Ignite Creation Date:
2024-05-06 @ 2:19 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02014870
Status:
COMPLETED
Last Update Posted:
2013-12-18
First Post:
2013-12-05
Brief Title:
Safety and Reactogenicity of a H1N1 Influenza Challenge Virus in Healthy Volunteers
Sponsor:
Immune Targeting Systems Ltd
Organization:
Immune Targeting Systems Ltd
Study Overview
Official Title:
A Phase I Open-label Ascending Dose Study to Determine the Safety and Reactogenicity of a Wild Type Seasonal ACalifornia H1N1 2009 Influenza Challenge Virus in Healthy Volunteers Following a Single Intranasal Administration
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective is to determine the dose level of live wild-type ACalifornia H1N1 2009 virus that has an appropriate safety and illnessinfectivity 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-002503-34 | EUDRACT_NUMBER | None | None |