Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above
A Phase 3, Randomized, Placebo-controlled, Observer-blind, Multi-country Study to Demonstrate the Efficacy of a Single Dose and Annual Revaccination Doses of GSK's RSVPreF3 OA Investigational Vaccine in Adults Aged 60 Years and Above
2 other identifiers
interventional
26,675
16 countries
260
Brief Summary
This study will evaluate the efficacy of the RSVPreF3 OA investigational vaccine in preventing Lower Respiratory Tract Disease (LRTD) caused by RSV in adults ≥60 years of age following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses in Northern Hemisphere (NH) and in Southern Hemisphere (SH). This study will also assess if the vaccine is safe and induces an immune response.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2021
Typical duration for phase_3
260 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2021
CompletedFirst Posted
Study publicly available on registry
May 14, 2021
CompletedStudy Start
First participant enrolled
May 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 11, 2022
CompletedResults Posted
Study results publicly available
August 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2024
CompletedJuly 31, 2025
July 1, 2025
11 months
April 29, 2021
April 10, 2023
July 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Lower Respiratory Tract Disease (LRTD) During the First Season Following a Single Dose of the RSVPreF3 OA Vaccine
First episode of Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated LRTD during the first season was assessed. The case definition for RSV-confirmed LRTD is as follows: Presence of at least one RSV-positive swab detected by RT-PCR.
From Day 15 post-vaccination up to end of season 1 in the Northern Hemisphere (NH) [a median of approximately 6.7 months (6.9 months in NH and 3.5 months in Southern Hemisphere [SH])]
Secondary Outcomes (44)
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD Over Several Seasons Following a Single Dose of the RSVPreF3 OA Vaccine
From Day 15 post first vaccination up to end of season 2 and up to end of season 3 in the Northern Hemisphere [NH] (assessed approximately over 2 and 3 years in NH)
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD Over Several Seasons Following Annual Revaccination Doses of the RSVPreF3 OA Vaccine
From Day 15 post first vaccination up to end of season 2 and up to end of season 3 in the NH (assessed approximately over 2 and 3 years in NH)
Number of Participants With First Episode of RT-PCR Confirmed RSV Subtype A and Subtype B LRTD Over 3 Seasons Following a Single Dose of the RSVPreF3 OA Vaccine
From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH, and 2.5-3 years in SH)
Number of Participants With First Episode of RT-PCR Confirmed RSV Subtype A and Subtype B LRTD Over 3 Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following 1 Annual Revaccination Dose
From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH, and 2.5-3 years in SH)
Number of Participants With First Episode of RT-PCR Confirmed LRTD Caused by Human Metapneumovirus (hMPV) up to the End of Season 1 Following a Single Dose of the RSVPreF3 OA Vaccine
From Day 15 post-vaccination up to end of season 1 in the SH [a median of approximately 11.5 months (11.6 months in NH and 9.1 months in SH)]
- +39 more secondary outcomes
Study Arms (2)
RSVPreF3 Group
EXPERIMENTALParticipants received a single dose of the RSVPreF3 OA vaccine at Day 1. Before the second vaccination participants in this group were re-randomized into 2 as: a group that received placebo every subsequent year, and a group that received an additional dose of RSVPreF3 OA vaccine every subsequent year of the study.
Placebo Group
PLACEBO COMPARATORParticipants received 1 dose of placebo at Day 1 and an additional dose of placebo every subsequent year of the study.
Interventions
Placebo administered intramuscularly into the deltoid of the non-dominant arm at day 1 and before Season 2 to the Placebo Group, and before Season 2 to the participants of the RSVPreF3 Group, that are re-randomized to the RSV\_1 dose group.
RSVPreF3 OA vaccine administered intramuscularly into the deltoid of the non-dominant arm at Day 1 in the RSVPreF3 group, and before Season 2 to the participants of the RSVPreF3 group that are re-randomized to the RSV\_annual group.
Eligibility Criteria
You may qualify if:
- A male or female ≥ 60 YOA at the time of first vaccination, who live in the community (community dwelling participants) or in a long-term care facility (LTCF participants).
- Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- Note: In case of physical incapacity that would preclude the self-completion of the diary cards and/or questionnaires, either site staff can assist the participant (for activities performed during site visits) or the participant may assign a caregiver to assist him/her with this activity (for activities performed at home or in the LTCF). However, at no time, the site staff or caregiver will evaluate the participant's health status while answering diaries and/or questionnaires or make decisions on behalf of the participant
- Written or witnessed informed consent obtained from the participant prior to performance of any study specific procedure.
- Participants who are medically stable in the opinion of the investigator at the time of first vaccination. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable.
You may not qualify if:
- Medical conditions
- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination (no laboratory testing required).
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- Hypersensitivity to latex.
- Serious or unstable chronic illness.
- Any history of dementia or any medical condition that moderately or severely impairs cognition.
- Note: If deemed necessary for clinical evaluation, the investigator can use tools such as Mini-Mental State Exam (MMSE), Mini-Cog or Montreal Cognitive Assessment (MoCA) to determine cognition levels of the participant.
- Recurrent or un-controlled neurological disorders or seizures. Participants with medically-controlled active neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol.
- Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
- Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- Prior/Concomitant therapy
- Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccine during the period beginning 30 days before the first study vaccine administration, or planned use during the study period.
- Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before each dose and ending 30 days after each dose of study vaccine administration, with the exception of inactivated and subunit influenza vaccines which can be administered up to 14 days before or from 14 days after each study vaccination.
- Previous vaccination with an RSV vaccine.
- Administration of long-acting immune-modifying drugs or planned administration at any time during the study period.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (277)
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
Laguna Hills, California, 92653, 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
Weeki Wachee, Florida, 34607, United States
GSK Investigational Site
West Palm Beach, Florida, 33409, United States
GSK Investigational Site
Atlanta, Georgia, 30328, 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
St Louis, Missouri, 63141, United States
GSK Investigational Site
Omaha, Nebraska, 68134, United States
GSK Investigational Site
Henderson, Nevada, 89052, United States
GSK Investigational Site
Binghamton, New York, 31406, United States
GSK Investigational Site
Jamaica, 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
Rocky Mount, North Carolina, 27804, United States
GSK Investigational Site
Salisbury, North Carolina, 28144, United States
GSK Investigational Site
Statesville, North Carolina, 28117, 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
Mt. Pleasant, South Carolina, 29405, United States
GSK Investigational Site
Knoxville, Tennessee, 37912, 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
Houston, Texas, 77055, United States
GSK Investigational Site
Keller, Texas, 76248, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Layton, Utah, 84041, United States
GSK Investigational Site
Murray, Utah, 84106, United States
GSK Investigational Site
Norfolk, Virginia, 23502, United States
GSK Investigational Site
Botany, New South Wales, 2217, Australia
GSK Investigational Site
Coffs Harbour, New South Wales, 2450, Australia
GSK Investigational Site
Darlinghurst, New South Wales, 2010, Australia
GSK Investigational Site
Morayfield, Queensland, 4506, Australia
GSK Investigational Site
Taringa, Queensland, 4068, Australia
GSK Investigational Site
Tarragindi, Queensland, 4121, Australia
GSK Investigational Site
Camberwell, Victoria, 3124, Australia
GSK Investigational Site
Geelong, Victoria, 3220, Australia
GSK Investigational Site
Spearwood, Western Australia, 6163, Australia
GSK Investigational Site
Aalst, 9300, Belgium
GSK Investigational Site
Alken, 3570, Belgium
GSK Investigational Site
Edegem, 2650, Belgium
GSK Investigational Site
Erpent, 5101, Belgium
GSK Investigational Site
Genk, 3600, Belgium
GSK Investigational Site
Ghent, 9000, Belgium
GSK Investigational Site
Ieper, 8900, Belgium
GSK Investigational Site
Linkebeek, 3500, Belgium
GSK Investigational Site
Linkebeek, 3545, Belgium
GSK Investigational Site
Linkebeek, 4987, Belgium
GSK Investigational Site
Linkebeek, 6534, Belgium
GSK Investigational Site
Linkebeek, 6887, Belgium
GSK Investigational Site
Linkebeek, 9690, Belgium
GSK Investigational Site
Mechelen, 2800, Belgium
GSK Investigational Site
Tremelo, 3120, Belgium
GSK Investigational Site
Edmonton, Alberta, T5A 4L8, Canada
GSK Investigational Site
New Westminster, British Columbia, V3L 3W4, Canada
