A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults

Part of paid clinical trials in San Bernardino, California.

Sponsor
ModernaTX, Inc.
Study ID
NCT07496450
Phase
PHASE3
Status
Recruiting
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Conditions

  • Influenza

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • mRNA-1018-H5 — BIOLOGICAL
    Sterile liquid for injection.
  • Placebo — BIOLOGICAL
    Sterile liquid for injection.

Study Details

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.

Key Dates

Start date
Mar 23, 2026
Status verified
Mar 2026
Primary completion
Jan 28, 2027
Completion
Jan 28, 2027

Study Design

Enrollment
4,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: mRNA-1018-H5 Vaccine
    Participants will receive mRNA-1018-H5 vaccine by intramuscular (IM) injection on Day 1 and Day 22.
  • Placebo Comparator: Placebo
    Participants will receive placebo matched to mRNA-1018-H5 vaccine by IM injection on Day 1 and Day 22.

Primary Outcome Measure

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

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Velocity Clinical Research, San BernardinoSan BernardinoCalifornia92408-
Velocity Clinical Research, SavannahSavannahGeorgia31406-
Velocity Clinical Research, BoiseMeridianIdaho83642-
Velocity Clinical Research, RockvilleRockvilleMaryland20854-
Velocity Clinical Research, OmahaOmahaNebraska68134-
Velocity Clinical Research, ClevelandBeachwoodOhio44122-
Velocity Clinical Research, ProvidenceEast GreenwichRhode Island02818-
Velocity Clinical Research, AndersonAndersonSouth Carolina29621-
Velocity Clinical Research, DallasDallasTexas75230-
Velocity Clinical Research, SuffolkSuffolkVirginia23435-

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