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Safety and Reactogenicity of a H1N1 Influenza Challenge Virus in Healthy Volunteers

NCT02014870 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2013-12-18

No results posted yet for this study

Summary

The primary objective is to determine the dose level of live, wild-type A/California/ H1N1 2009 virus that has an appropriate safety and illness/infectivity profile to be used as an influenza virus, challenge strain in future intervention studies.

Illness parameters were collected by subject symptom scores as well as by physical examination. Virus parameters were measured by PCR and cell culture assay (performed by VisMederi srl).

Conditions

Interventions

OTHER

1:1000 Live wild-type A/California/H1N1 2009

1:1000 dilution of neat virus

OTHER

1:100 Live wild-type A/California/H1N1 2009

1:100 dilution of neat virus

OTHER

1:10 Live wild-type A/California/H1N1 2009

1:10 dilution of neat virus

Sponsors & Collaborators

  • Immune Targeting Systems Ltd

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Belgium

Study Locations

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Entities

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 NCT02014870 on ClinicalTrials.gov