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A/H5N1/LT Dose Ranging Study

NCT00908687 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2021-12-10

Study results available
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Summary

This is a Phase 2, randomized, blinded, clinical trial. Up to 500 eligible subjects will be enrolled and randomized in a 1:2:2:1:2:2 ratio into one of six groups, and vaccinated in this study. Subjects will receive an intramuscular injection of the influenza A/H5N1 (low or high dose) on Day 0 with or without a patch (low or high dose).

Conditions

  • Pandemic Influenza

Interventions

BIOLOGICAL

A/H5N1

A/H5N1 Low Dose

BIOLOGICAL

A/H5N1

A/H5N1 High Dose

BIOLOGICAL

LT Adjuvant Patch

LT Adjuvant Patch Low Dose

BIOLOGICAL

LT Adjuvant Patch

LT Adjuvant Patch High Dose

Sponsors & Collaborators

Principal Investigators

  • Eric Sheldon, MD · Miami Research Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2010-01-31
Completion
2011-07-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00908687 on ClinicalTrials.gov