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Single Ascending Dose Challenge Study to Determine Safety and Reactogenicity of an Influenza Challenge Virus

NCT04106817 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2020-01-14

Study results available
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Summary

This is a non-controlled, open-label, single-center, dose-escalation study to determine the safety, infectivity, and immune responses elicited from of the potential influenza virus challenge strain. The study objective is to determine the dose with the optimal safety profile and infectivity rate of the viral challenge strain in healthy volunteers for use in subsequent challenge intervention studies to test potential influenza vaccines and/or therapeutics.

Conditions

Interventions

BIOLOGICAL

Live, wild-type A/California/H1N1 2009 influenza virus

Live, wild type influenza A virus that was inoculated and manufactured in allantoic fluid of SPF embryonated hen eggs

Sponsors & Collaborators

  • Stanford University

    collaborator OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

  • WCCT Global

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2015-01-19
Primary Completion
2015-08-10
Completion
2015-08-10
FDA Drug
Yes

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Diseases
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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 NCT04106817 on ClinicalTrials.gov