55423, United States|GSK Investigational Site, Kansas City, Missouri, 64114, United States|GSK Investigational Site, Saint Louis, Missouri, 63141, United States|GSK Investigational Site, Omaha, Nebraska, 68134, United States|GSK Investigational Site, Henderson, Nevada, 89052, United States|GSK Investigational Site, New York, New York, 10017, United States|GSK Investigational Site, Rochester, New York, 14609, United States|GSK Investigational Site, Hickory, North Carolina, 28601, United States|GSK Investigational Site, Mooresville, North Carolina, 28117, United States|GSK Investigational Site, Rocky Mount, North Carolina, 27804, United States|GSK Investigational Site, Salisbury, North Carolina, 28144, United States|GSK Investigational Site, Winston-Salem, North Carolina, 27103, United States|GSK Investigational Site, Akron, Ohio, 44311, United States|GSK Investigational Site, Centerville, Ohio, 45459, United States|GSK Investigational Site, Cincinnati, Ohio, 45236, United States|GSK Investigational Site, Columbus, Ohio, 43212, United States|GSK Investigational Site, Erie, Pennsylvania, 16508, United States|GSK Investigational Site, Pittsburgh, Pennsylvania, 15236, United States|GSK Investigational Site, Anderson, South Carolina, 29621, United States|GSK Investigational Site, Mount Pleasant, South Carolina, 29405, United States|GSK Investigational Site, Knoxville, Tennessee, 37938, United States|GSK Investigational Site, Memphis, Tennessee, 38119, United States|GSK Investigational Site, Dallas, Texas, 75234, United States|GSK Investigational Site, Fort Worth, Texas, 76104, United States|GSK Investigational Site, Houston, Texas, 77008, United States|GSK Investigational Site, Keller, Texas, 76248, United States|GSK Investigational Site, San Antonio, Texas, 78229, United States|GSK Investigational Site, San Antonio, Texas, 78229, United States|GSK Investigational Site, Salt Lake City, Utah, 84106, United States|GSK Investigational Site, Norfolk, Virginia, 23502, United States|GSK Investigational Site, Botany, 2019, Australia|GSK Investigational Site, Camberwell, 3124, Australia|GSK Investigational Site, Coffs Harbour, 2450, Australia|GSK Investigational Site, Darlinghurst, 2010, Australia|GSK Investigational Site, Geelong, 3220, Australia|GSK Investigational Site, Murdoch, 6163, Australia|GSK Investigational Site, Taringa, 4068, Australia|GSK Investigational Site, Tarragindi, 4121, Australia|GSK Investigational Site, Alken, 3570, Belgium|GSK Investigational Site, Edegem, 2610, Belgium|GSK Investigational Site, Erpent, 5101, Belgium|GSK Investigational Site, Genk, 3600, Belgium|GSK Investigational Site, Gent, 9000, Belgium|GSK Investigational Site, Ieper, 8900, Belgium|GSK Investigational Site, Linkebeek, 3544, Belgium|GSK Investigational Site, Linkebeek, 6534, Belgium|GSK Investigational Site, Linkebeek, 9690, Belgium|GSK Investigational Site, Mechelen, 2800, Belgium|GSK Investigational Site, Tremelo, 3120, Belgium|GSK Investigational Site, Chicoutimi, G7H 7Y8, Canada|GSK Investigational Site, Edmonton, T5A 4L8, Canada|GSK Investigational Site, Halifax, B3J 3G9, Canada|GSK Investigational Site, London-Ontario, N5W 6A2, Canada|GSK Investigational Site, Mirabel, J7J 2K8, Canada|GSK Investigational Site, New Westminster, V3L 3W4, Canada|GSK Investigational Site, Ottawa, K1H 8L6, Canada|GSK Investigational Site, Pointe-Claire, H9R4S3, Canada|GSK Investigational Site, Quebec, G1W 4R4, Canada|GSK Investigational Site, Sainte-Foy, G1E 7G9, Canada|GSK Investigational Site, Sarnia, N7T 4X3, Canada|GSK Investigational Site, Sherbrooke, J1J 2G2, Canada|GSK Investigational Site, St-Charles-Borromee, J6E 2B4, Canada|GSK Investigational Site, Sudbury, P3C 1X3, Canada|GSK Investigational Site, Surrey, V3S 2N6, Canada|GSK Investigational Site, Toronto, M9W 4L6, Canada|GSK Investigational Site, Truro, B2N 1L2, Canada|GSK Investigational Site, Vancouver, V6Z 2T1, Canada|GSK Investigational Site, Victoria, V8V 