Respiratory Syncytial Virus InfectionsPhase 3NCT05568797

A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone or Co-administered With an Adjuvanted Vaccine Against Influenza in Adults Aged 65 Years and Above

A Phase 3 study testing RSVPreF3 OA vaccine and FLU vaccine in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 37 sites in 5 countries.

Completed

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

Official record

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Trial summary

The aim of this study is to assess the immunogenicity, safety and reactogenicity of the RSV PreFusion protein 3 older adult (RSVPreF3 OA) investigational vaccine when co-administered with an adjuvanted quadrivalent influenza (FLU aQIV) vaccine, in adults aged 65 years of age (YOA). 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 vaccine and FLU vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,045 participants
Where: 37 sitesin 5 countries
Study dates: 14 Oct 2022to 17 Jul 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 (e.g., completion of the electronic diary cards [eDiaries], return for follow-up visits, ability to access and utilize a phone or other electronic communications).
A male or female ≥ 65 YOA 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 study intervention administration. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable.

Who cannot join

Medical conditions
Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination (no laboratory testing required).
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions, in particular any history of severe allergic reaction to egg protein or to a previous influenza vaccine.
Hypersensitivity to latex.
Guillain-Barré syndrome that occurred within 6 weeks of receipt of prior influenza vaccine.
Serious or unstable chronic illness.

Show all 25Show fewer

Any history of dementia or any medical condition that moderately or severely impairs cognition.
Recurrent or uncontrolled 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.
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 dose of study interventions, 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. In the case of COVID-19 vaccines, this time window can be decreased to 14 days before and after each study intervention administration provided this COVID-19 vaccine use is in line with local governmental recommendations.
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 administration of first dose of study interventions 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 intervention 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 (drug or 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.
Bedridden participants.
Planned move during the study conduct that prohibits participation until study end.
Participation of any study personnel or their immediate dependents, family, or household members.

Trial locations and contacts

37 sites in 5 countries.

Country

City, postcode or hospital

37 sites in 5 countries

Spain12 sites

GSK Investigational Site
Benalmádena, Málaga, 29630
GSK Investigational Site
Boadilla Del Monte (Madrid), 28660
GSK Investigational Site
Burgos, 09006
GSK Investigational Site
Centelles, 08540
GSK Investigational Site
La Roca Del Valles (Barcelona), 08430
GSK Investigational Site
Madrid, 28006
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Marbella - Málaga, Andalusia, 29603
GSK Investigational Site
Salamanca, 37007
GSK Investigational Site
Santander (Cantabria), 39008
GSK Investigational Site
Valladolid, 47005
GSK Investigational Site
Vic, 28500

Other trials in Spain

France8 sites

GSK Investigational Site
Angers, 49000
GSK Investigational Site
Clermont-Ferrand, 63003
GSK Investigational Site
Limoges, 87042
GSK Investigational Site
Lyon, 69317
GSK Investigational Site
Montpellier, 34295
GSK Investigational Site
Nîmes, 30029
GSK Investigational Site
Paris, 75679
GSK Investigational Site
Pierre-Bénite, 69495

Other trials in France

United Kingdom7 sites

GSK Investigational Site
Blackpool, FY3 7EN
GSK Investigational Site
Bollington, Cheshire, SK10 5JH
GSK Investigational Site
Bristol, BS37 4AX
GSK Investigational Site
Chippenham, Wiltshire, SN15 2SB
GSK Investigational Site
Chippenham, SN14 6GT
GSK Investigational Site
Peterborough, PE8 6PL
GSK Investigational Site
Soham, Cambridgeshire, CB7 5JD

Other trials in United Kingdom

Finland6 sites

GSK Investigational Site
Espoo, 02230
GSK Investigational Site
Helsinki, 00100
GSK Investigational Site
Kokkola, 67100
GSK Investigational Site
Oulu, 90220
GSK Investigational Site
Seinäjoki, 60100
GSK Investigational Site
Tampere, 33100

Other trials in Finland

Belgium4 sites

GSK Investigational Site
Edegem, 2650
GSK Investigational Site
Erpent, 5101
GSK Investigational Site
Genk, 3600
GSK Investigational Site
Ieper, 8900

