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Dose Finding Study of Single Dose GHB11L1 in Healthy Adults

NCT01078701 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2011-01-05

No results posted yet for this study

Summary

The purpose of this phase IIa trial is to evaluate the immunogenicity of a single dose of GHB11L1 administered by liquid nasal spray for vaccination against influenza A (H1N1) virus.

This study is also performed to assess safety, tolerability and pharmacokinetics (shedding) of a single dose of GHB11L1 administered by liquid nasal spray.

Conditions

  • Influenza, Human

Interventions

BIOLOGICAL

GHB11L1

GHB11L1 administration by liquid nasal spray at doses of 6.0 log10, 6.5 log10 and 7.0 log10 TCID50/volunteer

BIOLOGICAL

Placebo

SPGN buffer

Sponsors & Collaborators

  • AVIR Green Hills Biotechnology AG

    lead INDUSTRY

Principal Investigators

  • Volker Wacheck, MD · Medical University Vienna

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • Austria

Study Locations

More Related Trials

Entities

Drugs

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 NCT01078701 on ClinicalTrials.gov