Respiratory Syncytial Virus InfectionsPhase 3NCT05559476

A Study on the Immune Response and Safety Elicited by a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Influenza in Adults Aged 65 Years and Above

A Phase 3 study testing RSVPreF3 OA investigational vaccine and FLU HD vaccine in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 46 sites in United States.

Completed

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

Official record

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Trial summary

The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when co-administered with the high dose quadrivalent influenza (FLU HD) vaccine in adults aged 65 years and above compared to separate administration of the vaccines. Read more about this study

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Respiratory Syncytial Virus Infections
What is being tested?: RSVPreF3 OA investigational vaccine and FLU HD vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,029 participants
Where: 46 sitesUnited States
Study dates: 20 Oct 2022to 15 Aug 2023
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 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol
A male or female ≥65 years of age at the time of the first study intervention administration.
Participants living in the general community or in an assisted-living facility that provides minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.
Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure.
Participants who are medically stable in the opinion of the investigator at the time of first vaccination. Participants with chronic stable medical conditions with or without specific treatment are allowed to participate in this study if considered by the investigator as medically stable.

Who cannot join

Medical conditions
Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination (no laboratory testing required).
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
Hypersensitivity to latex.
History of Guillain Barré syndrome, or anaphylaxis.
Serious or unstable chronic illness.

Show all 26Show fewer

Any history of dementia or any medical condition that moderately or severely impairs cognition.
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 (e.g. completion of diary cards, attend regular phone calls/study site visits).
Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
Prior/Concomitant therapy
Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study interventions during the period beginning 30 days before the first study vaccine administration, or planned use during the study period.
Administration of an influenza vaccine during the 6 months preceding the study FLU vaccine administration.
Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first study intervention administration and ending 30 days after the last study intervention administration.
Note: In case an emergency mass vaccination for an unforeseen public health threat (e.g.: a pandemic) is recommended and/or organized by the public health authorities, outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly.
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 study vaccination 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 intervention (drug/invasive medical device).
Other exclusions
History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
Planned move during the study conduct that prohibits participation until 1 month post-last vaccine administration.
Bedridden participants.
Participation of any study personnel or their immediate dependents, family, or household members.

Trial locations and contacts

46 sites in 1 country.

City, postcode or hospital

46 sites in 1 country

United States46 sites

GSK Investigational Site
Ames, Iowa, 50010
GSK Investigational Site
Aurora, Colorado, 80012
GSK Investigational Site
Austin, Texas, 78745
GSK Investigational Site
Birmingham, Alabama, 35205
GSK Investigational Site
Canoga Park, California, 91303
GSK Investigational Site
Chicago, Illinois, 60640
GSK Investigational Site
Cincinnati, Ohio, 45236
GSK Investigational Site
Colton, California, 92324
GSK Investigational Site
Columbia, South Carolina, 21045
GSK Investigational Site
Coral Gables, Florida, 33134
GSK Investigational Site
Edmond, Oklahoma, 73013
GSK Investigational Site
El Dorado, Kansas, 67042
GSK Investigational Site
Evansville, Indiana, 47714
GSK Investigational Site
Fort Myers, Florida, 33912
GSK Investigational Site
Grand Island, Nebraska, 68803
GSK Investigational Site
Hialeah, Florida, 33012
GSK Investigational Site
Hickory, North Carolina, 28601
GSK Investigational Site
Immokalee, Florida, 34142
GSK Investigational Site
Jefferson City, Tennessee, 37760
GSK Investigational Site
Memphis, Tennessee, 38119
GSK Investigational Site
Methuen, Massachusetts, 01844
GSK Investigational Site
Miami, Florida, 33016
GSK Investigational Site
Miami, Florida, 33184
GSK Investigational Site
Minneapolis, Minnesota, 55402
GSK Investigational Site
Mishawaka, Indiana, 46544
GSK Investigational Site
Nashville, Tennessee, 37912
GSK Investigational Site
North Charleston, South Carolina, 29405
GSK Investigational Site
North Las Vegas, Nevada, 89030
GSK Investigational Site
Orlando, Florida, 32801
GSK Investigational Site
Papillion, Nebraska, 68046
GSK Investigational Site
Pittsburgh, Pennsylvania, 15243
GSK Investigational Site
Rocky Mount, North Carolina, 27804
GSK Investigational Site
Sacramento, California, 95864
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
San Antonio, Texas, 78237
GSK Investigational Site
San Diego, California, 92103-6204
GSK Investigational Site
Sandy Springs, Georgia, 30328
GSK Investigational Site
Savannah, Georgia, 31406
GSK Investigational Site
Spartanburg, South Carolina, 29303
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
Tempe, Arizona, 85281
GSK Investigational Site
Valparaiso, Indiana, 46383
GSK Investigational Site
Walnut Creek, California, 94598
GSK Investigational Site
Warren Township, New Jersey, 07059
GSK Investigational Site
West Palm Beach, Florida, 33409
GSK Investigational Site
Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: A Phase 3, Open-label, Randomized, Controlled, Multicountry Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With FLU HD Vaccine in Adults Aged 65 Years and Above