Other trials in Belgium

About this study

Official title: A Phase III, Open-label, Randomized, Controlled, Multi-country Study to Evaluate the Immune Response, Safety and Reactogenicity of an RSVPreF3 OA Investigational Vaccine When Co-administered With FLU aQIV (Inactivated Influenza Vaccine - Adjuvanted) in Adults Aged 65 Years and Above

Conditions: Respiratory Syncytial Virus Infections
Being tested: RSVPreF3 OA vaccine, FLU vaccine
Keywords: Respiratory syncytial virus, Adjuvanted 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 vaccineBiological
One dose of RSVPreF3 OA vaccine administered intramuscularly.
FLU vaccineBiological
Also called Fluad Tetra, FLUAD QUADRIVALENT, Fluad Quad
One dose of FLU vaccine administered intramuscularly.

Study groups in NCT05568797
Study group	Role	What they receive
Co-Ad Group	Experimental	Participants received one dose of FLU-aQIV 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 vaccine; Biological: FLU vaccine
Control Group	Active comparator	Participants received one dose of FLU-aQIV vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until end of study. Receives: Biological: RSVPreF3 OA vaccine; Biological: FLU vaccine

What is being measured

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

Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 FLU Vaccine Strains Expressed as Group Geometric Mean Titers (GMTs) at 1 Month After FLU Vaccine Dose
HI antibodies assessed were antibodies 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 flu strains.
Measured: At 1 month after the FLU vaccine dose (Day 31 for both groups)
RSV-A Neutralizing Antibody Titers Expressed as GMTs
RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dilution 60 (ED60).
Measured: At 1 month after the RSVPreF3 OA dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group)
RSV-B Neutralizing Antibody Titers Expressed as GMTs
RSV B neutralizing antibodies are given as GMTs and expressed as Estimated Dilution 60 (ED60).
Measured: At 1 month after the RSVPreF3 OA dose (Day 31 for the CoAd Group and Day 61 for the Control Group)

Secondary outcomes (11)

HI Seroconversion Rate (SCR) for 4 FLU Vaccine Strains
SCR for HI antibody is 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 Neutralization Antibody 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 Neutralization Antibody 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)
Titers for HI Antibodies Against 4 FLU Vaccine Strains
HI antibodies assessed were antibodies 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 flu strains. HI antibodies were expressed as GMT, in titers.
Measured: At Day 1 (Baseline) and Day 31
HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains
SPR for HI antibody was defined as the percentage of participants with a serum HI titer >= 1:40. 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 (Baseline) and Day 31
HI Antibody 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. 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 dose (Day 31 for both groups) compared to pre-vaccination (Day 1 for both groups)
Percentage of Participants Reporting Each Solicited Administration Site Event After Each Vaccine Dose Administration
The solicited administration site events after vaccination include erythema, pain and swelling.
Measured: Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Day 1 for CoAd Group and at Day 1 and Day 31 for Control group)
Percentage of Participants Reporting Each Solicited Systemic Event After Each Dose Administration
The solicited systemic events after vaccination include fever, headache, fatigue, myalgia and arthralgia.
Measured: Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Day 1 and Day 31 for C-oAd Group and at Day 1 and Day 31 for Control group)
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 Electronic Diary. Unsolicited events must be 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 (the day of vaccination and 29 subsequent days) after each vaccine administration
Percentage of Participants Reporting at Least One Serious Adverse Event (SAEs)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant.
Measured: From Day 1 until 6 months after last vaccination (Month 6 for the Co-Ad Group, Month 7 for the Control group)
Percentage of Participants Reporting at Least One 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 until 6 months after last vaccination (Month 6 for the Co-Ad Group, Month 7 for the Control group)

Timeline

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

14 Oct 202217 Jul 2023

First posted6 Oct 2022
Study start14 Oct 2022
Primary completion17 Feb 2023
Study completion17 Jul 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: 1,045 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05568797
Sponsor's protocol ID: 218350
Other IDs: 2022-000623-21
Status last verified: Sep 2024
First submitted: 3 Oct 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

