Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above

Respiratory Syncytial Virus Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04886596
• Other study ID #: 212494
• Secondary ID: 2020-000753-28
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 25, 2021
• Est. completion date: June 18, 2024

Study information

• Verified date: April 2024
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26668
• Est. completion date: June 18, 2024
• Est. primary completion date: April 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Camberwell	Victoria
Australia	GSK Investigational Site	Coffs Harbour	New South Wales
Australia	GSK Investigational Site	Darlinghurst	New South Wales
Australia	GSK Investigational Site	Geelong	Victoria
Australia	GSK Investigational Site	Kogarah	New South Wales
Australia	GSK Investigational Site	Morayfield	Queensland
Australia	GSK Investigational Site	Spearwood	Western Australia
Australia	GSK Investigational Site	Taringa	Queensland
Australia	GSK Investigational Site	Tarragindi	Queensland
Belgium	GSK Investigational Site	Aalst
Belgium	GSK Investigational Site	Alken
Belgium	GSK Investigational Site	Edegem
Belgium	GSK Investigational Site	Erpent
Belgium	GSK Investigational Site	Genk
Belgium	GSK Investigational Site	Gent
Belgium	GSK Investigational Site	Gozée
Belgium	GSK Investigational Site	Gribomont
Belgium	GSK Investigational Site	Halen
Belgium	GSK Investigational Site	Hasselt
Belgium	GSK Investigational Site	Ieper
Belgium	GSK Investigational Site	Kluisbergen
Belgium	GSK Investigational Site	Mechelen
Belgium	GSK Investigational Site	Stoumont
Belgium	GSK Investigational Site	Tremelo
Canada	GSK Investigational Site	Chicoutimi	Quebec
Canada	GSK Investigational Site	Edmonton	Alberta
Canada	GSK Investigational Site	Greater Sudbury	Ontario
Canada	GSK Investigational Site	Halifax	Nova Scotia
Canada	GSK Investigational Site	London	Ontario
Canada	GSK Investigational Site	Mirabel	Quebec
Canada	GSK Investigational Site	New Westminster	British Columbia
Canada	GSK Investigational Site	Ottawa	Ontario
Canada	GSK Investigational Site	Pointe-Claire	Quebec
Canada	GSK Investigational Site	Quebec
Canada	GSK Investigational Site	Québec City	Quebec
Canada	GSK Investigational Site	Sarnia	Ontario
Canada	GSK Investigational Site	Sherbrooke	Quebec
Canada	GSK Investigational Site	St. Charles-Borromee	Quebec
Canada	GSK Investigational Site	Surrey	British Columbia
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Truro	Nova Scotia
Canada	GSK Investigational Site	Vancouver	British Columbia
Canada	GSK Investigational Site	Victoria	British Columbia
Canada	GSK Investigational Site	Victoria	British Columbia
Estonia	GSK Investigational Site	Paide
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tartu
Finland	GSK Investigational Site	Espoo
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Jarvenpaa
Finland	GSK Investigational Site	Kokkola
Finland	GSK Investigational Site	Oulu
Finland	GSK Investigational Site	Pori
Finland	GSK Investigational Site	Seinajoki
Finland	GSK Investigational Site	Tampere
Finland	GSK Investigational Site	Turku
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Dachau	Bayern
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Floersheim	Hessen
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Freiberg	Sachsen
Germany	GSK Investigational Site	Freital	Sachsen
Germany	GSK Investigational Site	Goch	Nordrhein-Westfalen
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hannover	Niedersachsen
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Schenefeld	Schleswig-Holstein
Germany	GSK Investigational Site	Schmiedeberg	Sachsen
Germany	GSK Investigational Site	Wallerfing	Bayern
Germany	GSK Investigational Site	Wangen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Weinheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Witten	Nordrhein-Westfalen
Germany	GSK Investigational Site	Wuerzburg	Bayern
Italy	GSK Investigational Site	Alessandria	Piemonte
Italy	GSK Investigational Site	Bari	Puglia
Italy	GSK Investigational Site	Belluno	Veneto
Italy	GSK Investigational Site	Catanzaro	Calabria
Italy	GSK Investigational Site	Chieri (TO)
Italy	GSK Investigational Site	Cona (FE)	Emilia-Romagna
Italy	GSK Investigational Site	Genova	Liguria
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Napoli	Campania
Italy	GSK Investigational Site	Negrar	Veneto
Italy	GSK Investigational Site	Palermo	Sicilia
Italy	GSK Investigational Site	Pisa	Toscana
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Siena	Toscana
Italy	GSK Investigational Site	Vercelli	Piemonte
Japan	GSK Investigational Site	Chiba
Japan	GSK Investigational Site	Hiroshima
Japan	GSK Investigational Site	Ibaraki
Japan	GSK Investigational Site	Kumamoto
Japan	GSK Investigational Site	Okinawa
Japan	GSK Investigational Site	Osaka
Japan	GSK Investigational Site	Saitama
Japan	GSK Investigational Site	Shizuoka
