At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 662 enrolled
Drug / intervention
Adjuvanted H5N1 pandemic influenza vaccinebiological
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 II, Randomized, Observer-Blind, Multi-Center, Study to Evaluate Safety, Tolerability and Immunogenicity of an Adjuvanted Cell Culture-Derived H5N1 Subunit Influenza Virus Vaccine at Two Different Formulations in Healthy Pediatric Subjects.
In Brief
A Phase 2 clinical trial evaluating Adjuvanted H5N1 pandemic influenza vaccine for Pandemic H5N1 Influenza. Completed, enrolled 662 participants across 12 sites in 2 countries.
Detailed Summary
Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived influenza vaccine in children.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPandemic H5N1 Influenza
CountriesThailand, United States
CollaboratorsDepartment of Health and Human Services
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2013
First PostedJan 2013
Primary CompletionJun 2013
Study CompletionJun 2014
TodayJul 2026
First PostedJan 28, 2013
Enrollment StartJan 1, 2013
Primary CompletionJun 1, 2013
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 13.4 years ago
Interventions
Adjuvanted H5N1 pandemic influenza vaccinebiological
Comparison of two doses of aH5N1c vaccine