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Influenza, HumanPhase 1NCT05446740

A Study on the Safety, Reactogenicity and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults

A Phase 1 study testing GSK4382276A Dose level 1, GSK4382276A Dose level 2 and GSK4382276A Dose level 3 in people with Influenza, Human, run by GlaxoSmithKline at 7 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 first-time-in-human (FTiH) study is to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline's (GSK) messenger RNA (mRNA)-based monovalent vaccine (GSK4382276A) candidate against influenza in healthy younger adults (YA) and older adults (OA). Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Influenza, Human
What is being tested?
GSK4382276A Dose level 1, GSK4382276A Dose level 2 and GSK4382276A Dose level 3
Could I receive a placebo?
No, everyone receives an active treatment
How many people
324 participants
Where
7 sitesin 3 countries
Study dates
9 Aug 2022to 26 Mar 2024
Phase
Phase 1
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 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • A male or female between and including 18 and 45 years of age (YAs) or between and including 60 and 80 years of age (OAs) at the time of the study intervention administration. The age of sentinel participants in OA category will be limited to maximum 70 years.
  • Healthy or medically stable participants as established by medical history, safety laboratory assessments and clinical examination.
  • Body mass index >= 18 kg/m^2 and <= 32 kg/m^2.
  • Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the participant prior to performing any study-specific procedure.
  • Female participants of non-childbearing potential may be enrolled in the study.
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  • Female participants of childbearing potential may be enrolled in the study if the participant:
  • has practiced adequate contraception for 28 days prior to study intervention administration, and
  • has a negative pregnancy test on the day of study intervention administration, and
  • has agreed to continue adequate contraception for at least 1 month after study intervention administration.

Who cannot join

  • Medical conditions
  • Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or review of the participant's medical record.
  • Any clinically significant hematological coagulation or urine analysis laboratory abnormality.
  • The investigator should use his/her clinical judgement to decide which abnormalities are clinically significant.
  • Current or past malignancy, unless completely resolved without sequelae for >5 years.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection, based on medical history and physical examination (no laboratory testing required).
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  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention (including latex, poly-ethylene-glycol, egg protein and aminoglycoside antibiotics).
  • Recurrent history or uncontrolled neurological disorders or seizures, including Guillain-Barré syndrome and Bell's palsy, with the exception of febrile seizures during childhood.
  • Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
  • Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
  • Significant exposure to persons with influenza or laboratory-confirmed SARS-CoV-2 within 7 days prior to Visit 1 (Day 1) and for whom a SARS-CoV-2 PCR test has not (yet) been confirmed as negative.
  • Prior/Concomitant therapy
  • Administration of seasonal influenza vaccine within 180 days before enrollment or planned administration up to Visit 4 (Day 29).
  • Administration of a vaccine not foreseen by the study protocol in the period starting 28 days before the study intervention administration, or planned administration within 28 days after the study intervention administration*, with the exception of vaccines authorized or approved for the prevention of COVID-19 (regardless of the type of vaccine).
  • In case emergency mass vaccination for an unforeseen public health threat is organized by public health authorities outside the routine immunization program, the time period described above can be reduced to 7 days, if necessary, for that mass vaccination vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly.
  • Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study intervention during the period beginning 30 days before the study intervention administration, or their planned use during the study period.
  • Administration of long-acting immune-modifying drugs within 90 days before enrollment or planned use 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 study intervention administration, or planned administration during the study period. Administration of monoclonal antibodies specifically directed against the spike protein of SARS-CoV-2 virus, for treatment of COVID-19 disease is allowed.
  • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the study intervention administration. For corticosteroids, this will mean prednisone equivalent ≥ 20 mg/day. Inhaled, topical and intraarticular steroids are allowed.
  • Previous enrolment in this study.
  • Other exclusions
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions within the 1-month post-dosing period.
  • History of abusive alcohol and/or drug consumption in the past 5 years.
  • Any study personnel or their immediate dependents, family, or household members.
  • Participants with extensive tattoos covering deltoid region on both arms that would preclude the assessment of local reactogenicity.
  • Previous enrollment in this study.

Trial locations and contacts

7 sites in 3 countries.

7 sites in 3 countries

Spain3 sites

  • GSK Investigational Site

    Madrid, 28006

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Madrid, 28222

Other trials in Spain

Belgium2 sites

  • GSK Investigational Site

    Edegem, 2650

  • GSK Investigational Site

    Ghent, 9000

Other trials in Belgium

Canada2 sites

  • GSK Investigational Site

    Halifax, Nova Scotia, B3J 3G9

  • GSK Investigational Site

    Sherbrooke, Quebec, J1L 0H8

Other trials in Canada

About this study

Official title: A Phase 1 Randomized, Dose Escalation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of an mRNA-based Monovalent Influenza Vaccine Candidate in Healthy Younger and Older Adults

The purpose of this first-time-in-human (FTiH) study is to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline's (GSK) messenger RNA (mRNA)-based monovalent vaccine (GSK4382276A) candidate against influenza in healthy younger adults (YA) and older adults (OA).

Being tested
GSK4382276A Dose level 1, GSK4382276A Dose level 2, GSK4382276A Dose level 3, GSK4382276A Dose level 4, GSK4382276A Dose level 5
Keywords
Influenza, Safety, Reactogenicity, Immunogenicity, mRNA vaccine, Healthy younger adults, Healthy older adults
Medical subject headings
Influenza, Human

What participants receive

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

  • GSK4382276A Dose level 1Biological

    Also called Flu mRNA

    Single dose of intervention administered at Day 1

  • GSK4382276A Dose level 2Biological

    Also called Flu mRNA

    Single dose of intervention administered at Day 1

  • GSK4382276A Dose level 3Biological

    Also called Flu mRNA

    Single dose of intervention administered at Day 1

  • GSK4382276A Dose level 4Biological

    Also called Flu mRNA

    Single dose of intervention administered at Day 1

  • GSK4382276A Dose level 5Biological

    Also called Flu mRNA

    Single dose of intervention administered at Day 1

  • GSK4382276A Dose level 6Biological

    Also called Flu mRNA

    Single dose of intervention administered at Day 1

  • GSK4382276A Dose level 7Biological

    Also called Flu mRNA

    Single dose of intervention administered at Day 1

  • GSK4382276A Dose level 8Biological

    Also called Flu mRNA

    Single dose of intervention administered at Day 1

  • GSK4382276A Dose level 9Biological

    Also called Flu mRNA

    Single dose of intervention administered at Day 1

  • GSK4382276A Dose level 10Biological

    Also called Flu mRNA

    Single dose of intervention administered at Day 1

  • FDQ21A-NHCombination product

    Single dose of intervention administered at Day 1

  • FDQ22A-NHCombination product

    Single dose of intervention administered at Day 1

Study groups in NCT05446740
Study groupRoleWhat they receive
Flu mRNA_Dose level 1_Younger adults (YA)ExperimentalOn Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
Receives: Biological: GSK4382276A Dose level 1
Flu mRNA_Dose level 2 _YAExperimentalOn Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
Receives: Biological: GSK4382276A Dose level 2
Flu mRNA_Dose level 3_YAExperimentalOn Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2.
Receives: Biological: GSK4382276A Dose level 3
Flu mRNA_Dose level 4_YAExperimentalOn Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
Receives: Biological: GSK4382276A Dose level 4
Flu mRNA_Dose level 5_YAExperimentalOn Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
Receives: Biological: GSK4382276A Dose level 5
Flu mRNA_Dose level 6_YAExperimentalOn Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
Receives: Biological: GSK4382276A Dose level 6
Flu mRNA_Dose level 7_YAExperimentalOn Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
Receives: Biological: GSK4382276A Dose level 7
Flu mRNA_ Dose level 8_YAExperimentalOn Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
Receives: Biological: GSK4382276A Dose level 8
Flu mRNA_Dose level 9_YAExperimentalOn Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
Receives: Biological: GSK4382276A Dose level 9
Flu mRNA_Dose level 10_YAExperimentalOn Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
Receives: Biological: GSK4382276A Dose level 10
Pooled Control_YAActive comparatorOn Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
Receives: Combination Product: FDQ21A-NH; Combination Product: FDQ22A-NH
Flu mRNA_Dose level 7_Older adults (OA)ExperimentalOn Day 1, OA participants received Flu mRNA at Dose Level 7.
Receives: Biological: GSK4382276A Dose level 7
Control_OAActive comparatorOn Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
Receives: Combination Product: FDQ21A-NH

What is being measured

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

  1. Number of Participants Reporting Any Solicited Administration Site Events

    Assessed solicited administration site events included pain, erythema/redness, swelling and Lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade.

    Measured: Day 1 to Day 7

  2. Number of Participants Reporting Any Solicited Systemic Events

    Assessed solicited systemic events included fever, chills, headache, myalgia, arthralgia and fatigue. Any = occurrence of the symptom regardless of intensity grade.

    Measured: Day 1 to Day 7

  3. Number of Participants Reporting Any Unsolicited Adverse Events (AEs)

    An unsolicited AEs is an AEs that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow up for solicited events. Unsolicited AEs must have been communicated by a participant who has signed the informed consent or through his/her caregiver. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence of the symptom regardless of intensity grade or relation to study vaccination.

    Measured: Day 1 to Day 28

  4. Number of Participants Reporting Serious Adverse Events (SAEs)

    An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant, or resulted in abnormal pregnancy outcomes, or in other situations that were considered serious per medical or scientific judgment.

