A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults
ConditionInfluenza
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorModernaTX, Inc.
About this trial
The purpose of this study is to evaluate humoral immunogenicity after 2 doses of mRNA-1018-H5, and to evaluate the safety and reactogenicity of mRNA-1018-H5 in adults ≥18 years of age.
Eligibility criteria
Qualifiers
Healthy as determined by medical evaluation including medical history; and physical examination. Participants with clinically stable chronic medical conditions are permitted.
Is a person of nonchildbearing potential (PONCBP) OR
Is a person of childbearing potential (POCBP)
A POCBP must have a negative highly sensitive pregnancy test at Screening and on the day of the first dose of study intervention.
Disqualifiers
Participant is acutely ill or febrile (body temperature ≥ 38.0 degrees Celsius [°C]/100.4 degrees Fahrenheit [°F]) within 72 hours prior to or at the Screening Visit or Day 1.
History of myocarditis, pericarditis, or myopericarditis.
History of Guillain-Barre syndrome.
Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections disease.
Trial design
Treatments tested in this trial
- mRNA-1018-H5
- Placebo
Treatment groups
4,000 Participants
are divided into 2 treatment groupsLocations
36United Kingdom
Bristol (Unitary Authority)
Velocity Clinical Research-BristolBS8 2RA, Bristol United Kingdom
Buckinghamshire
Velocity Clinical Research - High WycombeHP11 2QW, High Wycombe United Kingdom
Cambridgeshire
Wansford Research LtdPE8 6PL, Peterborough United Kingdom
County Durham
Futuremeds Teesside Middlefield Centre University Hospital of North TeesTS19 8PE, Stockton-on-Tees United Kingdom
Sponsors and collaborators
ModernaTX, Inc.
Lead sponsor
Source ClinicalTrials.gov