The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular injection of different formulations of a hexavalent influenza messenger ribonucleic acid (mRNA) vaccine composed of differing dose levels of trivalent (TIV) mRNA hemagglutinin (HA) in combination with TIV mRNA-neuraminidase (NA) compared to an active control ((Fluzone standard-dose quadrivalent influenza vaccine (QIV-SD) or Fluzone high-dose quadrivalent influenza vaccine (QIV-HD) in adults 50 years of age and older.
Age range
50 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of participants with immediate unsolicited systemic adverse events (AEs)
Timeframe: Within 30 minutes after injection
Number of participants with solicited injection site reactions
Timeframe: Up to 7 days after injection
Number of participants with solicited systemic reactions
Timeframe: Up to 7 days after injection
Number of participants with unsolicited AEs
Timeframe: Up to 28 days after injection
Number of participants with medically attended adverse events (MAAEs)
Timeframe: Up to 180 days after injection
Number of participants with serious adverse events (SAEs)
Timeframe: SAEs throughout the study (Up to approximately 12 months)
Number of participants with adverse events of special interest (AESIs)
Timeframe: AESIs throughout the study (Up to approximately 12 months)
Number of participants with out-of-range biological test results
Timeframe: Up to 8 days after injection
Hemagglutinin inhibition (HAI) titers
Timeframe: At Day 1 and Day 29
Individual HAI antibody (Ab) titer ratio D29/D01
Timeframe: At Day 1 and Day 29
Seroconversion (HAI Ab titer)
Timeframe: At Day 1 and Day 29
HAI Ab titer ≥ 40 (1/dil)
Timeframe: At Day 29
Neuraminidase inhibition (NAI) titers
Timeframe: At Day 1 and Day 29
Individual NAI Ab titer ratio D29/D01
Timeframe: At Day 1 and Day 29
Seroconversion (NAI Ab titer)
Timeframe: At Day 1 and Day 29
NAI Ab titer ≥ 40 (1/dil)
Timeframe: At Day 29
2-fold and 4-fold rise in NAI titers
Timeframe: Day 1 to Day 29