A Phase 1 interventional study of mRNA-1010 and Fluarix Trivalent in Seasonal Influenza, sponsored by ModernaTX, Inc.. Not yet recruiting at 6 sites in United States. Open to participants aged 9 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by ModernaTX, Inc. (part of Moderna, Inc.) · Phase 1, Interventional, and Prevention
The purpose of this study is to evaluate safety, reactogenicity, and immunogenicity of mRNA-1010 in healthy children (9 to \<18 years of age).
2,264 studies on the registry are indexed under Influenza, Human; 173 are open to participants now.
This study's planned enrollment of 96 is below the median of 240 across 1,894 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →ModernaTX, Inc. is the lead sponsor of 117 studies on the registry; 16 are open to participants now.
Of its 63 completed or terminated interventional studies of FDA-regulated products, 35 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Note: Other protocol-defined inclusion and exclusion criteria may apply.
Participants will receive a single low dose of mRNA-1010 by intramuscular (IM) injection on Day 1.
Biological: mRNA-1010
Participants will receive a single full dose of mRNA-1010 by intramuscular (IM) injection on Day 1.
Biological: mRNA-1010
Participants will receive a single dose of Fluarix Trivalent by IM injection on Day 1.
Biological: Fluarix Trivalent
Suspension for injection
Also known as: Seasonal influenza vaccine
Suspension for injection
Also known as: A standard dose licensed inactivated seasonal influenza trivalent flu vaccine
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Time frame: Up to Day 7 (7 days after vaccination)
Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: Up to Day 28 (28 days after vaccination)
Number of Participants with AEs Leading to Discontinuation, Serious Adverse Events (SAEs), or Adverse Events of Special Interest (AESI)
Time frame: Day 1 through Day 365
Number of Participants with Medically Attended AEs (MAAEs)
Time frame: Day 1 through Day 181
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay
Time frame: Day 29
Percentage of Participants Reaching Seroconversion, as Measured by HAI Assay
Seroconversion is defined as either a pre-vaccination HAI titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HAI antibody titer.
Time frame: Day 29
Percentage of Participants With HAI Titer ≥ 1:40 at Day 29
Time frame: Day 29
Geometric Mean Fold Rise (GMFR) of Anti-HA antibodies, as Measured by HAI Assays
Time frame: Day 29
Start is estimated for Oct 2026; primary completion for Dec 2027, 14 months later.
Of 84 industry-sponsored phase 1 interventional studies under Influenza, Human, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 16. This study's planned 14 months is above that.
Counting every sponsor, half of 139 studies reached it within 11 months; a quarter within 4 and three quarters within 21.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: mRNA-1010 influenza vaccine