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A Study of mRNA-1010 Seasonal Influenza Vaccine in Healthy Adults

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: NCT04956575
Recruitment Status : Recruiting
First Posted : July 9, 2021
Last Update Posted : April 14, 2022
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Brief Summary:
The study comprises 3 parts: Phase 1/2, Phase 2 Northern Hemisphere (NH), and Phase 2 extension. The primary objective of this study is to evaluate the safety, reactogenicity, and humoral immunogenicity of mRNA-1010 vaccine.

Condition or disease Intervention/treatment Phase
Seasonal Influenza Biological: mRNA-1010 Biological: Placebo Biological: Active Comparator Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 880 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 1/2, Randomized, Stratified, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 Seasonal Influenza Vaccine in Healthy Adults 18 Years and Older
Actual Study Start Date : July 6, 2021
Estimated Primary Completion Date : September 22, 2022
Estimated Study Completion Date : September 22, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arm Intervention/treatment
Experimental: Phase 1/2: mRNA-1010 Dose Level A
Participants will receive mRNA-1010 at dose level A by intramuscular (IM) injection on Day 1.
Biological: mRNA-1010
Sterile liquid for injection
Other Name: Seasonal influenza vaccine

Experimental: Phase 1/2: mRNA-1010 Dose Level B
Participants will receive mRNA-1010 at dose level B by IM injection on Day 1.
Biological: mRNA-1010
Sterile liquid for injection
Other Name: Seasonal influenza vaccine

Experimental: Phase 1/2: mRNA-1010 Dose Level C
Participants will receive mRNA-1010 at dose level C by IM injection on Day 1.
Biological: mRNA-1010
Sterile liquid for injection
Other Name: Seasonal influenza vaccine

Experimental: Phase 1/2: Placebo
Participants will receive placebo matching to mRNA-1010 by IM injection on Day 1.
Biological: Placebo
0.9% sodium chloride solution for injection

Active Comparator: Phase 2 NH: Active Comparator Dose Level A
Participants will receive active comparator at dose level A by IM injection on Day 1.
Biological: Active Comparator
0.5 milliliter (mL) intramuscular (IM) injection
Other Name: Licensed quadrivalent seasonal influenza

Experimental: Phase 2 NH: mRNA-1010 Dose Level D
Participants will receive mRNA-1010 at dose level D by IM injection on Day 1.
Biological: mRNA-1010
Sterile liquid for injection
Other Name: Seasonal influenza vaccine

Experimental: Phase 2 NH: mRNA-1010 Dose Level A
Participants will receive mRNA-1010 at dose level A by IM injection on Day 1.
Biological: mRNA-1010
Sterile liquid for injection
Other Name: Seasonal influenza vaccine

Experimental: Phase 2 NH: mRNA-1010 Dose Level B
Participants will receive mRNA-1010 at dose level B by IM injection on Day 1.
Biological: mRNA-1010
Sterile liquid for injection
Other Name: Seasonal influenza vaccine

Active Comparator: Phase 2 Extension: Active Comparator Dose Level A
Participants will receive active comparator at dose level A by IM injection on Day 1.
Biological: Active Comparator
0.5 milliliter (mL) intramuscular (IM) injection
Other Name: Licensed quadrivalent seasonal influenza

Experimental: Phase 2 Extension: mRNA-1010 Dose Level D
Participants will receive mRNA-1010 at dose level D by IM injection on Day 1.
Biological: mRNA-1010
Sterile liquid for injection
Other Name: Seasonal influenza vaccine

Experimental: Phase 2 Extension: mRNA-1010 Dose Level E
Participants will receive mRNA-1010 at dose level E by IM injection on Day 1.
Biological: mRNA-1010
Sterile liquid for injection
Other Name: Seasonal influenza vaccine

Experimental: Phase 2 Extension: mRNA-1010 Dose Level F
Participants will receive mRNA-1010 at dose level F by IM injection on Day 1.
Biological: mRNA-1010
Sterile liquid for injection
Other Name: Seasonal influenza vaccine




Primary Outcome Measures :
  1. Phase 1/2, Phase 2 NH, and Phase 2 Extension: Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) [ Time Frame: Up to Day 7 (7 days after vaccination) ]
  2. Phase 1/2, Phase 2 NH, and Phase 2 Extension: Number of Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 28 (28 days after vaccination) ]
  3. Phase 1/2, Phase 2 NH, and Phase 2 Extension: Number of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically Attended Adverse Events (MAAEs) [ Time Frame: Day 1 through Day 181 ]
  4. Phase 1/2, Phase 2 NH, and Phase 2 Extension: Change From Baseline in Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay [ Time Frame: Baseline (Day 1), Day 29 ]
  5. Phase 1/2: Change From Baseline in Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay [ Time Frame: Baseline (Day 1), Day 29 ]
  6. Phase 1/2, Phase 2 NH, and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay [ Time Frame: Baseline (Day 1) to Day 29 ]
    Seroconversion is defined as a Day 29 titer ≥1:40 if baseline is <1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA antibodies measured by HAI assay.


Secondary Outcome Measures :
  1. Phase 1/2: Change From Baseline in GMT of Anti-HA Antibodies at Days 8, 29, and 181, as Measured by HAI or Microneutralization (MN) Assays [ Time Frame: Baseline (Day 1), Days 8, 29, and 181 ]
  2. Phase 1/2: Change From Baseline in GMFR of Anti-HA Antibodies at Days 8, 29, and 181, as Measured by HAI or MN Assays [ Time Frame: Baseline (Day 1), Days 8, 29, and 181 ]
  3. Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Seroconversion at Day 29 [ Time Frame: Day 29 ]
  4. Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥ 1:40 at Day 29 [ Time Frame: Day 29 ]
  5. Phase 2 NH and Phase 2 Extension: Change From Baseline in GMFR as Measured by HAI Assays [ Time Frame: Baseline (Day 1) to Day 29 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Key Inclusion Criteria:

Phase 1/2:

  • Participant has a body mass index (BMI) of 18 kilograms (kg)/square meter (m^2) to 35 kg/m^2 (inclusive) at the Screening Visit.
  • Participant is in good health, in the opinion of the Investigator, based on review of medical history and physical examination performed at screening.
  • 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, agreement to continue adequate contraception through 3 months following vaccine administration, and not currently breastfeeding.

Phase 2 NH and Phase 2 Extension:

  • Participant is medically stable, in the opinion of the Investigator, based on review of medical history and physical examination performed at screening.
  • 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, agreement to continue adequate contraception through 3 months following vaccine administration, and not currently breastfeeding.

Key Exclusion Criteria:

Phase 1/2:

  • Participant has had significant exposure to someone with laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, COVID-19, or influenza-like illness (ILI) in the past 14 days prior to the Screening Visit, as defined by the United States Centers for Disease Control and Prevention (CDC) as close contact with someone who has COVID-19.
  • Participant has a positive SARS-CoV-2 reverse transcriptase polymerase chain reaction (RT-PCR) or antigen test in the past 10 days prior to the Screening Visit.
  • Participant is acutely ill or febrile (body temperature ≥ 38.0 degrees Celsius [°C]/100.4 degrees Fahrenheit [°F]) 72 hours prior to or at the Screening Visit or Day 1.
  • Participant has a pre-existing medical condition that is not stable, at the discretion of the Investigator.
  • Participant has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation or that could interfere with safety assessments or interpretation of results according to the Investigator's judgment.
  • Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening Visit (for corticosteroids ≥10 milligrams [mg]/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
  • Participant has received or plans to receive any licensed vaccine ≤28 days prior to the investigational product (IP) injection (Day 1) or plans to receive a licensed vaccine within 28 days after the IP injection, with the exception of vaccines authorized or approved for the prevention of COVID-19 (regardless of type of vaccine) that become available to participants during the study. Efforts should be made to space study vaccination and COVID-19 vaccination by at least 7 and preferably 14 days, but COVID-19 vaccination should not be delayed.
  • Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine after 01 January 2021.

Phase 2 NH:

  • Participant has had close contact to someone with SARS-CoV-2 infection or COVID-19 as defined by the CDC (CDC 2021a) in the past 14 days prior to the Screening Visit, unless the participant has been fully vaccinated for COVID-19.
  • Participant is acutely ill or febrile (body temperature ≥ 38.0°C/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 medical, psychiatric, occupational condition, or history of substance abuse that may pose additional risk as a result of participation or that could interfere with safety assessments or interpretation of results according to the Investigator's judgment.
  • Participant has a current or previous diagnosis of immunocompromising/immunosuppressive condition, immune mediated disease requiring immune-modifying therapy, asplenia, recurrent severe infections (human immunodeficiency virus [HIV] positive participants on antiretroviral therapy with cluster of differentiation [CD] 4 count ≥ 350 cells/mm3 and HIV RNA ≤ 500 copies/mL within the past 12 months are permitted).
  • Participant has received systemic immunosuppressants or immune-modifying drugs for > 14 days in total within 6 months prior to 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.
  • Participant has a history of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine or any of the components contained in the mRNA 1010 or the comparator vaccine, which is an egg-based influenza vaccine.
  • Participant has received or plans to receive any licensed vaccine ≤ 28 days prior to the IP injection (Day 1) or plans to receive a licensed vaccine within 28 days after the IP injection, with the exception of vaccines authorized or approved for the prevention of COVID-19 (regardless of type of vaccine) that become available to participants during the study. Efforts should be made to space study vaccination and COVID-19 vaccination by at least 7 and preferably 14 days, but COVID-19 vaccination should not be delayed.
  • Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine within 6 months prior to the Screening Visit.
  • Participant has tested positive for influenza by CDC-recommended testing methods within 6 months prior to the Screening Visit.
  • Participant has participated in an interventional clinical study within 28 days prior to the Screening Visit based on the medical history interview or plans to do so while participating in this study.

Phase 2 Extension:

  • Participant has had close contact to someone with SARS-CoV-2 infection or COVID-19 as defined by the CDC in the past 10 days prior to the Screening Visit.
  • Participant is acutely ill or febrile (body temperature ≥ 38.0°C/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 medical, psychiatric, occupational condition, or history of substance abuse that may pose additional risk as a result of participation or that could interfere with safety assessments or interpretation of results according to the Investigator's judgment.
  • Participant has a current or previous diagnosis of immunocompromising/immunosuppressive condition, immune-mediated disease requiring immune-modifying therapy, asplenia, recurrent severe infections (HIV-positive participants on antiretroviral therapy with CD 4 count ≥ 350 cells/mm^3 and HIV-RNA ≤ 500 copies/mL within the past 365 days are permitted).
  • Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 180 days prior to 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.
  • Participant has a history of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine or any of the components contained in the mRNA-1010 or the comparator vaccine, which is an egg-based influenza vaccine.
  • Participant has received or plans to receive any licensed vaccine ≤ 28 days prior to the IP injection (Day 1) or plans to receive a licensed vaccine within 28 days after the IP injection, with the exception of vaccines authorized or approved for the prevention of COVID-19 (regardless of type of vaccine) that become available to participants during the study. Efforts should be made to space study vaccination and COVID-19 vaccination by at least 7 and preferably 14 days, but COVID-19 vaccination should not be delayed.
  • Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine within 180 days prior to the randomization visit.
  • Participant had tested positive for influenza by CDC-recommended testing methods within 180 days prior to the Screening Visit.
  • Participant has participated in an interventional clinical study within 28 days prior to the Screening Visit based on the medical history interview or plans to do so while participating in this study.

Other inclusion/exclusion criteria may apply.


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): NCT04956575


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.
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Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT04956575    
Other Study ID Numbers: mRNA-1010-P101
First Posted: July 9, 2021    Key Record Dates
Last Update Posted: April 14, 2022
Last Verified: April 2022

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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.:
Influenza 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