Seasonal Influenza
Conditions
Keywords
Flu, Influenza, Vaccine, mRNA vaccine, mRNA-1010, Moderna
Brief summary
The purpose of this study is to evaluate the immunogenicity and safety of updated strain-containing compositions of the mRNA-1010 vaccines within the current epidemiological environment.
Detailed description
This study uses a master protocol with a generic study design to allow flexibility in evaluating immunogenicity and safety of updated strain-containing compositions of the mRNA-1010 vaccines. As different strain-containing vaccine compositions will be evaluated, each study intervention will be described in the subprotocol. For each evaluation of an updated strain, a new subprotocol will be generated. Reported outcome measures are based upon each subprotocol. Not all reported outcome measures may be applicable to each subprotocol. Subprotocol 01 is to evaluate the 2026-2027 mRNA influenza vaccine.
Interventions
BIOLOGICALmRNA-1010
Sterile liquid for injection
BIOLOGICALLicensed High-Dose Seasonal Influenza Vaccine
Sterile liquid for injection
Sponsors
ModernaTX, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
This master protocol is a Phase 3b/4 study. Subprotocol 1 is a Phase 4 study.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol. * Female participants must be of non-childbearing potential. Key
Exclusion criteria
* Acutely ill or febrile (temperature ≥38.0 degrees Celsius (℃) \[100.4° Fahrenheit \[F\]\]) within 72 hours prior to at the Screening Visit or Day 1. * History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic or any components of an mRNA vaccine or therapeutic * History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable, potentially affects participant safety, could interfere with interpretation of study results or limit the participant's participation in the study. * History of myocarditis, pericarditis, or myopericarditis within 90 days prior to Day 1 (Baseline). * Received corticosteroids at ≥10 mg/day of prednisone or equivalent for \>14 days in total within 90 days prior to Day 1 (Baseline) or within 28 days after Day 1. * Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (eg, infliximab), within 180 days prior to Day 1 (Baseline) or plans to do so during the study. * Tested positive for influenza by US Centers for Disease Control and Prevention (CDC)-recommended testing methods within 180 days prior to Day 1. * Received systemic immunoglobulins or blood products within 90 days prior to Day 1 (Baseline) or plans to do so during the study. * Received any vaccine (excluding seasonal influenza vaccine) authorized or approved by local health agency within 28 days prior to Day 1 (Baseline) or plans to do so within 14 days after Day 1 (Baseline). * Received a licensed or investigational seasonal influenza vaccine within 6 months prior to Day 1 (Baseline) or plans to do so (outside of this study) at any time during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Day 29 | — |
| Number of Participants Reaching Seroconversion at Day 29 as Measured by HAI Assay | Day 29 | Seroconversion is defined as a Day 29 titer ≥1:40 if baseline is \<1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA antibodies measured by HAI assay. |
| Number of Participants with an HAI Titer ≥1:40 at Day 29 | Day 29 | — |
| Geometric Mean Fold Rise (GMFR), as Measured by HAI Assay | Baseline to Day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Unsolicited Adverse Events (AEs) | Day 1 through Day 29 |
| Number of Participants with Serious AEs, Medical-attended AEs and AE of Interest, and AEs Leading to Discontinuation | Day 1 through Day 29 |
Contacts
CONTACTModerna WeCare Team
Outcome results
None listed