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A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults 50 Years Old and Older

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05566639
Recruitment Status : Completed
First Posted : October 4, 2022
Last Update Posted : February 2, 2024
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of mRNA-1010 in preventing seasonal influenza in adults 50 years and older.

Condition or disease Intervention/treatment Phase
Seasonal Influenza Biological: mRNA-1010 Biological: Licensed quadrivalent inactivated seasonal influenza vaccine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22510 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Observer-blind, Active-controlled Study to Evaluate the Safety and Efficacy of mRNA-1010 Candidate Seasonal Influenza Vaccine in Adults 50 Years and Older
Actual Study Start Date : September 14, 2022
Actual Primary Completion Date : January 5, 2024
Actual Study Completion Date : January 5, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: mRNA-1010
Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.
 Biological: mRNA-1010
Sterile liquid for injection
Other Name: Seasonal influenza vaccine
Active Comparator: Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine
Participants will receive a single dose of licensed quadrivalent inactivated seasonal influenza vaccine by IM injection on Day 1.
 Biological: Licensed quadrivalent inactivated seasonal influenza vaccine
Sterile suspension for injection.
Other Name: Fluarix Tetra


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) [ Time Frame: Up to Day 7 (7 days after vaccination) ]
  2. Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 28 (28 days after vaccination) ]
  3. Number of Participants with Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically Attended Adverse Events (MAAEs), and AEs Leading to Discontinuation [ Time Frame: Day 1 through Day 361 ]
  4. Time to First Episode of Reverse Transcription Polymerase Chain Reaction (RT-PCR) Confirmed Protocol-Defined Influenza-Like Illness (ILI) Caused by Any Influenza A or B Virus Strains [ Time Frame: 14 days post-vaccination through Day 181 or end of influenza season, whichever ends later ]

Secondary Outcome Measures :
  1. Time to First Episode of RT-PCR Confirmed Protocol-Defined ILI Caused by Any Influenza A or B Virus Strains with Similarity to the Vaccine Strains [ Time Frame: 14 days post-vaccination through Day 181 or end of influenza season, whichever ends later ]
    Similarity to strains selected for the seasonal vaccine will be determined by antigenicity testing and/or genomic sequencing.

  2. Time to First Episode of RT-PCR Confirmed Protocol-Defined ILI Caused by Any Influenza A or B Virus Strains Antigenically Matched to the Vaccine Strains [ Time Frame: 14 days post-vaccination through Day 181 or end of influenza season, whichever ends later ]
    Antigenically matched to strains selected for the seasonal vaccine will be determined by antigenicity testing.

  3. Time to First Episode of RT-PCR Confirmed United States (US) Centers for Disease Control and Prevention (CDC)-Defined ILI Caused by Any Influenza A or B Virus Strains [ Time Frame: 14 days post-vaccination through Day 181 or end of influenza season, whichever ends later ]
    Any strains include any influenza A or B strains, influenza A or B strains with similarity to vaccine strains and influenza A or B strains that are antigenically matched to vaccine strains. Antigenically matched to strains selected for the seasonal vaccine will be determined by antigenicity testing.

  4. Time to First Episode of Culture-Confirmed Protocol-Defined ILI Caused by Any Influenza A or B [ Time Frame: 14 days post-vaccination through Day 181 or end of influenza season, whichever ends later ]

    Any influenza A or B strains regardless of antigenic match to strains selected for the seasonal vaccine.

    A positive result for influenza infection by viral culture is needed, following a positive result for influenza infection by RT-PCR.


  5. Time to First Episode of Culture-Confirmed CDC-Defined ILI Caused by Any Influenza A or B [ Time Frame: 14 days post-vaccination through Day 181 or end of influenza season, whichever ends later ]

    Any influenza A or B strains regardless of antigenic match to strains selected for the seasonal vaccine.

    A positive result for influenza infection by viral culture is needed, following a positive result for influenza infection by RT-PCR


  6. Number of Participants With Hospitalizations Associated With RT-PCR Confirmed Protocol-Defined ILI [ Time Frame: 14 days post-vaccination through Day 181 or end of influenza season, whichever ends later ]
  7. Geometric Mean Titer (GMT) as Measured by Hemagglutination Inhibition (HAI) Assay [ Time Frame: Day 29 ]
  8. Number of Participants Reaching Seroconversion as measured by HAI Assay [ Time Frame: Day 29 ]
    Seroconversion is defined as either a prevaccination HAI titer <1:10 and a postvaccination titer ≥1:40 or a prevaccination HAI titer ≥1:10 and a minimum 4-fold rise in postvaccination HAI antibody titer.

  9. Number of Participants with a Titer ≥1:40 as Measured by HAI Assay [ Time Frame: Day 29 ]
  10. Change from Baseline in Geometric Mean Fold Rise (GMFR) at Day 29 as Measured by HAI Assay [ Time Frame: Baseline, Day 29 ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 the first dose on Day 1, and agreement to continue adequate contraception through 90 days following vaccine administration.

Exclusion Criteria:

  • Participant has had close contact with someone with laboratory-confirmed influenza infection or with someone who has been treated with antiviral therapies for influenza (for example, Tamiflu®) within the past 5 days prior to the Screening visit.
  • Participant has had close contact to someone with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or COVID-19 as defined by the 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℃elcius [100.4°Fahrenheit]) 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.
  • 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 congenital or acquired immunodeficiency, immunocompromising/ immunosuppressive condition, asplenia, or recurrent severe infections.
  • 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 immunosuppressant drugs for >14 days in total within 180 days prior to the Screening visit (for glucocorticosteroids, ≥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 intervention (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 28 days before or after the study intervention.
  • Participant is unaware whether they have received an influenza vaccine in the previous influenza season.
  • Participant 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 Day 1.
  • 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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05566639


Locations
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Sponsors and Collaborators
ModernaTX, Inc.
More Information
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Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT05566639    
Other Study ID Numbers: mRNA-1010-P302
2022-001638-12 ( EudraCT Number )
First Posted: October 4, 2022    Key Record Dates
Last Update Posted: February 2, 2024
Last Verified: January 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ModernaTX, Inc.:
Flu
Influenza
Vaccine
 mRNA vaccine
mRNA-1010
Moderna
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs