Respiratory Syncytial Virus InfectionsPhase 3NCT04841577

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 60 Years and Above

A Phase 3 study testing RSVPreF3 OA investigational vaccine and FLU-QIV in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 14 sites in 3 countries.

Completed

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

Official record

Search all trials

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 seasonal quadrivalent influenza vaccine (FLU-QIV) in adults aged 60 years and above compared to separate administration of the vaccines. 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 and FLU-QIV
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 976 participants
Where: 14 sitesin 3 countries
Study dates: 27 Apr 2021to 8 Feb 2022
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol A male or female ≥60 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 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.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
Hypersensitivity to latex.
History of GBS, anaphylaxis, febrile seizures, Bell's palsy and narcolepsy.
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 dose of study vaccines and ending 30 days after the last vaccine administration, or planned use during the study period.
Administration of an influenza vaccine during the 6 months preceding the study FLU-QIV 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 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

14 sites in 3 countries.

Country

City, postcode or hospital

14 sites in 3 countries

New Zealand7 sites

GSK Investigational Site
Auckland, 1010
GSK Investigational Site
Auckland, 1701
GSK Investigational Site
Christchurch, 8011
GSK Investigational Site
Havelock North, 4130
GSK Investigational Site
Paraparaumu, 5032
GSK Investigational Site
Tauranga, 3001
GSK Investigational Site
Wellington, 6242

Other trials in New Zealand

Panama5 sites

GSK Investigational Site
Panama City, 0801
GSK Investigational Site
Panama City, 1001
GSK Investigational Site
Panama City, 7002
GSK Investigational Site
Panama City, 7099
GSK Investigational Site
Panama City, 7219

Other trials in Panama

South Africa2 sites

GSK Investigational Site
Boksburg, Gauteng, 1459
GSK Investigational Site
Middelburg, Mpumalanga, 1055

Other trials in South Africa

About this study

Official title: A Phase 3, Open-label, Randomized, Controlled, Multi-country Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With FLU-QIV Vaccine in Adults Aged 60 Years and Above

Conditions: Respiratory Syncytial Virus Infections
Being tested: RSVPreF3 OA investigational vaccine, FLU-QIV
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-QIVBiological
FLU-QIV administered intramuscularly in the deltoid region of the dominant (Co-Ad Group) arm or the non-dominant (Control Group) arm.

Study groups in NCT04841577
Study group	Role	What they receive
Co-Ad Group	Experimental	Participants received 1 dose of RSV_PreF3 Older Adult (OA) investigational vaccine and 1 dose of FLU-QIV at Day 1 and were followed up until the study end. Receives: Biological: RSVPreF3 OA investigational vaccine; Biological: FLU-QIV
Control Group	Active comparator	Participants received 1 dose of FLU-QIV at Day 1 and 1 dose of RSV_PreF3 OA investigational vaccine at Day 31 and were followed up until the study end. Receives: Biological: RSVPreF3 OA investigational vaccine; Biological: FLU-QIV

What is being measured

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

RSV-A Neutralization Antibody Titers Expressed as Geometric Mean Titers (GMTs)
The serum neutralization assay is a functional assay that measures the ability of serum antibodies to neutralize RSV-A entry and replication in a host cell line. The serum neutralizing antibody titer is expressed in ED60 (Estimated Dilution 60) and corresponds to the inverse of the interpolated serum dilution that yields a 60% reduction of the signal compared to a control without serum.
Measured: At 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group)
Hemagglutinin Inhibition (HI) Antibody Titers for Each of the FLU Vaccine Strains Expressed as Group GMTs
HI antibody titers were assessed for each of the Flu vaccine strains, namely Flu A/Hong Kong/2671/2019 (H3N2), Flu A/Victoria/2570/2019 (H1N1), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Washington/02/2019 (Victoria). The serum HI antibody titers are expressed in 1/Dilution (DIL) where DIL corresponds to the highest dilution that shows complete HI.
Measured: 1 month after the FLU vaccine dose (at Day 31)

Secondary outcomes (12)

Secondary: HI Seroconversion Status for Each of the Flu Vaccine Strains Expressed as Seroconversion Rate (SCR)
SCR for HI antibody response was defined as the percentage of vaccinees who have either a HI pre-dose titer < 1:10 and a post-dose titer >= 1:40 or a pre-dose titer >= 1:10 and at least a four-fold increase in post-dose titer. HI antibody titers were assessed for each of the Flu vaccine strains, namely Flu A/Hong Kong/2671/2019 (H3N2), Flu A/Victoria/2570/2019 (H1N1), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Washington/02/2019 (Victoria).
Measured: 1 month after the FLU vaccine dose (at Day 31)
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: 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group)
RSV-B Neutralization Antibody Titers Expressed as Geometric Mean Titers (GMT)
The serum neutralization assay is a functional assay that measures the ability of serum antibodies to neutralize RSV-B entry and replication in a host cell line. The serum neutralizing antibody titer is expressed in ED60 (Estimated Dilution 60) and corresponds to the inverse of the interpolated serum dilution that yields a 60% reduction of the signal compared to a control without serum.
Measured: 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the 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: 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group)
HI Antibody Titers for Each of the FLU Vaccine Strains Expressed as GMTs
HI antibody titers were assessed for each of the Flu vaccine strains, namely A/Hong Kong/2671/2019 (H3N2), Flu A/Victoria/2570/2019 (H1N1), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Washington/02/2019 (Victoria). The serum HI antibody titers are expressed in 1/DIL where DIL corresponds to the highest dilution that shows complete HI.
Measured: At baseline (at Day 1) and 1 month after the FLU vaccine dose (at Day 31)
HI Seroprotection Status for Each of the FLU Vaccine Strains Expressed as Seroprotection Rate (SPR)
SPR for HI antibody response was defined as percentage of vaccinees with a serum HI titer >= 1:40 that usually is accepted as indicating protection. HI antibody titers were assessed for each of the Flu vaccine strains, namely A/Hong Kong/2671/2019 (H3N2), Flu A/Victoria/2570/2019 (H1N1), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Washington/02/2019 (Victoria).
Measured: At baseline (at Day 1) and 1 month after the FLU vaccine dose (at Day 31)
HI Antibody Titers for Each of the 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. HI antibody were assessed for each of the FLUvaccine strain, namely A/Hong Kong/2671/2019 (H3N2), Flu A/Victoria/2570/2019 (H1N1), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Washington/02/2019 (Victoria).
Measured: 1 month after the FLU vaccine dose (at Day 31)
Percentage of Participants With Solicited Administration Site Events
Solicited administration site adverse events(AEs) assessed were erythema, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade.
Measured: Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination
Percentage of Participants With Solicited Systemic Events
Solicited systemic events assessed were arthralgia, fatigue, fever [defined as temperature equal to or above (>=) 38 degrees Celsius (C)/100.4 degrees Fahrenheit (F)], headache and myalgia. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination.
Measured: Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination
Percentage of Participants Reporting at Least One Unsolicited Adverse Event
An unsolicited AEs is any AE reported in addition to those solicited during the clinical study and that was not included in a list of solicited events using a Participant Diary. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. Unsolicited AEs include serious, non-serious AEs and potential immune-mediated diseases (pIMDs). Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Measured: Within 30 days (the day of vaccination and 29 subsequent days) after each vaccination
Percentage of Participants Reporting at Least One Serious Adverse Event (SAE)
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. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
Measured: From Day 1 up to study end (6 months after last vaccination)
Percentage of Participants Reporting at Least One Potential Immune-mediated Disease (pIMD)
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 Day 1 up to study end (6 months after last vaccination)

Timeline

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

27 Apr 20218 Feb 2022

First posted12 Apr 2021
Study start27 Apr 2021
Primary completion22 Sep 2021
Study completion8 Feb 2022

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: 976 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04841577
Sponsor's protocol ID: 214488
Status last verified: Aug 2024
First submitted: 8 Apr 2021
Last updated: 3 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

Chandler R, Montenegro N, Llorach C, Aguirre LN, Germain S, Kuriyakose SO, Lambert A, Descamps D, Olivier A, Hulstrom V. Immunogenicity, Reactogenicity, and Safety of AS01E-adjuvanted RSV Prefusion F Protein-based Candidate Vaccine (RSVPreF3 OA) When Co-administered With a Seasonal Quadrivalent Influenza Vaccine in Older Adults: Results of a Phase 3, Open-Label, Randomized Controlled Trial. Clin Infect Dis. 2024 Jan 8;83(1):e62-70. doi: 10.1093/cid/ciad786. Online ahead of print.
PubMed 38189778

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

RecruitingPhase 4
Immunogenicity and Safety of Respiratory Syncytial Virus Vaccine in Lung Transplant Recipients
Vaccination, Respiratory Syncytial Virus (RSV)
Active, not recruitingPhase 1/2
Safety and Immunogenicity Study of SCB-1022 and SCB-1033 in Healthy Older Adults
RSV Infection, Human Metapneumovirus Infection
Not yet recruitingObservational study
Severe Pediatric Respiratory Syncytial Virus Infections Occurring in the Era of Antiviral Prophylaxis
Children <24 Months Hospitalized for RSV-related Lower Respiratory Tract Infection
RecruitingObservational study
Real-World Effectiveness of Perinatal RSV Immunoprophylaxis
RSV Infection
RecruitingPhase 2
A Study of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus (RSV) Who Are at High Risk of Progression to Severe Disease
Respiratory Syncytial Virus Infections

