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Study of mRNA-1010 Seasonal Influenza Vaccine in Adults (IGNITE P303)

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: NCT05827978
Recruitment Status : Active, not recruiting
First Posted : April 25, 2023
Last Update Posted : February 13, 2024
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Tracking Information
First Submitted Date  ICMJE April 13, 2023
First Posted Date  ICMJE April 25, 2023
Last Update Posted Date February 13, 2024
Actual Study Start Date  ICMJE April 17, 2023
Estimated Primary Completion Date June 24, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2024)
  • Geometric Mean Titer (GMT) of Serum Antibody Level as Measured by Hemagglutination Inhibition (HAI) Assay at Day 29 [ 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 Participants with Solicited Local and Systemic 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 Medically-Attended AEs (MAAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs), and AEs Leading to Discontinuation [ Time Frame: Day 1 through Day 181 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 13, 2023)
  • Geometric Mean Titer (GMT) of Serum Antibody Level as Measured by Hemagglutination Inhibition (HAI) Assay at Day 29 [ 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 Participants with Solicited Local and Systemic 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 Medically-Attended AEs (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation from Study Participation [ Time Frame: Day 1 through Day 181 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2023)
  • Percentage of Participants with HAI Titer of ≥1:40 at Day 29 [ Time Frame: Day 29 ]
  • Change From Baseline in Geometric Mean Fold-Rise (GMFR) as Measured by HAI Assay at Day 29 [ Time Frame: Baseline (Day 1), Day 29 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of mRNA-1010 Seasonal Influenza Vaccine in Adults
Official Title  ICMJE A Phase 3, Randomized, Stratified, Observer-Blind, Active-Controlled Study to Evaluate the Immunogenicity, Reactogenicity and Safety of mRNA-1010 Seasonal Influenza Vaccine in Adults 18 Years and Older
Brief Summary This study includes 3 parts: Parts A, B, and C. The purpose of this study is to evaluate the immunogenicity and safety of mRNA-1010 seasonal influenza vaccine in adults.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Seasonal Influenza
Intervention  ICMJE
  • 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 Quadrivalent
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 20, 2023)
8400
Original Estimated Enrollment  ICMJE
 (submitted: April 13, 2023)
2400
Estimated Study Completion Date  ICMJE June 24, 2024
Estimated Primary Completion Date June 24, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 assigned females at birth and 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.

Part A:

  • At least 18 years of age inclusive, at the time of signing the informed consent form (ICF).

Part B:

  • At least 18 and <65 years of age, at the time of signing the ICF.

Part C:

  • At least 65 years of age or older, at the time of signing the ICF.

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 Day 1.
  • 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, immunosuppressive condition or immune-mediated disease, asplenia, or recurrent severe infections.
  • Participant has tested positive for influenza by local health authority-approved testing methods within 150 days (for Part A) or 180 days (for Parts B and C) prior to Day 1.
  • Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of mRNA vaccines or any components of the mRNA-1010 or influenza vaccines, including egg protein.
  • Participant has received systemic immunosuppressants for >14 days in total within 180 days prior to Day 1 (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. Intra-articular and epidural steroid injections are not allowed within 28 days before and/or after study intervention dosing.
  • Participant has received any vaccine authorized or approved by local health agency ≤28 days prior to study intervention dosing (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 28 days before or after study intervention dosing.
  • Participant has received a licensed seasonal influenza vaccine within 5 months (150 days) (for part A) or within 6 months (180 days) (for Parts B and C) prior to Day 1.
  • Participant has participated in any investigational seasonal influenza vaccine study within12 months prior to Day 1.
  • Participant is not aware whether they have received an influenza vaccine in the most recent influenza season (in the prior 12 months) (for Part A) or since September 2022 (for Parts B and C).
  • Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to Day 1 or plans to donate blood products during the study.

Note: Other inclusion and exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05827978
Other Study ID Numbers  ICMJE mRNA-1010-P303
Has Data Monitoring Committee No
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  ICMJE Not Provided
Current Responsible Party ModernaTX, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE ModernaTX, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ModernaTX, Inc.
Verification Date February 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP