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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05827978
Recruitment Status : Recruiting
First Posted : April 25, 2023
Last Update Posted : November 22, 2023
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Study Description
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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.

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)
Estimated Enrollment : 8400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 17, 2023
Estimated Primary Completion Date : July 10, 2024
Estimated Study Completion Date : July 10, 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 Quadrivalent


Outcome Measures
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Primary Outcome Measures :
  1. Parts A and C: Geometric Mean Titer (GMT) of Serum Antibody Level as Measured by Hemagglutination Inhibition (HAI) Assay at Day 29 [ Time Frame: Day 29 ]
  2. Parts A and C: 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.

  3. Parts A, B, and C: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to Day 7 (7 days after vaccination) ]
  4. Parts A, B, and C: Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 28 (28 days after vaccination) ]
  5. Parts A, B, and C: Number of Participants with Medically-Attended AEs (MAAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs) [ Time Frame: Day 1 through Day 181 ]
  6. Part A: Number of Participants With AEs Leading to Discontinuation from Study Participation [ Time Frame: Day 1 through Day 181 ]

Secondary Outcome Measures :
  1. Parts A and C: Percentage of Participants with HAI Titer of ≥1:40 at Day 29 [ Time Frame: Day 29 ]
  2. Parts A and C: Change From Baseline in Geometric Mean Fold-Rise (GMFR) as Measured by HAI Assay at Day 29 [ Time Frame: Baseline (Day 1), Day 29 ]

Eligibility Criteria
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Ages Eligible for Study:   18 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 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.

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): NCT05827978


Contacts
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Contact: Moderna Clinical Trials Support Center 1-877-777-7187 clinicaltrials@modernatx.com

Locations
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Sponsors and Collaborators
ModernaTX, Inc.
More Information
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Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT05827978    
Other Study ID Numbers: mRNA-1010-P303
First Posted: April 25, 2023    Key Record Dates
Last Update Posted: November 22, 2023
Last Verified: November 2023

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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.:
mRNA-1010
Virus Diseases
Flu
 Influenza vaccine
Moderna
mRNA vaccine
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