AzTrials
AzTrials

Respiratory Syncytial Virus InfectionsPhase 3RSV OA=ADJ=012NCT06534892

An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study

A Phase 3 study testing RSVPreF3 OA vaccine in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 251 sites in 17 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is: To investigate the optimal timing for revaccination after the initial RSVPreF3 OA vaccine dose, To evaluate the long-term immune persistence and safety up to 5 consecutive RSV seasons (approximately 60 months) of a single dose of RSVPreF3 OA vaccine, To give the opportunity to… 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
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10,212 participants
Where
251 sitesin 17 countries
Study dates
1 Aug 2024to 30 Sep 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Male or female participants who were previously enrolled in the RSV OA=ADJ-006 study and received placebo (Placebo group) or a single dose of the RSVPreF3 OA vaccine (RSV_1dose group).
  • Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, attend regular phone calls/study site visits, ability to access and utilize a phone or other electronic communications).
  • 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 study entry. 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.

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.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
  • Hypersensitivity to latex.
  • Serious or unstable chronic illness.
  • Recurrent or un-controlled neurological disorders or seizures.
Show all 27Show fewer
  • Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
  • Any other medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
  • Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
  • Any history of dementia or any medical condition that moderately or severely impairs cognition and understanding of the informed consent form and/or study procedures.
  • Participants who experienced an SAE or pIMD from first study intervention administration in the RSV OA=ADJ-006 study until enrollment in this study that was considered to be possibly or probably related to the study vaccine or non-study concomitant vaccines, either by the investigator or the sponsor, including hypersensitivity reactions.
  • Participants with a new onset of a pIMD or exacerbation of a pIMD from first study intervention administration in the RSV OA=ADJ-006 study until enrollment in this study, that, in the opinion of the investigator, exposes the participant to unacceptable risk from subsequent vaccination.
  • Prior/Concomitant Therapy:
  • Use of any investigational or non-registered product other than the study vaccine during the period beginning 30 days before the first dose of study vaccine, or planned use during the study period. • Previous vaccination with an RSV vaccine (investigational or licensed vaccine) and/or planned administration of an RSV vaccine during the study period other than the RSVPreF3 OA vaccine administered during the RSV OA=ADJ-006 study.
  • 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.
  • Other Exclusion Criteria:
  • 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.
  • Participation of any study personnel or their immediate dependents, family, or household members.
  • Bedridden participants.
  • Specific exclusion criteria for Crossover group:
  • Planned or administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after study intervention administration, with the exception of COVID vaccines which can be administered up to 14 days before or from 14 days after study vaccination. Inactivated seasonal influenza vaccines can be co-administered or administered at any time.
  • Specific exclusion criteria for RSVPreS4, RSVPreS5 and RSV1Dose groups:
  • Planned or administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after study intervention administration, with the exception of COVID vaccines and inactivated seasonal influenza vaccines which can be administered up to 14 days before or from 14 days after study intervention administration.
  • 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 visit or planned administration during the study period.
  • Chronic administration of immunosuppressants or other immunemodifying drugs during the period starting 90 days prior to the first study visit or planned administration during the study period. For corticosteroids, this will mean prednisone >= 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.

Trial locations and contacts

251 sites in 17 countries.

251 sites in 17 countries

United States56 sites

  • GSK Investigational Site

    Anderson, South Carolina, 29621

  • GSK Investigational Site

    Atlanta, Georgia, 30328

  • 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

    Dallas, Texas, 75234

  • GSK Investigational Site

    Doral, Florida, 33172-2513

  • GSK Investigational Site

    El Dorado, Kansas, 67042-2187

  • GSK Investigational Site

    Erie, Pennsylvania, 16508

  • GSK Investigational Site

    Evansville, Indiana, 47714

  • GSK Investigational Site

    Fort Myers, Florida, 33912-4316

  • GSK Investigational Site

    Fort Worth, Texas, 76104

  • GSK Investigational Site

    Hickory, North Carolina, 28601

  • GSK Investigational Site

    Houston, Texas, 77008

  • GSK Investigational Site

    Huntsville, Alabama, 35802

  • GSK Investigational Site

    Jacksonville, Florida, 32205

  • GSK Investigational Site

    Kansas City, Missouri, 64114

  • GSK Investigational Site

    Keller, Texas, 76248

  • GSK Investigational Site

    Knoxville, Tennessee, 37938

  • GSK Investigational Site

    Lake City, Florida, 32055

  • GSK Investigational Site

    Las Vegas, Nevada, 89113

  • GSK Investigational Site

    Lexington, Kentucky, 40509

  • GSK Investigational Site

    Melbourne, Florida, 32934-8172

  • GSK Investigational Site

    Memphis, Tennessee, 38119

  • GSK Investigational Site

    Miami, Florida, 33174

  • GSK Investigational Site

    Mishawaka, Indiana, 46544

  • GSK Investigational Site

    Mooresville, North Carolina, 28117

  • GSK Investigational Site

    Mt. Pleasant, South Carolina, 29405

  • GSK Investigational Site

    New York, New York, 10017

  • 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, 85020

  • 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

    Salt Lake City, Utah, 84106

  • GSK Investigational Site

    San Antonio, Texas, 78229-6306

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    Savannah, Georgia, 31406

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    The Villages, Florida, 32162

  • GSK Investigational Site

    Tucson, Arizona, 85741

  • GSK Investigational Site

    West Palm Beach, Florida, 33409

  • GSK Investigational Site

    Wichita, Kansas, 67205-1132

  • GSK Investigational Site

    Wichita, Kansas, 67226

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103-3914

Other trials in United States

Germany25 sites

  • GSK Investigational Site

    Berlin, 10117

  • GSK Investigational Site

    Berlin, 12627

  • GSK Investigational Site

    Berlin, 13347

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 51069

  • GSK Investigational Site

    Dachau, Bavaria, 85221

  • GSK Investigational Site

    Dippoldiswalde, 01744

  • GSK Investigational Site

    Dresden, 01279

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45359

  • GSK Investigational Site

    Essen, 45355

  • GSK Investigational Site

    Frankfurt, 60313

  • GSK Investigational Site

    Freiberg, Saxony, 09599

  • GSK Investigational Site

    Freital, 01705

  • GSK Investigational Site

    Goch, North Rhine-Westphalia, 47574

  • GSK Investigational Site

    Hamburg, 20095

  • GSK Investigational Site

    Hanover, Lower Saxony, 30159

  • GSK Investigational Site

    Hochheim am Main, 65239

  • GSK Investigational Site

    Leipzig, Saxony, 04103

  • GSK Investigational Site

    Mainz, 55116

  • GSK Investigational Site

    Munich, Bavaria, 80339

  • GSK Investigational Site

    Schenefeld, 22869

  • GSK Investigational Site

    Wallerfing, 94574

  • GSK Investigational Site

    Wangen, 88239

  • GSK Investigational Site

    Weinheim, Baden-Wurttemberg, 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, H9R4S3

  • 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 Kingdom18 sites

  • GSK Investigational Site

    Belfast, BT2 8BG

  • GSK Investigational Site

    Bellshill, Lanarkshire, ML4 3NJ

  • GSK Investigational Site

    Birmingham, B15 2SQ

  • GSK Investigational Site

    Bradford on Avon, Wiltshire, BA15 1DQ

  • GSK Investigational Site

    Cardiff, CF15 9SS

  • GSK Investigational Site

    Corby, NN17 2UR

  • GSK Investigational Site

    Hexham, NE46 1QJ

  • GSK Investigational Site

    Lancashire, PR7 7NA

  • GSK Investigational Site

    Liverpool, L22 0LG

  • GSK Investigational Site

    Manchester, M15 6SE

  • GSK Investigational Site

    Metropolitan Borough of Wirral, Merseyside, CH63 9JP

  • GSK Investigational Site

    Orpington, Kent, BR5 3QG

  • GSK Investigational Site

    Oxford, OX4 1XB

  • GSK Investigational Site

    Peterborough, PE8 6PL

  • GSK Investigational Site

    Royal Leamington Spa, CV32 4RA

  • GSK Investigational Site

    Thetford, IP24 1JD

  • GSK Investigational Site

    Witney, Oxfordshire, OX29 4QB

  • GSK Investigational Site

    Witney, OX28 6JS

Other trials in United Kingdom

Spain16 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, 08907

  • GSK Investigational Site

    Centelles, Barcelona, 08540

  • GSK Investigational Site

    Madrid, 28006

  • GSK Investigational Site

    Madrid, 28007

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Majadahonda, Madrid, 28222

  • GSK Investigational Site

    Santiago de Compostela, A Coruña, 15706

  • GSK Investigational Site

    Valencia, 46006

  • GSK Investigational Site

    Valencia, 46020

  • GSK Investigational Site

    Vic, Barcelona, 08500

Other trials in Spain

Poland15 sites

  • GSK Investigational Site

    Częstochowa, 42-202

  • 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

    Poznan, 60-702

  • GSK Investigational Site

    Warsaw, 02-672

  • GSK Investigational Site

    Warsaw, 03-291

  • GSK Investigational Site

    Wroclaw, 50-088

  • GSK Investigational Site

    Wroclaw, 53-671

Other trials in Poland

Japan12 sites

  • 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

    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, Seoul Teugbyeolsi, 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

Belgium11 sites

  • GSK Investigational Site

    Diepenbeek, Limburg, 3590

  • GSK Investigational Site

    Edegem, 2650

  • GSK Investigational Site

    Genk, 3600

  • GSK Investigational Site

    Ghent, Oost-Vlaanderen, 9000

  • GSK Investigational Site

    Ieper, 8900

  • GSK Investigational Site

    Kluisbergen, 9690

  • GSK Investigational Site

    Linkebeek, 3545

  • GSK Investigational Site

    Linkebeek, 6534

  • GSK Investigational Site

    Mechelen, 2800

  • GSK Investigational Site

    Namur, 5101

  • GSK Investigational Site

    Tremelo, 3120

Other trials in Belgium

Italy11 sites

  • GSK Investigational Site

    Alessandria, 15121

  • GSK Investigational Site

    Bari, 70124

  • GSK Investigational Site

    Belluno, 32100

  • GSK Investigational Site

    Ferrara, 44124

  • GSK Investigational Site

    Naples, 80131

  • GSK Investigational Site

    Negrar, VR, 37024

  • GSK Investigational Site

    Palermo, 90127

  • GSK Investigational Site

    Pessione - Chieri to, 10023

  • GSK Investigational Site

    Pisa, 56126

  • GSK Investigational Site

    Roma, 00128

  • GSK Investigational Site

    Siena, 53100

Other trials in Italy

Finland9 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

    Seinäjoki, 60100

  • GSK Investigational Site

    Tampere, 33100

  • GSK Investigational Site

    Turku, 20520

Other trials in Finland

Mexico9 sites

  • GSK Investigational Site

    Chihuahua City, 31203

  • GSK Investigational Site

    León, 37530

  • GSK Investigational Site

    Mérida, 97070

  • GSK Investigational Site

    Mexico City, 06760

  • GSK Investigational Site

    Monterrey, 64460

  • 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

Russia9 sites

  • GSK Investigational Site

    Barnaul, 656043

  • GSK Investigational Site

    Gatchina, Leningradskaya Oblast', 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

Australia8 sites

  • GSK Investigational Site

    Botany, New South Wales, 2019

  • GSK Investigational Site

    Camberwell, Victoria, 3124

  • GSK Investigational Site

    Coffs Harbour, New South Wales, 2450

  • GSK Investigational Site

    Geelong, Victoria, 3220

  • GSK Investigational Site

    Spearwood, Western Australia, 6163

  • GSK Investigational Site

    Sydney, New South Wales, 2010

  • GSK Investigational Site

    Taringa, Queensland, 4068

  • GSK Investigational Site

    Tarragindi, Queensland, 4121

Other trials in Australia

South Africa8 sites

  • GSK Investigational Site

    Bloemfontein, 9300

  • GSK Investigational Site

    Cape Town, 7700

  • GSK Investigational Site

    Ekurhuleni, Johannesburg, 1459

  • GSK Investigational Site

    Johannesburg, 1818

  • GSK Investigational Site

    Johannesburg, 2113

  • GSK Investigational Site

    Middelburg, 1050

  • GSK Investigational Site

    Moloto South, 1022

  • 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, 50411

Other trials in Estonia

New Zealand6 sites

  • GSK Investigational Site

    Grafton Auckland, 1010

  • GSK Investigational Site

    Hawke's Bay, 4122

  • GSK Investigational Site

    Kapiti, 5032

  • GSK Investigational Site

    Palmerston North, 4414

  • GSK Investigational Site

    Tauranga, 3110

  • GSK Investigational Site

    Wellington, 6021

Other trials in New Zealand

About this study

Official title: A Phase 3b, Randomized, Open Label, Multicountry, Multi-center, Extension and Crossover Vaccination Study to Evaluate the Immunogenicity and Safety of Different Revaccination Schedules and Persistence of a Single Dose of the RSVPreF3 OA Vaccine in Adults Aged 60 Years and Above Who Participated in the RSV OA=ADJ-006 Study

The purpose of this study is:

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

  • RSVPreF3 OA vaccineBiological

    RSVPreF3 OA vaccine administered at different timepoints (revaccination groups) or for the first time (crossover group)

Study groups in NCT06534892
Study groupRoleWhat they receive
RSV_PreS4ExperimentalParticipants in this group will receive 1 dose of RSVPreF3 OA vaccine before RSV Season 4.
Receives: Biological: RSVPreF3 OA vaccine
RSV_PreS5ExperimentalParticipants in this group will receive 1 dose of RSVPreF3 OA vaccine before RSV Season 5.
Receives: Biological: RSVPreF3 OA vaccine
RSV_1DoseNo interventionParticipants in this group will not receive any additional dose of RSV PreF3 OA vaccine.
CrossoverExperimentalParticipants in this group will receive a single dose of RSVPreF3 OA vaccine.
Receives: Biological: RSVPreF3 OA vaccine

What is being measured

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

  1. RSV-A neutralizing titers expressed as Geometric mean titers (GMTs) in RSV_PreS4 group at Day 1

    Measured: At Day 1

  2. RSV-A neutralizing titers expressed as GMTs in RSV_PreS4 group at Day 31

    Measured: At Day 31

  3. RSV-B neutralizing titers expressed as GMTs in RSV_PreS4 group at Day 1

    Measured: At Day 1

  4. RSV-B neutralizing titers expressed as GMTs in RSV_PreS4 group at Day 31

    Measured: At Day 31

  5. RSV-A neutralizing titers expressed as Mean geometric increase (MGI) in RSV_PreS4 group

    Measured: From Day 1 to Day 31

  6. RSV-B neutralizing titers expressed as MGI in RSV_PreS4 group

    Measured: From Day 1 to Day 31

  7. Percentage of participants with RSV-A neutralizing titers greater than or equal to (>=) cut-off in RSV_PreS4 group at Day 1

