Safety Study of FluMist With and Without Ampligen

NCT01591473 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2018-07-26

No results posted yet for this study

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

Placebo; 3 doses; nasal administration every 28 days

DRUG

FluMist

FluMist 0.2 ml; 3 doses; nasal administration every 28 days

Sponsors & Collaborators

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01591473 on ClinicalTrials.gov