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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Syncytial Virus Infections
• Intervention / Treatment: Biological: RSVPreF3 OA vaccine; Biological: Placebo

Detailed Description

Dose 1 Period will be conducted in 2 parts: Part 1: Participants in RSVPreF3 groups will receive lots 1, 2 and 3 of the investigational vaccine before Season 1. Part 2: Will be initiated when the vaccine lots in part 1 are exhausted at the study sites and participants in RSVPreF3 group will receive lot 4 of the investigational vaccine before Season 1.

• Study Type: Interventional
• Enrollment (Actual): 26675
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Botany, New South Wales, Australia, 2217
      • GSK Investigational Site
    • Coffs Harbour, New South Wales, Australia, 2450
      • GSK Investigational Site
    • Darlinghurst, New South Wales, Australia, 2010
      • GSK Investigational Site
  • Queensland
    • Morayfield, Queensland, Australia, 4506
      • GSK Investigational Site
    • Taringa, Queensland, Australia, 4068
      • GSK Investigational Site
    • Tarragindi, Queensland, Australia, 4121
      • GSK Investigational Site
  • Victoria
    • Camberwell, Victoria, Australia, 3124
      • GSK Investigational Site
    • Geelong, Victoria, Australia, 3220
      • GSK Investigational Site
  • Western Australia
    • Spearwood, Western Australia, Australia, 6163
      • GSK Investigational Site
• Belgium
  • Aalst, Belgium, 9300
    • GSK Investigational Site
  • Alken, Belgium, 3570
    • GSK Investigational Site
  • Edegem, Belgium, 2650
    • GSK Investigational Site
  • Erpent, Belgium, 5101
    • GSK Investigational Site
  • Genk, Belgium, 3600
    • GSK Investigational Site
  • Gent, Belgium, 9000
    • GSK Investigational Site
  • Ieper, Belgium, 8900
    • GSK Investigational Site
  • Linkebeek, Belgium, 6534
    • GSK Investigational Site
  • Linkebeek, Belgium, 9690
    • GSK Investigational Site
  • Linkebeek, Belgium, 3500
    • GSK Investigational Site
  • Linkebeek, Belgium, 4987
    • GSK Investigational Site
  • Linkebeek, Belgium, 6887
    • GSK Investigational Site
  • Linkebeek, Belgium, 3545
    • GSK Investigational Site
  • Mechelen, Belgium, 2800
    • GSK Investigational Site
  • Tremelo, Belgium, 3120
    • GSK Investigational Site
• Canada
  • Quebec, Canada, G1W 4R4
    • GSK Investigational Site
  • Alberta
    • Edmonton, Alberta, Canada, T5A 4L8
      • GSK Investigational Site
  • British Columbia
    • New Westminster, British Columbia, Canada, V3L 3W4
      • GSK Investigational Site
    • Surrey, British Columbia, Canada, V3S 2N6
      • GSK Investigational Site
    • Vancouver, British Columbia, Canada, V6Z 2T1
      • GSK Investigational Site
    • Victoria, British Columbia, Canada, V8V 3M9
      • GSK Investigational Site
    • Victoria, British Columbia, Canada, V8V 4A1
      • GSK Investigational Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3J 3G9
      • GSK Investigational Site
    • Truro, Nova Scotia, Canada, B2N 1L2
      • GSK Investigational Site
  • Ontario
    • London-Ontario, Ontario, Canada, N5W 6A2
      • GSK Investigational Site
    • Ottawa, Ontario, Canada, K1H 8L6
      • GSK Investigational Site
    • Sarnia, Ontario, Canada, N7T 4X3
      • GSK Investigational Site
    • Sudbury, Ontario, Canada, P3C 1X3
      • GSK Investigational Site
    • Toronto, Ontario, Canada, M9W 4L6
      • GSK Investigational Site
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 7Y8
      • GSK Investigational Site
    • Mirabel, Quebec, Canada, J7J 2K8
      • GSK Investigational Site
    • Pointe-Claire, Quebec, Canada, H9R 4S3
      • GSK Investigational Site
    • Sainte-Foy, Quebec, Canada, G1E 7G9
      • GSK Investigational Site
    • Sherbrooke, Quebec, Canada, J1J 2G2
      • GSK Investigational Site
    • St-Charles-Borromee, Quebec, Canada, J6E 2B4
      • GSK Investigational Site
• Estonia
  • Paide, Estonia, 72713
    • GSK Investigational Site
  • Tallinn, Estonia, 10117
    • GSK Investigational Site
  • Tallinn, Estonia, 10617
    • GSK Investigational Site
  • Tallinn, Estonia, 13619
    • GSK Investigational Site
  • Tallinn, Estonia, 10128
    • GSK Investigational Site
  • Tartu, Estonia, 51014
    • GSK Investigational Site
• Finland
  • Espoo, Finland, 02230
    • GSK Investigational Site
  • Helsinki, Finland, 00100
    • GSK Investigational Site
  • Helsinki, Finland, 00930
    • GSK Investigational Site
  • Jarvenpaa, Finland, 04400
    • GSK Investigational Site
  • Kokkola, Finland, 67100
    • GSK Investigational Site
  • Oulu, Finland, 90220
    • GSK Investigational Site
  • Pori, Finland, 28100
    • GSK Investigational Site
  • Seinajoki, Finland, 60100
    • GSK Investigational Site
  • Tampere, Finland, 33100
    • GSK Investigational Site
  • Turku, Finland, 20520
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 10117
    • GSK Investigational Site
  • Berlin, Germany, 13347
    • GSK Investigational Site
  • Berlin, Germany, 12627
    • GSK Investigational Site
  • Dachau, Germany, 85221
    • GSK Investigational Site
  • Dippoldiswalde, Germany, 01762
    • GSK Investigational Site
  • Dresden, Germany, 01279
    • GSK Investigational Site
  • Essen, Germany, 45355
    • GSK Investigational Site
  • Essen, Germany, 45359
    • GSK Investigational Site
  • Floersheim, Germany, 65439
    • GSK Investigational Site
  • Frankfurt, Germany, 60313
    • GSK Investigational Site
  • Freital, Germany, 01705
    • GSK Investigational Site
  • Goch, Germany, 47574
    • GSK Investigational Site
  • Hamburg, Germany, 22143
    • GSK Investigational Site
  • Hamburg, Germany, 20095
    • GSK Investigational Site
  • Hannover, Germany, 30159
    • GSK Investigational Site
  • Koeln, Germany, 51069
    • GSK Investigational Site
  • Leipzig, Germany, 04103
    • GSK Investigational Site
  • Leipzig, Germany, 04347
    • GSK Investigational Site
  • Mainz, Germany, 55116
    • GSK Investigational Site
  • Muenchen, Germany, 80339
    • GSK Investigational Site
  • Schenefeld, Germany, 22869
    • GSK Investigational Site
  • Wallerfing, Germany, 94574
    • GSK Investigational Site
  • Wangen, Germany, 88239
    • GSK Investigational Site
  • Weinheim, Germany, 69469
    • GSK Investigational Site
  • Witten, Germany, 58455
    • GSK Investigational Site
  • Wuerzburg, Germany, 97070
    • GSK Investigational Site
  • Sachsen
    • Freiberg, Sachsen, Germany, 09599
      • GSK Investigational Site
• Italy
  • Alessandria, Italy, 15100
    • GSK Investigational Site
  • Bari, Italy, 70121
    • GSK Investigational Site
  • Belluno, Italy, 32100
    • GSK Investigational Site
  • Catanzaro, Italy, 88100
    • GSK Investigational Site
  • Chieri Torino, Italy, 10023
    • GSK Investigational Site
  • Ferrara, Italy, 44124
    • GSK Investigational Site
  • Genova, Italy, 16132
    • GSK Investigational Site
  • Milano, Italy, 20157
    • GSK Investigational Site
  • Milano, Italy, 20162
    • GSK Investigational Site
  • Napoli, Italy, 80131
    • GSK Investigational Site
  • Negrar Verona, Italy, 37024
    • GSK Investigational Site
  • Palermo, Italy, 90127
    • GSK Investigational Site
  • Pisa, Italy, 56126
    • GSK Investigational Site
  • Roma, Italy, 00168
    • GSK Investigational Site
  • Roma, Italy, 00128
    • GSK Investigational Site
  • Siena, Italy, 53100
    • GSK Investigational Site
  • Vercelli, Italy, 13100
    • GSK Investigational Site
• Japan
  • Chiba, Japan, 292-0805
    • GSK Investigational Site
  • Hiroshima, Japan, 732-0053
    • GSK Investigational Site
  • Ibaraki, Japan, 306-0041
    • GSK Investigational Site
  • Kumamoto, Japan, 860-0863
    • GSK Investigational Site
  • Okinawa, Japan, 901-2393
    • GSK Investigational Site
  • Osaka, Japan, 530-0001
    • GSK Investigational Site
  • Saitama, Japan, 350-1122
    • GSK Investigational Site
  • Shizuoka, Japan, 421-0193
    • GSK Investigational Site
  • Tokyo, Japan, 160-0017
    • GSK Investigational Site
  • Tokyo, Japan, 121-0815
    • GSK Investigational Site
  • Tokyo, Japan, 165-0031
    • GSK Investigational Site
  • Tokyo, Japan, 169-0072
    • GSK Investigational Site
  • Yamagata, Japan, 990-0834
    • GSK Investigational Site
  • Yamaguchi, Japan, 750-0061
    • GSK Investigational Site
• Korea, Republic of
  • Ansan, Korea, Republic of, 15355
    • GSK Investigational Site
  • Bucheon-si Kyunggi-do 14584, Korea, Republic of, 14584
    • GSK Investigational Site
  • Daegu, Korea, Republic of, 41944
    • GSK Investigational Site
  • Incheon, Korea, Republic of, 400-711
    • GSK Investigational Site
  • Jeonju, Korea, Republic of, 54907
    • GSK Investigational Site
  • Kangwon-do, Korea, Republic of, 26426
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 06351
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 137-701
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 135-720
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 08308
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 07441
    • GSK Investigational Site
  • Suwon Gyeonggi-do, Korea, Republic of, 442-723
    • GSK Investigational Site
• Mexico
  • Chihuahua, Mexico, 31203
    • GSK Investigational Site
  • Leon, Mexico, 37530
    • GSK Investigational Site
  • Merida, Mexico, 97070
    • GSK Investigational Site
  • Mexico City, Mexico, 06760
    • GSK Investigational Site
  • Mexico City, Mexico, 01120
    • GSK Investigational Site
  • Monterrey, Mexico, 64570
    • GSK Investigational Site
  • Oaxaca, Mexico, 68000
    • GSK Investigational Site
  • Queretaro, Mexico, 76070
    • GSK Investigational Site
  • RM Pharmamexico CITY, Mexico, 03100
    • GSK Investigational Site
  • San Luis PotosI, Mexico, 78209
    • GSK Investigational Site
• New Zealand
  • Grafton Auckland, New Zealand, 1010
    • GSK Investigational Site
  • Havelock North, New Zealand, 4130
    • GSK Investigational Site
  • Kapiti, New Zealand, 5032
    • GSK Investigational Site
  • Palmerston North, New Zealand, 5032
    • GSK Investigational Site
  • Tauranga, New Zealand, 3001
    • GSK Investigational Site
  • Wellington, New Zealand, 6021
    • GSK Investigational Site
• Poland
  • Czestochowa, Poland, 42202
    • GSK Investigational Site
  • Elblag, Poland, 82-300
    • GSK Investigational Site
  • Gdansk, Poland, 80-382
    • GSK Investigational Site
  • Gdynia, Poland, 81-537
    • GSK Investigational Site
  • Katowice, Poland, 40-040
    • GSK Investigational Site
  • Katowice, Poland, 40-282
    • GSK Investigational Site
  • Katowice, Poland, 40-648
    • GSK Investigational Site
  • Krakow, Poland, 31-501
    • GSK Investigational Site
  • Lodz, Poland, 90-127
    • GSK Investigational Site
  • Lodz, Poland, 91-363
    • GSK Investigational Site
  • Piaseczno, Poland, 05-500
    • GSK Investigational Site
  • Poznan, Poland, 60-702
    • GSK Investigational Site
  • Warszawa, Poland, 03-291
    • GSK Investigational Site
  • Warszawa, Poland, 02-672
    • GSK Investigational Site
  • Warszawa, Poland, 96-500
    • GSK Investigational Site
  • Wroclaw, Poland, 53-673
    • GSK Investigational Site
  • Wroclaw, Poland, 50-381
    • GSK Investigational Site
• Russian Federation
  • Barnaul, Russian Federation, 656043
    • GSK Investigational Site
  • Ekaterinburg, Russian Federation, 620137
    • GSK Investigational Site
  • Gatchina, Russian Federation, 188300
    • GSK Investigational Site
  • Kemerovo, Russian Federation, 650066
    • GSK Investigational Site
  • Moscow, Russian Federation, 115478
    • GSK Investigational Site
  • Saint-Petersburg, Russian Federation, 196158
    • GSK Investigational Site
  • Saint-Petersburg, Russian Federation, 197022
    • GSK Investigational Site
  • StPetersburg, Russian Federation, 191119
    • GSK Investigational Site
  • StPetersburg, Russian Federation, 196143
    • GSK Investigational Site
• South Africa
  • Cape Town, South Africa, 7700
    • GSK Investigational Site
  • Johannesburg, South Africa, 2113
    • GSK Investigational Site
  • Johannesburg, South Africa, 1818
    • GSK Investigational Site
  • Middelburg, South Africa, 1055
    • GSK Investigational Site
  • Moloto South, South Africa, 1022
    • GSK Investigational Site
  • Newcastle, South Africa, 9301
    • GSK Investigational Site
  • Reiger Park, South Africa, 1459
    • GSK Investigational Site
  • Tembisa, South Africa, 1632
    • GSK Investigational Site
• Spain
  • Alcorcon, Spain, 28922
    • GSK Investigational Site
  • Barcelona, Spain, 08025
    • GSK Investigational Site
  • Barcelona, Spain, 08036
    • GSK Investigational Site
  • Barcelona, Spain, 08907
    • GSK Investigational Site
  • Barcelona, Spain, 8025
    • GSK Investigational Site
  • Barcelona, Spain, 08023
    • GSK Investigational Site
