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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-64
SponsorGlaxoSmithKline

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits, attendance to study contacts, and ability to access and utilize a phone or other electronic communications) independently or with the assistance of a caregiver.

A male or female participant between and including 18 to 64 years of age at the time of study intervention administration

has practiced adequate contraception for at least 30 days prior to study intervention administration, and

has a negative urine pregnancy test within 24 hours prior to study intervention administration, and

Disqualifiers

History of test confirmed influenza infection within 180 days prior to study intervention administration.

Confirmed or suspected immunosuppressive or immunodeficient condition, except for stable human immunodeficiency virus infection meeting protocol-defined stability criteria.

History of myocarditis or pericarditis considered causally associated with the administration of an mRNA vaccine.

History of hypersensitivity or allergic reaction to any previous influenza vaccine.

Trial design

Design model

Parallel

Treatments tested in this trial

  • mRNA Seasonal Flu vaccine

    Biological/Vaccine

    One dose of the mRNA Flu vaccine received intramuscularly.

  • Comparator 1

    Biological/Vaccine

    One dose of the comparator vaccine received intramuscularly.

  • Comparator 2

    Biological/Vaccine

    One dose of the comparator vaccine received intramuscularly.

Treatment groups

3,000 Participants
are divided into 4 treatment groups
Group A: mRNA Seasonal Flu Vaccine - Cohort 1Experimental treatment 1 intervention
Group B: Comparator 1_Cohort 1Active comparator 1 intervention
Group C: mRNA Seasonal Flu Vaccine - Cohort 2Experimental treatment 1 intervention
Group D: Comparator 2_Cohort 2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Geometric Mean Titer (GMT) of Antigen 1 Titer

Time frame
At Day 29
2

GMT of Antigen 2 Titer

Time frame
At Day 29
3

Percentage of participants with Antigen 1 seroconversion rate (SCR)

Time frame
From Day 1 to Day 29
4

Number of participants with solicited administration site adverse events

Time frame
Day 1 to Day 7

Secondary outcomes

1

GMT of Antigen 1 and Antigen 2 antibodies

Time frame
At Day 29
2

Percentage of Participants with Antigen 1 and Antigen 2 antibodies SCR

Time frame
Day 1 to Day 29
3

Geometric Mean Increase (GMI) of Antigen 1 Titer

Time frame
At Day 29 relative to baseline (Day 1)
4

GMI of Antigen 2 Titer

Time frame
At Day 29 relative to baseline (Day 1)

Other outcomes

Sponsors and contacts

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