Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00395174
Status:
COMPLETED
Last Update Posted:
2009-12-17
First Post:
2006-10-30
Brief Title:
Comparison of the Immunogenicity Safety and Reactogenicity of FluBlok To a Licensed Vaccine In Elderly Adults
Sponsor:
Protein Sciences Corporation
Organization:
Protein Sciences Corporation
Study Overview
Official Title:
Comparison of the Immunogenicity Safety and Reactogenicity of FluBlok Trivalent Recombinant Baculovirus-Expressed Hemagglutinin Influenza Vaccine to a Licensed Egg-Grown Influenza Vaccine In Ambulatory Elderly Adults
Status:
COMPLETED
Status Verified Date:
2009-12
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 purpose of this study were to obtain additional evidence in support of the safety and immunogenicity of a recombinant hemagglutinin rHA vaccine in an elderly population and to establish non-inferiority of the immunogenicity of the rHA vaccine when compared with a licensed trivalent influenza vaccine TIV Another purpose was to provide a preliminary estimate of the relative efficacy of the two vaccines against culture-positive influenza-like illness during the subsequent epidemic
Detailed Description:
Annual influenza epidemics are associated with serious excess morbidity and mortality particularly among the elderly Licensed trivalent inactivated influenza vaccines TIVs have been shown to reduce hospitalization and death following influenza in this vulnerable population but their efficacy is lower than that observed in younger healthy populations In addition recent studies have questioned the level of effectiveness of TIV in the elderly suggesting that cohort studies have overestimated the benefits of immunization with current TIV formulations in this age group In view of these considerations it is widely accepted that improved and alternative vaccines are needed for control of seasonal and pandemic influenza
Currently available TIVs are prepared from viruses that are grown in embryonated hens eggs Alternative substrates for vaccine production are desirable in order to reduce the vulnerability of and to expand influenza vaccine supply Recombinant DNA techniques allow for expression of the influenza hemagglutinin rHA by baculovirus vectors in insect cell cultures Advantages of this technique include speed of production absence of egg protein and a highly purified product Previous studies among healthy younger and older adults have confirmed that rHA vaccines are safe well tolerated and immunogenic at dosages up to nine times higher than those contained in TIV Dose-related increases in serum antibody levels after immunization also were observed
Currently available TIVs are prepared from viruses that are grown in embryonated hens eggs Alternative substrates for vaccine production are desirable in order to reduce the vulnerability of and to expand influenza vaccine supply Recombinant DNA techniques allow for expression of the influenza hemagglutinin rHA by baculovirus vectors in insect cell cultures Advantages of this technique include speed of production absence of egg protein and a highly purified product Previous studies among healthy younger and older adults have confirmed that rHA vaccines are safe well tolerated and immunogenic at dosages up to nine times higher than those contained in TIV Dose-related increases in serum antibody levels after immunization also were observed
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