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OpenTrials
Completed

NCT Number: NCT05823974

A Study to Assess the Safety and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults

The purpose of this study is to find and confirm the dose and asses the reactogenicity, safety and immune response of GlaxoSmithKline's (GSK) messenger RNA (mRNA)-based multivalent seasonal influenza vaccine (GSK4382276A) candidates administered in healthy younger and older adults (OA).

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

GSK Investigational Site, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A male or female between and including 18 and 50 years of age in Phase 1 and between and including 18 and 85 years of age (YA: 18-64; OA: 65-85) in Phase 2 at the time of the study intervention administration.
  • Healthy participants or medically stable participants as established by medical history, clinical examination, and safety laboratory assessments. Participants with chronic medical conditions with or without specific treatment are allowed to participate in this study if considered by the investigator as medically stable. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrollment.
  • Body mass index (BMI) >=18 kilograms per meter square (kg/m^2) and less than or equal to (<=) 35 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.
  • 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

Exclusion criteria

Medical conditions

  • Only in Phase 1: Any clinically significant* hematological, biochemical, urinalysis or (hemoglobin A1c) HbA1c laboratory abnormality.

*The investigator should use the clinical judgment to decide which abnormalities are clinically significant.

  • Participant tested positive for influenza by local health authority-approved testing methods within 180 days prior to Day 1.
  • Current or past malignancy, unless completely resolved without clinically significant 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). However, in Phase 2, HIV-infected individuals may be enrolled if participants have been stable on antiretroviral therapy for the past 6 consecutive months, i.e., their treatment has not been modified, their cluster of differentiation 4 (CD4) cell count is >=200/cubic millimeter (mm^3) and their viral load has been undetectable (i.e., HIV-RNA less than (<) 50 copies/milliliter [mL]) (based on medical records, no laboratory testing required).
  • History of myocarditis or pericarditis less than or equal to 10 years prior to vaccine administration, including a history of myocarditis or pericarditis following vaccination with an mRNA coronavirus disease 2019 (COVID-19) vaccine.
  • Participants with history of hypersensitivity or severe allergic reaction to any previous vaccine or hypersensitivity likely to be exacerbated by any component of the study intervention (including latex, polyethylene glycol, egg protein and aminoglycoside antibiotics).
  • History of, or uncontrolled neurological disorders or seizures, including Guillain-Barré syndrome and Bell's palsy, with the exception of febrile seizures during childhood.
  • Any history of dementia or any medical condition that moderately or severely impairs cognition.
  • 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.

Prior/Concomitant therapy

  • Administration of an influenza vaccine (including any of the study investigational vaccines) within 180 days before enrollment or planned administration within 28 days (Day 29) after the study intervention administration.
  • Phase 1: Administration of a vaccine not foreseen by the study protocol in the period starting 28 days (Day -28) before the study intervention administration or planned administration within 28 days (Day 29) after the study intervention administration. Phase 2: Administration of a vaccine not foreseen by the study protocol in the period starting 15 days (Day -15) before the study intervention administration or planned administration within 28 days (Day 29) after the study intervention administration.

*In case emergency mass vaccination for an unforeseen public health threat is recommended and/or 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 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 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), 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 milligrams (mg)/day. Inhaled, topical and intraarticular steroids are allowed.

Other exclusions

  • 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).
  • Pregnant or lactating female.
  • Bedridden participants.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions within the 1-month post-dosing period.
  • Alcoholism or substance use disorder within the past 24 months based on the presence of 2 or more of the following abuse criteria: hazardous use, social/interpersonal problems related to use, neglect of major roles to use, withdrawal, tolerance, use of larger amounts or longer, repeated attempts to quit or control use, much time spent using, physical or psychological problems related to use, activities given up to use, craving.
  • 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.

Treatment and study plan

F2C22C/DL001Z

Biological

Study intervention was administered intramuscularly in Phase 1, at Day 1.

F2B22A/DL001Z

Biological

Study intervention was administered intramuscularly in Phase 1, at Day 1.

F2B22B/DL001Z

Biological

Study intervention was administered intramuscularly in Phase 1, at Day 1.

F2B22C/DL001Z

Biological

Study intervention was administered intramuscularly in Phase 1, at Day 1.

F2B22D/DL001Z

Biological

Study intervention was administered intramuscularly in Phase 1, at Day 1.

F2B22E/DL001Z

Biological

Study intervention was administered intramuscularly in Phase 1, at Day 1.

F2F22A/DL001Z

Biological

Study intervention was administered intramuscularly in Phase 1, at Day 1.

F2F22B/DL001Z

Biological

Study intervention was administered intramuscularly in Phase 1, at Day 1.

F2F22C/DL001Z

Biological

Study intervention was administered intramuscularly in Phase 1, at Day 1.

F2F22D/DL001Z

Biological

Study intervention was administered intramuscularly in Phase 1, at Day 1.

F2F22E/DL001Z

Biological

Study intervention was administered intramuscularly in Phase 1, at Day 1.

Control 1

Combination Product

Control vaccine was administered intramuscularly in Phase 1, at Day 1.

F2F23D/DL001Z-NH

Biological

Study intervention was administered intramuscularly in Phase 2, at Day 1.

F2F23A/DL001Z-NH

Biological

Study intervention was administered intramuscularly in Phase 2, at Day 1.

F2F23B/DL001Z-NH

Biological

Study intervention was administered intramuscularly in Phase 2, at Day 1.

Control 2

Combination Product

Control vaccine was administered intramuscularly in Phase 2, at Day 1.

F2F23C/DL001Z-NH

Biological

Study intervention was administered intramuscularly in Phase 2, at Day 1.

Control 3

Combination Product

Control vaccine was administered intramuscularly in Phase 2, at Day 1.

F2F22F/DL001Z

Biological

Study intervention was administered intramuscularly in Phase 1, at Day 1.

Primary outcomes

  1. Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs)

    Time frame: Day 1 to Day 7

    Assessed solicited administration site events included pain, redness (Erythema), swelling, 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 or relation to the study vaccination.

  2. Number of Participants Reporting Any Solicited Systemic AEs

    Time frame: Day 1 to Day 7

    Assessed solicited systemic events included fever (defined as axillary temperature greater than or equal to (>=) 38.0°C/100.4°F), chills, headache, fatigue, myalgia, and arthralgia. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.

  3. Number of Participants Reporting Any Unsolicited AEs

    Time frame: Day 1 to Day 28

    An unsolicited AE is defined as an AE 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 include both serious and non-serious AEs. Any = occurrence the event regardless of intensity grade or relation to the study vaccination.

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

    Time frame: Day 1 to Day 183

    An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is an abnormal pregnancy outcome, or is a suspected transmission of any infectious agent via an authorized medicinal product. Any = occurrence the event regardless of intensity grade or relation to the study vaccination.

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

    Time frame: Day 1 to Day 183

    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). Any = occurrence the event regardless of intensity grade or relation to the study vaccination.

  6. Number of Participants Reporting Medically Attended Events (MAEs)

    Time frame: Day 1 to Day 183

    MAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., physician's office visits, emergency room visits or hospitalization). Any = occurrence the event regardless of intensity grade or relation to the study vaccination.

  7. Number of Participants Reporting a 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, and Clinical Chemistry

    Time frame: At Day 8 compared to baseline (Day 1)

    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.

  8. Number of Participants Reporting a 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, and Clinical Chemistry

    Time frame: At Day 29 compared to baseline (Day 1)

    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.

  9. Geometric Mean Titer (GMT) of Antigen 1 Antibody Titer

    Time frame: At Day 29

    Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.

  10. Geometric Mean Increase (GMI) of Antigen 1 Antibody Titers From Day 1 to Day 29

    Time frame: From Day 1 (baseline) to Day 29

    GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.

  11. Percentage of Participants With Antigen 1 Antibody Seroconversion Rate (SCR)

    Time frame: From Day 1 to Day 29

    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. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.

  12. Percentage of Participants With Antigen 1 Antibody Seroprotection Rate (SPR)

    Time frame: At Day 1

    SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer >= 1:40. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.

  13. Percentage of Participants With Antigen 1 Antibody SPR

    Time frame: At Day 29

    Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.

  14. GMT of Antigen 2 Antibody Titer

    Time frame: At Day 29

  15. GMI of Antigen 2 Antibody Titer From Day 1 to Day 29

    Time frame: From Day 1 (baseline) to Day 29

  16. Percentage of Participants With Antigen 2 Antibody SCR

    Time frame: From Day 1 to Day 29

Secondary outcomes

  1. GMT of Antigen 1 Antibody Titer

    Time frame: At Day 92

    Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.

  2. GMT of Antigen 1 Antibody Titer

    Time frame: At Day 183

    Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.

  3. GMI of Antigen 1 Antibody Titer From Day 1 to Day 92

    Time frame: From Day 1 (baseline) to Day 92

    Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.

  4. GMI of Antigen 1 Antibody Titer From Day 1 to Day 183

    Time frame: From Day 1 (baseline) to Day 183

    Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.

  5. Percentage of Participants With Antigen 1 Antibody SPR

    Time frame: At Day 183

    Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.

  6. GMT of Antigen 2 Antibody Titer

    Time frame: At Day 92 and Day 183

  7. GMI of Antigen 2 Antibody Titer

    Time frame: From Day 1 to Day 92 and Day 1 to Day 183

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Collaborators

  • CureVac

Registry information

Official study title

A Phase 1/2, Randomized, Dose-finding/Dose-confirmation Study to Evaluate the Reactogenicity, Safety and Immunogenicity of mRNA-based Multivalent Seasonal Influenza Vaccine Candidates Administered in Healthy Younger and Older Adults

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 21, 2023
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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