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.
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
- Type of treatment
- Vaccines, Injection or infusion
- 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
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
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
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
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
Japan3 sites
GSK Investigational Site
Fukuoka, 812-0025
GSK Investigational Site
Kumamoto, 861-4157
GSK Investigational Site
Tokyo, 160-0017
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.
- Conditions
- Respiratory Syncytial Virus Infections
- 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 group | Role | What they receive |
|---|---|---|
| RSV_annual Group | Experimental | Participants 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 Group | Experimental | Participants 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 Group | Experimental | Participants 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.
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
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
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
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
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
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
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
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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.
- First posted1 Feb 2021
- Study start15 Feb 2021
- Primary completion6 Jun 2022
- Study completion19 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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