Clinical Trials in the USA / NCT07496450
Active, not recruiting
Phase 3
A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults
NCT07496450 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Influenza
Investigational drug(s) / intervention(s)
mRNA-1018-H5Placebo
mRNA-1018-H5: Sterile liquid for injection.
Placebo: Sterile liquid for injection.
Study summary
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
Key Inclusion Criteria:
* Healthy as determined by medical evaluation including medical history; and physical examination. Participants with clinically stable chronic medical conditions are permitted.
* Participants who are assigned female at birth or could become pregnant are eligible to participate if the participant is not pregnant or breast/chest feeding, and one of the following conditions applies:
* 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.
Key Exclusion Criteria:
* 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.
* Treated with antiviral therapies for influenza (eg, Tamiflu, Xofluza) within 28 days prior to Day 1.
* Prior receipt of a pandemic influenza vaccine or participation in any pandemic influenza vaccine clinical study, including the mRNA-1018-P101 study.
* Any medical, psychiatric, or occupational condition, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with adherence to study procedures or the interpretation of study results.
* Participant has received systemic immunosuppressants including long-acting biological therapies that affect immune responses (eg, infliximab, methotrexate, omalizumab, etc.), within 180 days prior to Screening or plans to do so at any time during participation in the study.
* Participant has received corticosteroids at ≥10 mg/day of prednisone or equivalent for \>14 days in total within 90 days prior to Day 1 (Baseline) or is anticipating the need for corticosteroids at any time during the study.
* Participants has received any licensed vaccine authorized or approved by local health agency including mRNA vaccine ≤28 days prior to study intervention (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 21 days after the study intervention.
* Participant has participated in an interventional clinical study within 90 days prior to the Screening visit based on the medical history interview or plans to do so while participating in this study.
Note: Other inclusion/exclusion criteria may apply.
Primary outcome measure(s)
- Percentage of Participants With Hemagglutination Inhibition (HAI) Titer ≥ 1:40 at Day 43 — Day 43
HAI Titer \>=1:40. - Percentage of Participants With Seroconversion at Day 43, as Measured by HAI Assay — Day 43
Seroconversion is defined as a Day 43 titer ≥1:40 if baseline is \<1:10 or a 4-fold or greater rise if baseline is ≥1:10 in HAI titer measured by HAI assay. - Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) — Up to Day 29 (7 days after each injection)
- Number of Participants with Unsolicited Adverse Events (AEs) — Up to Day 50 (28 days after each injection)
- Number of Participants with AEs Leading to Discontinuation, Medically-attended AEs (MAAEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) — Day 1 to Day 205
Trial sites (35)
| Facility | City | Region | Status |
|---|---|---|---|
| Velocity Clinical Research, San Bernardino | San Bernardino | California | |
| Velocity Clinical Research, Savannah | Savannah | Georgia | |
| Velocity Clinical Research, Boise | Meridian | Idaho | |
| Velocity Clinical Research, Rockville | Rockville | Maryland | |
| Velocity Clinical Research, Omaha | Omaha | Nebraska | |
| Velocity Clinical Research, Cleveland | Beachwood | Ohio | |
| Velocity Clinical Research, Providence | East Greenwich | Rhode Island | |
| Velocity Clinical Research, Anderson | Anderson | South Carolina | |
| Velocity Clinical Research, Dallas | Dallas | Texas | |
| Velocity Clinical Research, Suffolk | Suffolk | Virginia | |
| Velocity Clinical Research-Bristol | Bristol | Bristol (Unitary Authority) | |
| Velocity Clinical Research - High Wycombe | High Wycombe | Buckinghamshire | |
| Wansford Research Ltd | Peterborough | Cambridgeshire | |
| Futuremeds Teesside Middlefield Centre University Hospital of North Tees | Stockton-on-Tees | County Durham | |
| NIHR Wessex CRDC - Bournemouth Research Hub (Under University Hospital Southampton NHS Foundation Trust) | Bournemouth | Dorset | |
| NIHR Wessex CRDC - Weymouth Research Hub (Under University Hospital Southampton NHS Foundation Trust) | Weymouth | Dorset | |
| Panthera Glasgow | Glasgow | Glasgow City (Scotland) | |
| Panthera Enfield | Enfield | Greater London | |
| Hounslow Medical Centre | Hounslow | Greater London | |
| hVIVO Services Limited | London | Greater London | |
| Velocity Clinical Research-North London | London | Greater London | |
| Accellacare North London | Northwood | Greater London | |
| Accellacare South London | Orpington | Greater London | |
| Velocity Clinical Research-Romford | Romford | Greater London | |
| Panthera Rochdale | Rochdale | Greater Manchester | |
| NIHR Wessex CRDC - Southampton Research Hub (Under University Hospital Southampton NHS FT) | Southampton | Hampshire | |
| Fylde Coast Clinical Research at Layton Medical Centre | Blackpool | Lancashire | |
| FutureMeds Liverpool | Metropolitan Borough of Wirral | Merseyside | |
| Lakeside Healthcare | Corby | North Northamptonshire | |
| Panthera York | York | North Yorkshire | |
| The University of Nottingham Health Service | Nottingham | Nottinghamshire | |
| Panthera Sheffield | Sheffield | South Yorkshire | |
| Accellacare Warwickshire | Coventry | West Midlands (Coventry) | |
| FutureMeds Birmingham Soho Road Health Centre | Birmingham | West Midlands | |
| Accellacare Yorkshire | Shipley | West Yorkshire |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07496450 on ClinicalTrials.gov ↗ ← All trials in the USA