  • Barcelona, Spain, 08540
    • GSK Investigational Site
  • Barcelona, Spain, 08430
    • GSK Investigational Site
  • Barcelona, Spain, 08500
    • GSK Investigational Site
  • Madrid, Spain, 28041
    • GSK Investigational Site
  • Madrid, Spain, 28006
    • GSK Investigational Site
  • Madrid, Spain, 28007
    • GSK Investigational Site
  • Madrid, Spain, 28046
    • GSK Investigational Site
  • Madrid, Spain, 28029
    • GSK Investigational Site
  • Madrid, Spain, 28222
    • GSK Investigational Site
  • Santiago de Compostela, Spain, 15706
    • GSK Investigational Site
  • Valencia, Spain, 46015
    • GSK Investigational Site
• United Kingdom
  • Bebington, United Kingdom, CH63 9JP
    • GSK Investigational Site
  • Belfast, United Kingdom, BT7 2EB
    • GSK Investigational Site
  • Birmingham, United Kingdom, B15 2SQ
    • GSK Investigational Site
  • Bradford On Avon Wiltsh, United Kingdom, BA15 1DQ
    • GSK Investigational Site
  • Cardiff, United Kingdom, CF15 9SS
    • GSK Investigational Site
  • Corby, United Kingdom, NN17 2UR
    • GSK Investigational Site
  • Eynsham, United Kingdom, OX29 4QB
    • GSK Investigational Site
  • Glasgow, United Kingdom, ML4 3NJ
    • GSK Investigational Site
  • Hardwick, United Kingdom, NE461QJ
    • GSK Investigational Site
  • Hexham, United Kingdom, NE46 1QJ
    • GSK Investigational Site
  • Lancashire, United Kingdom, PR7 7NA
    • GSK Investigational Site
  • Leamington Spa, United Kingdom, CV32 4RA
    • GSK Investigational Site
  • Liverpool, United Kingdom, L22 0LG
    • GSK Investigational Site
  • Manchester, United Kingdom, M15 6SX
    • GSK Investigational Site
  • Orpington, United Kingdom, BR5 3QG
    • GSK Investigational Site
  • Oxford, United Kingdom, OX4 1XB
    • GSK Investigational Site
  • Peterborough, United Kingdom, PE8 6PL
    • GSK Investigational Site
  • Romford, United Kingdom, BR5 3QG
    • GSK Investigational Site
  • Thetford Norfolk, United Kingdom, IP24 2HY
    • GSK Investigational Site
  • Witney, United Kingdom, OX28 6JS
    • GSK Investigational Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • GSK Investigational Site
    • Birmingham, Alabama, United States, 35211
      • GSK Investigational Site
    • Huntsville, Alabama, United States, 35802
      • GSK Investigational Site
  • Arizona
    • Phoenix, Arizona, United States, 85306
      • GSK Investigational Site
    • Tucson, Arizona, United States, 85741
      • GSK Investigational Site
  • California
    • Cerritos, California, United States, 90703
      • GSK Investigational Site
    • Laguna Hills, California, United States, 92653
      • GSK Investigational Site
  • Florida
    • Coral Gables, Florida, United States, 33134
      • GSK Investigational Site
    • Fort Myers, Florida, United States, 33912
      • GSK Investigational Site
    • Jacksonville, Florida, United States, 32205
      • GSK Investigational Site
    • Lake City, Florida, United States, 32055
      • GSK Investigational Site
    • Melbourne, Florida, United States, 32934
      • GSK Investigational Site
    • Miami, Florida, United States, 33174
      • GSK Investigational Site
    • Orlando, Florida, United States, 32806
      • GSK Investigational Site
    • Pinellas Park, Florida, United States, 33781
      • GSK Investigational Site
    • The Villages, Florida, United States, 32162
      • GSK Investigational Site
    • Weeki Wachee, Florida, United States, 34607
      • GSK Investigational Site
    • West Palm Beach, Florida, United States, 33409
      • GSK Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • GSK Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60602
      • GSK Investigational Site
  • Indiana
    • Evansville, Indiana, United States, 47714
      • GSK Investigational Site
    • Mishawaka, Indiana, United States, 46544
      • GSK Investigational Site
  • Kansas
    • El Dorado, Kansas, United States, 67042
      • GSK Investigational Site
    • Newton, Kansas, United States, 67114
      • GSK Investigational Site
    • Wichita, Kansas, United States, 67207
      • GSK Investigational Site
    • Wichita, Kansas, United States, 67205
      • GSK Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • GSK Investigational Site
  • Maryland
