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Study of Single Dose GHB16L2 Trivalent Influenza Vaccine in Healthy Adults

NCT01369862 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2014-01-10

No results posted yet for this study

Summary

The purpose of this phase I/II trial is to evaluate safety and tolerability of a single dose of GHB16L2 administered by liquid nasal spray for vaccination against seasonal influenza virus infection. It is also performed to assess immunogenicity and pharmacokinetics (shedding).

Conditions

  • Influenza, Human

Interventions

BIOLOGICAL

GHB16L2

A/Brisbane/59/07(H1N1)-like delNS1, A/Brisbane/10/07(H3N2)-like delNS1, B/Florida/04/06-like delNS1 virus reassortants

BIOLOGICAL

Placebo

SPGNH buffer

Sponsors & Collaborators

  • AVIR Green Hills Biotechnology AG

    lead INDUSTRY

Principal Investigators

  • Michael Wolzt, MD · Medical University Vienna

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-08-31
Completion
2011-08-31

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 NCT01369862 on ClinicalTrials.gov