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

• ClinicalTrials.gov Identifier: NCT05566639
• Recruitment Status: Completed
• First Posted: October 4, 2022
• Last Update Posted: February 2, 2024
• Sponsor: ModernaTX, Inc.
• Information provided by (Responsible Party): ModernaTX, Inc.

Tracking Information

• First Submitted Date: September 30, 2022
• First Posted Date: October 4, 2022
• Last Update Posted Date: February 2, 2024
• Actual Study Start Date: September 14, 2022
• Actual Primary Completion Date: January 5, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 31, 2023)

• Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) [ Time Frame: Up to Day 7 (7 days after vaccination) ]
• Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 28 (28 days after vaccination) ]
• 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 ]
• 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 ]

Original Primary Outcome Measures (submitted: September 30, 2022)

• Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) [ Time Frame: Up to Day 7 (7 days after vaccination) ]
• Number of Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 28 (28 days after vaccination) ]
• Number of 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 ]
• 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 ]

Current Secondary Outcome Measures (submitted: March 31, 2023)

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

Original Secondary Outcome Measures (submitted: September 30, 2022)

• 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.
• Time to First Episode of RT-PCR Confirmed Protocol-Defined ILI Caused by Any Influenza A or B Virus Strains with 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.
• 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.
• 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 ]
  A positive result for influenza infection by viral culture is needed, following a positive result for influenza infection by RT-PCR.
• 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 ]
  A positive result for influenza infection by viral culture is needed, following a positive result for influenza infection by RT-PCR
• 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 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults 50 Years Old and Older
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Seasonal Influenza

Intervention

• Biological: mRNA-1010
  Sterile liquid for injection
  Other Name: Seasonal influenza vaccine
• Biological: Licensed quadrivalent inactivated seasonal influenza vaccine
  Sterile suspension for injection.
  Other Name: Fluarix Tetra

Study Arms

• Experimental: mRNA-1010
  Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.
  Intervention: Biological: mRNA-1010
• 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.
  Intervention: Biological: Licensed quadrivalent inactivated seasonal influenza vaccine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 31, 2023): 22510
• Original Estimated Enrollment (submitted: September 30, 2022): 23000
• Actual Study Completion Date: January 5, 2024
• Actual Primary Completion Date: January 5, 2024 (Final data collection date for primary outcome measure)

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 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Bulgaria, Canada, Denmark, Estonia, Germany, Netherlands, Poland, Spain, Taiwan, United Kingdom, United States

Administrative Information

• NCT Number: NCT05566639
• Other Study ID Numbers: mRNA-1010-P302; 2022-001638-12 ( EudraCT Number )
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: ModernaTX, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: ModernaTX, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: ModernaTX, Inc.
• Verification Date: January 2024