3M9, Canada|GSK Investigational Site, Victoria, V8V 4A1, Canada|GSK Investigational Site, Paide, 72713, Estonia|GSK Investigational Site, Tallinn, 10117, Estonia|GSK Investigational Site, Tallinn, 10128, Estonia|GSK Investigational Site, Tallinn, 10617, Estonia|GSK Investigational Site, Tallinn, 13619, Estonia|GSK Investigational Site, Tartu, 51014, Estonia|GSK Investigational Site, Espoo, 02230, Finland|GSK Investigational Site, Helsinki, 00100, Finland|GSK Investigational Site, Helsinki, 00930, Finland|GSK Investigational Site, Jarvenpaa, 04400, Finland|GSK Investigational Site, Kokkola, 67100, Finland|GSK Investigational Site, Oulu, 90220, Finland|GSK Investigational Site, Seinajoki, 60100, Finland|GSK Investigational Site, Tampere, 33100, Finland|GSK Investigational Site, Turku, 20520, Finland|GSK Investigational Site, Berlin, 10117, Germany|GSK Investigational Site, Berlin, 12627, Germany|GSK Investigational Site, Berlin, 13347, Germany|GSK Investigational Site, Dachau, 85221, Germany|GSK Investigational Site, Dippoldiswalde, 01744, Germany|GSK Investigational Site, Dresden, 01279, Germany|GSK Investigational Site, Essen, 45355, Germany|GSK Investigational Site, Essen, 45359, Germany|GSK Investigational Site, Floersheim, 65439, Germany|GSK Investigational Site, Frankfurt, 60313, Germany|GSK Investigational Site, Freiberg, 09599, Germany|GSK Investigational Site, Freital, 01705, Germany|GSK Investigational Site, Goch, 47574, Germany|GSK Investigational Site, Hamburg, 20095, Germany|GSK Investigational Site, Hamburg, 22143, Germany|GSK Investigational Site, Hannover, 30159, Germany|GSK Investigational Site, Koeln, 51069, Germany|GSK Investigational Site, Leipzig, 04103, Germany|GSK Investigational Site, Mainz, 55116, Germany|GSK Investigational Site, Muenchen, 80339, Germany|GSK Investigational Site, Schenefeld, 22869, Germany|GSK Investigational Site, Wallerfing, 94574, Germany|GSK Investigational Site, Wangen, 88239, Germany|GSK Investigational Site, Weinheim, 69469, Germany|GSK Investigational Site, Witten, 58455, Germany|GSK Investigational Site, Wuerzburg, 97070, Germany|GSK Investigational Site, Alessandria, 15121, Italy|GSK Investigational Site, Bari, 70124, Italy|GSK Investigational Site, Belluno, 32100, Italy|GSK Investigational Site, Catanzaro, 88100, Italy|GSK Investigational Site, Ferrara, 44124, Italy|GSK Investigational Site, Napoli, 80131, Italy|GSK Investigational Site, Negrar Verona, 37024, Italy|GSK Investigational Site, Palermo, 90127, Italy|GSK Investigational Site, Pessione - Chieri TO, 10023, Italy|GSK Investigational Site, Pisa, 56126, Italy|GSK Investigational Site, Roma, 00128, Italy|GSK Investigational Site, Roma, 00168, Italy|GSK Investigational Site, Siena, 53100, Italy|GSK Investigational Site, Hiroshima, 732-0053, Japan|GSK Investigational Site, Ibaraki, 306-0041, Japan|GSK Investigational Site, Kumamoto, 860-0863, Japan|GSK Investigational Site, Okinawa, 901-2393, Japan|GSK Investigational Site, Saitama, 350-1122, Japan|GSK Investigational Site, Shizuoka, 421-0193, Japan|GSK Investigational Site, Tokyo, 121-0815, Japan|GSK Investigational Site, Tokyo, 160-0017, Japan|GSK Investigational Site, Tokyo, 165-0031, Japan|GSK Investigational Site, Tokyo, 169-0072, Japan|GSK Investigational Site, Yamagata, 990-0834, Japan|GSK Investigational Site, Yamaguchi, 750-0061, Japan|GSK Investigational Site, Ansan, 15355, Korea, Republic of|GSK Investigational Site, Bucheon-si Kyunggi-do 14584, 14584, Korea, Republic of|GSK Investigational Site, Daegu, 41944, Korea, Republic of|GSK Investigational Site, Incheon, 400-711, Korea, Republic of|GSK Investigational Site, Jeonju, 54907, Korea, Republic of|GSK Investigational Site, Kangwon-do, 26426, Korea, Republic of|GSK Investigational Site, Seoul, 06351, Korea, Republic of|GSK Investigational Site, Seoul, 07441, Korea, Republic of|GSK Investigational Site, Seoul, 08308, Korea, Republic of|GSK Investigational