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Yamagata
Japan	GSK Investigational Site	Yamaguchi
Korea, Republic of	GSK Investigational Site	Daegu
Korea, Republic of	GSK Investigational Site	Gangwon-do
Korea, Republic of	GSK Investigational Site	Gyeonggi
Korea, Republic of	GSK Investigational Site	Gyeonggi-do
Korea, Republic of	GSK Investigational Site	Gyeonggi-do
Korea, Republic of	GSK Investigational Site	Incheon
Korea, Republic of	GSK Investigational Site	Jeonju-si, Jeollabuk-do
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Mexico	GSK Investigational Site	Chihuahua
Mexico	GSK Investigational Site	Leon	Guanajuato
Mexico	GSK Investigational Site	Merida	Yucatán
Mexico	GSK Investigational Site	Mexico City
Mexico	GSK Investigational Site	Mexico City
Mexico	GSK Investigational Site	Mexico City	Ciudad De Mexico
Mexico	GSK Investigational Site	Monterrey	Nuevo León
Mexico	GSK Investigational Site	Oaxaca
Mexico	GSK Investigational Site	Queretaro	Querétaro
Mexico	GSK Investigational Site	San Luis Potosí
New Zealand	GSK Investigational Site	Auckland
New Zealand	GSK Investigational Site	Havelock North
New Zealand	GSK Investigational Site	Paraparaumu
New Zealand	GSK Investigational Site	Tauranga
New Zealand	GSK Investigational Site	Wellington
Poland	GSK Investigational Site	Czestochowa
Poland	GSK Investigational Site	Elblg
Poland	GSK Investigational Site	Gdansk
Poland	GSK Investigational Site	Gdynia
Poland	GSK Investigational Site	Katowice
Poland	GSK Investigational Site	Katowice
Poland	GSK Investigational Site	Katowice
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Lodz
Poland	GSK Investigational Site	Lodz
Poland	GSK Investigational Site	Piaseczno
Poland	GSK Investigational Site	Poznan
Poland	GSK Investigational Site	Sochaczew
Poland	GSK Investigational Site	Warszawa
Poland	GSK Investigational Site	Warszawa
Poland	GSK Investigational Site	Wroclaw
Poland	GSK Investigational Site	Wroclaw
Russian Federation	GSK Investigational Site	Barnaul
Russian Federation	GSK Investigational Site	Ekaterinburg
Russian Federation	GSK Investigational Site	Gatchina
Russian Federation	GSK Investigational Site	Kemerovo
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Saint Petersburg
Russian Federation	GSK Investigational Site	Saint-Petersburg
Russian Federation	GSK Investigational Site	St.Petersburg
Russian Federation	GSK Investigational Site	St.Petersburg
South Africa	GSK Investigational Site	Bloemfontein
South Africa	GSK Investigational Site	Boksburg	Gauteng
South Africa	GSK Investigational Site	Johannesburg	Gauteng
South Africa	GSK Investigational Site	Johannesburg	Gauteng
South Africa	GSK Investigational Site	Johannesburg	Gauteng
South Africa	GSK Investigational Site	Middelburg	Mpumalanga
South Africa	GSK Investigational Site	Moloto South	Gauteng
South Africa	GSK Investigational Site	Mowbray
Spain	GSK Investigational Site	Alcorcón (Madrid)
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Centelles (Barcelona)
Spain	GSK Investigational Site	Hospitalet de Llobregat
Spain	GSK Investigational Site	La Roca del Vallès
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Majadahonda (Madrid)
Spain	GSK Investigational Site	Santiago de Compostela
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Vic
United Kingdom	GSK Investigational Site	Bebington
United Kingdom	GSK Investigational Site	Belfast
United Kingdom	GSK Investigational Site	Bellshill	Lanarkshire
United Kingdom	GSK Investigational Site	Birmingham
United Kingdom	GSK Investigational Site	Bradford on Avon	Wiltshire
United Kingdom	GSK Investigational Site	Buckshaw Village, Chorley	Lancashire
United Kingdom	GSK Investigational Site	Corby	Northamptonshire
United Kingdom	GSK Investigational Site	Eynsham
United Kingdom	GSK Investigational Site	Gwaelod-y-Garth, Cardiff
United Kingdom	GSK Investigational Site	Hexham
United Kingdom	GSK Investigational Site	Hexham
United Kingdom	GSK Investigational Site	Leamington Spa	Warwickshire
United Kingdom	GSK Investigational Site	Liverpool
United Kingdom	GSK Investigational Site	Manchester
United Kingdom	GSK Investigational Site	Orpington	Kent
United Kingdom	GSK Investigational Site	Oxford
United Kingdom	GSK Investigational Site	Peterborough	Cambridgeshire
United Kingdom	GSK Investigational Site	Thetford	Norfolk
United Kingdom	GSK Investigational Site	Witney
United States	GSK Investigational Site	Akron	Ohio
United States	GSK Investigational Site	Anderson	South Carolina
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Centerville	Ohio
United States	GSK Investigational Site	Cerritos	California
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Columbus	Ohio
United States	GSK Investigational Site	Coral Gables	Florida
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	El Dorado	Kansas
United States	GSK Investigational Site	Erie	Pennsylvania
United States	GSK Investigational Site	Evansville	Indiana