All Respiratory Syncytial Virus Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Open-label, Randomized, Controlled, Multi-country Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With FLU-QIV Vaccine in Adults Aged 60 Years and Above
ClinicalTrials.gov ID: NCT04841577
Acronym / sponsor ID: 214488
Conditions: Respiratory Syncytial Virus Infections
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 976 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 27 Apr 2021 (actual)
Primary completion: 22 Sep 2021 (actual)
Study completion: 8 Feb 2022 (actual)
First posted: 12 Apr 2021 (actual)
Results: Posted 18 Oct 2022

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-QIVParticipants received 1 dose of RSV_PreF3 Older Adult (OA) investigational vaccine and 1 dose of FLU-QIV at Day 1 and were followed up until the study end.
Control Group	Active comparator	Biological: RSVPreF3 OA investigational vaccine, Biological: FLU-QIVParticipants received 1 dose of FLU-QIV at Day 1 and 1 dose of RSV_PreF3 OA investigational vaccine at Day 31 and were followed up until the study end.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol A male or female ≥60 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 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.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
Hypersensitivity to latex.
History of GBS, anaphylaxis, febrile seizures, Bell's palsy and narcolepsy.

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-QIVFLU-QIV administered intramuscularly in the deltoid region of the dominant (Co-Ad Group) arm or the non-dominant (Control Group) arm.	Biological	Co-Ad Group, Control Group

Primary outcome

RSV-A Neutralization Antibody Titers Expressed as Geometric Mean Titers (GMTs)
Time frame: At 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group)
The serum neutralization assay is a functional assay that measures the ability of serum antibodies to neutralize RSV-A entry and replication in a host cell line. The serum neutralizing antibody titer is expressed in ED60 (Estimated Dilution 60) and corresponds to the inverse of the interpolated serum dilution that yields a 60% reduction of the signal compared to a control without serum.
Hemagglutinin Inhibition (HI) Antibody Titers for Each of the FLU Vaccine Strains Expressed as Group GMTs
Time frame: 1 month after the FLU vaccine dose (at Day 31)
HI antibody titers were assessed for each of the Flu vaccine strains, namely Flu A/Hong Kong/2671/2019 (H3N2), Flu A/Victoria/2570/2019 (H1N1), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Washington/02/2019 (Victoria). The serum HI antibody titers are expressed in 1/Dilution (DIL) where DIL corresponds to the highest dilution that shows complete HI.

12 secondary outcomes

Secondary: HI Seroconversion Status for Each of the Flu Vaccine Strains Expressed as Seroconversion Rate (SCR)
Time frame: 1 month after the FLU vaccine dose (at Day 31)
RSV-A Neutralization Antibody Titers Expressed as Mean Geometric Increase (MGI)
Time frame: 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group)
RSV-B Neutralization Antibody Titers Expressed as Geometric Mean Titers (GMT)
Time frame: 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group)
RSV-B Neutralization Antibody Titers Expressed as MGI
Time frame: 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group)
HI Antibody Titers for Each of the FLU Vaccine Strains Expressed as GMTs
Time frame: At baseline (at Day 1) and 1 month after the FLU vaccine dose (at Day 31)
HI Seroprotection Status for Each of the FLU Vaccine Strains Expressed as Seroprotection Rate (SPR)
Time frame: At baseline (at Day 1) and 1 month after the FLU vaccine dose (at Day 31)
HI Antibody Titers for Each of the FLU Vaccine Strains Expressed as MGI
Time frame: 1 month after the FLU vaccine dose (at Day 31)
Percentage of Participants With Solicited Administration Site Events
Time frame: Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination
Percentage of Participants With Solicited Systemic Events
Time frame: Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination
Percentage of Participants Reporting at Least One Unsolicited Adverse Event
Time frame: Within 30 days (the day of vaccination and 29 subsequent days) after each vaccination
Percentage of Participants Reporting at Least One Serious Adverse Event (SAE)
Time frame: From Day 1 up to study end (6 months after last vaccination)
Percentage of Participants Reporting at Least One Potential Immune-mediated Disease (pIMD)
Time frame: From Day 1 up to study end (6 months after last vaccination)

Results and safety

Results posted to the registry on 18 Oct 2022, 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	442	429
Control Group	443	417

Primary outcome: RSV-A Neutralization Antibody Titers Expressed as Geometric Mean Titers (GMTs)

Time frame: At 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group). Geometric mean (95% Confidence Interval). Unit: Titers (ED 60)

Measure	Co-Ad Group n = 427	Control Group n = 398
Value	10060.5 (9126 to 11090.7)	12255 (11160.4 to 13456.9)

Co-Ad Group vs Control Group: Adjusted group GMT ratio: 1.27 (95% CI 1.12 to 1.44)

Population analysed: The analysis was performed on the Per Protocol set (PPS) which consisted of all eligible participants who received at least 1 study intervention as per protocol, had immunogenicity results pre-post-dose for at least 1 antigen, complied with blood draw intervals and contribution of participants to PPS at specific timepoint will be defined by timepoint, without intercurrent medical conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination.

Primary outcome: Hemagglutinin Inhibition (HI) Antibody Titers for Each of the FLU Vaccine Strains Expressed as Group GMTs

Time frame: 1 month after the FLU vaccine dose (at Day 31). Geometric mean (95% Confidence Interval). Unit: Titers (1/DIL)

Measure	Co-Ad Group n = 427	Control Group n = 411
Flu A/Hong Kong/2671/2019 H3N2	295.2 (263.6 to 330.6)	346.8 (306.6 to 392.3)
Flu A/Victoria/2570/2019 H1N1	267.1 (235.6 to 302.8)	325.4 (282.5 to 374.9)
Flu B/Phuket/3073/2013 Yamagata	28.9 (26 to 32.1)	34.8 (31.1 to 39.0)
Flu B/Washington/02/2019 Victoria	41.6 (37.1 to 46.6)	47.9 (41.9 to 54.8)

Co-Ad Group vs Control Group: Adjusted geometric mean titer ratio: 1.17 (95% CI 1.02 to 1.35)
Co-Ad Group vs Control Group: Adjusted geometric mean Titer ratio: 1.22 (95% CI 1.03 to 1.44)
Co-Ad Group vs Control Group: Adjusted geometric mean Titer ratio: 1.17 (95% CI 1.04 to 1.32)

Population analysed: The analysis was performed on the PPS which consisted of all eligible participants who received at least 1 study intervention as per protocol, had immunogenicity results pre-post-dose for at least 1 antigen, complied with blood draw intervals and contribution of participants to PPS at specific timepoint will be defined by timepoint, without intercurrent medical conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after 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	15 of 442 (3.4%)	290 of 442 (65.6%)	4 of 442
Control Group	20 of 443 (4.5%)	276 of 443 (62.3%)	8 of 443

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 38189778Chandler R, Montenegro N, Llorach C, Aguirre LN, Germain S, Kuriyakose SO, Lambert A, Descamps D, Olivier A, Hulstrom V. Immunogenicity, Reactogenicity, and Safety of AS01E-adjuvanted RSV Prefusion F Protein-based Candidate Vaccine (RSVPreF3 OA) When Co-administered With a Seasonal Quadrivalent Influenza Vaccine in Older Adults: Results of a Phase 3, Open-Label, Randomized Controlled Trial. Clin Infect Dis. 2024 Jan 8;83(1):e62-70. doi: 10.1093/cid/ciad786. Online ahead of print.
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

Related trials for Respiratory Syncytial Virus Infections

RecruitingPhase 4
Immunogenicity and Safety of Respiratory Syncytial Virus Vaccine in Lung Transplant Recipients
Vaccination, Respiratory Syncytial Virus (RSV)
Active, not recruitingPhase 1/2
Safety and Immunogenicity Study of SCB-1022 and SCB-1033 in Healthy Older Adults
RSV Infection, Human Metapneumovirus Infection
Not yet recruitingObservational study
Severe Pediatric Respiratory Syncytial Virus Infections Occurring in the Era of Antiviral Prophylaxis
Children <24 Months Hospitalized for RSV-related Lower Respiratory Tract Infection
RecruitingObservational study
Real-World Effectiveness of Perinatal RSV Immunoprophylaxis
RSV Infection
RecruitingPhase 2
A Study of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus (RSV) Who Are at High Risk of Progression to Severe Disease
Respiratory Syncytial Virus Infections

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.

14 sites in 3 countries: 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-QIV in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 14 sites in 3 countries.

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

Who may be eligible to take part?

The sponsor lists 4 inclusion and 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 3 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 14 sites in New Zealand, Panama, South Africa. 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 18 Oct 2022). 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 Neutralization Antibody Titers Expressed as Geometric Mean Titers (GMTs) (time frame: At 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group)). The study lists 2 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 NCT04841577, 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 3 Sep 2024.