A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults

A Phase 3, Randomized, Stratified, Observer-blind, Active-Controlled Study to Evaluate the Immunogenicity and Safety of mRNA-1010 Seasonal Influenza Vaccine in Adults 18 Years and Older

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.

Study Overview

• Status: Completed
• Conditions: Seasonal Influenza
• Intervention / Treatment: Biological: mRNA-1010; Biological: Fluarix Tetra

• Study Type: Interventional
• Enrollment (Actual): 6102
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • CEI -Centro de Estudios Infectológicos
  • Ciudad Autonoma Buenos Aires, Argentina
    • Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
  • Ciudad Autónoma Buenos Aires, Argentina
    • Swiss Medical Center Barrio Parque
  • Ciudad Autónoma de Buenos Aires, Argentina
    • Consultorios Médicos Dr. Doreski
  • Ciudad Autónoma de Buenos Aires, Argentina
    • Expertia S.A- Mautalen Salud e Investigación
  • Ciudad Autónoma de Buenos Aires, Argentina
    • Fundación Socolinsky Centro de Vacunación Proteger
  • Ciudad De Cordoba, Argentina
    • Sanatorio Allende S.A.
  • La Plata, Argentina
    • Instituto Medico Platense
  • Rosario, Argentina
    • Instituto Medico de la Fundacion Estudios Clinicos
  • Río Cuarto, Argentina
    • Instituto Medico Río Cuarto
  • San Miguel de Tucumán, Argentina
    • AES - AS - Clinica Mayo de Urgencias Medicas Cruz Blanca S.R.L. ("CLINICA MAYO") Tucumán
• Australia
  • Adelaide, Australia
    • PARC Clinical Research
  • Albion, Australia
    • Paratus Clinical Research - Brisbane Clinic
  • Blacktown, Australia
    • Paratus Clinical Research - Western Sydney
  • Brookvale, Australia
    • Northern Beaches Clinical Research
  • Bruce, Australia
    • Paratus Clinical Research - Canberra
  • Camberwell, Australia
    • Emeritus Research
  • Clayton, Australia
    • Monash Health, Monash Medical Centre
  • Kanwal, Australia
    • Paratus Clinical Research - Central Coast
  • Maroubra, Australia
    • Australian Clinical Research Network
  • Parkville, Australia
    • University of Melbourne
  • Sippy Downs, Australia
    • University of the Sunshine Coast
  • Southport, Australia
    • Griffith University
  • Tarragindi, Australia
    • AusTrials (Wellers Hill)
  • Woodville, Australia
    • CMAX - Woodville
• Colombia
  • Acacías, Colombia
    • Centro de Atención e Investigación Médica S.A. - CAIMED - Acacías
  • Aguazul, Colombia
    • Centro de Atención e Investigación Médica S.A. - CAIMED - Aguazul
  • Armenia, Colombia
    • Centro de Atención e Investigación Médica S.A. - CAIMED - Armenia
  • Barranquilla, Colombia
    • Clinica de la Costa Ltda - PPDS
  • Bogotá, Colombia
    • Caja de Compensacion Familiar CAFAM sede Centro de atención en salud CAFAM Floresta
  • Bogotá, Colombia
    • Centro de Atención e Investigación Médica S.A. - CAIMED - Bogota
  • Bogotá, Colombia
    • Unidad Integral de Endocrinologia
  • Chía, Colombia
    • Centro de Atención e Investigación Médica S.A. - CAIMED - Chia
  • Floridablanca, Colombia
    • Fundación Oftalmológica de Santander FOSCAL
  • Girardot, Colombia
    • Centro de Atención e Investigación Médica S.A. - CAIMED - Girardot
  • Ibague, Colombia
    • Centro de Atención e Investigación Médica S.A. - CAIMED - Ibague
  • Medellín, Colombia
    • Clínica Universitaria Bolivariana
  • Medellín, Colombia
    • AES - AS - Centro de Investigación Clínica CIC S.A.S (CECIC) Medelin
  • Santiago de Cali, Colombia
    • Centro de Estudios en Infectología Pediatrica S.A.S - PPDS
  • Soledad, Colombia
    • Fundación Hospital Universidad del Norte
  • Yopal, Colombia
    • Centro de Atención e Investigación Médica S.A. - CAIMED - Yopal
• Panama
  • Ciudad De Panamá, Panama
    • Centro De Vacunacion Internacional, S.A. (Cevaxin) Sede La Chorrera
  • Panamá, Panama
    • CEVAXIN 24 de Diciembre
  • Panamá, Panama
    • CEVAXIN Avenida Mexico
• Philippines
  • Iloilo City, Philippines
    • West Visayas State University Medical Center
  • Iloilo City, Philippines
    • Healthlink Iloil
  • Iloilo City, Philippines
    • St. Paul's Hospital
  • Mandaluyong City, Philippines
    • Health Cube Medical Clinics
  • Manila City, Philippines
    • Manila Doctors Hospital
  • Manila City, Philippines
    • Medical Center Manila
  • Muntinlupa, Philippines
    • Asian Hospital And Medical Center
  • Pasay, Philippines
    • San Juan De Dios Hospital
  • Quezon City, Philippines
    • Lung Center of the Philippines

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mRNA-1010; Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.	Biological: mRNA-1010; Sterile liquid for injection; Other Names: Seasonal influenza vaccine
Active Comparator: Fluarix Tetra; Participants will receive a single dose of Fluarix Tetra by IM injection on Day 1.	Biological: Fluarix Tetra; Sterile suspension for injection; Other Names: Fluarix Quadrivalent; Licensed quadrivalent inactivated seasonal influenza vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage.	Day 29
Percentage of Participants Reaching Seroconversion at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains	Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion was defined as either a Baseline HAI titer <1:10 and a post-Baseline titer ≥1:40 or a Baseline HAI titer ≥1:10 and a minimum 4-fold rise in post-Baseline HAI Ab titer.	Day 29
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)	Solicited ARs (local and systemic) were collected in an electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. All solicited ARs considered causally related to injection were graded 0-4 (per Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials); lower score indicates lower severity, and a higher score indicates greater severity. Note, not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.	7 days post-vaccination
Number of Participants With Unsolicited AEs	An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time [PT]/partial thromboplastin time [PTT]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. Number of participants with unsolicited AEs (SAEs and non-serious AEs) up to 28 days post-vaccination are reported in this outcome measure.	Up to 28 days post-vaccination
Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation	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/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. An MAAE is an AE that lead to an unscheduled visit to an healthcare practitioner. This included visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and/or coronavirus disease 2019 [COVID-19] and visits to healthcare practitioners external to the study site (for example, urgent care, primary care physician). Number of participants with SAEs, AESIs, MAAEs, and AEs leading to discontinuation up to the end of study (Day 361) are reported in this outcome measure.	Day 1 through Day 361 (Month 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	A protocol-defined ILI was determined by the occurrence of at least 1 respiratory illness symptom concurrently with at least 1 systemic symptom, or the occurrence of any 2 or more respiratory symptoms. Respiratory symptoms included sore throat, cough/rhinorrhea/nasal congestion (≥1 of the 3 symptoms count as 1 respiratory symptom), sputum production, wheezing, or difficulty breathing. Systemic symptoms included body temperature >37.2 degrees Celsius (°C) (>99 degrees Fahrenheit [°F]), chills, tiredness, headache, myalgia, nausea/vomiting, or diarrhea.	14 days post-vaccination through Day 181 (Month 6)
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	A CDC-defined ILI was defined as body temperature ≥37.8°C (100°F) accompanied by cough and/or sore throat.	14 days post-vaccination through Day 181 (Month 6)
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	A protocol-defined ILI was determined by the occurrence of at least 1 respiratory illness symptom concurrently with at least 1 systemic symptom, or the occurrence of any 2 or more respiratory symptoms. Respiratory symptoms included sore throat, cough/rhinorrhea/nasal congestion (≥1 of the 3 symptoms count as 1 respiratory symptom), sputum production, wheezing, or difficulty breathing. Systemic symptoms included body temperature >37.2°C (>99°F), chills, tiredness, headache, myalgia, nausea/vomiting, or diarrhea.	14 days post-vaccination through Day 181 (Month 6)
Percentage of Participants With HAI Titer ≥ 1:40 at Day 29	Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage.	Day 29
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	The GMFR measures 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.	Baseline, Day 29

Collaborators and Investigators

• Sponsor: ModernaTX, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2022
• Primary Completion (Actual): September 4, 2023
• Study Completion (Actual): September 4, 2023

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Actual): September 24, 2024
• Last Update Submitted That Met QC Criteria: August 30, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: mRNA-1010-P301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No