Phase 3
N=6,102
A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults
Seasonal Influenza
Bottom Line
View on ClinicalTrials.gov: NCT05415462 ↗Enrolled (actual)
6,102
Serious AEs
4.3%
Results posted
Sep 2024
Primary outcome: Primary: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains — 266.52; 268.94; 175.06; 290.19 titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- mRNA-1010 (Biological); Fluarix Tetra (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ModernaTX, Inc.
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains |
266.52; 268.94; 175.06; 290.19; 127.50; 84.16 | — |
| PRIMARY Percentage of Participants Reaching Seroconversion at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains |
70.6; 76.4; 63.2; 80.1; 49.7; 32.4 | — |
| PRIMARY Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) |
1463; 2137; 1051; 1160; 309; 659 | — |
| PRIMARY Number of Participants With Unsolicited AEs |
749; 800 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation |
131; 132; 13; 9; 1481; 1422 | — |
| SECONDARY Number of Participants With First Episode of Reverse Transcription Polymerase Chain Reaction (RT-PCR)-Confirmed Protocol-Defined Influenza-Like Illness (ILI) Caused by Any Strain of Influenza Virus |
54; 64 | — |
| SECONDARY Number of Participants With First Episode of RT-PCR Confirmed Centers for Disease Control and Prevention (CDC)-Defined ILI Caused by Any Strain of Influenza Virus |
22; 24 | — |
| SECONDARY Number of Participants With First Episode of RT-PCR-Confirmed Protocol-Defined ILI Caused by Any Strain of Influenza Virus in Participants Aged 50 Years and Older or 65 Years and Older |
15; 21; 3; 5 | — |
| SECONDARY Percentage of Participants With HAI Titer ≥ 1:40 at Day 29 |
97.0; 97.6; 92.1; 96.9; 88.0; 80.7 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains |
7.27; 7.42; 4.92; 8.15; 3.59; 2.38 | — |
Summary
The primary objectives of this study are to evaluate the humoral immunogenicity of mRNA-1010 relative to that of an active comparator against vaccine-matched influenza A and B strains at Day 29, and to evaluate the safety and reactogenicity of mRNA-1010.
Eligibility Criteria
Inclusion Criteria
- Investigator has assessed that the participant understands and is willing and physically able to comply with protocol mandated follow-up, including all procedures.
- For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, and agreement to continue adequate contraception through 90 days following vaccine administration.
Exclusion Criteria
- Participant has had close contact to someone with SARS-CoV-2 infection or COVID-19 as defined by the United States (US) CDC or has had a positive SARS-CoV-2 test in the past 10 days prior to the Screening Visit.
- Participant is acutely ill or febrile (temperature ≥38.0℃ [100.4°F]) 72 hours prior to or at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled within the 28-day screening window and will retain their initially assigned participant number.
- Participant has a history of a diagnosis or condition that, in the judgment of the investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
- Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA or influenza vaccines or any components of the mRNA or influenza vaccines, including egg protein.
- Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 180 days prior to the Screening Visit (for corticosteroids, ≥10 milligrams (mg)/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. Inhaled, nasal, and topical steroids are allowed.
- Participant has received any vaccine authorized or approved by local health agency ≤28 days prior to study injection (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 28 days before or after the study injection.
- Participant is not aware whether they have received an influenza vaccine in the past 12 months or has received a seasonal influenza vaccine or any other investigational influenza vaccine within 180 days prior to Day 1.
- Participant has tested positive for influenza by local health authority-approved testing methods within 180 days prior to the Screening Visit.
- Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study.
Note: Other inclusion and exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT05415462). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.