Site, Seoul, 135-720, Korea, Republic of|GSK Investigational Site, Seoul, 137-701, Korea, Republic of|GSK Investigational Site, Suwon Gyeonggi-do, 442-723, Korea, Republic of|GSK Investigational Site, Chihuahua, 31203, Mexico|GSK Investigational Site, Leon, 37530, Mexico|GSK Investigational Site, Merida, 97070, Mexico|GSK Investigational Site, Mexico City, 06760, Mexico|GSK Investigational Site, Monterrey, 64460, Mexico|GSK Investigational Site, Oaxaca, 68000, Mexico|GSK Investigational Site, Queretaro, 76070, Mexico|GSK Investigational Site, RM Pharmamexico CITY, 03100, Mexico|GSK Investigational Site, San Luis PotosI, 78209, Mexico|GSK Investigational Site, Grafton Auckland, 1010, New Zealand|GSK Investigational Site, Hawke's Bay, 4122, New Zealand|GSK Investigational Site, Kapiti, 5032, New Zealand|GSK Investigational Site, Palmerston North, 4414, New Zealand|GSK Investigational Site, Tauranga, 3110, New Zealand|GSK Investigational Site, Wellington, 6021, New Zealand|GSK Investigational Site, Czestochowa, 42-202, Poland|GSK Investigational Site, Elblag, 82-300, Poland|GSK Investigational Site, Gdansk, 80-382, Poland|GSK Investigational Site, Gdynia, 81-537, Poland|GSK Investigational Site, Katowice, 40-040, Poland|GSK Investigational Site, Katowice, 40-282, Poland|GSK Investigational Site, Katowice, 40-648, Poland|GSK Investigational Site, Krakow, 31-501, Poland|GSK Investigational Site, Lodz, 90-127, Poland|GSK Investigational Site, Lodz, 91-363, Poland|GSK Investigational Site, Poznan, 60-702, Poland|GSK Investigational Site, Warsaw, 03-291, Poland|GSK Investigational Site, Warszawa, 02-672, Poland|GSK Investigational Site, Wroclaw, 50-088, Poland|GSK Investigational Site, Wroclaw, 53-671, Poland|GSK Investigational Site, Barnaul, 656043, Russian Federation|GSK Investigational Site, Ekaterinburg, 620137, Russian Federation|GSK Investigational Site, Gatchina, 188300, Russian Federation|GSK Investigational Site, Kemerovo, 650066, Russian Federation|GSK Investigational Site, Moscow, 115478, Russian Federation|GSK Investigational Site, Saint-Petersburg, 196158, Russian Federation|GSK Investigational Site, Saint-Petersburg, 197022, Russian Federation|GSK Investigational Site, StPetersburg, 191119, Russian Federation|GSK Investigational Site, StPetersburg, 196143, Russian Federation|GSK Investigational Site, Bloemfontein, 9300, South Africa|GSK Investigational Site, Cape Town, 7700, South Africa|GSK Investigational Site, Johannesburg, 1818, South Africa|GSK Investigational Site, Johannesburg, 2113, South Africa|GSK Investigational Site, Middelburg, 1050, South Africa|GSK Investigational Site, Moloto South, 1022, South Africa|GSK Investigational Site, Reiger Park, 1459, South Africa|GSK Investigational Site, Tembisa, 1632, South Africa|GSK Investigational Site, AlcorcOn, 28922, Spain|GSK Investigational Site, Barcelona, 08023, Spain|GSK Investigational Site, Barcelona, 08036, Spain|GSK Investigational Site, Barcelona, 08430, Spain|GSK Investigational Site, Barcelona, 08540, Spain|GSK Investigational Site, Barcelona, 8025, Spain|GSK Investigational Site, Barcelona, ?08500, Spain|GSK Investigational Site, Barcelona, ?08907, Spain|GSK Investigational Site, Madrid, 28006, Spain|GSK Investigational Site, Madrid, 28007, Spain|GSK Investigational Site, Madrid, 28041, Spain|GSK Investigational Site, Madrid, 28046, Spain|GSK Investigational Site, Madrid, 28222, Spain|GSK Investigational Site, Santiago de Compostela, 15706, Spain|GSK Investigational Site, Valencia, 46020, Spain|GSK Investigational Site, Bradford on Avon, Wiltshire, BA15 1DQ, United Kingdom|GSK Investigational Site, Bebington, CH63 9JP, United Kingdom|GSK Investigational Site, Belfast, BT2 8BG, United Kingdom|GSK Investigational Site, Birmingham, B15 2SQ, United Kingdom|GSK Investigational Site, Cardiff, CF15 9SS, United Kingdom|GSK Investigational Site, Corby, NN17 2UR, United Kingdom|GSK Investigational Site, Eynsham, OX29 