Safety Study of FluMist With and Without Ampligen
NCT01591473 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 55
Last updated 2018-07-26
Summary
The purpose of this study is to evaluate FluMist with and without Ampligen in healthy volunteers.
Conditions
- Influenza, Human
Interventions
- DRUG
-
Poly I:Poly C12U 50 ug
Poly I:Poly C12U 50 ug; 3 doses; nasal administration every 28 days
- DRUG
-
Poly I:Poly C12U 200 ug
Poly I:Poly C12U 200 ug; 3 doses; nasal administration every 28 days
- DRUG
-
Poly I:Poly C12U 500 ug
Poly I:Poly C12U 500 ug; 3 doses; nasal administration every 28 days
- DRUG
-
Poly I:Poly C12U 1250 ug
Poly I:Poly C12U 1250 ug; 3 doses; nasal administration every 28 days
- DRUG
-
Placebo; 3 doses; nasal administration every 28 days
- DRUG
-
FluMist
FluMist 0.2 ml; 3 doses; nasal administration every 28 days
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
David R Strayer, MD · AIM ImmunoTech Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 49 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-04-30
- Primary Completion
- 2014-09-30
- Completion
- 2015-08-31
Countries
- United States
Study Locations
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