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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.Check my eligibility
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.See study design
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 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
Eligible participants receive 1 dose of study intervention at Day 1 intramuscularly.
Group II: Flu mRNA_YA_Group 3Experimental Treatment1 Intervention
Eligible participants receive 1 dose of study intervention at Day 1 intramuscularly.
Group III: Flu mRNA_YA_Group 2Experimental Treatment1 Intervention
Eligible participants receive 1 dose of study intervention at Day 1 intramuscularly.
Group IV: Flu mRNA_YA_Group 1Experimental Treatment1 Intervention
Eligible participants receive 1 dose of study intervention at Day 1 intramuscularly.
Group V: Flu mRNA_OA_Group 4Experimental Treatment1 Intervention
Eligible participants receive 1 dose of study intervention at Day 1 intramuscularly.
Group VI: Flu mRNA_OA_Group 3Experimental Treatment1 Intervention
Eligible participants receive 1 dose of study intervention at Day 1 intramuscularly.
Group VII: Flu mRNA_OA_Group 2Experimental Treatment1 Intervention
Eligible participants receive 1 dose of study intervention at Day 1 intramuscularly.
Group VIII: Flu mRNA_OA_Group 1Experimental Treatment1 Intervention
Eligible participants receive 1 dose of study intervention at Day 1 intramuscularly.
Group IX: YA_Active Comparator Group 1Active Control1 Intervention
Eligible participants receive 1 dose of an active comparator at Day 1 intramuscularly.
Group X: OA_Active Comparator Group 2Active Control1 Intervention
Eligible participants receive 1 dose of an active comparator at Day 1 intramuscularly.

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,772 Previous Clinical Trials
8,106,403 Total Patients Enrolled
~0 spots leftby Jul 2024