Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00328107
Status:
COMPLETED
Last Update Posted:
2010-01-12
First Post:
2006-05-17
Brief Title:
Immunogenicity and Safety of Trivalent Recombinant Hemagglutinin Influenza Vaccine in Healthy Adults
Sponsor:
Protein Sciences Corporation
Organization:
Protein Sciences Corporation
Study Overview
Official Title:
Evaluation of the Immunogenicity and Safety of Two Preparations of Trivalent Recombinant Baculovirus-Expressed Hemagglutinin Influenza Vaccine Administered Intramuscularly in Healthy Adults Ages 18-49 Years
Status:
COMPLETED
Status Verified Date:
2010-01
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 was to determine the dose-related safety immunogenicity and protective efficacy of a trivalent recombinant hemagglutinin influenza vaccine in healthy adults
Detailed Description:
All currently licensed influenza vaccines in the United States are produced in embryonated hens eggs There are several well-recognized disadvantages to the use of eggs as the substrate for influenza vaccine Eggs require specialized manufacturing facilities and could be difficult to scale up rapidly in response to an emerging need such as a pandemic It is usually necessary to adapt candidate vaccine viruses for high-yield growth in eggs a process that can be time consuming is not always successful and can select receptor variants that may have suboptimal immunogenicity In addition agricultural diseases that affect chicken flocks and that might be an important issue in a pandemic due to an avian influenza virus strain could easily disrupt the supply of eggs for vaccine manufacturing Therefore development of alternative substrates for influenza vaccine production has been identified as a high-priority objective
One potential alternative method for production of influenza vaccine is expression of the influenza virus hemagglutinin HA using recombinant DNA techniques This alternative avoids dependence on eggs and is very efficient because of the high levels of protein expression under the control of the baculovirus polyhedrin promoter
One potential alternative method for production of influenza vaccine is expression of the influenza virus hemagglutinin HA using recombinant DNA techniques This alternative avoids dependence on eggs and is very efficient because of the high levels of protein expression under the control of the baculovirus polyhedrin promoter
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