Phase 3
N=22,502
A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults 50 Years Old and Older
Seasonal Influenza
Bottom Line
View on ClinicalTrials.gov: NCT05566639 ↗Enrolled (actual)
22,502
Serious AEs
4.5%
Results posted
Jan 2025
Primary outcome: Primary: Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) — 5620; 7989; 3840; 4433 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- mRNA-1010 (Biological); Fluarix Quadrivalent (Biological)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- ModernaTX, Inc.
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) |
5620; 7989; 3840; 4433; 1535; 3050 | — |
| PRIMARY Number of Participants With Unsolicited Adverse Events (AEs) |
1495; 1351 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation |
495; 518; 13; 10; 3166; 3126 | — |
| PRIMARY Number of Participants With First Episode of RT-PCR-Confirmed Protocol-Defined Influenza-Like Illness (ILI) Caused by Any Seasonal Influenza A or B Virus Strains Regardless of Antigenic Match to Strains Selected for the Seasonal Vaccine |
142; 140 | 0.1715 |
| SECONDARY Number of Participants With First Episode of RT-PCR-Confirmed Protocol-Defined ILI Caused by Influenza A or B Strains With Similarity to Those Selected for the Seasonal Vaccine |
— | — |
| SECONDARY Number of Participants With First Episode of RT-PCR-Confirmed Protocol-Defined ILI Caused by Influenza A or B Strains Antigenically Matched to the Vaccine Strains Selected for the Seasonal Vaccine |
85; 75 | — |
| SECONDARY Number of Participants With First Episode of RT-PCR Confirmed United States (US) Centers for Disease Control and Prevention (CDC)-Defined ILI Caused by Any Influenza A or B Strains |
70; 70 | — |
| SECONDARY Number of Participants With First Episode of RT-PCR CDC-Defined ILI Caused by Influenza A or B Strains With Similarity to Vaccine Strains |
— | — |
| SECONDARY Number of Participants With First Episode of RT-PCR CDC-Defined ILI Caused by Influenza A or B Strains That Were Antigenically Matched to Vaccine Strains |
44; 38 | — |
| SECONDARY Number of Participants With First Episode of Culture-Confirmed Protocol-Defined ILI Caused by Any Seasonal Influenza A or B Virus Strains Regardless of Antigenic Match to Strains Selected for the Seasonal Vaccine |
91; 81 | — |
| SECONDARY Number of Participants With First Episode of Culture-Confirmed CDC-Defined ILI Caused by Any Seasonal Influenza A or B Virus Strains Regardless of Antigenic Match to Strains Selected for the Seasonal Vaccine |
45; 40 | — |
| SECONDARY Number of Participants With Hospitalizations Associated With RT-PCR Confirmed Protocol-Defined ILI Caused by Any Seasonal Influenza A or B Virus Strains Regardless of Antigenic Match to Strains Selected for the Seasonal Vaccine |
3; 3 | — |
| SECONDARY 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 |
105.34; 149.14; 85.99; 104.06; 140.50; 132.24 | — |
| SECONDARY Percentage of Participants Reaching Seroconversion at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains |
29.4; 44.8; 39.7; 52.0; 27.5; 26.6 | — |
| SECONDARY Percentage of Participants With HAI Titer ≥ 1:40 at Day 29 |
90.0; 94.4; 85.5; 89.6; 94.6; 94.8 | — |
| 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 |
2.42; 3.42; 3.04; 3.74; 2.46; 2.28 | — |
Summary
The purpose of this study is to evaluate the safety and efficacy of mRNA-1010 in preventing seasonal influenza in adults 50 years and older.
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 the first dose on Day 1, and agreement to continue adequate contraception through 90 days following vaccine administration.
Exclusion Criteria
- Participant has had close contact with someone with laboratory-confirmed influenza infection or with someone who has been treated with antiviral therapies for influenza (for example, Tamiflu®) within the past 5 days prior to the Screening visit.
- Participant has had close contact to someone with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or COVID-19 as defined by the 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℃elcius [100.4°Fahrenheit]) 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.
- 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 congenital or acquired immunodeficiency, immunocompromising/ immunosuppressive condition, asplenia, or recurrent severe infections.
- 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 immunosuppressant drugs for >14 days in total within 180 days prior to the Screening visit (for glucocorticosteroids, ≥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 intervention (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 28 days before or after the study intervention.
- Participant is unaware whether they have received an influenza vaccine in the previous influenza season.
- Participant 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 Day 1.
- 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 (NCT05566639). 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.