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A Study Evaluating the Safety and Tolerability of a Seasonal Influenza Vaccine Containing LIQ001

NCT01224262 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2013-03-01

No results posted yet for this study

Summary

This study is designed to evaluate the safety, tolerability, and immune response of LIQ001 mixed with a commercially available seasonal influenza vaccine (Fluzone) in two populations of subjects; healthy adult subjects 18 to 49 years of age and healthy elderly subjects 65 years of age or older.

Conditions

Interventions

BIOLOGICAL

Fluzone® (2010/2011 Inactivated Trivalent Influenza Vaccine)

A single vaccination of Fluzone alone

BIOLOGICAL

LIQ001 (0.45mg)

A single vaccination of 0.45 mg LIQ001

BIOLOGICAL

LIQ001 (1.8mg)

A single vaccination of 1.8 mg LIQ001

Sponsors & Collaborators

  • Accelovance

    collaborator INDUSTRY

  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER

  • Liquidia Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Frank Malinoski, MD, PhD · Liquidia Technologies, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01224262 on ClinicalTrials.gov