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.
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
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.
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
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
South Africa2 sites
GSK Investigational Site
Boksburg, Gauteng, 1459
GSK Investigational Site
Middelburg, Mpumalanga, 1055
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
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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