Clinical trial NCT05415462: A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Influenza
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-13
Enrollment: 6102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Note: Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: 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
timeFrame: Day 29
measure: Percentage of Participants Reaching Seroconversion at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
timeFrame: Day 29
measure: Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
timeFrame: 7 days post-vaccination
measure: Number of Participants With Unsolicited AEs
timeFrame: Up to 28 days post-vaccination
measure: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation
timeFrame: Day 1 through Day 361 (Month 12)
Secondary outcomes:
measure: 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
timeFrame: 14 days post-vaccination through Day 181 (Month 6)
measure: 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
timeFrame: 14 days post-vaccination through Day 181 (Month 6)
measure: 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
timeFrame: 14 days post-vaccination through Day 181 (Month 6)
measure: Percentage of Participants With HAI Titer ≥ 1:40 at Day 29
timeFrame: Day 29
measure: 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
timeFrame: Baseline, Day 29
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: CEI -Centro de Estudios Infectológicos
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
city: Ciudad Autónoma Buenos Aires
country: Argentina
facility: Swiss Medical Center Barrio Parque
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Consultorios Médicos Dr. Doreski
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Expertia S.A- Mautalen Salud e Investigacion
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Fundación Socolinsky Centro de Vacunación Proteger
city: Ciudad De Cordoba
country: Argentina
facility: Sanatorio Allende S.A.
city: La Plata
country: Argentina
facility: Instituto Medico Platense
city: Rosario
country: Argentina
facility: Instituto Médico de la Fundación Estudios Clínicos
city: Río Cuarto
country: Argentina
facility: Instituto Médico Río Cuarto
city: San Miguel de Tucumán
country: Argentina
facility: AES - AS - Clinica Mayo de Urgencias Medicas Cruz Blanca S.R.L. ("CLINICA MAYO") Tucumán
city: Adelaide
country: Australia
facility: PARC Clinical Research
city: Albion
country: Australia
facility: Paratus Clinical Research - Brisbane Clinic
city: Blacktown
country: Australia
facility: Paratus Clinical Research - Western Sydney
city: Brookvale
country: Australia
facility: Northern Beaches Clinical Research
city: Bruce
country: Australia
facility: Paratus Clinical Research - Canberra
city: Camberwell
country: Australia
facility: Emeritus Research
city: Clayton
country: Australia
facility: Monash Health, Monash Medical Centre
city: Kanwal
country: Australia
facility: Paratus Clinical Research - Central Coast
city: Maroubra
country: Australia
facility: Australian Clinical Research Network
city: Parkville
country: Australia
facility: University of Melbourne
city: Sippy Downs
country: Australia
facility: University of the Sunshine Coast
city: Southport
country: Australia
facility: Griffith University
city: Tarragindi
country: Australia
facility: AusTrials (Wellers Hill)
city: Woodville
country: Australia
facility: CMAX - Woodville
city: Acacías
country: Colombia
facility: Centro de Atención e Investigación Médica S.A. - CAIMED - Acacías
city: Aguazul
country: Colombia
facility: Centro de Atención e Investigación Médica S.A. - CAIMED - Aguazul
city: Armenia
country: Colombia
facility: Centro de Atención e Investigación Médica S.A. - CAIMED - Armenia
city: Barranquilla
country: Colombia
facility: Clinica de la Costa Ltda - PPDS
city: Bogotá
country: Colombia
facility: Caja de Compensacion Familiar CAFAM sede Centro de atención en salud CAFAM Floresta
city: Bogotá
country: Colombia
facility: Centro de Atención e Investigación Médica S.A. - CAIMED - Bogota
city: Bogotá
country: Colombia
facility: Unidad Integral de Endocrinologia
city: Chía
country: Colombia
facility: Centro de Atención e Investigación Médica S.A. - CAIMED - Chia
city: Floridablanca
country: Colombia
facility: Fundacion Oftalmologica de Santander Foscal
city: Girardot
country: Colombia
facility: Centro de Atención e Investigación Médica S.A. - CAIMED - Girardot
city: Ibague
country: Colombia
facility: Centro de Atención e Investigación Médica S.A. - CAIMED - Ibague
city: Medellín
country: Colombia
facility: AES - AS - Centro de Investigación Clínica CIC S.A.S (CECIC) Medelin
city: Medellín
country: Colombia
facility: Clínica Universitaria Bolivariana
city: Santiago de Cali
country: Colombia
facility: Centro de Estudios en Infectología Pediatrica S.A.S - PPDS
city: Soledad
country: Colombia
facility: Fundación Hospital Universidad del Norte
city: Yopal
country: Colombia
facility: Centro de Atención e Investigación Médica S.A. - CAIMED - Yopal
city: Ciudad De Panamá
country: Panama
facility: Centro De Vacunacion Internacional, S.A. (Cevaxin) Sede La Chorrera
city: Panamá
country: Panama
facility: CEVAXIN 24 de diciembre
city: Panamá
country: Panama
facility: CEVAXIN Avenida México
city: Iloilo City
country: Philippines
facility: Healthlink Iloil
city: Iloilo City
country: Philippines
facility: St. Paul's Hospital
city: Iloilo City
country: Philippines
facility: West Visayas State University Medical Center
city: Mandaluyong City
country: Philippines
facility: Health Cube Medical Clinics
city: Manila City
country: Philippines
facility: Manila Doctors Hospital
city: Manila City
country: Philippines
facility: Medical Center Manila
city: Muntinlupa
country: Philippines
facility: Asian Hospital and Medical Center
city: Pasay
country: Philippines
facility: San Juan de Dios Hospital
city: Quezon City
country: Philippines
facility: Lung Center of The Philippines
Study officials:
References: