At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 353 enrolled
Drug / intervention
Reverse Genetic (RG) reassortant A/H9N2 influenza vaccinebiological
Likely dose
Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine 3.75 µgfrom 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, Multi-center, Phase 1/2 Study to Assess Safety and Immunogenicity of Five Dose Levels of a Reverse Genetic (RG) Reassortant H9N2 Pandemic Influenza Vaccine in Healthy Subjects Aged 18 to 49 Years
In Brief
A Phase 2 clinical trial evaluating Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine for Influenza. Completed, enrolled 353 participants across 5 sites.
Detailed Summary
The purpose of the study is to identify the optimal dose level of a reverse genetic (RG) reassortant H9N2 pandemic influenza vaccine for further product development.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2011
First PostedMar 2011
Primary CompletionJun 2011
Study CompletionMay 2012
TodayJul 2026
First PostedMar 22, 2011
Enrollment StartMar 1, 2011
Primary CompletionJun 1, 2011
Study CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 15.3 years ago
Interventions
Reverse Genetic (RG) reassortant A/H9N2 influenza vaccinebiological
Two intramuscular vaccinations; 5 dose groups: 3.75 µg, 7.5 µg, 15 µg, 30 µg or 45 µg HA antigen (strain A/H9N2/chicken/Hong Kong/G9/97; non-adjuvanted formulation