AzTrials
AzTrials

Respiratory Syncytial Virus InfectionsPhase 3NCT04732871

Immunogenicity, Safety, Reactogenicity and Persistence of an Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above

A Phase 3 study testing RSVPreF3 OA investigational vaccine in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 46 sites in 5 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 assess the safety, reactogenicity, immunogenicity and long-term persistence of immune response up to 5 years following a single dose vaccination of GSK's investigational vaccine RSVPreF3 OA, in adults aged 60 years and above. 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 investigational vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,720 participants
Where
46 sitesin 5 countries
Study dates
15 Feb 2021to 19 Feb 2027
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

  • Male or female participants ≥60 YOA at first vaccination, who live in the community (CD 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.
  • 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. Patients 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.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
  • Hypersensitivity to latex.
  • Serious or unstable chronic illness.
  • Recurrent or un-controlled neurological disorders or seizures. Participants with medically-controlled active or chronic 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.
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  • 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.
  • Any history of dementia or any medical condition that moderately or severely impairs cognition.
  • 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.
  • 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, split virion 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 dose of 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 vaccine dose 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.
  • 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 participation in the trial until the 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.

Trial locations and contacts

46 sites in 5 countries.

46 sites in 5 countries

United States18 sites

  • GSK Investigational Site

    Coral Gables, Florida, 33134

  • GSK Investigational Site

    Evansville, Indiana, 47714

  • GSK Investigational Site

    Fort Myers, Florida, 33912-4316

  • GSK Investigational Site

    Kansas City, Missouri, 64114-4859

  • GSK Investigational Site

    Mobile, Alabama, 36608

  • GSK Investigational Site

    Mt. Pleasant, South Carolina, 29464

  • GSK Investigational Site

    Norfolk, Virginia, 23502

  • GSK Investigational Site

    Phoenix, Arizona, 85020

  • GSK Investigational Site

    Richfield, Minnesota, 55423

  • GSK Investigational Site

    Riverside, California, 92503

  • GSK Investigational Site

    Rochester, New York, 14609-3173

  • GSK Investigational Site

    San Antonio, Texas, 78229-6306

  • GSK Investigational Site

    San Diego, California, 92103

  • GSK Investigational Site

    Sarasota, Florida, 34243

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    The Villages, Florida, 32162

  • GSK Investigational Site

    Wenatchee, Washington, 98801-2028

  • GSK Investigational Site

    Wichita, Kansas, 67226

Other trials in United States

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, Satakunta, 28100

  • GSK Investigational Site

    Seinäjoki, 60100

  • GSK Investigational Site

    Tampere, 33100

  • GSK Investigational Site

    Turku, 20520

Other trials in Finland

Germany8 sites

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45359

  • GSK Investigational Site

    Essen, 45355

  • GSK Investigational Site

    Goch, North Rhine-Westphalia, 47574

  • GSK Investigational Site

    Hamburg, 20095

  • GSK Investigational Site

    Mainz, 55116

  • GSK Investigational Site

    München, 80339

  • GSK Investigational Site

    Wallerfing, 94574

  • GSK Investigational Site

    Würzburg, 97074

Other trials in Germany

Taiwan7 sites

  • GSK Investigational Site

    Changhua, 500

  • GSK Investigational Site

    Taichung, 40447

  • GSK Investigational Site

    Taichung, 407

  • GSK Investigational Site

    Taipei, 100

  • GSK Investigational Site

    Taipei, 104

  • GSK Investigational Site

    Taipei, 112

  • GSK Investigational Site

    Taoyuan, 333

Other trials in Taiwan

Japan3 sites

  • GSK Investigational Site

    Fukuoka, 812-0025

  • GSK Investigational Site

    Kumamoto, 861-4157

  • GSK Investigational Site

    Tokyo, 160-0017

Other trials in Japan

About this study

Official title: A Phase 3, Randomized, Open-label, Multi-country Study to Evaluate the Immunogenicity, Safety, Reactogenicity and Persistence of a Single Dose of the RSVPreF3 OA Investigational Vaccine and Different Revaccination Schedules in Adults Aged 60 Years and Above

The purpose of this study is to assess the safety, reactogenicity, immunogenicity and long-term persistence of immune response up to 5 years following a single dose vaccination of GSK's investigational vaccine RSVPreF3 OA, in adults aged 60 years and above. The study will also evaluate the immunogenicity, safety and reactogenicity of additional vaccine doses given according to different revaccination schedules.