United States	GSK Investigational Site	Fort Myers	Florida
United States	GSK Investigational Site	Fort Worth	Texas
United States	GSK Investigational Site	Glendale	Arizona
United States	GSK Investigational Site	Henderson	Nevada
United States	GSK Investigational Site	Hickory	North Carolina
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Huntsville	Alabama
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Kansas City	Missouri
United States	GSK Investigational Site	Keller	Texas
United States	GSK Investigational Site	Knoxville	Tennessee
United States	GSK Investigational Site	Laguna Hills	California
United States	GSK Investigational Site	Lake City	Florida
United States	GSK Investigational Site	Layton	Utah
United States	GSK Investigational Site	Lexington	Kentucky
United States	GSK Investigational Site	Melbourne	Florida
United States	GSK Investigational Site	Memphis	Tennessee
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Mishawaka	Indiana
United States	GSK Investigational Site	Mooresville	North Carolina
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Newton	Kansas
United States	GSK Investigational Site	Norfolk	Virginia
United States	GSK Investigational Site	North Charleston	South Carolina
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Pinellas Park	Florida
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Richfield	Minnesota
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	Rockville	Maryland
United States	GSK Investigational Site	Rocky Mount	North Carolina
United States	GSK Investigational Site	Saint Louis	Missouri
United States	GSK Investigational Site	Salisbury	North Carolina
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	Savannah	Georgia
United States	GSK Investigational Site	The Villages	Florida
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Weeki Wachee	Florida
United States	GSK Investigational Site	West Palm Beach	Florida
United States	GSK Investigational Site	Wichita	Kansas
United States	GSK Investigational Site	Wichita	Kansas
United States	GSK Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

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

References & Publications (1)

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 prefusion F protein vaccine (RSVPreF3 OA) in older adults over 2 RSV seasons. Clin Infect Dis. 2024 Jan 22:ciae010. doi: 10.1093/cid/ciae010. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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) [assessed approximately 6.7 months per participant]
Secondary	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 will be assessed against RSV A and/or B confirmed LRTD over several seasons according to the case definition.; The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.	From Day 15 post first vaccination up to end of season 2 and up to end of season 3 in the Northern Hemishpere (NH) (assessed approximately over 2 and 3 years in NH, and 1.5-2 and 2.5-3 years in Southern Hemisphere [SH])
Secondary	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 will be assessed against RSV A and/or B confirmed LRTD over several seasons according to the case definition.; The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. Participants in RSVPreF3 groups will be randomized before Season 2 into 2 sub-groups (RSV_annual group and RSV_1dose group). Results for RSV_annual group and RSV_1dose group of subsequent seasons will be updated during final posting.	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, and 1.5-2 and 2.5-3 years in Southern Hemisphere [SH])
Secondary	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.; Results for the entire study period will be updated at the final results disclosure stage.	From Day 15 post first vaccination up to end of season 3 in the Northern Hemisphere (NH) (assessed approximately over 3 years in the NH and 2.5-3 years in Southern Hemisphere [SH])
Secondary	Number of Participants With First Episode of RT-PCR Confirmed RSV Subtype A and Subtype B LRTD Over 3 Seasons Following Annual Revaccination Doses of the RSVPreF3 OA Vaccine	Efficacy of annual revaccination doses of the RSVPreF3 OA vaccine will be assessed against LRTD episode caused by RSV A and B subtype over 3 seasons according to the case definition.; The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. Participants in RSVPreF3 groups will be randomized before Season 2 into 2 sub-groups (RSV_annual group and RSV_1dose group). Results for RSV_annual group and RSV_1dose group of subsequent seasons will be updated during final posting.	From Day 15 post first vaccination up to end of season 3 in the Northern Hemisphere (NH) (approximately 3 years for NH and 2.5-3 years for Southern Hemisphere [SH])
Secondary	Number of Participants With First Episode of RT-PCR Confirmed LRTD Caused by Other Respiratory Pathogens Over 3 Seasons Following a Single Dose of the RSVPreF3 OA Vaccine	Efficacy of a single dose of the RSVPreF3 OA vaccine will be assessed against LRTD episode caused by other respiratory pathogens over 3 seasons according to the case definition. A LRTD caused by other respiratory pathogens is characterized by at least one positive swab for other respiratory pathogens detected by RT-PCR.; Results for the entire study period will be updated at the final results disclosure stage.	From Day 15 post first vaccination up to end of season 3 in the Northern Hemisphere (NH) (approximately 3 years for NH and 2.5-3 years for Southern Hemisphere [SH])
Secondary	Number of Participants With First Episode of RT-PCR Confirmed LRTD Caused by Other Respiratory Pathogens Over 3 Seasons Following Annual Revaccination Doses of the RSVPreF3 OA Vaccine	Efficacy of annual revaccination doses of the RSVPreF3 OA vaccine will be assessed against LRTD episode caused by other respiratory pathogens over 3 seasons according to the case definition. A LRTD caused by other respiratory pathogens is characterized by at least one positive swab for other respiratory pathogens detected by RT-PCR.; The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. Participants in RSVPreF3 groups will be randomized before Season 2 into 2 sub-groups (RSV_annual group and RSV_1dose group). Results for RSV_annual group and RSV_1dose group of subsequent seasons will be updated during final posting.	From Day 15 post first vaccination up to end of season 3 in the Northern Hemisphere (NH) (approximately 3 years for NH and 2.5-3 years for Southern Hemisphere [SH])
Secondary	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: =65 YOA, =70 YOA and =80 YOA.; Results for LRTD by age will be updated at the final results disclosure stage.	From Day 15 post first dose to the first occurrence of RSV LRTD (assessed approximately over 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
Secondary	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 will be 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 at least one-month 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.; Results for LRTD by Season will be updated at the final results disclosure stage.	From Day 15 post first-vaccination 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
Secondary	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 will be 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 at least one month post vaccination at first year, and for the next years, excluding analysis of participants who already reported a case in the previous year.; Results for LRTD by year will be updated during final result posting stage.	From Day 15 post first and each revaccination dose up to next dose or end of study (assessed approximately over a year after each vaccination)
Secondary	Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities 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 (such as COPD, asthma, any chronic respiratory or pulmonary disease, diabetes mellitus type 1 or 2, chronic heart failure and advanced liver or renal disease) and according to 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).; Results for LRTD by baseline comorbidities will be updated at the final results disclosure stage.	From Day 15 post first and each revaccination dose to first occurrence of RSV LRTD (assessed approximately over 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
Secondary	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 <0.4m/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 >=1 m/s.; Results for LRTD by baseline frailty status will be updated at the final results disclosure stage.	From Day 15 post first and each revaccination dose to first occurrence of RSV LRTD (assessed approximately over 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
Secondary	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. 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 (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 (case definition 2) and with at least one RSV positive swab detected by RT-PCR.; Results for severe LRTD will be updated at the final results disclosure stage.	From Day 15 post first and each revaccination dose to the first occurrence of RSV severe LRTD (assessed approximately over 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
Secondary	Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Acute Respiratory Illness (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.; Results for RSV A and/or B Associated ARI will be updated at the final results disclosure stage.	From Day 15 post first and each revaccination dose to first occurrence of RSV ARI (assessed approximately over 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
