A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults

NCT ID: NCT05415462

Last Updated: 2024-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 6102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-06
• Study Completion Date: 2023-09-04

Brief Summary

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.

Conditions

Seasonal Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

mRNA-1010

Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.

Group Type: EXPERIMENTAL

mRNA-1010

Intervention Type: BIOLOGICAL

Sterile liquid for injection

Fluarix Tetra

Participants will receive a single dose of Fluarix Tetra by IM injection on Day 1.

Group Type: ACTIVE_COMPARATOR

Fluarix Tetra

Intervention Type: BIOLOGICAL

Sterile suspension for injection

Interventions

mRNA-1010

Sterile liquid for injection

Intervention Type: BIOLOGICAL

Fluarix Tetra

Sterile suspension for injection

Intervention Type: BIOLOGICAL

Other Intervention Names

Seasonal influenza vaccine; Licensed quadrivalent inactivated seasonal influenza vaccine; Fluarix Quadrivalent

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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ModernaTX, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CEI -Centro de Estudios Infectológicos

Buenos Aires, , Argentina

Consultorios Médicos Dr. Doreski

Buenos Aires, , Argentina

Expertia S.A- Mautalen Salud e Investigacion

Buenos Aires, , Argentina

Fundación Socolinsky Centro de Vacunación Proteger

Buenos Aires, , Argentina

Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

Ciudad Autonoma Buenos Aires, , Argentina

Swiss Medical Center Barrio Parque

Ciudad Autónoma Buenos Aires, , Argentina

Sanatorio Allende S.A.

Córdoba, , Argentina

Instituto Medico Platense

La Plata, , Argentina

Instituto Médico Río Cuarto

Río Cuarto, , Argentina

Instituto Médico de la Fundación Estudios Clínicos

Rosario, , Argentina

AES - AS - Clinica Mayo de Urgencias Medicas Cruz Blanca S.R.L. ("CLINICA MAYO") Tucumán

San Miguel de Tucumán, , Argentina

PARC Clinical Research

Adelaide, , Australia

Paratus Clinical Research - Brisbane Clinic

Albion, , Australia

Paratus Clinical Research - Western Sydney

Blacktown, , Australia

Northern Beaches Clinical Research

Brookvale, , Australia

Paratus Clinical Research - Canberra

Bruce, , Australia

Emeritus Research

Camberwell, , Australia

Monash Health, Monash Medical Centre

Clayton, , Australia

Paratus Clinical Research - Central Coast

Kanwal, , Australia

Australian Clinical Research Network

Maroubra, , Australia

University of Melbourne

Parkville, , Australia

University of the Sunshine Coast

Sippy Downs, , Australia

Griffith University

Southport, , Australia

AusTrials (Wellers Hill)

Tarragindi, , Australia

CMAX - Woodville

Woodville, , Australia

Centro de Atención e Investigación Médica S.A. - CAIMED - Acacías

Acacías, , Colombia

Centro de Atención e Investigación Médica S.A. - CAIMED - Aguazul

Aguazul, , Colombia

Centro de Atención e Investigación Médica S.A. - CAIMED - Armenia

Armenia, , Colombia

Clinica de la Costa Ltda - PPDS

Barranquilla, , 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

Bogotá, , Colombia

Centro de Atención e Investigación Médica S.A. - CAIMED - Chia

Chía, , Colombia

Fundacion Oftalmologica de Santander Foscal

Floridablanca, , Colombia

Centro de Atención e Investigación Médica S.A. - CAIMED - Girardot

Girardot, , Colombia

Centro de Atención e Investigación Médica S.A. - CAIMED - Ibague

Ibagué, , Colombia

AES - AS - Centro de Investigación Clínica CIC S.A.S (CECIC) Medelin

Medellín, , Colombia

Clínica Universitaria Bolivariana

Medellín, , Colombia

Centro de Estudios en Infectología Pediatrica S.A.S - PPDS

Santiago de Cali, , Colombia

Fundación Hospital Universidad del Norte

Soledad, , Colombia

Centro de Atención e Investigación Médica S.A. - CAIMED - Yopal

Yopal, , Colombia

Centro De Vacunacion Internacional, S.A. (Cevaxin) Sede La Chorrera

Panama City, , Panama

CEVAXIN 24 de diciembre

Panama City, , Panama

CEVAXIN Avenida México

Panama City, , Panama

Asian Hospital and Medical Center

City of Muntinlupa, , Philippines

Healthlink Iloil

Iloilo City, , Philippines

St. Paul's Hospital

Iloilo City, , Philippines

West Visayas State University Medical Center

Iloilo City, , Philippines

Health Cube Medical Clinics

Mandaluyong, , Philippines

Manila Doctors Hospital

Manila, , Philippines

Medical Center Manila

Manila, , Philippines

San Juan de Dios Hospital

Pasay, , Philippines

Lung Center of The Philippines

Quezon City, , Philippines

Countries

Argentina; Australia; Colombia; Panama; Philippines

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

mRNA-1010-P301

Identifier Type: -

Identifier Source: org_study_id