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

NCT ID: NCT05823974

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 1275 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-27
• Study Completion Date: 2024-12-18

Brief Summary

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).

Conditions

Influenza, Human

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Flu mRNA_Ph1_1 Younger Adults (YA) Group

YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.

Group Type: EXPERIMENTAL

F2C22C/DL001Z

Intervention Type: BIOLOGICAL

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

Flu mRNA_Ph1_2 YA Group

YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.

Group Type: EXPERIMENTAL

F2B22A/DL001Z

Intervention Type: BIOLOGICAL

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

Flu mRNA_Ph1_3 YA Group

YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.

Group Type: EXPERIMENTAL

F2B22B/DL001Z

Intervention Type: BIOLOGICAL

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

Flu mRNA_Ph1_4 YA Group

YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.

Group Type: EXPERIMENTAL

F2B22C/DL001Z

Intervention Type: BIOLOGICAL

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

Flu mRNA_Ph1_5 YA Group

YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.

Group Type: EXPERIMENTAL

F2B22D/DL001Z

Intervention Type: BIOLOGICAL

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

Flu mRNA_Ph1_6 YA Group

YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.

Group Type: EXPERIMENTAL

F2B22E/DL001Z

Intervention Type: BIOLOGICAL

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

Flu mRNA_Ph1_7 YA Group

YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.

Group Type: EXPERIMENTAL

F2F22A/DL001Z

Intervention Type: BIOLOGICAL

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

Flu mRNA_Ph1_8 YA Group

YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.

Group Type: EXPERIMENTAL

F2F22B/DL001Z

Intervention Type: BIOLOGICAL

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

Flu mRNA_Ph1_9 YA Group

YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.

Group Type: EXPERIMENTAL

F2F22C/DL001Z

Intervention Type: BIOLOGICAL

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

Flu mRNA_Ph1_10 YA Group

YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.

Group Type: EXPERIMENTAL

F2F22D/DL001Z

Intervention Type: BIOLOGICAL

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

Flu mRNA_Ph1_11 YA Group

YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.

Group Type: EXPERIMENTAL

F2F22E/DL001Z

Intervention Type: BIOLOGICAL

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

Flu mRNA_Ph1_12 YA Group

YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.

Group Type: EXPERIMENTAL

F2F22F/DL001Z

Intervention Type: BIOLOGICAL

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

Control Ph1_YA Group

YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.

Group Type: ACTIVE_COMPARATOR

Control 1

Intervention Type: COMBINATION_PRODUCT

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

Flu mRNA_Ph2_1_YA Group

YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.

Group Type: EXPERIMENTAL

F2F23D/DL001Z-NH

Intervention Type: BIOLOGICAL

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

Flu mRNA_Ph2_2_YA Group

YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.

Group Type: EXPERIMENTAL

F2F23A/DL001Z-NH

Intervention Type: BIOLOGICAL

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

Flu mRNA_Ph2_3_YA Group

YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.

Group Type: EXPERIMENTAL

F2F23B/DL001Z-NH

Intervention Type: BIOLOGICAL

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

Control_Ph2_YA Group

YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.

Group Type: ACTIVE_COMPARATOR

Control 2

Intervention Type: COMBINATION_PRODUCT

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

Flu mRNA_Ph2_1_Older adults (OA) Group

OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.

Group Type: EXPERIMENTAL

F2F23A/DL001Z-NH

Intervention Type: BIOLOGICAL

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

Flu mRNA_Ph2_2_OA Group

OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.

Group Type: EXPERIMENTAL

F2F23B/DL001Z-NH

Intervention Type: BIOLOGICAL

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

Flu mRNA_Ph2_3_OA Group

OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.

Group Type: EXPERIMENTAL

F2F23C/DL001Z-NH

Intervention Type: BIOLOGICAL

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

Control_Ph2_OA Group

OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.

Group Type: ACTIVE_COMPARATOR

Control 3

Intervention Type: COMBINATION_PRODUCT

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

Interventions

Control 3

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

Intervention Type: COMBINATION_PRODUCT

F2F22F/DL001Z

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

Intervention Type: BIOLOGICAL

F2C22C/DL001Z

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

Intervention Type: BIOLOGICAL

F2B22A/DL001Z

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

Intervention Type: BIOLOGICAL

F2B22B/DL001Z

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

Intervention Type: BIOLOGICAL

F2B22C/DL001Z

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

Intervention Type: BIOLOGICAL

F2B22D/DL001Z

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

Intervention Type: BIOLOGICAL

F2B22E/DL001Z

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

Intervention Type: BIOLOGICAL

F2F22A/DL001Z

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

Intervention Type: BIOLOGICAL

F2F22B/DL001Z

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

Intervention Type: BIOLOGICAL

F2F22C/DL001Z

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

Intervention Type: BIOLOGICAL

F2F22D/DL001Z

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

Intervention Type: BIOLOGICAL

F2F22E/DL001Z

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

Intervention Type: BIOLOGICAL

Control 1

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

Intervention Type: COMBINATION_PRODUCT

F2F23D/DL001Z-NH

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

Intervention Type: BIOLOGICAL

F2F23A/DL001Z-NH

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

Intervention Type: BIOLOGICAL

F2F23B/DL001Z-NH

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

Intervention Type: BIOLOGICAL

Control 2

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

Intervention Type: COMBINATION_PRODUCT

F2F23C/DL001Z-NH

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CureVac

INDUSTRY

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Hialeah, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Chicago, Illinois, United States

GSK Investigational Site

Valparaiso, Indiana, United States

GSK Investigational Site

Lenexa, Kansas, United States

GSK Investigational Site

Wichita, Kansas, United States

GSK Investigational Site

Lexington, Kentucky, United States

GSK Investigational Site

Boston, Massachusetts, United States

GSK Investigational Site

Dearborn, Michigan, United States

GSK Investigational Site

Papillion, Nebraska, United States

GSK Investigational Site

Rochester, New York, United States

GSK Investigational Site

Syracuse, New York, United States

GSK Investigational Site

Denver, North Carolina, United States

GSK Investigational Site

Greensboro, North Carolina, United States

GSK Investigational Site

Raleigh, North Carolina, United States

GSK Investigational Site

Wilmington, North Carolina, United States

GSK Investigational Site

Dayton, Ohio, United States

GSK Investigational Site

East Greenwich, Rhode Island, United States

GSK Investigational Site

Knoxville, Tennessee, United States

GSK Investigational Site

Fort Worth, Texas, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

Tomball, Texas, United States

GSK Investigational Site

Newport News, Virginia, United States

GSK Investigational Site

Norfolk, Virginia, United States

GSK Investigational Site

Antwerp, , Belgium

GSK Investigational Site

Edegem, , Belgium

GSK Investigational Site

Ghent, , Belgium

GSK Investigational Site

Ieper, , Belgium

GSK Investigational Site

Kluisbergen, , Belgium

GSK Investigational Site

Mechelen, , Belgium

GSK Investigational Site

Tielt, , Belgium

GSK Investigational Site

Zwalm, , Belgium

GSK Investigational Site

Halifax, Nova Scotia, Canada

GSK Investigational Site

Truro, Nova Scotia, Canada

GSK Investigational Site

Chicoutimi, Quebec, Canada

GSK Investigational Site

Québec, Quebec, Canada

GSK Investigational Site

Sherbrooke, Quebec, Canada

GSK Investigational Site

Buffalo, , South Africa

GSK Investigational Site

Cape Town, , South Africa

GSK Investigational Site

Johannesburg, , South Africa

GSK Investigational Site

Tembisa, , South Africa

Countries

United States; Belgium; Canada; South Africa

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2022-502308-66-00

Identifier Type: OTHER

Identifier Source: secondary_id

217884

Identifier Type: -

Identifier Source: org_study_id