Being tested
RSVPreF3 OA investigational vaccine
Keywords
Respiratory syncytial virus, Vaccine, Safety, Reactogenicity, Immunogenicity
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 investigational vaccineBiological

    RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.

Study groups in NCT04732871
Study groupRoleWhat they receive
RSV_annual GroupExperimentalParticipants receive one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and are followed up until Month 60.
Receives: Biological: RSVPreF3 OA investigational vaccine
RSV_Flexible revaccination GroupExperimentalParticipants receive one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 24 months post-Dose 1 and at 48 months post-Dose 1, respectively and are followed up until Month 60.
Receives: Biological: RSVPreF3 OA investigational vaccine
RSV_1dose GroupExperimentalParticipants receive one dose of RSVPreF3 OA investigational vaccine at Day 1 and are followed up until Month 36. At Month 36, participants in this group will be re-randomized in 2 groups: RSV_1dose_M36 (which will receive 1 additional revaccination dose at Month 36 and will be followed up until Month 60) and RSV_1dose_Flexible (which will receive 1 additional revaccination dose at Month 60, and will be followed up until study end at Month 72).
Receives: Biological: RSVPreF3 OA investigational vaccine

What is being measured

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

  1. Humoral Immune Response in Terms of Respiratory Syncytial Virus (RSV)-A Neutralizing Antibody Geometric Mean Titers (GMTs) at Day 1

    RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

    Measured: At Day 1

  2. Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Day 31

    RSV-A neutralizing antibodies were given as GMTs and expressed as ED60.

    Measured: At Day 31

  3. Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 6

    RSV-A neutralizing antibodies were given as GMTs and expressed as ED60.

    Measured: At Month 6

  4. Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 12

    RSV-A neutralizing antibodies were given as GMTs and expressed as ED60.

    Measured: At Month 12

  5. Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 1

    RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.

    Measured: At Day 1

  6. Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 31

    RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.

    Measured: At Day 31

  7. Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 6

    RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.

    Measured: At Month 6

  8. Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 12

    RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.

    Measured: At Month 12

Secondary outcomes (58)

  1. Humoral Immune Response in Terms of RSVPreF3 Immunoglobulin G (IgG) Antibody Geometric Mean Concentrations (GMCs) at Day 1

    Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by enzyme-linked immunosorbent assay (ELISA). The corresponding antibody GMC was expressed in Elisa Laboratory Units/milliliter (ELU/mL).

    Measured: At Day 1

  2. Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Day 31

    Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.

    Measured: At Day 31

  3. Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 6

    Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.

    Measured: At Month 6

  4. Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 12

    Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.

    Measured: At Month 12

  5. Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 18

    Month 18 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

    Measured: At Month 18

  6. Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 24

    Month 24 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

    Measured: At Month 24

  7. Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 30

    Month 30 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

    Measured: At Month 30

  8. Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 36

    Month 36 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

    Measured: At Month 36

  9. Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 13

    Month 13 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

    Measured: At Month 13

  10. Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 25

    Month 25 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

    Measured: At Month 25

  11. Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 18

    Month 18 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

    Measured: At Month 18

  12. Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 24

    Month 24 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

    Measured: At Month 24

  13. Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 30

    Month 30 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

    Measured: At Month 30

  14. Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 36

    Month 36 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

    Measured: At Month 36

  15. Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 13

    Month 13 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

    Measured: At Month 13

  16. Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 25

    Month 25 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

    Measured: At Month 25

  17. Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 18

    Month 18 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.

    Measured: At Month 18

  18. Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 24

    Month 24 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.

    Measured: At Month 24

  19. Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 30

    Month 30 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.

    Measured: At Month 30

  20. Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 36

    Month 36 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.

    Measured: At Month 36

  21. Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 13

    Month 13 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.

    Measured: At Month 13

  22. Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 25

    Month 25 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.

    Measured: At Month 25

  23. Cell-Mediated Immunity (CMI) Response in Terms of Frequency of RSVPreF3-specific Cluster of Differentiation CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 1

    Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.

    Measured: At Day 1

  24. CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 1

    Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations.

    Measured: At Day 1

  25. CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 31

    Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations.

    Measured: At Day 31

  26. CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 31

    Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations.

    Measured: At Day 31

  27. CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 6

    Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations.

    Measured: At Month 6

  28. CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 6

    Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations.

    Measured: At Month 6

  29. CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 12

    Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations.

    Measured: At Month 12

  30. CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 12

    Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations.

    Measured: At Month 12

  31. CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 18

    Month 18 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.

    Measured: At Month 18

  32. CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 18

    Month 18 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.

    Measured: At Month 18

  33. CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 24

    Month 24 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.

    Measured: At Month 24

  34. CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 24

    Month 24 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.

    Measured: At Month 24

  35. CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 30

    Month 30 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.

    Measured: At Month 30

  36. CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 30

    Month 30 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.

    Measured: At Month 30

  37. CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 36

    Month 36 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.

    Measured: At Month 36

  38. CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 36

    Month 36 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.

    Measured: At Month 36

  39. CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 13

    Month 13 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.

    Measured: At Month 13

  40. CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 13

    Month 13 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.

    Measured: At Month 13

  41. CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 25

    Month 25 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.

    Measured: At Month 25

  42. CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 25

    Month 25 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.

    Measured: At Month 25

  43. Number of Participants With at Least One Solicited Administration-site Event Following Vaccination at Day 1

    The solicited administration-site events were erythema, pain and swelling at the injection site.

    Measured: During the 4-day follow up period after first vaccination (vaccine administered on Day 1)

  44. Number of Participants With at Least One Solicited Administration-site Event Following Vaccination at Month 12

    Month 12 to Month 18 data will be disclosed during final posting. The solicited administration-site events were erythema, pain and swelling at the injection site.

    Measured: During the 4-day follow up period after vaccination (vaccine administered at Month 12)

  45. Number of Participants With at Least One Solicited Administration-site Event Following Vaccination at Month 24

    Month 24 data will be disclosed during final posting. The solicited administration-site events were erythema, pain and swelling at the injection site.

    Measured: During the 4-day follow up period after vaccination (vaccine administered at Month 24)

  46. Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Day 1

    The solicited systemic events included arthralgia, fatigue, fever (defined as temperature equal to or above 38.0 degree Celsius [°C]), headache and myalgia.

    Measured: During the 4-day follow up period after vaccination (vaccine administered on Day 1)

  47. Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Month 12

    Month 12 to Month 18 data will be disclosed during final posting. The solicited systemic events included arthralgia, fatigue, fever (defined as temperature equal to or above 38.0°C), headache and myalgia.

    Measured: During the 4-day follow up period after vaccination (vaccine administered at Month 12)

  48. Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Month 24

    Month 24 data will be disclosed during final posting. The solicited systemic events included arthralgia, fatigue, fever (defined as temperature equal to or above 38.0 degree Celsius (°C)), headache and myalgia.

    Measured: During the 4-day follow up period after vaccination (vaccine administered at Month 24)

  49. Number of Participants With Any Unsolicited Adverse Events (AEs) Following Vaccination at Day 1

    An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of study intervention, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study, and/or any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

    Measured: During the 30-day follow up period after vaccination (vaccine administered on Day 1)

  50. Number of Participants With Any Unsolicited AEs Following Vaccination at Month 12

    Month 12 to Month 18 data will be disclosed during final posting. An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of study intervention, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study, and/or any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

    Measured: During the 4-day follow up period after vaccination (vaccine administered at Month 12)

  51. Number of Participants With Any Unsolicited AEs Following Vaccination at Month 24

    Month 24 data will be disclosed during final posting. An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of study intervention, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study, and/or any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

    Measured: During the 4-day follow up period after vaccination (vaccine administered at Month 24)

  52. Number of Participants With Serious Adverse Events (SAE) Following Vaccination at Day 1

    An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study participant.

    Measured: From first vaccination (Day 1) up to 6 months post-Dose 1 (Month 6)

  53. Number of Participants With SAEs Following Vaccination at Month 12

    Month 12 to Month 18 data will be disclosed during final posting. An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study participant.

    Measured: During the 4-day follow up period after vaccination (vaccine administered at Month 12)

  54. Number of Participants With SAEs Following Vaccination at Month 24

    Month 24 data will be disclosed during final posting. An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study participant.

    Measured: During the 4-day follow up period after vaccination (vaccine administered at Month 24)

  55. Number of Participants Reporting Any Potential Immune-mediated Disease (pIMD) Following Vaccination at Day 1

    pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

    Measured: From first vaccination (Day 1) up to 6 months post-Dose 1 (Month 6)

  56. Number of Participants Reporting Any pIMD Following Vaccination at Month 12

    Month 12 to Month 18 data will be disclosed during final posting. pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

    Measured: During the 4-day follow up period after vaccination (vaccine administered at Month 12)

  57. Number of Participants Reporting Any pIMD Following Vaccination at Month 24

    Month 24 data will be disclosed during final posting. pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

    Measured: During the 4-day follow up period after vaccination (vaccine administered at Month 24)

  58. Number of Participants With a Fatal SAE, Related SAE and Related pIMDs

    A fatal SAE is any untoward medical occurrence that results in death. A related SAE is an SAE considered to be causally related to the study intervention. A related pIMD is a pIMD considered to be causally related to the study intervention.

    The study is ongoing at the time of the results posting. Results for Months 18 up to study end (Month 36) will be updated during final posting.

    Measured: From first vaccination (Day 1) up to study end (Month 36)

Timeline

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

  1. First posted1 Feb 2021
  2. Study start15 Feb 2021
  3. Primary completion6 Jun 2022
  4. Study completion19 Feb 2027 (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
Masking
None (open label)
Enrolment
1,720 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04732871
Sponsor's protocol ID
212496
Other IDs
2024-512291-34
Status last verified
Sep 2026
First submitted
27 Jan 2021
Last updated
28 Sep 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

  • Schwarz TF, Hwang SJ, Ylisastigui P, Liu CS, Takazawa K, Yono M, Ervin JE, Andrews CP, Fogarty C, Eckermann T, Collete D, de Heusch M, De Schrevel N, Salaun B, Lambert A, Marechal C, Olivier A, Nakanwagi P, Lievens M, Hulstrom V. Immunogenicity and Safety Following 1 Dose of AS01E-Adjuvanted Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults: A Phase 3 Trial. J Infect Dis. 2024 Jul 25;230(1):e102-e110. doi: 10.1093/infdis/jiad546.

    PubMed 39052726

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RSVPreF3 OA investigational vaccine in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 46 sites in 5 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 25 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 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United States, Finland, Germany, Taiwan, Japan. 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?

Yes. Results are posted in the registry (first posted 21 Dec 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?

Humoral Immune Response in Terms of Respiratory Syncytial Virus (RSV)-A Neutralizing Antibody Geometric Mean Titers (GMTs) at Day 1 (time frame: At Day 1). The study lists 8 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 NCT04732871, which also lists 1 linked publication.

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 28 Sep 2026.

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