GSK Investigational Site
Surrey, British Columbia, V3S 2N6, Canada
GSK Investigational Site
Vancouver, British Columbia, V6Z 2T1, Canada
GSK Investigational Site
Victoria, British Columbia, V8V 3M9, Canada
GSK Investigational Site
Victoria, British Columbia, V8V 4A1, Canada
GSK Investigational Site
Halifax, Nova Scotia, B3J 3G9, Canada
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2, Canada
GSK Investigational Site
Greater Sudbury, Ontario, P3C 1X3, Canada
GSK Investigational Site
London-Ontario, Ontario, N5W 6A2, Canada
GSK Investigational Site
Ottawa, Ontario, K1H 8L6, Canada
GSK Investigational Site
Sarnia, Ontario, N7T 4X3, Canada
GSK Investigational Site
Toronto, Ontario, M9W 4L6, Canada
GSK Investigational Site
Chicoutimi, Quebec, G7H 7Y8, Canada
GSK Investigational Site
Mirabel, Quebec, J7J 2K8, Canada
GSK Investigational Site
Pointe-Claire, Quebec, H9R 4S3, Canada
GSK Investigational Site
Québec, Quebec, G1W 4R4, Canada
GSK Investigational Site
Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
GSK Investigational Site
Sainte-Foy, Quebec, G1E 7G9, Canada
GSK Investigational Site
Sherbrooke, Quebec, J1J 2G2, 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
Pori, 28100, Finland
GSK Investigational Site
Seinäjoki, 60100, Finland
GSK Investigational Site
Tampere, 33100, Finland
GSK Investigational Site
Turku, 20520, Finland
GSK Investigational Site
Freiberg, Saxony, 09599, Germany
GSK Investigational Site
Berlin, 10117, Germany
GSK Investigational Site
Berlin, 12627, Germany
GSK Investigational Site
Berlin, 13347, Germany
GSK Investigational Site
Cologne, 51069, Germany
GSK Investigational Site
Dachau, 85221, Germany
GSK Investigational Site
Dippoldiswalde, 01762, Germany
GSK Investigational Site
Dresden, 01279, Germany
GSK Investigational Site
Essen, 45355, Germany
GSK Investigational Site
Essen, 45359, Germany
GSK Investigational Site
Flörsheim, 65439, Germany
GSK Investigational Site
Frankfurt, 60313, 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
Hanover, 30159, Germany
GSK Investigational Site
Leipzig, 04103, Germany
GSK Investigational Site
Leipzig, 04347, Germany
GSK Investigational Site
Mainz, 55116, Germany
GSK Investigational Site
MĂ¼nchen, 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
WĂ¼rzburg, 97070, Germany
GSK Investigational Site
Alessandria, 15100, Italy
GSK Investigational Site
Bari, 70121, Italy
GSK Investigational Site
Belluno, 32100, Italy
GSK Investigational Site
Catanzaro, 88100, Italy
GSK Investigational Site
Chieri Torino, 10023, Italy
GSK Investigational Site
Ferrara, 44124, Italy
GSK Investigational Site
Genova, 16132, Italy
GSK Investigational Site
Milan, 20157, Italy
GSK Investigational Site
Milan, 20162, Italy
GSK Investigational Site
Napoli, 80131, Italy
GSK Investigational Site
Negrar Verona, 37024, Italy
GSK Investigational Site
Palermo, 90127, 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
Vercelli, 13100, Italy
GSK Investigational Site
Chiba, 292-0805, Japan
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
Osaka, 530-0001, 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
Chihuahua City, 31203, Mexico
GSK Investigational Site
LeĂ³n, 37530, Mexico
GSK Investigational Site
Mexico City, 01120, Mexico
GSK Investigational Site
Mexico City, 06760, Mexico
GSK Investigational Site
MĂ©rida, 97070, Mexico
GSK Investigational Site
Monterrey, 64570, Mexico
GSK Investigational Site
Oaxaca City, 68000, Mexico
GSK Investigational Site
Querétaro, 76070, Mexico
GSK Investigational Site
RM Pharmamexico CITY, 03100, Mexico
GSK Investigational Site
San Luis PotosĂ City, 78209, Mexico
GSK Investigational Site
Grafton Auckland, 1010, New Zealand
GSK Investigational Site
Havelock North, 4130, New Zealand
GSK Investigational Site
Kapiti, 5032, New Zealand
GSK Investigational Site
Palmerston North, 5032, New Zealand
GSK Investigational Site
Tauranga, 3001, New Zealand
GSK Investigational Site
Wellington, 6021, New Zealand
GSK Investigational Site
Częstochowa, 42202, 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
Piaseczno, 05-500, Poland
GSK Investigational Site
Poznan, 60-702, Poland
GSK Investigational Site
Warsaw, 02-672, Poland
GSK Investigational Site
Warsaw, 03-291, Poland
GSK Investigational Site
Warsaw, 96-500, Poland
GSK Investigational Site
Wroclaw, 50-381, Poland
GSK Investigational Site
Wroclaw, 53-673, Poland
GSK Investigational Site
Barnaul, 656043, Russia
GSK Investigational Site
Gatchina, 188300, Russia
GSK Investigational Site
Kemerovo, 650066, Russia
GSK Investigational Site
Moscow, 115478, Russia
GSK Investigational Site
Saint Petersburg, 196158, Russia
GSK Investigational Site
Saint Petersburg, 197022, Russia
GSK Investigational Site
StPetersburg, 191119, Russia
GSK Investigational Site
StPetersburg, 196143, Russia
GSK Investigational Site
Yekaterinburg, 620137, Russia
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, 1055, South Africa
GSK Investigational Site
Moloto South, 1022, South Africa
GSK Investigational Site
Newcastle, 9301, South Africa
GSK Investigational Site
Reiger Park, 1459, South Africa
GSK Investigational Site
Tembisa, 1632, South Africa
GSK Investigational Site
Ansan, 15355, South Korea
GSK Investigational Site
Bucheon-si Kyunggi-do 14584, 14584, South Korea
GSK Investigational Site
Daegu, 41944, South Korea
GSK Investigational Site
Incheon, 400-711, South Korea
GSK Investigational Site
Jeonju, 54907, South Korea
GSK Investigational Site
Kangwon-do, 26426, South Korea
GSK Investigational Site
Seoul, 06351, South Korea
GSK Investigational Site
Seoul, 07441, South Korea
GSK Investigational Site
Seoul, 08308, South Korea
GSK Investigational Site
Seoul, 135-720, South Korea
GSK Investigational Site
Seoul, 137-701, South Korea
GSK Investigational Site
Suwon Gyeonggi-do, 442-723, South Korea
GSK Investigational Site
AlcorcĂ³n, 28922, Spain
GSK Investigational Site
Barcelona, 08023, Spain
GSK Investigational Site
Barcelona, 08025, Spain
GSK Investigational Site
Barcelona, 08036, Spain
GSK Investigational Site
Barcelona, 08430, Spain
GSK Investigational Site
Barcelona, 08500, Spain
GSK Investigational Site
Barcelona, 08540, Spain
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Barcelona, 08907, Spain
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Barcelona, 8025, Spain
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Madrid, 28006, Spain
GSK Investigational Site
Madrid, 28007, Spain
GSK Investigational Site
Madrid, 28029, Spain
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Madrid, 28041, Spain
GSK Investigational Site
Madrid, 28046, Spain
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Madrid, 28222, Spain
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Santiago de Compostela, 15706, Spain
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Valencia, 46015, Spain
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Bebington, CH63 9JP, United Kingdom
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Belfast, BT7 2EB, United Kingdom
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Birmingham, B15 2SQ, United Kingdom
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Bradford on Avon Wiltsh, BA15 1DQ, United Kingdom
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Cardiff, CF15 9SS, United Kingdom
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Corby, NN17 2UR, United Kingdom
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Eynsham, OX29 4QB, United Kingdom
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Glasgow, ML4 3NJ, United Kingdom
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Hardwick, NE461QJ, United Kingdom
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Hexham, NE46 1QJ, United Kingdom
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Lancashire, PR7 7NA, United Kingdom
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Liverpool, L22 0LG, United Kingdom
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Manchester, M15 6SX, United Kingdom
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Orpington, BR5 3QG, United Kingdom
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Oxford, OX4 1XB, United Kingdom
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Peterborough, PE8 6PL, United Kingdom
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Romford, BR5 3QG, United Kingdom
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Royal Leamington Spa, CV32 4RA, United Kingdom
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Thetford Norfolk, IP24 2HY, United Kingdom
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Witney, OX28 6JS, United Kingdom
Related Publications (8)
Ison MG, Papi A, Athan E, Feldman RG, Langley JM, Lee DG, Leroux-Roels I, Martinon-Torres F, Schwarz TF, van Zyl-Smit RN, Verheust C, Dezutter N, Gruselle O, Fissette L, David MP, Kostanyan L, Hulstrom V, Olivier A, Van der Wielen M, Descamps D; AReSVi-006 Study Group. Efficacy and Safety of Respiratory Syncytial Virus (RSV) Prefusion F Protein Vaccine (RSVPreF3 OA) in Older Adults Over 2 RSV Seasons. Clin Infect Dis. 2024 Jun 14;78(6):1732-1744. doi: 10.1093/cid/ciae010.
