At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 500 enrolled
Drug / intervention
A/H5N1 +3 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 Blinded, LT Dose-ranging Study to Assess the Immunogenicity and Safety of Different Doses of LT Adjuvant Patch Administered in Conjunction With Different Doses of Inactivated Influenza A/H5N1 Vaccine in Healthy Adults
In Brief
A Phase 2 clinical trial evaluating A/H5N1 and LT Adjuvant Patch for Pandemic Influenza. Completed, enrolled 500 participants across 6 sites.
Detailed Summary
This is a Phase 2, randomized, blinded, clinical trial. Up to 500 eligible subjects will be enrolled and randomized in a 1:2:2:1:2:2 ratio into one of six groups, and vaccinated in this study. Subjects will receive an intramuscular injection of the influenza A/H5N1 (low or high dose) on Day 0 with or without a patch (low or high dose).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPandemic Influenza
CountriesUnited States
CollaboratorsDepartment of Health and Human Services
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2009
First PostedMay 2009
Primary CompletionJan 2010
Study CompletionJul 2011
TodayJul 2026
First PostedMay 27, 2009
Enrollment StartMay 1, 2009
Primary CompletionJan 1, 2010
Study CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 17.1 years ago
Interventions
A/H5N1biological
A/H5N1 Low Dose
A/H5N1biological
A/H5N1 High Dose
LT Adjuvant Patchbiological
LT Adjuvant Patch Low Dose
LT Adjuvant Patchbiological
LT Adjuvant Patch High Dose