    Measured: Day 1 to Day 183

  5. Number of Participants Reporting AEs of Special Interest (AESIs)

    The following events were considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, myocarditis/pericarditis and potential immune-mediated diseases (pIMDs).

    Measured: Day 1 to Day 183

  6. Number of Participants Reporting Shift From Abnormal Non-clinically Significant and Normal or Missing Laboratory Value on Day 1 to Clinically Significant Abnormal Laboratory Value on Day 8 for Hematology, Clinical Chemistry, Coagulation and Urine Analysis

    Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participants condition. Normal or missing values refer to laboratory values that were within normal range or missing at baseline.

    Measured: At Day 8 compared to baseline (Day 1)

  7. Number of Participants Reporting Shift From Abnormal Non-clinically Significant and Normal or Missing Laboratory Value on Day 1 to Clinically Significant Abnormal Laboratory Value on Day 29 for Hematology,Clinical Chemistry, Coagulation and Urine Analysis

    Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participants condition. Normal or missing values refer to laboratory values that were within normal range or missing at baseline.

    Measured: At Day 29 compared to baseline (Day 1)

  8. Geometric Mean Titers (GMT) of Anti-vaccine Antibody Titers

    Measured: At Day 1

  9. GMT of Anti-vaccine Antibody Titers

    Measured: At Day 22

  10. Geometric Mean Increase (GMI) of Anti-vaccine Antibody Titers From Day 1 (Baseline) to Day 22

    GMI is defined as the geometric mean of the ratios of the post-dose anti-vaccine antibody titers over the Day 1 anti-vaccine antibody titers.

    Measured: From Day 1 to Day 22

  11. Percentage of Participants With Anti-vaccine Antibody Seroconversion Rate (SCR)

    SCR is defined as the percentage of dosed participants who have either an anti-vaccine antibody pre-dose titer < 1:10 and a post-dose anti-vaccine antibody titer ≥ 1:40 or a pre-dose anti-vaccine antibody titer ≥ 1:10 and at least a 4-fold increase in post-dose anti-vaccine antibody titer.

    Measured: From Day 1 to Day 22

  12. Percentage of Participants With Anti-vaccine Antibody Seroprotection Rate (SPR)

    SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer ≥ 1:40.

    Measured: At Day 22

Secondary outcomes (4)

  1. GMT of Anti-vaccine Antibody Titers

    Measured: At Day 62 and Day 183

  2. GMI of Anti-vaccine Antibody Titers From Day 1 (Baseline) to Day 62

    GMI is defined as the geometric mean of the ratios of the post-dose anti-vaccine antibody titer over the Day 1 anti-vaccine antibody titer.

    Measured: From Day 1 to Day 62

  3. GMI of Anti-vaccine Antibody Titers From Day 1 (Baseline) to Day 183

    GMI is defined as the geometric mean of the ratios of the post-dose anti-vaccine antibody titer over the Day 1 anti-vaccine antibody titer.

    Measured: From Day 1 to Day 183

  4. Percentage of Participants With Anti-vaccine Antibody SPR

    SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titers ≥ 1:40.

    Measured: At Day 62 and Day 183

Timeline

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

  1. First posted7 Jul 2022
  2. Study start9 Aug 2022
  3. Primary completion26 Mar 2024
  4. Study completion26 Mar 2024

Resources

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 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
324 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05446740
Sponsor's protocol ID
217895
Other IDs
2022-000489-17
Status last verified
Feb 2026
First submitted
28 Jun 2022
Last updated
10 Mar 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

  • Leroux-Roels I, De Coster I, Borobia AM, Langley JM, Ochoa Mazarro D, Ruiz-Antoran B, Berre S, Germain S, Knauer C, Koch SD, Mann P, Mesia Vela D, Ovbude LJ, Pardo IA, Srivastava B, Moldt B, Nordgren M. Safety and immunogenicity of an investigational mRNA-lipid nanoparticle-based monovalent influenza vaccine: Results from a phase 1, randomized, dose-escalation study. Hum Vaccin Immunother. 2026 Dec;22(1):2631804. doi: 10.1080/21645515.2026.2631804. Epub 2026 Feb 17.

    PubMed 41701031

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK4382276A Dose level 1, GSK4382276A Dose level 2 and GSK4382276A Dose level 3 in people with Influenza, Human, run by GlaxoSmithKline at 7 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 10 inclusion and 27 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 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Spain, Belgium, Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 10 Mar 2026). 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?

Number of Participants Reporting Any Solicited Administration Site Events (time frame: Day 1 to Day 7). The study lists 12 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 NCT05446740, 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 10 Mar 2026.

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