    Measured: At Day 1

  8. Percentage of participants with RSV-A neutralizing titers >= cut-off in RSV_PreS4 group at Day 31

    Measured: At Day 31

  9. Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS4 group at Day 1

    Measured: At Day 1

  10. Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS4 group at Day 31

    Measured: At Day 31

  11. Percentage of participants with seroresponse rate (SRR) for RSV-A neutralizing titers in RSV_PreS4 group

    Measured: At Day 31

  12. Percentage of participants with SRR for RSV-B neutralizing titers in RSV_PreS4 group

    Measured: At Day 31

  13. RSV-A neutralizing titers expressed as GMT in RSV_PreS5 group at Day 1

    Measured: At Day 1

  14. RSV-A neutralizing titers expressed as GMT in RSV_PreS5 group at Month 12

    Measured: At Month 12

  15. RSV-A neutralizing titers expressed as GMT in RSV_PreS5 group at Month 13

    Measured: At Month 13

  16. RSV-A neutralizing titers expressed as GMT in RSV_PreS5 group at Month 24

    Measured: At Month 24

  17. RSV-B neutralizing titers expressed as GMTs in RSV_PreS5 group at Day 1

    Measured: At Day 1

  18. RSV-B neutralizing titers expressed as GMTs in RSV_PreS5 group at Month 12

    Measured: At Month 12

  19. RSV-B neutralizing titers expressed as GMTs in RSV_PreS5 group at Month 13

    Measured: At Month 13

  20. RSV-B neutralizing titers expressed as GMTs in RSV_PreS5 group at Month 24

    Measured: At Month 24

  21. RSV-A neutralizing titers expressed as MGI in RSV_PreS5 group from Month 12 to Month 13

    Measured: From Month 12 to Month 13

  22. RSV-A neutralizing titers expressed as MGI in RSV_PreS5 group from Month 12 to Month 24

    Measured: From Month 12 to Month 24

  23. RSV-B neutralizing titers expressed as MGI in RSV_PreS5 group from Month 12 to Month 13

    Measured: From Month 12 to Month 13

  24. RSV-B neutralizing titers expressed as MGI in RSV_PreS5 group from Month 12 to Month 24

    Measured: From Month 12 to Month 24

  25. Percentage of participants with RSV-A neutralizing titers >=cut-off in RSV_PreS5 group at Day 1

    Measured: At Day 1

  26. Percentage of participants with RSV-A neutralizing titers >=cut-off in RSV_PreS5 group at Month 12

    Measured: At Month 12

  27. Percentage of participants with RSV-A neutralizing titers >=cut-off in RSV_PreS5 group at Month 13

    Measured: At Month 13

  28. Percentage of participants with RSV-A neutralizing titers >=cut-off in RSV_PreS5 group at Month 24

    Measured: At Month 24

  29. Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS5 group at Day 1

    Measured: At Day 1

  30. Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS5 group at Month 12

    Measured: At Month 12

  31. Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS5 group at Month 13

    Measured: At Month 13

  32. Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS5 group at Month 24

    Measured: At Month 24

  33. Percentage of participants with seroresponse rate (SRR) for RSV-A neutralizing titers in RSV_PreS5 group

    Measured: At Month 13

  34. Percentage of participants with SRR for RSV-B neutralizing titers in RSV_PreS5 group

    Measured: At Month 13

Secondary outcomes (10)

  1. RSV-A neutralizing titers expressed as GMTs in RSV_1Dose group

    Measured: At Day 1, Month 12 and at Month 24

  2. RSV-B neutralizing titers expressed as GMTs in RSV_1Dose group

    Measured: At Day 1, Month 12 and at Month 24

  3. Percentage of participants with RSV-A neutralizing titers >= cut-off in RSV_1Dose group

    Measured: At Day 1, Month 12 and at Month 24

  4. Percentage of participants with RSV-B neutralizing titers >= cut-off in RSV_1Dose group

    Measured: At Day 1, Month 12 and at Month 24

  5. Number of participants with unsolicited adverse events

    Measured: At Day 30 post vaccination

  6. Number of participants with any serious adverse events (SAEs)

    Measured: From day of vaccination and up to 6 months post each vaccine administration

  7. Number of participants with SAEs related to study intervention

    Measured: From Day 1 and up to end of study

  8. Number of participants with any potential immune-mediated disease (pIMDs)

    Measured: From day of vaccination and up to 6 months post each vaccine administration

  9. Number of participants with pIMDs related to study intervention

    Measured: From Day 1 and up to end of study

  10. Number of participants with fatal SAEs

    Measured: From Day 1 and up to end of study

Timeline

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

  1. First posted2 Aug 2024
  2. Study start1 Aug 2024
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

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
Model description
This is an extension and crossover study.
Masking
None (open label)
Enrolment
10,212 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06534892
Sponsor's protocol ID
222090
Other IDs
2023-509762-38-00, 2023
Acronym
RSV OA=ADJ=012
Status last verified
Sep 2026
First submitted
30 Jul 2024
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
No
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 to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf.

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 251 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 4 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 251 sites in United States, Germany, Canada, United Kingdom, Spain 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. 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?

This study is still under way. Results are not available in the source record yet.

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?

RSV-A neutralizing titers expressed as Geometric mean titers (GMTs) in RSV_PreS4 group at Day 1 (time frame: At Day 1). The study lists 34 primary outcomes in all. 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 NCT06534892.

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 1 Oct 2026.

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