Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-01-02 @ 3:21 AM
Study NCT ID:
NCT00943358
Status:
COMPLETED
Last Update Posted:
2012-08-08
First Post:
2009-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity of A/H1N1v Vaccines in Healthy Adults
Sponsor:
University Hospitals, Leicester
Organization:
Study Overview
Official Title:
Safety and Immunogenicity of Cell-culture Non-adjuvanted and MF59-adjuvanted Influenza H1N1 Vaccines in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2012-08
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 purpose of this study is to evaluate the antibody response to one and two doses of influenza A/H1N1v vaccine in healthy adults.
Detailed Description:
An observer-blind, single-centre study in which 7 groups of 25-30 male and female adults ≥18-50 years of age will be randomly allocated to receive two doses of cell culture non-adjuvanted or MF59-adjuvanted influenza A/California/4/2009 (H1N1) surface antigen vaccine containing 3.75, 7.5 or 15µg haemagglutinin by intramuscular injection. A second dose of the same vaccine containing the same quantity of antigen as in the first dose will be administered 21 days later. Three additional groups will receive two doses of MF59-adjuvanted influenza A/California/4/2009 (H1N1) surface antigen vaccine containing 7.5 µg haemagglutinin by intramuscular injection on day 0 or separated by 7 or 14 days. Subjects will be observed for local and systemic reactions for 30 minutes after each immunisation and will be monitored for any reactions and other adverse events for 7 days after each immunisation.
Study Oversight
Has Oversight DMC:
True
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?: