At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 330 enrolled
Drug / intervention
NanoFlu +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 Phase 1/2, Randomized, Observer-Blinded, Active-Controlled Trials to Evaluate the Safety and Immunogenicity of a Recombinant Trivalent Nanoparticle Influenza Vaccine With Matrix-M1 Adjuvant (NanoFlu) in Healthy Older Adults
In Brief
A Phase 2 clinical trial evaluating NanoFlu, Fluzone HD - Day 0, and 2 other interventions for Influenza. Completed, enrolled 330 participants across 3 sites.
Detailed Summary
This was a Phase 1/2, randomized, observer-blinded, active-controlled trial to assess the Safety and Tolerability of a Recombinant Trivalent Nanoparticle Influenza Vaccine (Tri-NIV) with Matrix M1™ Adjuvant in Healthy Older Adults ≥ 60 Years of Age
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
Enrollment StartSep 2017
First PostedSep 2017
Primary CompletionMar 2018
Study CompletionOct 2018
TodayJul 2026
First PostedSep 26, 2017
Enrollment StartSep 18, 2017
Primary CompletionMar 14, 2018
Study CompletionOct 29, 2018
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 8.8 years ago
Interventions
NanoFlubiological
Vaccine
Fluzone HD - Day 0biological
Vaccine
Fluzone HD - Day 21biological
Vaccine
Saline - Day 21other
Placebo