Clark R, Davies S, Labrador J, Loubet P, Natalini Martinez S, Morinigo HM, Nicolas JF, Vera MP, Ramet M, Rebollo-Rodrigo MH, Sanz-Munoz I, Dezutter N, Germain S, David MP, Jayadev A, Amare Hailemariam H, Kotb S, Meyer N. Safety and Immunogenicity of Respiratory Syncytial Virus Prefusion F Protein Vaccine when Co-administered with Adjuvanted Seasonal Quadrivalent Influenza Vaccine in Older Adults: A Phase 3 Randomized Trial. Clin Infect Dis. 2024 Oct 15;79(4):1088-1098. doi: 10.1093/cid/ciae365.
PubMed 39099085

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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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 III, Open-label, Randomized, Controlled, Multi-country Study to Evaluate the Immune Response, Safety and Reactogenicity of an RSVPreF3 OA Investigational Vaccine When Co-administered With FLU aQIV (Inactivated Influenza Vaccine - Adjuvanted) in Adults Aged 65 Years and Above
ClinicalTrials.gov ID: NCT05568797
Acronym / sponsor ID: 218350
Conditions: Respiratory Syncytial Virus Infections
Keywords: Respiratory syncytial virus, Adjuvanted quadrivalent influenza vaccine, Immunogenicity, Safety, Reactogenicity, Adults aged 65 years and above
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,045 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 14 Oct 2022 (actual)
Primary completion: 17 Feb 2023 (actual)
Study completion: 17 Jul 2023 (actual)
First posted: 6 Oct 2022 (actual)
Results: Posted 15 Mar 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 vaccine, Biological: FLU vaccineParticipants received one dose of FLU-aQIV 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 vaccine, Biological: FLU vaccineParticipants received one dose of FLU-aQIV vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until end of study.

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 (e.g., completion of the electronic diary cards [eDiaries], return for follow-up visits, ability to access and utilize a phone or other electronic communications).
A male or female ≥ 65 YOA 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 study intervention administration. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable.

Key exclusion criteria (25 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 study interventions, in particular any history of severe allergic reaction to egg protein or to a previous influenza vaccine.
Hypersensitivity to latex.
Guillain-Barré syndrome that occurred within 6 weeks of receipt of prior influenza vaccine.

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 vaccineOne dose of RSVPreF3 OA vaccine administered intramuscularly.	Biological	Co-Ad Group, Control Group
FLU vaccineAlso: Fluad Tetra, FLUAD QUADRIVALENT, Fluad QuadOne dose of FLU vaccine administered intramuscularly.	Biological	Co-Ad Group, Control Group

Primary outcome

Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 FLU Vaccine Strains Expressed as Group Geometric Mean Titers (GMTs) at 1 Month After FLU Vaccine Dose
Time frame: At 1 month after the FLU vaccine dose (Day 31 for both groups)
HI antibodies assessed were antibodies 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 flu strains.
RSV-A Neutralizing Antibody Titers Expressed as GMTs
Time frame: At 1 month after the RSVPreF3 OA dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group)
RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dilution 60 (ED60).
RSV-B Neutralizing Antibody Titers Expressed as GMTs
Time frame: At 1 month after the RSVPreF3 OA dose (Day 31 for the CoAd Group and Day 61 for the Control Group)
RSV B neutralizing antibodies are given as 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 Neutralization Antibody 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 Neutralization Antibody 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)
Titers for HI Antibodies Against 4 FLU Vaccine Strains
Time frame: At Day 1 (Baseline) and Day 31
HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains
Time frame: At Day 1 (Baseline) and Day 31
HI Antibody Titers for 4 FLU Vaccine Strains Expressed as MGI
Time frame: At 1 month after the FLU dose (Day 31 for both groups) compared to pre-vaccination (Day 1 for both groups)
Percentage of Participants Reporting Each Solicited Administration Site Event After Each Vaccine Dose Administration
Time frame: Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Day 1 for CoAd Group and at Day 1 and Day 31 for Control group)
Percentage of Participants Reporting Each Solicited Systemic Event After Each Dose Administration
Time frame: Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Day 1 and Day 31 for C-oAd Group and at Day 1 and Day 31 for Control group)
Percentage of Participants Reporting Unsolicited Adverse Events (AEs)
Time frame: Within 30 days (the day of vaccination and 29 subsequent days) after each vaccine administration
Percentage of Participants Reporting at Least One Serious Adverse Event (SAEs)
Time frame: From Day 1 until 6 months after last vaccination (Month 6 for the Co-Ad Group, Month 7 for the Control group)
Percentage of Participants Reporting at Least One Potential Immune-mediated Disease (pIMDs)
Time frame: From Day 1 until 6 months after last vaccination (Month 6 for the Co-Ad Group, Month 7 for the Control group)

