A Study to Determine the Safety and Attack Rate of the Seasonal Flu in Healthy Volunteers
NCT04372719 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2020-05-04
Summary
This is a non-controlled, open-label, single-centre, dose-escalation study to determine the safety, infectivity and immunology of the potential novel influenza virus H3N2 challenge strain. The term 'challenge agent' used in this protocol refers to the Influenza virus H3N2 A/Belgium/4217/2015. The study utilises an adaptive study design and consists of 2 parts.
Conditions
- Influenza, Human
Interventions
- DRUG
-
H3N2
Sponsors & Collaborators
-
SGS Life Sciences, a division of SGS Belgium NV
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-11-02
- Primary Completion
- 2016-12-28
- Completion
- 2016-12-28
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