A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults

Seasonal Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05415462
• Other study ID #: mRNA-1010-P301
• Status: Completed
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Influenza, Human
• Seasonal Influenza

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