Viewing Study NCT01623518



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Last Modification Date: 2024-10-26 @ 10:52 AM
Study NCT ID: NCT01623518
Status: COMPLETED
Last Update Posted: 2014-12-02
First Post: 2012-06-13

Brief Title: A Phase I Study to Determine the Safety and Immunogenicity of the Candidate Influenza Vaccine ChAdOx1-NPM1
Sponsor: University of Oxford
Organization: University of Oxford

Study Overview

Official Title: A Phase I Study to Determine the Safety and Immunogenicity of the Candidate Influenza Vaccine ChAdOx1-NPM1
Status: COMPLETED
Status Verified Date: 2014-11
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: This is a first in man dose escalation study to assess the safety and immunogenicity of the candidate influenza vaccine ChAdOx1-NPM1 All volunteers recruited will be healthy adults aged 18-50 Volunteers will be enrolled and doses will be escalated according to a 33 study plan Up to 24 volunteers will be vaccinated Following one dose of the vaccine volunteers will be followed up to assess the side effect profile of the vaccine and to take blood tests A series of immunology assays will be performed to determine how potent the vaccine is at inducing an immune response
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
2012-000641-12 EUDRACT_NUMBER None None