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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516240-26-00
Acronym
mRNA-1010-P304
Enrollment
15490
Registered
2024-09-06
Start date
2024-10-11
Completion date
2025-07-04
Last updated
2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Brief summary

Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) from day 1 to day 7, Number of Participants with Unsolicited Adverse Events (AEs) from day 1 to day 28, Number of Participants with Medically Attended AEs (MAAEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), or Adverse Events of Special Interest (AESI) from day 1 to day 181, Time to First Episode of Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) Confirmed Protocol Defined ILI (ILI caused by any influenza A or B strain from day 14 up to End of Season (up to approximately day 181)

Detailed description

Number of Participants with First Episode of RT-PCR Confirmed Modified US Centers for Disease Control and Prevention (CDC)-Defined ILI (ILI caused by any influenza A or B strains) from Day 14 up to End of Season (up to approximately Day 181), Number of Participants with First Episode of RT-PCR Confirmed Protocol-Defined ILI or Modified CDC-Defined ILI (ILI caused by influenza A or B strains with antigenic match to the vaccine strains) from Day 14 up to End of Season (up to approximately Day 181), Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) (Humoral immunogenicity) at day 29, Number of Participants Reaching Seroconversion as Measured by HAI at Day 29, Number of Participants with an HAI Titer ≥1:40 at Day 29, Geometric Mean Fold Rise (GMFR) of HAI Titers at Day 1 and Day 29, HAI Titer (As measured by the HAI Assay) at Day 29, Number of Participants with First Episode of RT-PCR-Confirmed Protocol-Defined ILI (Correlates of Risk (CoR) and Correlates of Protection (CoP)) from Day 14 up to End of Season (up to approximately Day 181)

Interventions

DRUGInflusplit Tetra 2024/2025 Injektionssuspension in Fertigspritze Influenza-Spaltimpfstoff (inaktiviert)

Sponsors

Moderna Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) from day 1 to day 7, Number of Participants with Unsolicited Adverse Events (AEs) from day 1 to day 28, Number of Participants with Medically Attended AEs (MAAEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), or Adverse Events of Special Interest (AESI) from day 1 to day 181, Time to First Episode of Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) Confirmed Protocol Defined ILI (ILI caused by any influenza A or B strain from day 14 up to End of Season (up to approximately day 181)

Secondary

MeasureTime frame
Number of Participants with First Episode of RT-PCR Confirmed Modified US Centers for Disease Control and Prevention (CDC)-Defined ILI (ILI caused by any influenza A or B strains) from Day 14 up to End of Season (up to approximately Day 181), Number of Participants with First Episode of RT-PCR Confirmed Protocol-Defined ILI or Modified CDC-Defined ILI (ILI caused by influenza A or B strains with antigenic match to the vaccine strains) from Day 14 up to End of Season (up to approximately Day 181), Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) (Humoral immunogenicity) at day 29, Number of Participants Reaching Seroconversion as Measured by HAI at Day 29, Number of Participants with an HAI Titer ≥1:40 at Day 29, Geometric Mean Fold Rise (GMFR) of HAI Titers at Day 1 and Day 29, HAI Titer (As measured by the HAI Assay) at Day 29, Number of Participants with First Episode of RT-PCR-Confirmed Protocol-Defined ILI (Correlates of Risk (CoR) and Correlates of Protection (CoP))

Countries

Belgium, Bulgaria, Estonia, Finland, Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026