Conditions: Respiratory Syncytial Virus Infections
Being tested: RSVPreF3 OA investigational vaccine, FLU HD vaccine
Keywords: Respiratory syncytial virus, High dose quadrivalent influenza vaccine, Immunogenicity, Safety, Reactogenicity, Adults aged 65 years and above
Medical subject headings: Respiratory Syncytial Virus Infections

What participants receive

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

RSVPreF3 OA investigational vaccineBiological
RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
FLU HD vaccineBiological
FLU HD vaccine administered intramuscularly in the deltoid region of the dominant arm (Co-Ad Group) or the non-dominant arm (Control Group).

Study groups in NCT05559476
Study group	Role	What they receive
Co-Ad Group	Experimental	Participants received one dose of FLU-HD vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study. Receives: Biological: RSVPreF3 OA investigational vaccine; Biological: FLU HD vaccine
Control Group	Active comparator	Participants received one dose of FLU-HD vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until the study end. Receives: Biological: RSVPreF3 OA investigational vaccine; Biological: FLU HD vaccine

What is being measured

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

RSV-A Neutralizing Titers Expressed as Group Geometric Mean Titers (GMTs)
RSV-A neutralizing titers were given as group GMTs and expressed as Estimated Dilution 60 (ED60).
Measured: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group)
Hemagglutinin Inhibition (HI) Titers for 4 FLU Vaccine Strains Expressed as Group GMTs
HI titers were assessed against the Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata strains.
Measured: At 1 month after the FLU vaccine dose (Day 31 for both groups)
RSV-B Neutralizing Titers Expressed as Group GMTs
RSV-B neutralizing titers were given as group GMTs and expressed as Estimated Dilution 60 (ED60).
Measured: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group)

Secondary outcomes (11)

