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Cancer Vaccine

mRNA Vaccine for Flu

Phase 2

Recruiting

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female between 18 and 85 years of age at the time of the study intervention administration

Female participants of non-childbearing potential

Must not have

Recurrent or uncontrolled neurological disorders or seizures

Conditions making intramuscular injection unsafe

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to day 183

Awards & highlights

Summary

This trial aims to test the safety and effectiveness of GlaxoSmithKline's mRNA-based flu vaccine in both younger and older adults.

Who is the study for?

This trial is for healthy adults, both young and older, who are interested in participating in a study to evaluate the immune response and safety of various mRNA-based flu vaccine formulations. Specific health criteria must be met to join.

What is being tested?

The trial is testing multiple mRNA flu vaccine formulations against influenza. Participants will receive one of several new vaccine candidates or an existing comparator vaccine to assess their immune responses and safety profiles.

What are the potential side effects?

Potential side effects may include typical reactions seen with vaccines such as pain at the injection site, fatigue, headache, muscle pain, chills, fever, and nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 85 years old.

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I cannot become pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have ongoing seizures or neurological issues.

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It is unsafe for me to receive shots in my muscles.

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I am a woman planning to become pregnant or stop using birth control.

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I have received all required vaccines within the specified timeframes.

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I have had myocarditis, pericarditis, or unexplained heart muscle disease.

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I am not on long-term immune-modifying drugs.

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I am bedridden.

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I have a condition that weakens my immune system.

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I have received immunoglobulins, blood products, or plasma derivatives.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to day 183

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to day 183

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 183 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Geometric mean increase (GMI) of Antigen 1 antibody titer

Geometric mean titer (GMT) of antigen 1 antibody

Percentage of participants with antigen 1 seroconversion rate (SCR)

+2 more

Secondary outcome measures

GMI of antigen 2 antibody titer

GMT of antigen 2 antibody

Percentage of participants reporting adverse events of special interest (AESIs)

+6 more

Trial Design

10Treatment groups

Experimental Treatment

Active Control

Group I: Flu mRNA_YA_Group 4Experimental Treatment1 Intervention