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Characterisation of a New Wild-Type H3N2 Virus for the Human Viral Challenge Model

NCT02525055 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2020-01-27

Study results available
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Summary

The study will characterise Influenza A/Perth/16/2009(H3N2) virus in healthy participants using the viral challenge model. The study includes two cohorts.

Cohort 1: A randomised, double-blind study of 4 titres of Challenge Virus to determine the optimum titre.

Cohort 2: An open-label extension arm in which all participants will receive the 'optimum' titre as identified from Cohort 1.

Conditions

Interventions

OTHER

Infectious titre 1 (H3N2)

Infectious titre 1: 2.8 x 10\*3 TCID50/mL

OTHER

Infectious titre 2 (H3N2)

Infectious titre 2: 2.5 x 10\*4 TCID50/mL

OTHER

Infectious titre 3 (H3N2)

Infectious titre 3: 3.6 x 10\*5 TCID50/mL

OTHER

Infectious titre 4 (H3N2)

Infectious titre 4: 4.7 x 10\*6 TCID50/mL

OTHER

Infectious titre 5 (H3N2) (Subjects aged 18 to 45 years old)

Infectious titre 5: 3.5 x 10\*5 TCID50/mL

OTHER

Infectious titre 5 (H3N2) (Subjects aged 46 to 64 years old)

Infectious titre 5: 3.5 x 10\*5 TCID50/mL

Sponsors & Collaborators

  • Hvivo

    lead INDUSTRY

Principal Investigators

  • Bryan Muray, MD · Hvivo

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-08-11
Completion
2014-08-11

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Diseases

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 NCT02525055 on ClinicalTrials.gov