4QB, United Kingdom|GSK Investigational Site, Glasgow, ML4 3NJ, United Kingdom|GSK Investigational Site, Hexham, NE46 1QJ, United Kingdom|GSK Investigational Site, Lancashire, PR7 7NA, United Kingdom|GSK Investigational Site, Leamington Spa, CV32 4RA, United Kingdom|GSK Investigational Site, Liverpool, L22 0LG, United Kingdom|GSK Investigational Site, Manchester, M15 6SE, United Kingdom|GSK Investigational Site, Orpington, BR5 3QG, United Kingdom|GSK Investigational Site, Oxford, OX4 1XB, United Kingdom|GSK Investigational Site, Peterborough, PE8 6PL, United Kingdom|GSK Investigational Site, Thetford, IP24 1JD, United Kingdom|GSK Investigational Site, Witney, OX28 6JS, United Kingdom

Summary:
The purpose of this study is:

* To investigate the optimal timing for revaccination after the initial RSVPreF3 OA vaccine dose,
* To evaluate the long-term immune persistence and safety up to 5 consecutive RSV seasons (approximately 60 months) of a single dose of RSVPreF3 OA vaccine,
* To give the opportunity to participants who received only placebo in the RSVOA=ADJ- 006 study, to receive a dose of the RSVPreF3 OA vaccine and collect additional safety information.

Primary Outcome Measures: RSV-A neutralizing titers expressed as Geometric mean titers (GMTs) in RSV_PreS4 group, At Day 1, Day 31, Month 12, and at Month 24|RSV-B neutralizing titers expressed as GMTs in RSV_PreS4 group, At Day 1, Day 31, Month 12, and at Month 24|RSV-A neutralizing titers expressed as Mean geometric increase (MGI) in RSV_PreS4 group, From Day 1 to Day 31, Month 12 and Month 24|RSV-B neutralizing titers expressed as MGI in RSV_PreS4 group, From Day 1 to Day 31, Month 12 and Month 24|Percentage of participants with RSV-A neutralizing titers greater than or equal to (>=) cut-off in RSV_PreS4 group, At Day 1, Day 31, Month 12, and at Month 24|Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS4 group, At Day 1, Day 31, Month 12, and at Month 24|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 RSVB neutralizing titers in RSV_PreS4 group, At Day 31|RSV-A neutralizing titers expressed as GMT in RSV_PreS5 group, At Day 1 , Month 12 , Month 13 and at Month 24|RSV-B neutralizing titers expressed as GMTs in RSV_PreS5 group, At Day 1, Month 12 , Month 13 and at Month 24|RSV-A neutralizing titers expressed as MGI in RSV_PreS5 group, At Day 1, Month 12 , Month 13 and at Month 24|RSV-B neutralizing titers expressed as MGI in RSV_PreS5 group, From Month 12 to Month 13 and Month 24|Percentage of participants with RSV-A neutralizing titers >=cut-off in RSV_PreS5 group, At Day 1, Month 12 , Month 13 and at Month 24|Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS5 group, At Day 1, Month 12 , Month 13 and 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 RSVB neutralizing titers in RSV_PreS5 group, At Month 13
Secondary Outcome Measures: RSV-A neutralizing titers expressed as GMTs in RSV_1Dose group, At Day 1, Month 12 and at Month 24|RSV-B neutralizing titers expressed as GMTs in RSV_1Dose group, At Day 1, Month 12 and at Month 24|Percentage of participants with RSV-A neutralizing titers >= cut-off in RSV_1Dose group, At Day 1, Month 12 and at Month 24|Percentage of participants with RSV-B neutralizing titers >= cut-off in RSV_1Dose group, At Day 1, Month 12 and at Month 24|Number of participants with unsolicited adverse events, At Day 30 post vaccination|Number of participants with any serious adverse events (SAEs), From day of vaccination and up to 6 months post each vaccine administration|Number of participants with SAEs related to study intervention, From Day 1 and up to end of study|Number of participants with any potential immune-mediated disease (pIMDs), From day of vaccination and up to 6 months post each vaccine administration|Number of participants with pIMDs related to study intervention, From Day 1 and up to end of study|Number of participants with fatal SAEs, From Day 1 and up to end of study