    • Rockville, Maryland, United States, 20854
      • GSK Investigational Site
  • Minnesota
    • Richfield, Minnesota, United States, 55423
      • GSK Investigational Site
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • GSK Investigational Site
    • Saint Louis, Missouri, United States, 63141
      • GSK Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • GSK Investigational Site
  • Nevada
    • Henderson, Nevada, United States, 89052
      • GSK Investigational Site
  • New York
    • Binghamton, New York, United States, 31406
      • GSK Investigational Site
    • Jamaica, New York, United States, 10017
      • GSK Investigational Site
    • Rochester, New York, United States, 14609
      • GSK Investigational Site
  • North Carolina
    • Hickory, North Carolina, United States, 28601
      • GSK Investigational Site
    • Rocky Mount, North Carolina, United States, 27804
      • GSK Investigational Site
    • Salisbury, North Carolina, United States, 28144
      • GSK Investigational Site
    • Statesville, North Carolina, United States, 28117
      • GSK Investigational Site
    • Winston-Salem, North Carolina, United States, 27103
      • GSK Investigational Site
  • Ohio
    • Akron, Ohio, United States, 44311
      • GSK Investigational Site
    • Centerville, Ohio, United States, 45459
      • GSK Investigational Site
    • Cincinnati, Ohio, United States, 45236
      • GSK Investigational Site
    • Columbus, Ohio, United States, 43212
      • GSK Investigational Site
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16508
      • GSK Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15236
      • GSK Investigational Site
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • GSK Investigational Site
    • Mount Pleasant, South Carolina, United States, 29405
      • GSK Investigational Site
  • Tennessee
    • Knoxville, Tennessee, United States, 37912
      • GSK Investigational Site
    • Memphis, Tennessee, United States, 38119
      • GSK Investigational Site
  • Texas
    • Dallas, Texas, United States, 75234
      • GSK Investigational Site
    • Fort Worth, Texas, United States, 76104
      • GSK Investigational Site
    • Houston, Texas, United States, 77055
      • GSK Investigational Site
    • Houston, Texas, United States, 77008
      • GSK Investigational Site
    • Keller, Texas, United States, 76248
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78229
      • GSK Investigational Site
  • Utah
    • Layton, Utah, United States, 84041
      • GSK Investigational Site
    • Murray, Utah, United States, 84106
      • GSK Investigational Site
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 56 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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.
• Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the first study vaccine or planned administration during the study period.
• Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the first study vaccine administration or planned administration during the study period. For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Inhaled and topical steroids are allowed.

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 (drug or medical device).

Other exclusions

• History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
• Bedridden participants.

• Planned move during the study period that will prohibit participating in the trial until study end. This includes:

  • Planned move during the study period to another LTCF that will prohibit participation in the trial until study end.
  • Planned move from the community to a LTCF that will prohibit participation in the trial until study end.
• Participation of any study personnel or their immediate dependants, family, or household members.

• Planned leave or holiday of 4 consecutive weeks or more during the RSV seasons* covered by the study, that would prohibit the reporting of ARI cases and attendance to ARI visit.

  • RSV seasons are from October to April in NH and from March to September in SH.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RSVPreF3 Group; Participants 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.	Biological: RSVPreF3 OA vaccine; 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.
