At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 420 enrolled
Drug / intervention
H5N1 antigen combined with MF59 adjuvantbiological
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 Phase 2, Randomized, Observer-Blind, Multicenter Study to Evaluate the Immunogenicity and Safety of Several Doses of Antigen and MF59 Adjuvant Content in a Monovalent H5N1 Pandemic Influenza Vaccine in Healthy Pediatric Subjects 6 Months to < 9 Years of Age
In Brief
A Phase 2 clinical trial evaluating H5N1 antigen combined with MF59 adjuvant for Influenza, Human. Completed, enrolled 420 participants across 7 sites in 2 countries.
Detailed Summary
This study is a pediatric dose-ranging study to evaluate the safety and immunogenicity of vaccination with different MF59-adjuvanted H5N1 vaccine formulations.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza, Human
CountriesEstonia, Philippines
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedDec 2020
Enrollment StartDec 2020
Primary CompletionApr 2022
TodayJul 2026
First PostedDec 17, 2020
Enrollment StartDec 19, 2020
Primary CompletionApr 15, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 5.5 years ago
Interventions
H5N1 antigen combined with MF59 adjuvantbiological
Eligible subjects will be stratified by age at the time of enrollment into one of 2 age cohorts and within each age cohort will be randomly assigned (equally) to 1 of 6 study vaccine groups. Subjects in each study vaccine group will be scheduled to receive 2 injections of aH5N1 vaccine 3 weeks apart