A Phase I/II, Two-Staged, Single-Center, Randomized, Double-Blind, Antibody Titer Study to Assess Immunogenicity and Safety of FluMist Intranasal Influenza Vaccine Administered With and Without a TLR-3 Agonist, Ampligen
Phase of Trial: Phase I/II
Latest Information Update: 14 Aug 2017
At a glance
- Drugs Rintatolimod (Primary) ; Influenza virus vaccine live
- Indications Influenza A virus H5N1 subtype
- Focus Adverse reactions
- Sponsors Hemispherx Biopharma
- 14 Aug 2017 According to a Hemispherx Biopharma media release, this trial was closed previously but full data analysis awaited the FDAs evaluation of preliminary reports of blinded study findings. That evaluation was completed after formal notification from the FDA on August 9, 2017.
- 22 Feb 2017 Status changed from active, no longer recruiting to discontinued.
- 03 Aug 2016 Planned End Date changed from 1 Jun 2017 to 1 Jun 2018.