Placebo Comparator: Placebo Group; Participants received 1 dose of placebo at Day 1 and an additional dose of placebo every subsequent year of the study.	Biological: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Efficacy of a single dose of the RSVPreF3 OA vaccine was assessed against RSV A and/or B confirmed LRTD over several seasons according to the case definition.	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	Efficacy of annual revaccination doses of the RSVPreF3 OA vaccine was assessed against RSV A and/or B confirmed LRTD over several seasons according to the case definition.	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	Efficacy of a single dose of the RSVPreF3 OA vaccine was assessed against LRTD episode caused by RSV A and B subtype over 3 seasons according to the case definition.	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	Efficacy of a single dose and 1 annual revaccination dose of the RSVPreF3 OA vaccine was assessed against LRTD episode caused by RSV A and B subtype over 3 seasons according to the case definition.	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)]
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD, by Age Categories Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses	Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses was assessed against RSV A and/or B confirmed LRTD episode according to the case definition, in the following age categories: greater than or equal to (≥) 65 years of age (YOA), ≥70 YOA and ≥80 YOA.	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 A and/or B Associated LRTD by RSV Season Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses	Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses was assessed against RSV A and/or B confirmed LRTD episode according to the case definition, by RSV season as follows: VE after each season includes the first occurrence of episodes reported from Day 15 post vaccination at first season, and for the next seasons, excluding analysis of participants who already reported a case in the previous season. The RSV season may be extended based on epidemiology data.	From Day 15 post first dose or start of the RSV season to the first occurrence of RSV-confirmed LRTD at each RSV season (assessed approximately over 7 months at each season [Seasons 1 and 2 in SH, Seasons 1, 2 and 3 in NH])
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Year Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses	Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses was assessed against RSV A and/or B confirmed LRTD episode according to the case definition, by years after vaccination as follows: VE at each year includes the first occurrence of episodes reported from Day 14 post vaccination at first year, and for the next years, excluding analysis of participants who already reported a case in the previous year.	From Day 15 post first dose and each revaccination dose up to next dose or end of study (assessed approximately over a year after each vaccination [at Year 1, Year 2 and Year 3])
Number of Participants With First Episode of RT-PCR Confirmed RSV A and /or B Associated LRTD, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses		From Day 15 post first dose to the first occurrence of RSV LRTD (assessed approximately over 3 years in the NH and 2.5-3 years in SH)
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities Using Charlson Comorbidity Index Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses	Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV A and/or B associated LRTD episode by baseline comorbidities using Charlson Comorbidity Index. Low/medium Risk = Participants with co-morbidity score at baseline less than or equal to 3 (Charlson Index); High Risk = Participants with co-morbidity score at baseline greater than 3 (Charlson Index).	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 A and/or B Associated LRTD by Baseline Comorbidities According to Comorbidities of Interest Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses	Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV A and/or B associated LRTD episode by baseline comorbidities of interest divided into 2: cardiorespiratory conditions such as chronic obstructive pulmonary disease (COPD), asthma, any chronic respiratory or pulmonary disease, and endocrinometabolic conditions such as diabetes mellitus type 1 or 2, chronic heart failure and advanced liver or renal disease.	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 A and/or B Associated LRTD by Baseline Frailty Status Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses	Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV A and /or B associated LRTD episode according to the case definition, by baseline frailty status of frail, pre-frail and fit. Frail = Participants with a walking speed of less than (<) 0.4 meters per second (m/s) or who were not able to perform the test; Pre-Frail = Participants with a walking speed between 0.4-0.99 m/s; Fit = Participants with a walking speed of ≥1 m/s.	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 A and/or B Associated Severe LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses	Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV A and/or B associated severe LRTD episode. Case definition for RSV-confirmed severe LRTD: An RT-PCR confirmed case of RSV-associated severe LRTD is characterized by presence of lower respiratory signs or an LRTD episode assessed as severe by the investigator (Severe LRTD case definition 1) or presence of an LRTD with need for oxygen supplementation or need for positive airway pressure therapy or need for other types of mechanical ventilation (Severe LRTD case definition 2) and with at least one RSV positive swab detected by RT-PCR.	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 A and/or B Associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses	Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV confirmed A and/or B associated ARI episode. A case of RT-PCR confirmed RSV-associated ARI is characterized by the presence of respiratory symptoms/signs for at least 24 hours OR respiratory symptom/sign + systemic symptom/sign for at least 24 hours with at least one RSV-positive swab detected by RT-PCR.	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 Any ARI or Any LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses	Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against any ARI and any LRTD.	From Day 15 post first vaccination up to study end (approximately 3 years for NH and 2.5-3 years for SH)
