Status:
COMPLETED
Safety, Tolerability, and Immunogenicity of VAL-339851 in Healthy Adult Subjects
Lead Sponsor:
ModernaTX, Inc.
Conditions:
Influenza
Eligibility:
All Genders
18-49 years
Phase:
PHASE1
Brief Summary
This clinical study will assess the safety, tolerability and immunogenicity of VAL-339851 in healthy subjects.
Eligibility Criteria
Inclusion
- Agrees to comply with the study procedures and provides written informed consent
- 18 to 49 years of age
- Body mass index between 18 and 35 kg/m2
- Negative urine pregnancy test at the Screening visit and the day of each vaccination for females of childbearing potential.
- Female subjects must either be of non-childbearing potential or use acceptable methods of contraception from at least 3 weeks prior to enrollment and through the end of study visit
- In good health based on medical history, physical examination, vital sign measurements and laboratory safety tests performed prior to initial study vaccination
- Has access to a consistent and reliable means of telephone contact and agrees to stay in contact with the study site for the duration of the study
Exclusion
- Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care
- Administration of another investigational product within 60 days, or 5 half-lives, whichever is longer
- Participation in an investigational study involving lipid nanoparticles
- A history of hypersensitivity or serious reactions to previous influenza vaccinations
- History of Guillain-Barré Syndrome within 6 weeks following a previous influenza vaccine
- History of narcolepsy
- Administration of any licensed (inactivated or live) vaccines within 4 weeks before enrollment or plans to receive any vaccine within 12 weeks of the last study drug administration; receipt of any other avian H7N9 influenza vaccine at any time prior to or during the study is exclusionary
- Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination.
- Any chronic administration of immunosuppressant or other immune-modifying drugs within 6 months prior to administration of study vaccine
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
- Any acute disease at the time of enrollment
- Any significant disorder of coagulation requiring ongoing or intermittent treatment
- Active neoplastic disease or a history of any hematologic malignancy
- History of alcohol abuse or drug addiction within 1 year before the planned day of dose administration
- A positive test result for drugs of abuse or alcohol at screening or before the first dose administration
- Persons employed in a capacity that involves handling poultry or wild birds.
- The subject has any abnormality or permanent body art (eg, tattoo) that, in the opinion of the investigator, would obstruct the ability to observe local reactions at the injection site
- Any condition, that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of the study results
- A positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at screening
- Donation of blood or blood products \> 450 mL within 30 days of dosing
Key Trial Info
Start Date :
May 11 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 13 2018
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT03345043
Start Date
May 11 2016
End Date
August 13 2018
Last Update
January 11 2021
Active Locations (1)
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1
Miami Research Associates
Miami, Florida, United States, 33143