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

  • STATUS
    Recruiting
  • End date
    Feb 9, 2022
  • participants needed
    180
  • sponsor
    ModernaTX, Inc.
Updated on 23 July 2021

Summary

The primary objective of this study is to evaluate the safety and reactogenicity of 3 dose levels of mRNA-1010 vaccine administered as a single dose.

Details
Condition Seasonal Influenza
Treatment Placebo, mRNA-1010
Clinical Study IdentifierNCT04956575
SponsorModernaTX, Inc.
Last Modified on23 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participant is in good health, in the opinion of the Investigator, based on review of medical history and physical examination performed at screening
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 (Day 0)
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

Exclusion Criteria

Participant has had significant exposure to someone with laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, COVID-19, or influenza in the past 14 days prior to the Screening Visit (Day 0), 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 (Day 0)
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 (Day 0) 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
Other inclusion/exclusion criteria may apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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