A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults

NCT05415462 | Completed Phase 3 Results FDA Drug

• 1 other identifier: mRNA-1010-P301
• Study Type: interventional
• Target: 6,102
• Locations: 5 countries
• Sites: 53

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• 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

  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

  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

  14 days post-vaccination through Day 181 (Month 6)

• Percentage of Participants With HAI Titer ≥ 1:40 at Day 29

  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

  Baseline, Day 29

Study Arms (2)

mRNA-1010

EXPERIMENTAL

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

Biological: mRNA-1010

Fluarix Tetra

ACTIVE COMPARATOR

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

Biological: Fluarix Tetra

Interventions

mRNA-1010 BIOLOGICAL

Sterile liquid for injection

Also known as: Seasonal influenza vaccine

mRNA-1010

Fluarix Tetra BIOLOGICAL

Sterile suspension for injection

Also known as: Licensed quadrivalent inactivated seasonal influenza vaccine, Fluarix Quadrivalent

Fluarix Tetra

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (53)

CEI -Centro de Estudios Infectológicos

Buenos Aires, Argentina

Location

Consultorios Médicos Dr. Doreski

Buenos Aires, Argentina

Location

Expertia S.A- Mautalen Salud e Investigacion

Buenos Aires, Argentina

Location

Fundación Socolinsky Centro de Vacunación Proteger

Buenos Aires, Argentina

Location

Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

Ciudad Autonoma Buenos Aires, Argentina

Location

Swiss Medical Center Barrio Parque

Ciudad Autónoma Buenos Aires, Argentina

Location

Sanatorio Allende S.A.

Córdoba, Argentina

Location

Instituto Medico Platense

La Plata, Argentina

Location

Instituto Médico Río Cuarto

Río Cuarto, Argentina

Location

Instituto Médico de la Fundación Estudios Clínicos

Rosario, Argentina

Location

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

San Miguel de Tucumán, Argentina

Location

PARC Clinical Research

Adelaide, Australia

Location

Paratus Clinical Research - Brisbane Clinic

Albion, Australia

Location

Paratus Clinical Research - Western Sydney

Blacktown, Australia

Location

Northern Beaches Clinical Research

Brookvale, Australia

Location

Paratus Clinical Research - Canberra

Bruce, Australia

Location

Emeritus Research

Camberwell, Australia

Location

Monash Health, Monash Medical Centre

Clayton, Australia

Location

Paratus Clinical Research - Central Coast

Kanwal, Australia

Location

Australian Clinical Research Network

Maroubra, Australia

Location

University of Melbourne

Parkville, Australia

Location

University of the Sunshine Coast

Sippy Downs, Australia

Location

Griffith University

Southport, Australia

Location

AusTrials (Wellers Hill)

Tarragindi, Australia

Location

CMAX - Woodville

Woodville, Australia

Location

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

Acacías, Colombia

Location

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

Aguazul, Colombia

Location

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

Armenia, Colombia

Location

Clinica de la Costa Ltda - PPDS

Barranquilla, Colombia

Location

Caja de Compensacion Familiar CAFAM sede Centro de atención en salud CAFAM Floresta

Bogotá, Colombia

Location

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

Bogotá, Colombia

Location

Unidad Integral de Endocrinologia

Bogotá, Colombia

Location

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

Chía, Colombia

Location

Fundacion Oftalmologica de Santander Foscal

Floridablanca, Colombia

Location

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

Girardot, Colombia

Location

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

Ibagué, Colombia

Location

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

Medellín, Colombia

Location

Clínica Universitaria Bolivariana

Medellín, Colombia

Location

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

Santiago de Cali, Colombia

Location

Fundación Hospital Universidad del Norte

Soledad, Colombia

Location

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

Yopal, Colombia

Location

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

Panama City, Panama

Location

CEVAXIN 24 de diciembre

Panama City, Panama

Location

CEVAXIN Avenida México

Panama City, Panama

Location

Asian Hospital and Medical Center

City of Muntinlupa, Philippines

Location

Healthlink Iloil

Iloilo City, Philippines

Location

St. Paul's Hospital

Iloilo City, Philippines

Location

West Visayas State University Medical Center

Iloilo City, Philippines

Location

Health Cube Medical Clinics

Mandaluyong, Philippines

Location

Manila Doctors Hospital

Manila, Philippines

Location

Medical Center Manila

Manila, Philippines

Location

San Juan de Dios Hospital

Pasay, Philippines

Location

Lung Center of The Philippines

Quezon City, Philippines

Location

MeSH Terms

Interventions

mRNA-1010 influenza vaccine

Results Point of Contact

• Title: Moderna Clinical Trials Support Center
• Organization: ModernaTX, Inc.

clinicaltrials@modernatx.com

1-877-777-7187

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 13, 2022
• Study Start: June 6, 2022
• Primary Completion: September 4, 2023
• Study Completion: September 4, 2023
• Last Updated: September 24, 2024
• Results First Posted: September 24, 2024

Record last verified: 2024-08

Locations

PA (3); CO (16); AR (11); AU (14); PH (9)