Secondary	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 will be assessed against any ARI and any LRTD.; Results for the entire study period will be updated at the final results disclosure stage.	From Day 15 post first vaccination up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])
Secondary	Number of Hospitalizations Due to Respiratory Diseases or Due to a Complication Related to Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses	A diagnosis of respiratory disease include: acute respiratory illnesses, 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.; Results for the entire study period will be updated at the final results disclosure stage.	From start of the first RSV season up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])
Secondary	Number of Hospitalizations Due to RSV-confirmed Respiratory Diseases or Due to Complication Related to RSV-confirmed Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses	RSV infection was confirmed by RT-PCR. Results for this outcome measure is not disclosed at this stage in order to maintain blinding within the ongoing trial. Data will be added at the final results posting stage.	From start of the first RSV season up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])
Secondary	Number of Complications Related to ARI and RSV-confirmed ARI During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses	RSV infection is confirmed by RT-PCR. Results for the entire study period will be updated at the final results disclosure stage.	From start of the first RSV season up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])
Secondary	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	The Health Related -Quality of life (HR-QOL) score is measured by Flu-PRO questionnaire. 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 FLU-PRO total score is computed as the mean score across all 32 items, with the total scores ranging from 0 (symptom free) to 4 (very severe symptoms). Results for the entire study period will be updated at the final results disclosure stage.	During the first 7 days from the onset of ARI symptoms (assessed from 2 weeks post first vaccination dose until end of study- approximately 3 years in NH and 2.5-3 years in SH)
Secondary	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	Individual questions are assessed on the 5-point response categories and Flu-PRO total score is tabulated.; Participants in RSVPreF3 groups will be randomized before Season 2 into 2 sub-groups (RSV_annual group and RSV_1dose group). Results for RSV_annual group and RSV_1dose group of subsequent seasons will be updated during final posting.	During the first 7 days from the onset of ARI symptoms (assessed from 2 weeks post first vaccination dose until end of study- approximately 3 years in NH and 2.5-3 years in SH)
Secondary	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. The health states indicated in these 5 dimensions are converted and presented as a single mean index value as recommended by EuroQol group. Values range from 0 (worst) to 1 (full health).; Results for the entire study period will be updated at the final results disclosure stage.	At the ARI visit (assessed from 2 weeks post first vaccination dose until end of study- approximately 3 years in NH and 2.5-3 years in SH)
Secondary	Short Form-12 (SF-12) Physical Functioning 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	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. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.; Results for the entire study period will be updated at the final results disclosure stage.	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)
Secondary	Duration of RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes	The duration in days of RT-PCR confirmed RSV ARI and LRTD episodes will be described.; Results for the entire study period will be updated at the final results disclosure stage.	Assessed during the study period (approximately 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
Secondary	Number of Participants With Each Reported Symptom/Sign of RT-PCR Confirmed RSV A and/or B ARI Episodes	RSV infection is confirmed by RT-PCR. Results for the entire study period will be updated at the final results disclosure stage.	Assessed during the study period (approximately 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
Secondary	Number of Participants With Each Reported Symptom/Sign of RT-PCR Confirmed RSV A and/or B LRTD Episodes	RSV infection is confirmed by RT-PCR. Results for the entire study period will be updated at the final results disclosure stage.	Assessed during the study period (approximately 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
