A Study to Assess the Immune Response and Safety of a Vaccine Against Influenza in Adults 18 Years of Age and Older

NCT07121192 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: 3003562025-522278-35
• Study Type: interventional
• Target: 776
• Locations: 1 country
• Sites: 22

Brief Summary

"The purpose of this study is to assess the reactogenicity, safety and immune response of GlaxoSmithKlines (GSK) messenger RNA (mRNA)-based multivalent seasonal influenza vaccine candidates administered in healthy younger and older adults."

Conditions

Influenza, Human

Keywords

Influenza; Human; Virus Diseases; Infections; mRNA vaccine; Younger Adults; Older Adults; multivalent seasonal influenza vaccine

Outcome Measures

Primary Outcomes (11)

• Geometric Mean Titer (GMT) Ratio of Antigen 1 Titer

  At Day 29

• Geometric Mean Increase (GMI) of Antigen 1 Titer

  From Day 1 to Day 29

• Percentage of Participants with Antigen 1 Seroconversion Rate (SCR)

  From Day 1 to Day 29

• Percentage of Participants with Antigen 1 Seroprotection Rate (SPR)

  At Day 1 and Day 29

• Number of Participants with Solicited Administration Site Adverse Events (Aes)

  The solicited administration site AEs considered are pain, redness, swelling and lymphadenopathy.

  From Day 1 to Day 7

• Number of Participants with Solicited Systemic Aes

  The solicited systemic AEs considered are fever, headache, fatigue, myalgia, arthralgia and chills. Fever is defined as temperature greater than or equal to (\>=) 38 °C/100.4°F regardless the location of measurement.

  From Day 1 to Day 7

• Number of Participants with Unsolicited Aes

  An unsolicited AE is 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.

  From Day 1 to Day 28

• Number of Participants with Serious Adverse Events (SAEs)

  SAE is an AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or other situations that are considered serious per medical or scientific judgment.

  From Day 1 to Day 181 (study end)

• Number of Participants with Adverse Events of Special Interest (AESIs)

  From Day 1 to Day 181 (study end)

• Number of Participants with Medically Attended Adverse Events (MAAEs)

  A MAAE is an AE for which the participant received medical attention including any symptom or illness requiring hospitalization, or an emergency room visit, or visit to/by a healthcare professional.

  From Day 1 to Day 181 (study end)

• Number of Participants with any Laboratory abnormalities

  Click here to enter text.

  From Day 1 to Day 29

Secondary Outcomes (3)

• GMT Ratio of Antigen 2 Titer

  At Day 29

• GMI of Antigen 2 Titer

  From Day 1 to Day 29

• Percentage of Participants with Antigen 2 SCR

  From Day 1 to Day 29

Study Arms (9)

Flu mRNA_1_YA

EXPERIMENTAL

Eligible Younger Adults (YA) participants receive a single dose of Flu mRNA Formulation A (GSK6479720A) as study intervention at Day 1.

Biological: Flu mRNA (Formulation A)

Flu mRNA_2_YA

EXPERIMENTAL

Eligible YA participants receive a single dose of Flu mRNA Formulation B (GSK6479715A) as study intervention at Day 1.

Biological: Flu mRNA (Formulation B)

Comparator_1_YA

ACTIVE COMPARATOR

Eligible YA participants receive a single dose of comparator 1 at Day 1.

Combination Product: Comparator 1

Comparator_2_YA

ACTIVE COMPARATOR

Eligible YA participants receive a single dose of comparator 2 at Day 1.

Combination Product: Comparator 2

Flu mRNA_1_OA

EXPERIMENTAL

Eligible Older Adults (OA) participants receive a single dose of Flu mRNA Formulation A (GSK6479720A) as study intervention at Day 1.

Biological: Flu mRNA (Formulation A)

Flu mRNA_2_OA

EXPERIMENTAL

Eligible OA participants receive a single dose of Flu mRNA Formulation B (GSK6479715A) as study intervention at Day 1.

Biological: Flu mRNA (Formulation B)

Comparator_1_OA

EXPERIMENTAL

Eligible OA participants receive a single dose of comparator 1 at Day 1.

Combination Product: Comparator 1

Comparator_2_OA

ACTIVE COMPARATOR

Eligible OA participants receive a single dose of comparator 2 at Day 1.

Combination Product: Comparator 2

Comparator_3_OA

ACTIVE COMPARATOR

Eligible OA participants receive a single dose of comparator 3 at Day 1.

Combination Product: Comparator 3

Interventions

Flu mRNA (Formulation A) BIOLOGICAL

One dose of Flu mRNA (Formulation A) received intramuscularly.

Also known as: GSK6479720A

Flu mRNA_1_OA; Flu mRNA_1_YA

Flu mRNA (Formulation B) BIOLOGICAL

One dose of Flu mRNA (Formulation B) received intramuscularly.

Also known as: GSK6479715A

Flu mRNA_2_OA; Flu mRNA_2_YA

Comparator 1 COMBINATION_PRODUCT

One dose of Comparator 1 received intramuscularly.

Comparator_1_OA; Comparator_1_YA

Comparator 2 COMBINATION_PRODUCT

One dose of Comparator 2 received intramuscularly.

Also known as: Click here to enter text.

Comparator_2_OA; Comparator_2_YA

Comparator 3 COMBINATION_PRODUCT

One dose of Comparator 3 received intramuscularly.

Comparator_3_OA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, attendance to study contacts and study site visits, and ability to access and utilize a phone or other electronic communications) independently or with the assistance of a caregiver.
• Written (physically, or digitally) informed consent obtained from the participant prior to performance of any study-specific procedure.
• A male or female at least 18 YOA at the time of the screening.
• Healthy participants or medically stable patients as established by medical history, and clinical examination. Participants with chronic medical conditions with or without specific treatment (e.g., chronic metabolic, cardiac, pulmonary, renal, neurologic, and hematologic diseases) 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.
• Female participants of non-childbearing potential may be enrolled in the clinical study.
• Female participants of childbearing potential may be enrolled in the clinical study, if the participant:
• Has practiced adequate contraception for at least 4 weeks prior to the study intervention administration, and
• Has a negative urine pregnancy test within 24 hours prior to the study intervention administration, and
• Has agreed to continue adequate contraception for at least 8 weeks after study intervention administration.
• Body mass index (BMI) between18 kg/m\^² and 33kg/m\^².

You may not qualify if:

• Immunosuppressive or immunodeficient conditions by history/exam; stable HIV-positive individuals on therapy can participate.
• History of Guillain-Barré Syndrome within 6 weeks of receiving any vaccine.
• Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 1 year).
• Hypersensitivity to latex.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
• History of hypersensitivity or severe allergic reaction to any previous influenza vaccine.
• History of hypersensitivity or severe allergic reaction to any previous mRNA vaccine.
• History of or current suspicion of myocarditis or pericarditis, or medical issues increasing such risks.
• 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 clinical study.
• History of confirmed influenza infection by local health authority-approved testing methods within 180 days prior to study intervention administration.
• Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study intervention(s) during the period beginning 28 days before the dose of study intervention(s) (Day -28 to Day 1), or their planned use during the study period.
• Administration of an influenza vaccine within 180 days before the study intervention administration or planned administration prior to Visit 4 (Day 29) during the study.
• Administration of any non-live attenuated non-study vaccine in the period starting 14 days before the study intervention administration, or planned administration within 14 days after study intervention administration.
• Administration of any live attenuated and/or mRNA non-study non-influenza vaccine in the period starting 28 days before the study intervention administration, or planned administration within 28 days after study intervention administration.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (22)

GSK Investigational Site

Anniston, Alabama, 36207, United States

Location

GSK Investigational Site

Fair Oaks, California, 95628, United States

Location

GSK Investigational Site

San Diego, California, 92120, United States

Location

GSK Investigational Site

San Diego, California, 92123, United States

Location

GSK Investigational Site

Walnut Creek, California, 94598, United States

Location

GSK Investigational Site

Hialeah, Florida, 33012, United States

Location

GSK Investigational Site

Jupiter, Florida, 33458, United States

Location

GSK Investigational Site

Miami, Florida, 33186, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30281, United States

Location

GSK Investigational Site

Valparaiso, Indiana, 46383, United States

Location

GSK Investigational Site

Lenexa, Kansas, 66219, United States

Location

GSK Investigational Site

Springfield, Massachusetts, 01103, United States

Location

GSK Investigational Site

Carson City, Nevada, 89706, United States

Location

GSK Investigational Site

Rochester, New York, 14609, United States

Location

GSK Investigational Site

Greensboro, North Carolina, 27408, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44122, United States

Location

GSK Investigational Site

North Charleston, South Carolina, 29405, United States

Location

GSK Investigational Site

Austin, Texas, 78705, United States

Location

GSK Investigational Site

DeSoto, Texas, 75115, United States

Location

GSK Investigational Site

Fort Worth, Texas, 76135, United States

Location

GSK Investigational Site

Newport News, Virginia, 23606, United States

Location

GSK Investigational Site

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Influenza, Human; Virus Diseases; Infections

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Orthomyxoviridae Infections; RNA Virus Infections; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is an Observer-blind study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 13, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

Locations

US (22)