AzTrials
AzTrials

Respiratory Syncytial Virus InfectionsPhase 3NCT04886596

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

A Phase 3 study testing RSVPreF3 OA vaccine in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 277 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Respiratory Syncytial Virus Infections
What is being tested?
RSVPreF3 OA vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
26,675 participants
Where
277 sitesin 17 countries
Study dates
25 May 2021to 31 May 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

277 sites in 17 countries.

277 sites in 17 countries

United States60 sites

  • GSK Investigational Site

    Akron, Ohio, 44311

  • GSK Investigational Site

    Anderson, South Carolina, 29621

  • GSK Investigational Site

    Atlanta, Georgia, 30328

  • GSK Investigational Site

    Binghamton, New York, 31406

  • GSK Investigational Site

    Birmingham, Alabama, 35205

  • GSK Investigational Site

    Birmingham, Alabama, 35211

  • GSK Investigational Site

    Centerville, Ohio, 45459

  • GSK Investigational Site

    Cerritos, California, 90703

  • GSK Investigational Site

    Chicago, Illinois, 60602

  • GSK Investigational Site

    Cincinnati, Ohio, 45236

  • GSK Investigational Site

    Columbus, Ohio, 43212

  • GSK Investigational Site

    Coral Gables, Florida, 33134

  • GSK Investigational Site

    Dallas, Texas, 75234

  • GSK Investigational Site

    El Dorado, Kansas, 67042

  • GSK Investigational Site

    Erie, Pennsylvania, 16508

  • GSK Investigational Site

    Evansville, Indiana, 47714

  • GSK Investigational Site

    Fort Myers, Florida, 33912

  • GSK Investigational Site

    Fort Worth, Texas, 76104

  • GSK Investigational Site

    Henderson, Nevada, 89052

  • GSK Investigational Site

    Hickory, North Carolina, 28601

  • GSK Investigational Site

    Houston, Texas, 77008

  • GSK Investigational Site

    Houston, Texas, 77055

  • GSK Investigational Site

    Huntsville, Alabama, 35802

  • GSK Investigational Site

    Jacksonville, Florida, 32205

  • GSK Investigational Site

    Jamaica, New York, 10017

  • GSK Investigational Site

    Kansas City, Missouri, 64114

  • GSK Investigational Site

    Keller, Texas, 76248

  • GSK Investigational Site

    Knoxville, Tennessee, 37912

  • GSK Investigational Site

    Laguna Hills, California, 92653

  • GSK Investigational Site

    Lake City, Florida, 32055

  • GSK Investigational Site

    Layton, Utah, 84041

  • GSK Investigational Site

    Lexington, Kentucky, 40509

  • GSK Investigational Site

    Melbourne, Florida, 32934

  • GSK Investigational Site

    Memphis, Tennessee, 38119

  • GSK Investigational Site

    Miami, Florida, 33174

  • GSK Investigational Site

    Mishawaka, Indiana, 46544

  • GSK Investigational Site

    Mt. Pleasant, South Carolina, 29405

  • GSK Investigational Site

    Murray, Utah, 84106

  • GSK Investigational Site

    Newton, Kansas, 67114

  • GSK Investigational Site

    Norfolk, Virginia, 23502

  • GSK Investigational Site

    Omaha, Nebraska, 68134

  • GSK Investigational Site

    Orlando, Florida, 32806

  • GSK Investigational Site

    Phoenix, Arizona, 85306

  • GSK Investigational Site

    Pinellas Park, Florida, 33781

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15236

  • GSK Investigational Site

    Richfield, Minnesota, 55423

  • GSK Investigational Site

    Rochester, New York, 14609

  • GSK Investigational Site

    Rockville, Maryland, 20854

  • GSK Investigational Site

    Rocky Mount, North Carolina, 27804

  • GSK Investigational Site

    Salisbury, North Carolina, 28144

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    Statesville, North Carolina, 28117

  • GSK Investigational Site

    The Villages, Florida, 32162

  • GSK Investigational Site

    Tucson, Arizona, 85741

  • GSK Investigational Site

    Weeki Wachee, Florida, 34607

  • GSK Investigational Site

    West Palm Beach, Florida, 33409

  • GSK Investigational Site

    Wichita, Kansas, 67205

  • GSK Investigational Site

    Wichita, Kansas, 67207

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103

Other trials in United States

Germany27 sites

  • GSK Investigational Site

    Berlin, 10117

  • GSK Investigational Site

    Berlin, 12627

  • GSK Investigational Site

    Berlin, 13347

  • GSK Investigational Site

    Cologne, 51069

  • GSK Investigational Site

    Dachau, 85221

  • GSK Investigational Site

    Dippoldiswalde, 01762

  • GSK Investigational Site

    Dresden, 01279

  • GSK Investigational Site

    Essen, 45355

  • GSK Investigational Site

    Essen, 45359

  • GSK Investigational Site

    Flörsheim, 65439

  • GSK Investigational Site

    Frankfurt, 60313

  • GSK Investigational Site

    Freiberg, Saxony, 09599

  • GSK Investigational Site

    Freital, 01705

  • GSK Investigational Site

    Goch, 47574

  • GSK Investigational Site

    Hamburg, 20095

  • GSK Investigational Site

    Hamburg, 22143

  • GSK Investigational Site

    Hanover, 30159

  • GSK Investigational Site

    Leipzig, 04103

  • GSK Investigational Site

    Leipzig, 04347

  • GSK Investigational Site

    Mainz, 55116

  • GSK Investigational Site

    München, 80339

  • GSK Investigational Site

    Schenefeld, 22869

  • GSK Investigational Site

    Wallerfing, 94574

  • GSK Investigational Site

    Wangen, 88239

  • GSK Investigational Site

    Weinheim, 69469

  • GSK Investigational Site

    Witten, 58455

  • GSK Investigational Site

    Würzburg, 97070

Other trials in Germany

Canada20 sites

  • GSK Investigational Site

    Chicoutimi, Quebec, G7H 7Y8

  • GSK Investigational Site

    Edmonton, Alberta, T5A 4L8

  • GSK Investigational Site

    Greater Sudbury, Ontario, P3C 1X3

  • GSK Investigational Site

    Halifax, Nova Scotia, B3J 3G9

  • GSK Investigational Site

    London-Ontario, Ontario, N5W 6A2

  • GSK Investigational Site

    Mirabel, Quebec, J7J 2K8

  • GSK Investigational Site

    New Westminster, British Columbia, V3L 3W4

  • GSK Investigational Site

    Ottawa, Ontario, K1H 8L6

  • GSK Investigational Site

    Pointe-Claire, Quebec, H9R 4S3

  • GSK Investigational Site

    Québec, Quebec, G1W 4R4

  • GSK Investigational Site

    Saint-Charles-Borromée, Quebec, J6E 2B4

  • GSK Investigational Site

    Sainte-Foy, Quebec, G1E 7G9

  • GSK Investigational Site

    Sarnia, Ontario, N7T 4X3

  • GSK Investigational Site

    Sherbrooke, Quebec, J1J 2G2

  • GSK Investigational Site

    Surrey, British Columbia, V3S 2N6

  • GSK Investigational Site

    Toronto, Ontario, M9W 4L6

  • GSK Investigational Site

    Truro, Nova Scotia, B2N 1L2

  • GSK Investigational Site

    Vancouver, British Columbia, V6Z 2T1

  • GSK Investigational Site

    Victoria, British Columbia, V8V 3M9

  • GSK Investigational Site

    Victoria, British Columbia, V8V 4A1

Other trials in Canada

United Kingdom20 sites

  • GSK Investigational Site

    Bebington, CH63 9JP

  • GSK Investigational Site

    Belfast, BT7 2EB

  • GSK Investigational Site

    Birmingham, B15 2SQ

  • GSK Investigational Site

    Bradford on Avon Wiltsh, BA15 1DQ

  • GSK Investigational Site

    Cardiff, CF15 9SS

  • GSK Investigational Site

    Corby, NN17 2UR

  • GSK Investigational Site

    Eynsham, OX29 4QB

  • GSK Investigational Site

    Glasgow, ML4 3NJ

  • GSK Investigational Site

    Hardwick, NE461QJ

  • GSK Investigational Site

    Hexham, NE46 1QJ

  • GSK Investigational Site

    Lancashire, PR7 7NA

  • GSK Investigational Site

    Liverpool, L22 0LG

  • GSK Investigational Site

    Manchester, M15 6SX

  • GSK Investigational Site

    Orpington, BR5 3QG

  • GSK Investigational Site

    Oxford, OX4 1XB

  • GSK Investigational Site

    Peterborough, PE8 6PL

  • GSK Investigational Site

    Romford, BR5 3QG

  • GSK Investigational Site

    Royal Leamington Spa, CV32 4RA

  • GSK Investigational Site

    Thetford Norfolk, IP24 2HY

  • GSK Investigational Site

    Witney, OX28 6JS

Other trials in United Kingdom

Italy17 sites

  • GSK Investigational Site

    Alessandria, 15100

  • GSK Investigational Site

    Bari, 70121

  • GSK Investigational Site

    Belluno, 32100

  • GSK Investigational Site

    Catanzaro, 88100

  • GSK Investigational Site

    Chieri Torino, 10023

  • GSK Investigational Site

    Ferrara, 44124

  • GSK Investigational Site

    Genova, 16132

  • GSK Investigational Site

    Milan, 20157

  • GSK Investigational Site

    Milan, 20162

  • GSK Investigational Site

    Naples, 80131

  • GSK Investigational Site

    Negrar Verona, 37024

  • GSK Investigational Site

    Palermo, 90127

  • GSK Investigational Site

    Pisa, 56126

  • GSK Investigational Site

    Roma, 00128

  • GSK Investigational Site

    Roma, 00168

  • GSK Investigational Site

    Siena, 53100

  • GSK Investigational Site

    Vercelli, 13100

Other trials in Italy

Poland17 sites

  • GSK Investigational Site

    Częstochowa, 42202

  • GSK Investigational Site

    Elblag, 82-300

  • GSK Investigational Site

    Gdansk, 80-382

  • GSK Investigational Site

    Gdynia, 81-537

  • GSK Investigational Site

    Katowice, 40-040

  • GSK Investigational Site

    Katowice, 40-282

  • GSK Investigational Site

    Katowice, 40-648

  • GSK Investigational Site

    Krakow, 31-501

  • GSK Investigational Site

    Lodz, 90-127

  • GSK Investigational Site

    Lodz, 91-363

  • GSK Investigational Site

    Piaseczno, 05-500

  • GSK Investigational Site

    Poznan, 60-702

  • GSK Investigational Site

    Warsaw, 02-672

  • GSK Investigational Site

    Warsaw, 03-291

  • GSK Investigational Site

    Warsaw, 96-500

  • GSK Investigational Site

    Wroclaw, 50-381

  • GSK Investigational Site

    Wroclaw, 53-673

Other trials in Poland

Spain17 sites

  • GSK Investigational Site

    Alcorcón, 28922

  • GSK Investigational Site

    Barcelona, 08023

  • GSK Investigational Site

    Barcelona, 08025

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    Barcelona, 08430

  • GSK Investigational Site

    Barcelona, 08500

  • GSK Investigational Site

    Barcelona, 08540

  • GSK Investigational Site

    Barcelona, 08907

  • GSK Investigational Site

    Barcelona, 8025

  • GSK Investigational Site

    Madrid, 28006

  • GSK Investigational Site

    Madrid, 28007

  • GSK Investigational Site

    Madrid, 28029

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Madrid, 28222

  • GSK Investigational Site

    Santiago de Compostela, 15706

  • GSK Investigational Site

    Valencia, 46015

Other trials in Spain

Belgium15 sites

  • GSK Investigational Site

    Aalst, 9300

  • GSK Investigational Site

    Alken, 3570

  • GSK Investigational Site

    Edegem, 2650

  • GSK Investigational Site

    Erpent, 5101

  • GSK Investigational Site

    Genk, 3600

  • GSK Investigational Site

    Ghent, 9000

  • GSK Investigational Site

    Ieper, 8900

  • GSK Investigational Site

    Linkebeek, 3500

  • GSK Investigational Site

    Linkebeek, 3545

  • GSK Investigational Site

    Linkebeek, 4987

  • GSK Investigational Site

    Linkebeek, 6534

  • GSK Investigational Site

    Linkebeek, 6887

  • GSK Investigational Site

    Linkebeek, 9690

  • GSK Investigational Site

    Mechelen, 2800

  • GSK Investigational Site

    Tremelo, 3120

Other trials in Belgium

Japan14 sites

  • GSK Investigational Site

    Chiba, 292-0805

  • GSK Investigational Site

    Hiroshima, 732-0053

  • GSK Investigational Site

    Ibaraki, 306-0041

  • GSK Investigational Site

    Kumamoto, 860-0863

  • GSK Investigational Site

    Okinawa, 901-2393

  • GSK Investigational Site

    Osaka, 530-0001

  • GSK Investigational Site

    Saitama, 350-1122

  • GSK Investigational Site

    Shizuoka, 421-0193

  • GSK Investigational Site

    Tokyo, 121-0815

  • GSK Investigational Site

    Tokyo, 160-0017

  • GSK Investigational Site

    Tokyo, 165-0031

  • GSK Investigational Site

    Tokyo, 169-0072

  • GSK Investigational Site

    Yamagata, 990-0834

  • GSK Investigational Site

    Yamaguchi, 750-0061

Other trials in Japan

South Korea12 sites

  • GSK Investigational Site

    Ansan, 15355

  • GSK Investigational Site

    Bucheon-si Kyunggi-do 14584, 14584

  • GSK Investigational Site

    Daegu, 41944

  • GSK Investigational Site

    Incheon, 400-711

  • GSK Investigational Site

    Jeonju, 54907

  • GSK Investigational Site

    Kangwon-do, 26426

  • GSK Investigational Site

    Seoul, 06351

  • GSK Investigational Site

    Seoul, 07441

  • GSK Investigational Site

    Seoul, 08308

  • GSK Investigational Site

    Seoul, 135-720

  • GSK Investigational Site

    Seoul, 137-701

  • GSK Investigational Site

    Suwon Gyeonggi-do, 442-723

Other trials in South Korea

Finland10 sites

  • GSK Investigational Site

    Espoo, 02230

  • GSK Investigational Site

    Helsinki, 00100

  • GSK Investigational Site

    Helsinki, 00930

  • GSK Investigational Site

    Jarvenpaa, 04400

  • GSK Investigational Site

    Kokkola, 67100

  • GSK Investigational Site

    Oulu, 90220

  • GSK Investigational Site

    Pori, 28100

  • GSK Investigational Site

    Seinäjoki, 60100

  • GSK Investigational Site

    Tampere, 33100

  • GSK Investigational Site

    Turku, 20520

Other trials in Finland

Mexico10 sites

  • GSK Investigational Site

    Chihuahua City, 31203

  • GSK Investigational Site

    León, 37530

  • GSK Investigational Site

    Mérida, 97070

  • GSK Investigational Site

    Mexico City, 01120

  • GSK Investigational Site

    Mexico City, 06760

  • GSK Investigational Site

    Monterrey, 64570

  • GSK Investigational Site

    Oaxaca City, 68000

  • GSK Investigational Site

    Querétaro, 76070

  • GSK Investigational Site

    RM Pharmamexico CITY, 03100

  • GSK Investigational Site

    San Luis Potosí City, 78209

Other trials in Mexico

Australia9 sites

  • GSK Investigational Site

    Botany, New South Wales, 2217

  • GSK Investigational Site

    Camberwell, Victoria, 3124

  • GSK Investigational Site

    Coffs Harbour, New South Wales, 2450

  • GSK Investigational Site

    Darlinghurst, New South Wales, 2010

  • GSK Investigational Site

    Geelong, Victoria, 3220

  • GSK Investigational Site

    Morayfield, Queensland, 4506

  • GSK Investigational Site

    Spearwood, Western Australia, 6163

  • GSK Investigational Site

    Taringa, Queensland, 4068

  • GSK Investigational Site

    Tarragindi, Queensland, 4121

Other trials in Australia

Russia9 sites

  • GSK Investigational Site

    Barnaul, 656043

  • GSK Investigational Site

    Gatchina, 188300

  • GSK Investigational Site

    Kemerovo, 650066

  • GSK Investigational Site

    Moscow, 115478

  • GSK Investigational Site

    Saint Petersburg, 196158

  • GSK Investigational Site

    Saint Petersburg, 197022

  • GSK Investigational Site

    StPetersburg, 191119

  • GSK Investigational Site

    StPetersburg, 196143

  • GSK Investigational Site

    Yekaterinburg, 620137

Other trials in Russia

South Africa8 sites

  • GSK Investigational Site

    Cape Town, 7700

  • GSK Investigational Site

    Johannesburg, 1818

  • GSK Investigational Site

    Johannesburg, 2113

  • GSK Investigational Site

    Middelburg, 1055

  • GSK Investigational Site

    Moloto South, 1022

  • GSK Investigational Site

    Newcastle, 9301

  • GSK Investigational Site

    Reiger Park, 1459

  • GSK Investigational Site

    Tembisa, 1632

Other trials in South Africa

Estonia6 sites

  • GSK Investigational Site

    Paide, 72713

  • GSK Investigational Site

    Tallinn, 10117

  • GSK Investigational Site

    Tallinn, 10128

  • GSK Investigational Site

    Tallinn, 10617

  • GSK Investigational Site

    Tallinn, 13619

  • GSK Investigational Site

    Tartu, 51014

Other trials in Estonia

New Zealand6 sites

  • GSK Investigational Site

    Grafton Auckland, 1010

  • GSK Investigational Site

    Havelock North, 4130

  • GSK Investigational Site

    Kapiti, 5032

  • GSK Investigational Site

    Palmerston North, 5032

  • GSK Investigational Site

    Tauranga, 3001

  • GSK Investigational Site

    Wellington, 6021

Other trials in New Zealand

About this study

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

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.

Read the 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.

Being tested
Placebo, RSVPreF3 OA vaccine
Keywords
Respiratory syncytial virus, Lower respiratory tract disease, Efficacy study, Adults aged 60 years and above
Medical subject headings
Respiratory Syncytial Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboBiological

    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 vaccineBiological

    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.

Study groups in NCT04886596
Study groupRoleWhat they receive
RSVPreF3 GroupExperimentalParticipants 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.
Receives: Biological: RSVPreF3 OA vaccine
Placebo GroupPlacebo comparatorParticipants received 1 dose of placebo at Day 1 and an additional dose of placebo every subsequent year of the study.
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Lower Respiratory Tract Disease (LRTD) During the First Season Following a Single Dose of the RSVPreF3 OA Vaccine

    First episode of Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated LRTD during the first season was assessed. The case definition for RSV-confirmed LRTD is as follows: Presence of at least one RSV-positive swab detected by RT-PCR.

    Measured: From Day 15 post-vaccination up to end of season 1 in the Northern Hemisphere (NH) [a median of approximately 6.7 months (6.9 months in NH and 3.5 months in Southern Hemisphere [SH])]

Secondary outcomes (44)

  1. 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.

    Measured: 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)

  2. 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.

    Measured: 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)

  3. 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.

    Measured: 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)

  4. 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.

    Measured: 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)

  5. 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

    Measured: 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)]

  6. 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.

    Measured: 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)

  7. 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.

    Measured: 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])

  8. 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.

    Measured: 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])

  9. 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

    Measured: 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)

  10. 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).

    Measured: 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)

  11. 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.

    Measured: 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)

  12. 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.

    Measured: 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)

  13. 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.

    Measured: 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)

  14. 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.

    Measured: 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)

  15. 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.

    Measured: From Day 15 post first vaccination up to study end (approximately 3 years for NH and 2.5-3 years for SH)

  16. 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.

    Measured: From Day 15 post-first vaccination up to study end (approximately 3 years for NH and 2.5-3 years for SH)

  17. 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.

    Measured: From Day 15 post-first vaccination up to study end (approximately 3 years for NH and 2.5-3 years for SH)

  18. 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.

    Measured: From Day 15 post-first vaccination up to study end (approximately 3 years for NH and 2.5-3 years for SH)

  19. 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.

    Measured: From Day 15 post-first vaccination up to study end (approximately 3 years for NH and 2.5-3 years for SH)

  20. 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).

    Measured: 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])

  21. 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).

    Measured: 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])

  22. 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).

    Measured: 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)

  23. 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.

    Measured: 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)

  24. 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.

    Measured: 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]

  25. 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.

    Measured: 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)]

  26. 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.

    Measured: 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])

  27. 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.

    Measured: From start of Season 3 up to end of Season 3 in NH (a median of approximately 7 months)

  28. 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.

    Measured: 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)]

  29. 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.

    Measured: 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])

  30. 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.

    Measured: From start of Season 3 up to end of Season 3 in NH (a median of approximately 7 months)

  31. 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.

    Measured: Assessed during the study period (approximately 3 years for NH and 2.5-3 years for SH)

  32. 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).

    Measured: 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)

  33. RSV A Neutralizing Antibody Titers

    The RSV A neutralizing antibody titers are expressed as geometric mean titers (GMTs).

    Measured: 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)

  34. RSV B Neutralizing Antibody Titers

    RSV B neutralizing antibodies are expressed as GMTs.

    Measured: 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)

  35. 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.

    Measured: 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])

  36. 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.

    Measured: 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])

  37. Number of Days With Solicited Administration Site Adverse Events

    Measured: 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])

  38. Number of Days With Solicited Systemic Adverse Events

    Measured: 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])

  39. 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.

    Measured: 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)

  40. 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.

    Measured: 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])

  41. 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.

    Measured: 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])

  42. 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.

    Measured: From Day 1 up to study end (approximately 3 years for NH and 2.5-3 years for SH)

  43. Number of Participants With Fatal SAEs

    Fatal SAEs that occur throughout the study are assessed. Fatal SAEs= Any SAEs leading to deaths.

    Measured: From Day 1 up to study end (approximately 3 years for NH and 2.5-3 years for SH)

  44. Number of Participants With Related pIMDs

    Related pIMD = pIMD assessed by the investigator as related to the study vaccination.

    Measured: From Day 1 up to study end (approximately 3 years for NH and 2.5-3 years for SH)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2021
  2. Study start25 May 2021
  3. Primary completion11 Apr 2022
  4. Study completion31 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
26,675 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04886596
Sponsor's protocol ID
212494
Other IDs
2020-000753-28
Status last verified
Jul 2025
First submitted
29 Apr 2021
Last updated
31 Jul 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

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.

    PubMed 38253338

  • Park SB, Mishra S, Shin SK, Xavier S, Zigon G, Zocco M, Van Der Wielen M, Lee DG; AReSVi-006 study group. Long-term Immunogenicity and Safety Profile of the Adjuvanted RSVPreF3 Vaccine in Korean Older Adults: A Sub-analysis of a Phase 3 Trial. Infect Chemother. 2026 Sep;58(3):332-342. doi: 10.3947/ic.2026.0016.

    PubMed 42847629

  • Tajima K, Zarkadoulas E, Simons J, Kurai D, Grace M, Graham J, Ho Y, Verelst F. Cost-effectiveness of the adjuvanted respiratory syncytial virus prefusion F protein (RSVPreF3) vaccine in Japanese adults aged 50-59 years at increased risk of severe RSV disease and those aged >/=60 years. Expert Rev Vaccines. 2026 Dec;25(1):2626921. doi: 10.1080/14760584.2026.2626921. Epub 2026 Feb 11.

    PubMed 41637686

  • Ison MG, Papi A, Athan E, Feldman RG, Langley JM, Lee DG, Leroux-Roels I, Martinon-Torres F, Schwarz TF, van Zyl-Smit RN, Cuadripani S, Deraedt Q, Dezutter N, Gerard C, Fissette L, Xavier S, David MP, Olivier A, Van der Wielen M, Descamps D; AReSVi-006 study group. Efficacy, safety, and immunogenicity of the AS01E-adjuvanted respiratory syncytial virus prefusion F protein vaccine (RSVPreF3 OA) in older adults over three respiratory syncytial virus seasons (AReSVi-006): a multicentre, randomised, observer-blinded, placebo-controlled, phase 3 trial. Lancet Respir Med. 2025 Jun;13(6):517-529. doi: 10.1016/S2213-2600(25)00048-7. Epub 2025 Apr 14.

    PubMed 40245915

  • Sanchez-Martinez ZV, Alpuche-Lazcano SP, Stuible M, Durocher Y. CHO cells for virus-like particle and subunit vaccine manufacturing. Vaccine. 2024 Apr 11;42(10):2530-2542. doi: 10.1016/j.vaccine.2024.03.034. Epub 2024 Mar 19.

    PubMed 38503664

  • Kurai D, Mizukami A, Preckler V, Verelst F, Molnar D, Matsuki T, Ho Y, Igarashi A. The potential public health impact of the respiratory syncytial virus prefusion F protein vaccine in people aged >/=60 years in Japan: results of a Markov model analysis. Expert Rev Vaccines. 2024 Jan-Dec;23(1):303-311. doi: 10.1080/14760584.2024.2323128. Epub 2024 Mar 1.

    PubMed 38426479

  • Curran D, Matthews S, Cabrera ES, Perez SN, Breva LP, Ramet M, Helman L, Park DW, Schwarz TF, Melendez IMG, Schaefer A, Roy N, Stephan B, Molnar D, Kostanyan L, Powers JH 3rd, Hulstrom V; Members of the AReSVi-006 Study Group. The respiratory syncytial virus prefusion F protein vaccine attenuates the severity of respiratory syncytial virus-associated disease in breakthrough infections in adults >/=60 years of age. Influenza Other Respir Viruses. 2024 Feb 3;18(2):e13236. doi: 10.1111/irv.13236. eCollection 2024 Feb.

    PubMed 38314063

  • Feldman RG, Antonelli-Incalzi R, Steenackers K, Lee DG, Papi A, Ison MG, Fissette L, David MP, Marechal C, Van der Wielen M, Kostanyan L, Hulstrom V; AReSVi-006 Study Group. Respiratory Syncytial Virus Prefusion F Protein Vaccine Is Efficacious in Older Adults With Underlying Medical Conditions. Clin Infect Dis. 2024 Jan 25;78(1):202-209. doi: 10.1093/cid/ciad471.

    PubMed 37698366

  • Papi A, Ison MG, Langley JM, Lee DG, Leroux-Roels I, Martinon-Torres F, Schwarz TF, van Zyl-Smit RN, Campora L, Dezutter N, de Schrevel N, Fissette L, David MP, Van der Wielen M, Kostanyan L, Hulstrom V; AReSVi-006 Study Group. Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. N Engl J Med. 2023 Feb 16;388(7):595-608. doi: 10.1056/NEJMoa2209604.

    PubMed 36791160

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RSVPreF3 OA vaccine in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 277 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 277 sites in United States, Germany, Canada, United Kingdom, Italy and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 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])]). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04886596, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.

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