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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05415462
Other study ID # mRNA-1010-P301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 6, 2022
Est. completion date September 4, 2023

Study information

Verified date September 2023
Source ModernaTX, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 6102
Est. completion date September 4, 2023
Est. primary completion date September 4, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 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 Design


Related Conditions & MeSH terms


Intervention

Biological:
mRNA-1010
Sterile liquid for injection
Licensed quadrivalent inactivated seasonal influenza vaccine
Sterile suspension for injection

Locations

Country Name City State
Argentina CEI -Centro de Estudios Infectológicos 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 Consultorios Médicos Dr. Doreski Ciudad Autónoma de Buenos Aires
Argentina Expertia S.A- Mautalen Salud e Investigacion Ciudad Autónoma de Buenos Aires
Argentina Fundación Socolinsky Centro de Vacunación Proteger Ciudad Autónoma de Buenos Aires
Argentina Sanatorio Allende S.A. Ciudad De Cordoba
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
Australia 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
Colombia 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 Ibague
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
Panama Centro De Vacunacion Internacional, S.A. (Cevaxin) Sede La Chorrera Ciudad De Panamá
Panama CEVAXIN 24 de diciembre Panamá
Panama CEVAXIN Avenida México Panamá
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 City
Philippines Manila Doctors Hospital Manila City
Philippines Medical Center Manila Manila City
Philippines Asian Hospital and Medical Center Muntinlupa
Philippines San Juan de Dios Hospital Pasay
Philippines Lung Center of The Philippines Quezon City

Sponsors (1)

Lead Sponsor Collaborator
ModernaTX, Inc.

Countries where clinical trial is conducted

Argentina,  Australia,  Colombia,  Panama,  Philippines, 

Outcome

Type Measure Description Time frame Safety issue
Primary Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay Day 29
Primary Percentage of Participants Reaching Seroconversion, as Measured by HAI Assay Seroconversion is defined as either a pre-vaccination HAI titer <1:10 and a post-vaccination titer =1:40 or a pre-vaccination HAI titer =1:10 and a minimum 4-fold rise in post-vaccination HAI antibody titer. Day 29
Primary Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) Up to Day 7 (7 days after vaccination)
Primary Number of Unsolicited Adverse Events (AEs) Up to Day 28 (28 days after vaccination)
Primary Number of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically Attended Adverse Events (MAAEs), and AEs Leading to Discontinuation Day 1 through Day 361
Secondary Number of Participants With First Episode of Reverse Transcription Polymerase Chain Reaction (RT-PCR)-Confirmed Protocol-Defined Influenza-Like Illness (ILI) A protocol-defined ILI is determined by the occurrence of at least 1 respiratory illness symptom concurrently with at least 1 systemic symptom (Body temperature >37.2 degrees celsius (°C) [> 99 degrees fahrenheit {°F}]; Chills; Tiredness; Headache; Myalgia; Nausea/vomiting; Diarrhea), or the occurrence of any 2 or more respiratory symptoms (Sore throat; Cough/rhinorrhea/nasal congestion [= 1 of the 3 symptoms count as 1 respiratory symptom]; Sputum production; Wheezing; Difficulty breathing). Protocol-defined ILI caused by any strain of influenza virus regardless of antigenic match to the strains selected for seasonal vaccine will be reported. 14 days post-vaccination through Day 181
Secondary Number of Participants With First Episode of RT-PCR Confirmed Centers for Disease Control and Prevention (CDC)-Defined ILI A CDC-defined ILI is defined as body =37.8°C (100°F) accompanied by cough and/or sore throat. CDC-defined ILI caused by any strain of influenza virus regardless of antigenic match to the strains selected for seasonal vaccine will be reported. 14 days post-vaccination through Day 181
Secondary Number of Participants With First Episode of RT-PCR-Confirmed Protocol-Defined ILI in Participants Aged 50 Years and Older or 65 Years and Older A protocol-defined ILI is determined by the occurrence of at least 1 respiratory illness symptom concurrently with at least 1 systemic symptom (Body temperature >37.2°C [> 99°F]; Chills; Tiredness; Headache; Myalgia; Nausea/vomiting; Diarrhea), or the occurrence of any 2 or more respiratory symptoms (Sore throat; Cough/rhinorrhea/nasal congestion [= 1 of the 3 symptoms count as 1 respiratory symptom]; Sputum production; Wheezing; Difficulty breathing). Protocol-defined ILI caused by any strain of influenza virus regardless of antigenic match to the strains selected for seasonal vaccine will be reported. 14 days post-vaccination through Day 181
Secondary Percentage of Participants With HAI Titer = 1:40 at Day 29 Day 29
Secondary Change From Baseline in Geometric Mean Fold Rise (GMFR) as Measured by HAI Assays Baseline, Up to Day 29
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