At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 170 enrolled
Drug / intervention
INFLUENZA G1 mHA +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled, First-in-human Phase 1/2a Study to Evaluate Safety, Reactogenicity and Immunogenicity of a Universal Influenza (Uniflu) Vaccine With INFLUENZA G1 mHA in Healthy Adults
In Brief
A Phase 2 clinical trial evaluating INFLUENZA G1 mHA, Placebo, and 1 other intervention for Influenza Prevention. Completed, enrolled 170 participants across 4 sites.
Detailed Summary
The primary purpose of this study is to evaluate safety/ reactogenicity of INFLUENZA G1 mini-hemagglutinin stem-derived protein vaccine antigen (mHA), with or without Al(OH)3 adjuvant, in healthy adults greater than or equal to (\>=) 18 to less than or equal to (\<=) 45 years of age.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza Prevention
CountriesUnited States
Timeline
Phase 2CompletedFinished
202420252026
Enrollment StartMay 2023
First PostedJun 2023
Primary CompletionAug 2024
TodayJul 2026
First PostedJun 13, 2023
Enrollment StartMay 17, 2023
Primary CompletionAug 19, 2024
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 3.1 years ago
Interventions
INFLUENZA G1 mHAbiological
INFLUENZA G1 mHA will be administered intramuscularly.
Placebobiological
Placebo will be administered intramuscularly.
Al(OH)3biological
Al(OH)3 will be administered intramuscularly.