Study of mRNA-1010 Seasonal Influenza Vaccine in Adults

Phase 3

Completed

Conditions: Seasonal Influenza

Interventions: Biological: mRNA-1010
Biological: Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine

Registration Number: NCT05827978

Lead Sponsor: ModernaTX, Inc.

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 8411

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 <65 years of age, at the time of signing the ICF.

Part C:

At least 65 years of age or older, at the time of signing the ICF.

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 Day 1.
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, immunosuppressive condition or immune-mediated disease, asplenia, or recurrent severe infections.
Participant has tested positive for influenza by local health authority-approved testing methods within 150 days (for Part A) or 180 days (for Parts B and C) prior to Day 1.
Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of mRNA vaccines or any components of the mRNA-1010 or influenza vaccines, including egg protein.
Participant has received systemic immunosuppressants for >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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mRNA-1010	mRNA-1010	Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.
Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine	Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine	Participants will receive a single dose of licensed quadrivalent inactivated seasonal influenza vaccine by IM injection on Day 1.

Primary Outcome Measures

Name	Time	Method
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibody Levels as Measured by Hemagglutination Inhibition (HAI)	Day 29	Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria and Yamagata strains. Antibody values reported as below lower limit of quantification (LLOQ) were replaced by 0.5\*LLOQ. Values greater than the upper limit of quantification (ULOQ) were converted to the ULOQ.
Percentage of Participants Reaching Seroconversion, as Measured by HAI	Day 29	Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria and Yamagata strains. Seroconversion rate was defined as the percentage of participants with either a Baseline HAI titer \<1:10 and a postbaseline titer ≥1:40 or a Baseline HAI titer ≥1:10 and a minimum 4-fold rise in postbaseline HAI antibody titer. Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were converted to the ULOQ.
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)	Up to 7 days after study injection	Solicited ARs, representative of vaccine reactogenicity, were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Per prespecified analysis, only solicited ARs that were assessed and confirmed by the Investigator as both serious and related to IP were recorded as an adverse event. These adverse events were recorded as a serious AE (SAE) and are included in the summary of SAEs in the "Reported Adverse Events" section.
Number of Participants With Unsolicited Adverse Events (AEs)	Up to 28 days after study injection	An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Unsolicited AEs included any AE not collected as a solicited AR, and also included solicited ARs assessed and confirmed as both serious and related by the Investigator. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Number of Participants With Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), SAEs, and AEs Leading to Discontinuation	Day 1 through Day 181	An MAAE was an AE that led to an unscheduled visit to a healthcare practitioner. An AESI was an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required. An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With HAI Titer ≥1:40	Day 29	Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria and Yamagata strains.
Geometric Mean Fold-Rise (GMFR) of Postinjection Anti-HA Antibodies for Influenza, as Measured by HAI Assay	Baseline (Day 1) to Day 29	Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria and Yamagata strains. The GMFR measured the changes in immunogenicity titers or levels from Baseline within participants. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% confidence interval (CI) for GMFR was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.

Trial Locations

Locations (87): Pinnacle Research Group
🇺🇸
Anniston, Alabama, United States
North Alabama Research Center LLC
🇺🇸
Athens, Alabama, United States
Cullman Research Center
🇺🇸
Cullman, Alabama, United States
Medical Affiliated Research Center Inc
🇺🇸
Huntsville, Alabama, United States
Desert Clinical Research - CCT
🇺🇸
Mesa, Arizona, United States
Foothills Research Center - CCT
🇺🇸
Phoenix, Arizona, United States
Fiel Family & Sports Medicine - PC - CCT
🇺🇸
Tempe, Arizona, United States
Noble Clinical Research
🇺🇸
Tucson, Arizona, United States
Baptist Health Center for Clinical Research
🇺🇸
Little Rock, Arkansas, United States
Velocity Clinical Research, Banning
🇺🇸
Banning, California, United States
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Pinnacle Research Group
🇺🇸Anniston, Alabama, United States