Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • mRNA-1018-H5

    Biological/Vaccine

    Sterile liquid for injection.

  • Placebo

    Biological/Vaccine

    Sterile liquid for injection.

Treatment groups

4,000 Participants
are divided into 2 treatment groups
Group A: mRNA-1018-H5 VaccineExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Participants With Hemagglutination Inhibition (HAI) Titer ≥ 1:40 at Day 43

HAI Titer \>=1:40.

Time frame
Day 43
2

Percentage of Participants With Seroconversion at Day 43, as Measured by HAI Assay

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.

Time frame
Day 43
3

Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)

Time frame
Up to Day 29 (7 days after each injection)
4

Number of Participants with Unsolicited Adverse Events (AEs)

Time frame
Up to Day 50 (28 days after each injection)

Secondary outcomes

1

Geometric Mean Titer (GMT) of Anti-H5N1 Antibodies at Day 43, as Measured by Microneutralization (MN) Assay

Time frame
Day 43
2

GMT of HAI Antibodies at Days 22 and 205, as Measured by HAI Assay

Time frame
Days 22 and 205
3

GMT of HAI Antibodies at Days 22 and 205, as Measured by MN Assay

Time frame
Days 22 and 205
4

Percentage of Participants with HAI Titers at Different Cut-Offs

Cutoff included \>= 1:80.

Time frame
Up to Day 205

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ModernaTX, Inc.

Lead sponsor

Source ClinicalTrials.gov
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