Results and safety

Results posted to the registry on 15 Mar 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	523	518
Control Group	522	499

Primary outcome: Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 FLU Vaccine Strains Expressed as Group Geometric Mean Titers (GMTs) at 1 Month After FLU Vaccine Dose

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 = 429	Control Group n = 400
Flu A/Darwin/6/2021 H3N2	43.8 (38.9 to 49.4)	57.7 (51.0 to 65.3)
Flu A/Victoria/2570/2019 H1N1	143.0 (128.6 to 159.0)	148.5 (133.2 to 165.6)
Flu B/Austria/1359417/2021 Victoria	613.9 (575.1 to 655.2)	597.5 (558.7 to 639.1)
Flu B/Phuket/3073/2013 Yamagata	406.2 (380.0 to 434.2)	421.0 (393.0 to 451.0)

Co-Ad Group vs Control Group: GMT Ratio: 1.32 (0.95% CI 1.13 to 1.53)
Co-Ad Group vs Control Group: GMT Ratio: 1.04 (0.95% CI 0.91 to 1.18)
Co-Ad Group vs Control Group: GMT Ratio: 0.97 (0.95% CI 0.90 to 1.06)

Population analysed: Analysis was performed on Per Protocol Set for FLU analysis which included eligible participants who: received at least one control group intervention or all Co-Ad group interventions, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, with immunogenicity data available for the specified analysis at the specified time point post-FLU vaccine dose, who lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination.

Primary outcome: RSV-A Neutralizing Antibody Titers Expressed as GMTs

Time frame: At 1 month after the RSVPreF3 OA 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 = 471	Control Group n = 373
Value	6673.4 (6057.2 to 7352.4)	6591.8 (5917.8 to 7342.6)

Co-Ad Group vs Control Group: GMT Ratio: 0.99 (0.95% CI 0.87 to 1.12)

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

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

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

Measure	Co-Ad Group n = 469	Control Group n = 373
Value	7880.1 (7195.4 to 8629.8)	9134.1 (8255.9 to 10105.7)

Co-Ad Group vs Control Group: GMT Ratio: 1.16 (0.95% CI 1.03 to 1.30)

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected 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	21 of 523 (4%)	427 of 523 (81.6%)	0 of 523
Control Group	36 of 522 (6.9%)	428 of 522 (82%)	6 of 522

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 39099085Clark R, Davies S, Labrador J, Loubet P, Natalini Martinez S, Morinigo HM, Nicolas JF, Vera MP, Ramet M, Rebollo-Rodrigo MH, Sanz-Munoz I, Dezutter N, Germain S, David MP, Jayadev A, Amare Hailemariam H, Kotb S, Meyer N. Safety and Immunogenicity of Respiratory Syncytial Virus Prefusion F Protein Vaccine when Co-administered with Adjuvanted Seasonal Quadrivalent Influenza Vaccine in Older Adults: A Phase 3 Randomized Trial. Clin Infect Dis. 2024 Oct 15;79(4):1088-1098. doi: 10.1093/cid/ciae365.
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.

37 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RSVPreF3 OA vaccine and FLU vaccine in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 37 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 5 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: 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 37 sites in Spain, France, United Kingdom, Finland, Belgium. 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 15 Mar 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?

Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 FLU Vaccine Strains Expressed as Group Geometric Mean Titers (GMTs) at 1 Month After FLU Vaccine Dose (time frame: At 1 month after the FLU vaccine dose (Day 31 for both groups)). 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 NCT05568797, 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.