A Study on the Efficacy of a Vaccine Against Influenza in Adults ≥65 Years of Age

Conditions

• Influenza, Human

Eligibility Criteria

Sex

ALL

Age

65 Years - N/A

Healthy Volunteers

Accepted

Interventions

• mRNA Seasonal Flu vaccine — COMBINATION_PRODUCT
  Single-dose intramuscular administration of the season-adapted investigational mRNA Seasonal Flu vaccine.
• Licensed Influenza Vaccine — COMBINATION_PRODUCT
  Single-dose intramuscular administration of an age-appropriate and season-adapted licensed influenza vaccine used as the active comparator.

Study Details

This study will compare an investigational mRNA flu vaccine with a licensed flu vaccine in adults 65 years of age and older. Participants will receive one injection and will be followed during the flu season. The study will measure prevention of laboratory-confirmed flu illness, side effects, and immune responses.

Key Dates

First listed

Sep 4, 2026

Start date

Sep 2, 2026

Status verified

Sep 2026

Primary completion

Jun 9, 2028

Completion

Jun 9, 2028

Study Design

Enrollment

54,000 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: mRNA Seasonal Flu Vaccine
  Participants will receive a single dose of investigational mRNA Seasonal Flu vaccine on Day 1.
• Active Comparator: Active Comparator
  Participants will receive a single dose of an age-appropriate and season-adapted licensed influenza vaccine Day 1.

Primary Outcome Measure

Laboratory-confirmed protocol-defined influenza-like illness (ILI) assessed by incidence rate ratio [ Time Frame: From Day 15 through the end of the influenza Season ]

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 (163)

Find similar trials in Anniston, AL

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