Secondary	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 assessed as 'severe' by the investigator. Severe is defined as "An ARI/LRTD episode which prevents normal, everyday activities. Such an event would, for example, prevent attendance at work and would necessitate the administration of corrective therapy".; Number of subjects with Severe ARI and Severe LRTD episodes has not been disclosed at this stage in order to maintain blinding within the ongoing trial. It will be added at the final results posting stage.; Results for the entire study period will be updated at the final results disclosure stage	Assessed during the study period (approximately 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
Secondary	RSVPreF3 Specific Immunoglobulin G (IgG) Antibody Concentrations	The RSV IgG antibody concentrations are measures as Geometric Mean Concentrations (GMCs) and expressed as ELISA units per milliliter (EU/mL).	At Day 1 (Pre-Dose 1) and Day 31
Secondary	RSVPreF3 Specific Immunoglobulin G (IgG) Antibody Concentrations	The RSV IgG antibody concentrations are measures as Geometric Mean Concentrations (GMCs) and expressed as ELISA units per milliliter (EU/mL).; The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.	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)
Secondary	RSV A Neutralizing Antibody Titers	RSV A neutralizing antibodies are given as Geometric Mean Titers (GMTs) and expressed as Estimated Dilution 60 (ED60).	At Day 1 (Pre-Dose 1) and Day 31
Secondary	RSV A Neutralizing Antibody Titers	RSV A neutralizing antibodies are given as Geometric Mean Titers (GMTs) and expressed as Estimated Dilution 60 (ED60).; The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.	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)
Secondary	RSV B Neutralizing Antibody Titers	RSV B neutralizing antibodies are given as GMTs.	At Day 1 (Pre-Dose 1) and Day 31
Secondary	RSV B Neutralizing Antibody Titers	RSV B neutralizing antibodies are given as GMTs. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.	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)
Secondary	Number of Participants With Any, 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. Grade 3 AE = an AE which prevented normal, everyday activities. The assessed administration site events include pain, erythema and swelling.; Number of participants with grade 3 AEs has not been disclosed at this stage in order to maintain blinding within the ongoing trial. Those will be added at the final results posting stage.	During the 4-day follow up period after first vaccination (vaccine administered on Day 1)
Secondary	Number of Participants With Any, 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. Grade 3 AE = an AE which prevented normal, everyday activities. The assessed administration site events include pain, erythema and swelling.; The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.	During the 4-day follow up period after second vaccination (vaccine administered pre-season 2)
Secondary	Number of Participants With Any, 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. Grade 3 AE = an AE which prevented normal, everyday activities. The assessed administration site events include pain, erythema and swelling.; The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.	During the 4-day follow up period after the third vaccination (administered pre-season 3-only applicable for participants in Northern Hemisphere [NH]))
Secondary	Number of Participants With Any, Grade 3 Solicited Systemic Adverse Events	The assessed solicited systemic events include fever, headache, fatigue, myalgia and arthralgia. Fever is defined as a temperature = 38.0°C/100.4°F by any route (oral/ axillary/tympanic).; Number of subjects with Grade 3 Fever and Grade 3 Headache has not been disclosed at this stage in order to maintain blinding within the ongoing trial. It will be added at the final results posting stage.	During the 4-day follow up period after first vaccination (vaccine administered on Day 1)
Secondary	Number of Participants With Any, Grade 3 Solicited Systemic Adverse Events	The assessed solicited systemic events include fever, headache, fatigue, myalgia and arthralgia. Fever is defined as a temperature = 38.0°C/100.4°F by any route (oral/ axillary/tympanic).; The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.	During the 4-day follow up period after second vaccination (vaccine or placebo administered pre-season 2)
Secondary	Number of Participants With Any, Grade 3 Solicited Systemic Adverse Events	The assessed solicited systemic events include fever, headache, fatigue, myalgia and arthralgia. Fever is defined as a temperature = 38.0°C/100.4°F by any route (oral/ axillary/tympanic).; The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.	During the 4-day follow up period after third vaccination (vaccine or placebo administered pre-season 3-only applicable for participants in Northern Hemisphere)
Secondary	Number of Days With Solicited Administration Site Adverse Events	Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade. The assessed administration site events include pain, erythema and swelling.	During the 4-day follow up period after first vaccination (vaccine or placebo administered on Day 1)