PMID: 38253338BACKGROUNDTajima K, Zarkadoulas E, Simons J, Kurai D, Grace M, Graham J, Ho Y, Verelst F. Cost-effectiveness of the adjuvanted respiratory syncytial virus prefusion F protein (RSVPreF3) vaccine in Japanese adults aged 50-59 years at increased risk of severe RSV disease and those aged >/=60 years. Expert Rev Vaccines. 2026 Feb 4:2626921. doi: 10.1080/14760584.2026.2626921. Online ahead of print.
PMID: 41637686DERIVEDIson MG, Papi A, Athan E, Feldman RG, Langley JM, Lee DG, Leroux-Roels I, Martinon-Torres F, Schwarz TF, van Zyl-Smit RN, Cuadripani S, Deraedt Q, Dezutter N, Gerard C, Fissette L, Xavier S, David MP, Olivier A, Van der Wielen M, Descamps D; AReSVi-006 study group. Efficacy, safety, and immunogenicity of the AS01E-adjuvanted respiratory syncytial virus prefusion F protein vaccine (RSVPreF3 OA) in older adults over three respiratory syncytial virus seasons (AReSVi-006): a multicentre, randomised, observer-blinded, placebo-controlled, phase 3 trial. Lancet Respir Med. 2025 Jun;13(6):517-529. doi: 10.1016/S2213-2600(25)00048-7. Epub 2025 Apr 14.
PMID: 40245915DERIVEDSanchez-Martinez ZV, Alpuche-Lazcano SP, Stuible M, Durocher Y. CHO cells for virus-like particle and subunit vaccine manufacturing. Vaccine. 2024 Apr 11;42(10):2530-2542. doi: 10.1016/j.vaccine.2024.03.034. Epub 2024 Mar 19.
PMID: 38503664DERIVEDKurai D, Mizukami A, Preckler V, Verelst F, Molnar D, Matsuki T, Ho Y, Igarashi A. The potential public health impact of the respiratory syncytial virus prefusion F protein vaccine in people aged >/=60 years in Japan: results of a Markov model analysis. Expert Rev Vaccines. 2024 Jan-Dec;23(1):303-311. doi: 10.1080/14760584.2024.2323128. Epub 2024 Mar 1.
PMID: 38426479DERIVEDCurran D, Matthews S, Cabrera ES, Perez SN, Breva LP, Ramet M, Helman L, Park DW, Schwarz TF, Melendez IMG, Schaefer A, Roy N, Stephan B, Molnar D, Kostanyan L, Powers JH 3rd, Hulstrom V; Members of the AReSVi-006 Study Group. The respiratory syncytial virus prefusion F protein vaccine attenuates the severity of respiratory syncytial virus-associated disease in breakthrough infections in adults >/=60 years of age. Influenza Other Respir Viruses. 2024 Feb 3;18(2):e13236. doi: 10.1111/irv.13236. eCollection 2024 Feb.
PMID: 38314063DERIVEDFeldman RG, Antonelli-Incalzi R, Steenackers K, Lee DG, Papi A, Ison MG, Fissette L, David MP, Marechal C, Van der Wielen M, Kostanyan L, Hulstrom V; AReSVi-006 Study Group. Respiratory Syncytial Virus Prefusion F Protein Vaccine Is Efficacious in Older Adults With Underlying Medical Conditions. Clin Infect Dis. 2024 Jan 25;78(1):202-209. doi: 10.1093/cid/ciad471.
PMID: 37698366DERIVEDPapi A, Ison MG, Langley JM, Lee DG, Leroux-Roels I, Martinon-Torres F, Schwarz TF, van Zyl-Smit RN, Campora L, Dezutter N, de Schrevel N, Fissette L, David MP, Van der Wielen M, Kostanyan L, Hulstrom V; AReSVi-006 Study Group. Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. N Engl J Med. 2023 Feb 16;388(7):595-608. doi: 10.1056/NEJMoa2209604.
PMID: 36791160DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- This is an observer blind study.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2021
First Posted
May 14, 2021
Study Start
May 25, 2021
Primary Completion
April 11, 2022
Study Completion
May 31, 2024
Last Updated
July 31, 2025
Results First Posted
August 4, 2023
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
- Access Criteria
- Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer tohttps://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf.