At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 162 enrolled
Drug / intervention
15 µg HA/strain and 1% Endocine™ +5 morebiological
Likely dose
15 µg HA/strain and 1% Endocine™from 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 I/II, Randomised, Placebo-controlled, Partially-blinded, Parallel-group Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU
In Brief
A Phase 2 clinical trial evaluating 15 µg HA/strain and 1% Endocine™, 15 µg HA/strain and 2% Endocine™, and 4 other interventions for Influenza, Human. Completed, enrolled 162 participants across 2 sites.
Detailed Summary
The main purpose of the this study is to evaluate the safety and tolerability of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigen.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza, Human
CountriesSweden
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartSep 2016
First PostedDec 2016
Primary CompletionJun 2017
TodayJul 2026
First PostedDec 21, 2016
Enrollment StartSep 1, 2016
Primary CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 9.5 years ago
Interventions
15 µg HA/strain and 1% Endocine™biological
intranasal administration
15 µg HA/strain and 2% Endocine™biological
intranasal administration
15 µg HA/strainbiological
intranasal administration
intramuscular comparatorbiological
intramuscular administration
intranasal comparatorbiological
intranasal administration
Placebo, Salinebiological
intranasal administration