A Study to Evaluate the Immune Response and Safety of a Vaccine Against Influenza in Adults 18-64 Years of Age

Conditions

• Influenza, Human

Eligibility Criteria

Sex

ALL

Age

18 Years - 64 Years

Healthy Volunteers

Accepted

Interventions

• mRNA Seasonal Flu vaccine — BIOLOGICAL
  One dose of the mRNA Flu vaccine received intramuscularly.
• Comparator 1 — BIOLOGICAL
  One dose of the comparator vaccine received intramuscularly.
• Comparator 2 — BIOLOGICAL
  One dose of the comparator vaccine received intramuscularly.

Study Details

This clinical trial will study an investigational seasonal influenza vaccine in adults 18 to 64 years of age. The vaccine is based on messenger ribonucleic acid, also called mRNA. The main goals of the study are to learn how well the vaccine helps the body make an immune response against influenza and what medical problems participants may have after vaccination. Researchers will also compare immune responses in adults 18 to 64 years of age from this study, with immune responses in adults 65 years of age and older from another study. Participants will receive 1 injection into the upper arm muscle and will be followed for about 6 months.

Key Dates

First listed

Oct 1, 2026

Start date

Oct 1, 2026

Status verified

Oct 2026

Primary completion

Jul 9, 2027

Completion

Jul 9, 2027

Study Design

Enrollment

3,000 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: mRNA Seasonal Flu Vaccine - Cohort 1
  Participants 18 to 64 years of age will receive a single dose of investigational mRNA Seasonal Flu vaccine on Day 1.
• Active Comparator: Comparator 1_Cohort 1
  Participants 18 to 64 years of age will receive a single dose of comparator 1 on Day 1.
• Experimental: mRNA Seasonal Flu Vaccine - Cohort 2
  Participants 60 to 64 years of age will receive a single dose of investigational mRNA Seasonal Flu vaccine on Day 1.
• Active Comparator: Comparator 2_Cohort 2
  Participants 60 to 64 years of age will receive a single dose of comparator 2 on Day 1.

Primary Outcome Measure

Geometric Mean Titer (GMT) of Antigen 1 Titer [ Time Frame: At Day 29 ]

Central Contacts

• US GSK Clinical Trials Call Center
  877-379-3718
  [email protected]
• EU GSK Clinical Trials Call Center
  +44 (0) 20 89904466
  [email protected]

Locations (12)

Find similar trials in Glendale, AZ

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