Secondary	Number of Days With Solicited Administration Site Adverse Events	Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade. The assessed administration site events include pain, erythema and swelling.; The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.	During the 4-day follow up period after second vaccination (vaccine administered pre-season 2)
Secondary	Number of Days With Solicited Administration Site Adverse Events	Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade. The assessed administration site events include pain, erythema and swelling.; The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.	During the 4-day follow up period after third vaccination (vaccine administered pre-season 3-only applicable for participants in Northern Hemisphere [NH]))
Secondary	Number of Days With Solicited Systemic Adverse Events	The assessed solicited systemic events include fever, headache, fatigue, myalgia and arthralgia. Fever is defined as a temperature = 38.0°C/100.4°F by any route (oral/ axillary/tympanic).	During the 4-day follow up period after first vaccination (vaccine or placebo administered on Day 1)
Secondary	Number of Days With Solicited Systemic Adverse Events	The assessed solicited systemic events include fever, headache, fatigue, myalgia and arthralgia. Fever is defined as a temperature = 38.0°C/100.4°F by any route (oral/ axillary/tympanic).; The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.	During the 4-day follow up period after second vaccination (vaccine or placebo administered pre-season 2)
Secondary	Number of Days With Solicited Systemic Adverse Events	The assessed solicited systemic events include fever, headache, fatigue, myalgia and arthralgia. Fever is defined as a temperature = 38.0°C/100.4°F by any route (oral/ axillary/tympanic).; The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.	During the 4-day follow up period after third vaccination (vaccine or placebo administered pre-season 3-only applicable for participants in Northern Hemisphere [NH])
Secondary	Number of Participants With Any Unsolicited AEs	An Adverse Event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.	During the 30-day follow up period after first vaccination (vaccine or placebo administered on Day 1)
Secondary	Number of Participants With Any Unsolicited AEs	An Adverse Event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.; The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.	During the 30-day follow up period after second vaccination (vaccine administered pre-season 2)
Secondary	Number of Participants With Any Unsolicited AEs	An Adverse Event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.; The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.	During the 30-day follow up period after third vaccination (vaccine or placebo administered pre-season 3-only applicable for participants in Northern Hemisphere [NH])
Secondary	Number of Participants With Serious Adverse Events (SAEs)	An SAE is defined as any untoward medical occurrence that results in death, are life threatening, require hospitalization or prolongation of hospitalization or results in disability/incapacity.; The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. Results for the entire study period will be updated at the final results disclosure stage.	From the day of the vaccination up to 6 months after each vaccination (vaccine or placebo administered on Day 1, pre-season 2 and pre-season 3-only applicable for participants in Northern Hemisphere [NH])
Secondary	Number of Participants With Potential Immune Mediated Diseases (pIMDs)	pIMDs are 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.; The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. Results for the entire study period will be updated at the final results disclosure stage.	From the day of the vaccination up to 6 months after each vaccination (vaccine or placebo administered on Day 1, pre-season 2 and pre-season 3-only applicable for participants in Northern Hemisphere [NH])
Secondary	Number of Participants With Related SAEs and Fatal SAEs	Related SAEs and fatal 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. Fatal SAEs= Any SAEs leading to deaths. Results for the entire study period will be updated at the final results disclosure stage.	From Day 1 up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])
Secondary	Number of Participants With Related pIMDs	pIMDs are 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. Related pIMD = pIMD assessed by the investigator as related to the study vaccination.; Results for the entire study period will be updated at the final results disclosure stage.	From Day 1 up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])