mRNA-1010
BiologicalIntramuscular (IM) injection
NCT Number: NCT06602024
The primary objectives of this study are to evaluate the safety and reactogenicity of mRNA-1010, and to evaluate relative vaccine efficacy (rVE) of mRNA-1010 versus an active comparator against reverse transcription polymerase chain reaction (RT-PCR)-confirmed protocol-defined influenza-like illness (ILI) caused by any influenza A or B strains.
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Notify Me50 year and older
All sexes
Interventional
Phase 3
Anima Research Center, Alken, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intramuscular (IM) injection
IM injection
IM injection
IM injection
IM injection
Time frame: Day 1 to Day 7
Time frame: Day 1 to Day 28
Time frame: Day 1 to Day 181
Time frame: Day 14 up to End of Season (up to approximately Day 181)
ILI caused by any influenza A or B strains.
Time frame: Day 14 up to End of Season (up to approximately Day 181)
ILI caused by any influenza A or B strains.
Time frame: Day 14 up to End of Season (up to approximately Day 181)
ILI caused by influenza A or B strains with antigenic match to the vaccine strains.
Time frame: Day 29
Humoral immunogenicity.
Time frame: Day 29
Time frame: Day 29
Time frame: Day 1, Day 29
Time frame: Day 29
As measured by the HAI Assay.
Time frame: Day 14 up to End of Season (up to approximately Day 181)
Correlates of Risk (CoR) and Correlates of Protection (CoP).
ModernaTX, Inc.
Industry
A Phase 3, Randomized, Observer-blind, Active-controlled, Case-driven Study to Investigate the Safety, Efficacy, and Immunogenicity of mRNA-1010 Candidate Seasonal Influenza Vaccine Compared With a Licensed Inactivated Seasonal Influenza Vaccine in Adults ≥50 Years of Age
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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