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New treatment option for Influenza
Official title A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults
ClinicalTrials.gov ID: NCT07496450
What this study is testing
What is mRNA-1018-H5?
mRNA-1018-H5 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for influenza.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Healthy as determined by medical evaluation including medical history; and physical examination. Participants with clinically stable chronic medical...
- Participants who are assigned female at birth or could become pregnant are eligible to participate if the participant is not pregnant or breast/chest...
- 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
You likely can't join if
- 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...
- 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.
See the full eligibility 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
- 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...
- 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...
- 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...
- 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...
- Participant has participated in an treatment 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...
The study team makes the final eligibility decision.
Where it's taking place
- San Bernardino, California, United States
- Savannah, Georgia, United States
- Meridian, Idaho, United States
- Rockville, Maryland, United States
- Omaha, Nebraska, United States
- Beachwood, Ohio, United States
- East Greenwich, Rhode Island, United States
- Anderson, South Carolina, United States
- Dallas, Texas, United States
- Suffolk, Virginia, United States
- Bristol, Bristol (Unitary Authority), United Kingdom
- High Wycombe, Buckinghamshire, United Kingdom
- Peterborough, Cambridgeshire, United Kingdom
- Stockton-on-Tees, County Durham, United Kingdom
- Bournemouth, Dorset, United Kingdom
- Weymouth, Dorset, United Kingdom
- Glasgow, Glasgow City (Scotland), United Kingdom
- Enfield, Greater London, United Kingdom
- Hounslow, Greater London, United Kingdom
- London, Greater London, United Kingdom
+ 15 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Bernardino, California, United States; Savannah, Georgia, United States; Meridian, Idaho, United States; Rockville, Maryland, United States; Omaha, Nebraska, United States; Beachwood, Ohio, United States and 29 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.