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Two Doses of GHB04L1 for Pandemic Influenza Prophylaxis in Healthy Adults

NCT03745274 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2018-11-20

No results posted yet for this study

Summary

This study evaluates safety, tolerability and immunogenicity of two doses of GHB04L1, a liquid formulation of the replication- deficient influenza A/Vietnam/1203/04(H5N1)-like ∆NS1 virus in healthy adults. Subjects are randomised at a ratio of 2:1 for GHB04L1 (6.8 log10 or 7.5 log10 TCID50/dose/volunteer) or placebo.

Conditions

  • Influenza, Avian

Interventions

BIOLOGICAL

GHB04L1

Solution

OTHER

Placebo

Buffer solution

Sponsors & Collaborators

  • AVIR Green Hills Biotechnology AG

    lead INDUSTRY

Principal Investigators

  • Oleg Kiselev, Prof · Research Institute of Influenza, Russian Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2008-12-19
Primary Completion
2009-05-27
Completion
2009-05-27

Countries

  • Russia

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 NCT03745274 on ClinicalTrials.gov