Number of Hospitalizations Due to RSV-confirmed Respiratory Diseases or Due to Complication Related to RSV-confirmed Respiratory Diseases, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study	RSV infection was confirmed by RT-PCR.	From Day 15 post-first vaccination up to study end (approximately 3 years for NH and 2.5-3 years for SH)
Number of Hospitalizations Due to Any Respiratory Diseases or Due to a Complication Related to Any Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study	A diagnosis of respiratory disease included: acute respiratory infections, other diseases of upper respiratory tract, pneumonia and influenza, chronic obstructive pulmonary disease and allied conditions, pneumoconioses and other lung diseases due to external agents, other diseases of respiratory system.	From Day 15 post-first vaccination up to study end (approximately 3 years for NH and 2.5-3 years for SH)
Number of Complications Related to RSV-confirmed ARI During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study	RSV infection was confirmed by RT-PCR.	From Day 15 post-first vaccination up to study end (approximately 3 years for NH and 2.5-3 years for SH)
Number of Complications Related to Any ARI During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study	RSV infection was confirmed by RT-PCR.	From Day 15 post-first vaccination up to study end (approximately 3 years for NH and 2.5-3 years for SH)
Maximum Influenza Patient-Reported Outcome (Flu-PRO) Chest Score for the Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses	For this outcome measure, the Health Related -Quality of life (HR-QOL) score is measured by Flu-PRO questionnaire version 2.0. The Flu-PRO is a 32 items daily diary, which assesses influenza signs across 6 body systems- nose, throat, eyes, chest/respiratory, gastrointestinal and body/systemic. The objective of this outcome measure was to present data only for chest/respiratory system after a single dose and after annual revaccination. The FLU-PRO score was computed as the mean score across questionaire items for chest/respiratory body system, with the scores ranging from 0 (symptom free) to 4 (very severe symptoms).	During the first 7 days from the onset of ARI symptoms (assessed from Day 15 post first vaccination dose until end of study [approximately 3 years in NH and 2.5-3 years in SH])
Least Square Mean Flu-PRO Total Score for the Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses	The Flu-PRO questionnaire version 2.0 is a 32 items daily diary, which assesses influenza signs across 6 body systems- nose, throat, eyes, chest/respiratory, gastrointestinal and body/systemic. The FLU-PRO total score was computed as the mean score across all 32 items of the questionaire for all 6 body systems, with the total scores ranging from 0 (symptom free) to 4 (very severe symptoms).	During the first 7 days from the onset of ARI symptoms (assessed from Day 15 post first vaccination dose until end of study [approximately 3 years in NH and 2.5-3 years in SH])
EuroQol 5-dimension Health Questionnaire (EQ-5D) Utility Score for Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses	The EQ-5D is a general health utility questionnaire with health states, defined through 5 dimensions- mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression. A participant who responds 1 (no problem/no symptom) to all 5 items has a profile "11111" and similarly a participant who responds 3 (the highest level of difficulty or symptom) to all items has a profile "33333". The health states indicated in these 5 dimensions are converted and presented as a single mean index value as recommended by EuroQol group, where values range from 0 (worst) to 1 (full health).	At the ARI visit (assessed from Day 15 post first vaccination dose until end of study- approximately 3 years in NH and 2.5-3 years in SH)
Least Square Mean of Short Form-12 (SF-12) Health Survey for Participants With RT-PCR Confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses	SF-12 is a health survey with 12 questions, covering 8 domains- physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. Summary scores are computed from these domains for the physical and mental component. The total score of the SF-12 questionnaire is evaluated on a scale from 0 to 100, with a higher score indicating a better perceived health-related quality of life.	At the ARI visit (assessed from one-month post first vaccination dose until end of study- approximately 3 years in NH and 2.5-3 years in SH)
Duration in Days of RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes	The duration in days of RT-PCR confirmed RSV A and/or B ARI and LRTD episodes are described.	From Day 15 post first dose to end of Season 1, from 15 days post-second dose administration to end of Season 2, and from start to end of Season 3 [all seasons summing approximately 3 years in NH and 2.5-3 years in SH]
Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1	RSV infection was confirmed by RT-PCR, and the symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B ARI episodes were reported. Fever was defined as a temperature ≥38.0 degrees Celsius (°C) by any route.	From Day 15 post-dose 1 administration 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)]
Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2	RSV infection was confirmed by RT-PCR, and the symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B ARI episodes were reported. Fever was defined as a temperature ≥38.0 degrees Celsius (°C) by any route.	From Day 15 post-dose 2 administration up to end of Season 2 in SH (a median of approximately 11.9 months [11.9 months in NH and 7.5 months in SH])
Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3	RSV infection was confirmed by RT-PCR, and the symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B ARI episodes were reported. Fever was defined as a temperature ≥38.0 degrees Celsius (°C) by any route.	From start of Season 3 up to end of Season 3 in NH (a median of approximately 7 months)
Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1	RSV infection was confirmed by RT-PCR, and the symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B LRTD episodes were reported. Fever was defined as a temperature ≥38.0°C by any route.	From Day 15 post-dose 1 administration 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)]
Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2	RSV infection was confirmed by RT-PCR, and the symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B LRTD episodes were reported. Fever was defined as a temperature ≥38.0°C by any route.	From Day 15 post-dose 2 administration up to end of Season 2 in SH (a median of approximately 11.9 months [11.9 months in NH and 7.5 months in SH])
Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3	RSV infection was confirmed by RT-PCR, and the symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B LRTD episodes were reported. Fever was defined as a temperature ≥38.0°C by any route.	From start of Season 3 up to end of Season 3 in NH (a median of approximately 7 months)
Number of Participants With RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes According to Severity	RSV A and/or B ARI and LRTD episodes were assessed as "mild", "moderate" or "severe" by the investigator after the single dose and after annual revaccination. Mild = an ARI/LRTD episode which is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities. Moderate = an ARI/LRTD episode which is sufficiently discomforting to interfere with normal everyday activities. Severe = an ARI/LRTD episode which prevents normal, everyday activities.	Assessed during the study period (approximately 3 years for NH and 2.5-3 years for SH)
RSVPreF3 Specific Immunoglobulin G(IgG) Antibody Concentrations	The RSVPreF3 IgG antibody concentrations are expressed as geometric mean concentrations (GMCs) in ELISA units per milliliter (EU/mL).	At pre-dose 1 (Day 1), Day 31 post-dose 1, pre-season 2 (approximately 10-17 months post Day 1 in NH; 12-21 months post Day 1 in SH) and pre-season 3 (approximately 24-27 months post Day 1, only in NH)
RSV A Neutralizing Antibody Titers	The RSV A neutralizing antibody titers are expressed as geometric mean titers (GMTs).	At pre-dose 1 (Day 1), Day 31 post-dose 1, pre-season 2 (approximately 10-17 months post Day 1 in NH; 12-21 months post Day 1 in SH) and pre-season 3 (approximately 24-27 months post Day 1, only in NH)
RSV B Neutralizing Antibody Titers	RSV B neutralizing antibodies are expressed as GMTs.	At pre-dose 1 (Day 1), Day 31 post-dose 1, pre-season 2 (approximately 10-17 months post Day 1 in NH; 12-21 months post Day 1 in SH) and pre-season 3 (approximately 24-27 months post Day 1, only in NH)
Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events	Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade or relation to study vaccination. Grade 3 = an event which prevented normal, everyday activities. The assessed administration site events include pain, erythema and swelling.	During the 4-day follow up period after first vaccination (Day 1), second vaccination (administered pre-season 2) and after the third vaccination (administered pre-season 3 -only applicable for participants in NH])
Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events	Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade or relation to study vaccination. Grade 3 = an event which prevented normal, everyday activities. The assessed solicited systemic events include arthralgia, fatigue, fever, headache and myalgia. Fever is defined as a temperature ≥ 38.0°C by any route. Grade 3 fever is defined as temperature >39°C by any route.	During the 4-day follow up period after first vaccination (Day 1), second vaccination (administered pre-season 2) and after the third vaccination (administered pre-season 3 -only applicable for participants in NH])
Number of Days With Solicited Administration Site Adverse Events		During the 4-day follow up period after first vaccination (Day 1), second vaccination (administered pre-season 2) and after the third vaccination (administered pre-season 3 -only applicable for participants in NH])
Number of Days With Solicited Systemic Adverse Events		During the 4-day follow up period after first vaccination (Day 1), second vaccination (administered pre-season 2) and after the third vaccination (administered pre-season 3 -only applicable for participants in NH])
Number of Participants With Any Unsolicited AEs	An unsolicited AE is defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside of the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Any= occurrence of the event regardless of intensity grade or relation to the study vaccination.	During the 30-day follow up period after first vaccination (Day 1), second vaccination (administered pre-season 2) and after the third vaccination (administered pre-season 3 -only applicable for participants in NH)
Number of Participants With Serious Adverse Events (SAEs)	An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant, or in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to study vaccination.	From the day of the vaccination up to 6 months after each vaccination (first vaccination: at Day 1, second vaccination: at pre-season 2 and the third vaccination: at pre-season 3 -only applicable for participants in NH])
Number of Participants With Potential Immune Mediated Diseases (pIMDs)	pIMDs aredefined as a subset of Adverse Events of Specific Interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any= occurrence of any pIMD regardless of intensity grade or relation to the study vaccination.	From the day of the vaccination up to 6 months after each vaccination (first vaccination: at Day 1, second vaccination: at pre-season 2 and the third vaccination: at pre-season 3 -only applicable for participants in NH])
Number of Participants With Related SAEs	Related SAEs that occur throughout the study are assessed. Related SAEs= Any SAE related to investigational vaccine or related to study participation or to a GSK concomitant medication/vaccine as assessed by the investigator.	From Day 1 up to study end (approximately 3 years for NH and 2.5-3 years for SH)
Number of Participants With Fatal SAEs	Fatal SAEs that occur throughout the study are assessed. Fatal SAEs= Any SAEs leading to deaths.	From Day 1 up to study end (approximately 3 years for NH and 2.5-3 years for SH)
Number of Participants With Related pIMDs	Related pIMD = pIMD assessed by the investigator as related to the study vaccination.	From Day 1 up to study end (approximately 3 years for NH and 2.5-3 years for SH)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2021
• Primary Completion (Actual): April 11, 2022
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (Actual): May 14, 2021

Study Record Updates

• Last Update Posted (Actual): July 31, 2025
• Last Update Submitted That Met QC Criteria: July 11, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Respiratory syncytial virus; Lower respiratory tract disease; Efficacy study; Adults aged 60 years and above
• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: 212494; 2020-000753-28 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No