HI Seroconversion Rate (SCR) for 4 FLU Vaccine Strains
SCR for HI titers was defined as the percentage of participants who have either a HI predose titer less than (<) 1:10 and a post-dose titer greater than or equal to (>=) 1:40, or a pre-dose titer >= 1:10 and at least a 4-fold increase in post-dose titer. The assessed Flu strains were: Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata.
Measured: At 1 month after the FLU vaccine dose (Day 31 for both groups)
RSV-A Neutralizing Titers Expressed as Mean Geometric Increase (MGI)
MGI was defined as the geometric mean of the within-participant ratios of the post-dose titer over the pre-dose titer.
Measured: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) compared to pre-vaccination (Day 1 for Co-Ad group and Day 31 for Control group)
RSV-B Neutralizing Titers Expressed as MGI
MGI was defined as the geometric mean of the within-participant ratios of the post-dose titer over the pre-dose titer.
Measured: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) compared to pre-vaccination (Day 1 for Co-Ad group and Day 31 for Control group)
HI Titers for Each of the 4 FLU Vaccine Strains Expressed as GMT
HI titers were assessed against the Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata strains. HI antibodies were expressed as GMTs, in titers.
Measured: At Day 1 and 1 month after FLU vaccine dose administration (Day 31 for both groups)
HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains
SPR for HI titers was defined as the percentage of participants with a serum HI titer >= 1:40. The assessed Flu strains were: The assessed Flu strains were: Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata.
Measured: At Day 1 and 1 month after FLU vaccine dose administration (Day 31 for both groups)
HI Titers for 4 FLU Vaccine Strains, Expressed as MGI
MGI was defined as the geometric mean of the within-participant ratios of the post-dose titer over the pre-dose titer.
Measured: At 1 month after the FLU vaccine dose administration (Day 31 for both groups)
Percentage of Participants With Solicited Administration Site Events After Each Vaccine Dose Administration
The solicited administration site events after vaccination included erythema, pain and swelling.
Measured: Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on Day 1 and 31)
Percentage of Participants Reporting Each Solicited Systemic Event After Each Vaccine Dose Administration
The solicited systemic events after vaccination include arthralgia, fatigue, fever, headache and myalgia.
Measured: Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on Day 1 and 31)
Percentage of Participants Reporting Unsolicited Adverse Events (AEs)
An unsolicited AEs is an AE that is not included in a list of solicited events using a participant diary. Unsolicited events must have been spontaneously communicated by a participant who signs the informed consent. Unsolicited AEs include both serious, non-serious AEs and potential immune-mediated diseases (pIMDs).
Measured: Within 30 days after vaccine administration (the day of vaccination and 29 subsequent days after vaccination)
Percentage of Participants Reporting Serious Adverse Events (SAEs)
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, is a congenital anomaly/birth defect in the offspring of a study participant.
Measured: From Day 1 up to study end (6 months after last vaccination - Month 6 for Co-Ad Group and Month 7 for Control group)
Percentage of Participants Reporting Potential Immune-mediated Disease (pIMDs)
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. The investigator must exercise his/her medical/scientific judgment to determine whether other diseases have an autoimmune origin (i.e. pathophysiology involving systemic or organ-specific pathogenic autoantibodies) and should also be recorded as a pIMD.
Measured: From Day 1 up to study end (6 months after last vaccination - Month 6 for Co-Ad Group and Month 7 for Control group)

Timeline

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

20 Oct 202215 Aug 2023

First posted29 Sep 2022
Study start20 Oct 2022
Primary completion7 Mar 2023
Study completion15 Aug 2023

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: 1,029 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05559476
Sponsor's protocol ID: 214489
Other IDs: 2021-001356-34
Status last verified: Sep 2024
First submitted: 26 Sep 2022
Last updated: 24 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
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 (IPD) 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

Publications

Buynak R, Cannon K, DeAtkine D, Kirby J, Usdan L, Bhavsar A, Gerard C, Kuznetsova A, Jayadev A, Amare H, Valenciano S, Meyer N. Randomized, Open-Label Phase 3 Study Evaluating Immunogenicity, Safety, and Reactogenicity of RSVPreF3 OA Coadministered with FLU-QIV-HD in Adults Aged >/= 65. Infect Dis Ther. 2024 Aug;13(8):1789-1805. doi: 10.1007/s40121-024-00985-4. Epub 2024 Jun 26.
PubMed 38981954

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 2
Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons
Respiratory Syncytial Virus (RSV)
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TARSILA Real-World Evidence Study
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All Respiratory Syncytial Virus Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Open-label, Randomized, Controlled, Multicountry Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With FLU HD Vaccine in Adults Aged 65 Years and Above
ClinicalTrials.gov ID: NCT05559476
Acronym / sponsor ID: 214489
Conditions: Respiratory Syncytial Virus Infections
Keywords: Respiratory syncytial virus, High dose quadrivalent influenza vaccine, Immunogenicity, Safety, Reactogenicity, Adults aged 65 years and above
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,029 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 20 Oct 2022 (actual)
Primary completion: 7 Mar 2023 (actual)
Study completion: 15 Aug 2023 (actual)
First posted: 29 Sep 2022 (actual)
Results: Posted 4 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Co-Ad Group	Experimental	Biological: RSVPreF3 OA investigational vaccine, Biological: FLU HD vaccineParticipants received one dose of FLU-HD vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
Control Group	Active comparator	Biological: RSVPreF3 OA investigational vaccine, Biological: FLU HD vaccineParticipants received one dose of FLU-HD vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until the study end.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (5 listed)

Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol
A male or female ≥65 years of age at the time of the first study intervention administration.
Participants living in the general community or in an assisted-living facility that provides minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.
Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure.
Participants who are medically stable in the opinion of the investigator at the time of first vaccination. Participants with chronic stable medical conditions with or without specific treatment are allowed to participate in this study if considered by the investigator as medically stable.

Key exclusion criteria (26 listed)

Medical conditions
Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination (no laboratory testing required).
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
Hypersensitivity to latex.
History of Guillain Barré syndrome, or anaphylaxis.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RSVPreF3 OA investigational vaccineRSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.	Biological	Co-Ad Group, Control Group
FLU HD vaccineFLU HD vaccine administered intramuscularly in the deltoid region of the dominant arm (Co-Ad Group) or the non-dominant arm (Control Group).	Biological	Co-Ad Group, Control Group

Primary outcome

RSV-A Neutralizing Titers Expressed as Group Geometric Mean Titers (GMTs)
Time frame: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group)
RSV-A neutralizing titers were given as group GMTs and expressed as Estimated Dilution 60 (ED60).
Hemagglutinin Inhibition (HI) Titers for 4 FLU Vaccine Strains Expressed as Group GMTs
Time frame: At 1 month after the FLU vaccine dose (Day 31 for both groups)
HI titers were assessed against the Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata strains.
RSV-B Neutralizing Titers Expressed as Group GMTs
Time frame: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group)
RSV-B neutralizing titers were given as group GMTs and expressed as Estimated Dilution 60 (ED60).

11 secondary outcomes

HI Seroconversion Rate (SCR) for 4 FLU Vaccine Strains
Time frame: At 1 month after the FLU vaccine dose (Day 31 for both groups)
RSV-A Neutralizing Titers Expressed as Mean Geometric Increase (MGI)
Time frame: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) compared to pre-vaccination (Day 1 for Co-Ad group and Day 31 for Control group)
RSV-B Neutralizing Titers Expressed as MGI
Time frame: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) compared to pre-vaccination (Day 1 for Co-Ad group and Day 31 for Control group)
HI Titers for Each of the 4 FLU Vaccine Strains Expressed as GMT
Time frame: At Day 1 and 1 month after FLU vaccine dose administration (Day 31 for both groups)
HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains
Time frame: At Day 1 and 1 month after FLU vaccine dose administration (Day 31 for both groups)
HI Titers for 4 FLU Vaccine Strains, Expressed as MGI
Time frame: At 1 month after the FLU vaccine dose administration (Day 31 for both groups)
Percentage of Participants With Solicited Administration Site Events After Each Vaccine Dose Administration
Time frame: Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on Day 1 and 31)
Percentage of Participants Reporting Each Solicited Systemic Event After Each Vaccine Dose Administration
Time frame: Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on Day 1 and 31)
Percentage of Participants Reporting Unsolicited Adverse Events (AEs)
Time frame: Within 30 days after vaccine administration (the day of vaccination and 29 subsequent days after vaccination)
Percentage of Participants Reporting Serious Adverse Events (SAEs)
Time frame: From Day 1 up to study end (6 months after last vaccination - Month 6 for Co-Ad Group and Month 7 for Control group)
Percentage of Participants Reporting Potential Immune-mediated Disease (pIMDs)
Time frame: From Day 1 up to study end (6 months after last vaccination - Month 6 for Co-Ad Group and Month 7 for Control group)

Results and safety

Results posted to the registry on 4 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Co-Ad Group	516	493
Control Group	513	485

Primary outcome: RSV-A Neutralizing Titers Expressed as Group Geometric Mean Titers (GMTs)

Time frame: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group). Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Co-Ad Group n = 457	Control Group n = 414
Value	5876.3 (5299.5 to 6515.9)	6935.3 (6200.0 to 7757.9)

Co-Ad Group vs Control Group: GMT Ratio: 1.18 (95% CI 1.03 to 1.35)

Population analysed: Analysis was performed on Per Protocol Set (PPS) for RSV analysis which included eligible participants who: received RSVPreF3 OA vaccine dose in Control group and all study doses in Co-Ad group, had pre and post-dose immunogenicity results, adhered to specified blood draw intervals, had immunogenicity data available for the specified analysis at the specified time point post-RSVPreF3 OA vaccine dose, lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination.

Primary outcome: Hemagglutinin Inhibition (HI) Titers for 4 FLU Vaccine Strains Expressed as Group GMTs

Time frame: At 1 month after the FLU vaccine dose (Day 31 for both groups). Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Co-Ad Group n = 456	Control Group n = 440
Flu A/Darwin/6/2021 H3N2	72.7 (64.1 to 82.5)	72.3 (63.7 to 82.1)
Flu A/Victoria/2570/2019 H1N1	189.9 (167.6 to 215.1)	177.3 (156.4 to 200.9)
Flu B/Austria/1359417/2021 Victoria	859.8 (805.8 to 917.5)	820.9 (768.8 to 876.6)
Flu B/Phuket/3073/2013 Yamagata	758.7 (699.1 to 823.4)	703.4 (647.7 to 763.9)

Co-Ad Group vs Control Group: GMT Ratio: 0.99 (95% CI 0.85 to 1.16)
Co-Ad Group vs Control Group: GMT Ratio: 0.93 (95% CI 0.80 to 1.09)
Co-Ad Group vs Control Group: GMT Ratio: 0.95 (95% CI 0.88 to 1.03)

Population analysed: Analysis was performed on PPS for FLU analysis which included eligible participants who: received FLU vaccine dose in Control group and all study doses in Co-Ad group, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, had immunogenicity data available for the specified analysis at the specified time point post-FLU vaccine dose, lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination.

Primary outcome: RSV-B Neutralizing Titers Expressed as Group GMTs

Time frame: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group). Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Co-Ad Group n = 457	Control Group n = 355
Value	8251.5 (7460.6 to 9126.3)	8359.0 (7492.8 to 9325.3)

Co-Ad Group vs Control Group: GMT Ratio: 1.01 (95% CI 0.89 to 1.15)

Population analysed: Analysis was performed on PPS for RSV analysis which included eligible participants who: received RSVPreF3 OA vaccine dose in Control group and all study doses in Co-Ad group, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, had immunogenicity data available for the specified analysis at the specified time point post- RSVPreF3 OA vaccine dose, lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Co-Ad Group	12 of 516 (2.3%)	339 of 516 (65.7%)	1 of 516
Control Group	15 of 513 (2.9%)	319 of 513 (62.2%)	0 of 513

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 38981954Buynak R, Cannon K, DeAtkine D, Kirby J, Usdan L, Bhavsar A, Gerard C, Kuznetsova A, Jayadev A, Amare H, Valenciano S, Meyer N. Randomized, Open-Label Phase 3 Study Evaluating Immunogenicity, Safety, and Reactogenicity of RSVPreF3 OA Coadministered with FLU-QIV-HD in Adults Aged >/= 65. Infect Dis Ther. 2024 Aug;13(8):1789-1805. doi: 10.1007/s40121-024-00985-4. Epub 2024 Jun 26.
Individual participant dataSharing planned: Yes. GSK will assess requests from qualified researchers for anonymized individual patient-level data (IPD) 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

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

46 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RSVPreF3 OA investigational vaccine and FLU HD vaccine in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 46 sites in United States.

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

Who may be eligible to take part?

The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2024. 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. 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 4 Apr 2024). 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?

RSV-A Neutralizing Titers Expressed as Group Geometric Mean Titers (GMTs) (time frame: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group)). The study lists 3 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 NCT05559476, 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 24 Sep 2024.