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Open-label Study to Assess Immunogenicity and Safety of a Vaccine Enhancement Patch When Administered With 2 Doses of H5N1 Vaccine

NCT01353534 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2012-10-18

No results posted yet for this study

Summary

Groups 1 to 3 will receive two vaccinations on Day 0 and Day 21. Group 1 will receive 3.8µg A/H5N1 antigen formulated with AS03 adjuvant, administered by IM injection. Group 2 will receive 15µg A/H5N1 by IM alone. Group 3 will also receive 15µg A/H5N1 antigen administered IM but followed by the topical application of a VEP at the vaccination site. Group 4 will receive a single vaccination on Day 0 of 30µg A/H5N1antigen by IM, followed by application of a VEP at the vaccination site.

The VEP (Vaccine Enhancement Patch) contains 50 mcg LT (heat-labile enterotoxin of E. coli)

Conditions

  • Healthy

Interventions

BIOLOGICAL

A/H5N1 Antigen

A/H5N1 Antigen

DRUG

Vaccine Enhancement Patch

Vaccine Enhancement Patch

Sponsors & Collaborators

  • Intercell USA, Inc.

    lead INDUSTRY

Principal Investigators

  • Bernd Jilma, MD · Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2011-12-31
Completion
2012-10-31

Countries

  • Austria
  • Belgium

Study Locations

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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 NCT01353534 on ClinicalTrials.gov