Phase 3
N=8,411
Study of mRNA-1010 Seasonal Influenza Vaccine in Adults
Seasonal Influenza
Bottom Line
View on ClinicalTrials.gov: NCT05827978 ↗Enrolled (actual)
8,411
Serious AEs
2.1%
Results posted
Jul 2025
Primary outcome: Primary: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibody Levels as Measured by Hemagglutination Inhibition (HAI) — 147.49; 220.17; 137.90; 208.10 titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- mRNA-1010 (Biological); Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ModernaTX, Inc.
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibody Levels as Measured by Hemagglutination Inhibition (HAI) |
147.49; 220.17; 137.90; 208.10; 130.09; 174.81 | — |
| PRIMARY Percentage of Participants Reaching Seroconversion, as Measured by HAI |
34.9; 50.2; 45.0; 64.4; 36.3; 49.7 | — |
| PRIMARY Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) |
682; 1060; 796; 1158; 734; 1131 | — |
| PRIMARY Number of Participants With Unsolicited Adverse Events (AEs) |
134; 145; 134; 147; 137; 155 | — |
| PRIMARY Number of Participants With Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), SAEs, and AEs Leading to Discontinuation |
195; 226; 223; 217; 248; 257 | — |
| SECONDARY Percentage of Participants With HAI Titer ≥1:40 |
93.7; 96.7; 92.0; 96.4; 92.3; 96.5 | — |
| SECONDARY Geometric Mean Fold-Rise (GMFR) of Postinjection Anti-HA Antibodies for Influenza, as Measured by HAI Assay |
2.78; 4.03; 3.29; 4.99; 2.60; 3.49 | — |
Summary
This study includes 3 parts: Parts A, B, and C. The purpose of this study is to evaluate the immunogenicity and safety of mRNA-1010 seasonal influenza vaccine in adults.
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 assigned females at birth and 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.
Part A:
- At least 18 years of age inclusive, at the time of signing the informed consent form (ICF).
Part B:
- At least 18 and 14 days in total within 180 days prior to Day 1 (for corticosteroids, ≥10 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. Intra-articular and epidural steroid injections are not allowed within 28 days before and/or after study intervention dosing.
- Participant has received any vaccine authorized or approved by local health agency ≤28 days prior to study intervention dosing (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 28 days before or after study intervention dosing.
- Participant has received a licensed seasonal influenza vaccine within 5 months (150 days) (for part A) or within 6 months (180 days) (for Parts B and C) prior to Day 1.
- Participant has participated in any investigational seasonal influenza vaccine study within12 months prior to Day 1.
- Participant is not aware whether they have received an influenza vaccine in the most recent influenza season (in the prior 12 months) (for Part A) or since September 2022 (for Parts B and C).
- Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to Day 1 or plans to donate blood products during the study.
Note: Other inclusion and exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT05827978). 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.