A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults

• ClinicalTrials.gov Identifier: NCT05415462
• Recruitment Status: Active, not recruiting
• First Posted: June 13, 2022
• Last Update Posted: September 21, 2022
• Sponsor: ModernaTX, Inc.
• Information provided by (Responsible Party): ModernaTX, Inc.

Tracking Information

• First Submitted Date: June 8, 2022
• First Posted Date: June 13, 2022
• Last Update Posted Date: September 21, 2022
• Actual Study Start Date: June 6, 2022
• Estimated Primary Completion Date: August 22, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 23, 2022)

• Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay [ Time Frame: Day 29 ]
• Percentage of Participants Reaching Seroconversion, as Measured by HAI Assay [ Time Frame: Day 29 ]
  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.
• 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 ]

Original Primary Outcome Measures (submitted: June 8, 2022)

• Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay [ Time Frame: Day 29 ]
• Percentage of Participants Reaching Seroconversion, as Measured by HAI Assay [ Time Frame: Day 29 ]
  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.
• 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) [ Time Frame: Day 1 through Day 361 ]

Current Secondary Outcome Measures (submitted: August 23, 2022)

• Number of Participants With First Episode of Reverse Transcription Polymerase Chain Reaction (RT-PCR)-Confirmed Protocol-Defined Influenza-Like Illness (ILI) [ Time Frame: 14 days post-vaccination through Day 181 ]
  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.
• Number of Participants With First Episode of RT-PCR Confirmed Centers for Disease Control and Prevention (CDC)-Defined ILI [ Time Frame: 14 days post-vaccination through Day 181 ]
  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.
• 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 [ Time Frame: 14 days post-vaccination through Day 181 ]
  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.
• Percentage of Participants With HAI Titer ≥ 1:40 at Day 29 [ Time Frame: Day 29 ]
• Change From Baseline in Geometric Mean Fold Rise (GMFR) as Measured by HAI Assays [ Time Frame: Baseline, Up to Day 29 ]

Original Secondary Outcome Measures (submitted: June 8, 2022)

• Number of Participants With Reverse Transcription Polymerase Chain Reaction (RT-PCR)-Confirmed Protocol-Defined Influenza-Like Illness (ILI) [ Time Frame: 14 days post-vaccination through Day 361 ]
  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.
• Number of Participants With Centers for Disease Control and Prevention (CDC)-Defined ILI [ Time Frame: 14 days post-vaccination through Day 361 ]
  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.
• Number of Participants With RT-PCR-Confirmed Protocol-Defined ILI in Participants Aged 50 Years and Older or 65 Years and Older [ Time Frame: 14 days post-vaccination through Day 361 ]
  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.
• Percentage of Participants With HAI Seroconversion at Day 29 [ Time Frame: Day 29 ]
• Percentage of Participants With HAI Titer ≥ 1:40 at Day 29 [ Time Frame: Day 29 ]
• Change From Baseline in Geometric Mean Fold Rise (GMFR) as Measured by HAI Assays [ Time Frame: Baseline, Up to Day 29 ]

• 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
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, 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: Active, not recruiting
• Estimated Enrollment (submitted: September 19, 2022): 6102
• Original Estimated Enrollment (submitted: June 8, 2022): 6000
• Estimated Study Completion Date: August 22, 2023
• Estimated Primary Completion Date: August 22, 2023 (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 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 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: Argentina, Australia, Colombia, Panama, Philippines

Administrative Information

• NCT Number: NCT05415462
• Other Study ID Numbers: mRNA-1010-P301
• 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: September 2022