Back to resultsStudy to Evaluate Reactogenicity and Immunogenicity of Revaccination With Adjuvanted Influenza Vaccine in Elderly
Primary Purpose
Influenza
Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Fluarix and adjuvanted influenza vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza, improved vaccine, elderly
Eligibility Criteria
Inclusion Criteria:
- The subjects must be healthy elderly >/= 67 years and previously vaccinated with Fluarix or the adjuvanted vaccine.
Exclusion Criteria:
- Subjects will be excluded if they take/have taken chronically high doses of immunosuppressants or other immunemodifying drugs within six months before vaccination, or immunoglobulins or blood products within three months before vaccination, or any investigational product within 30 days before vaccination, have a history of influenza infection since previous vaccination, or if subjects have acute or chronic clinically significant disease or an immunosuppressive/deficient condition, or have contra-indications to influenza vaccination
Sites / Locations
- GSK Investigational Site
Outcomes
Primary Outcome Measures
Evaluation of the safety and reactogenicity of repeated vaccination with adjuvanted influenza vaccine, during 21 days following administration of the vaccine.
Secondary Outcome Measures
Evaluation of the humoral immune response & cell-mediated immune response 21 days after revaccination with candidate vaccine.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00386113
Brief Title
Study to Evaluate Reactogenicity and Immunogenicity of Revaccination With Adjuvanted Influenza Vaccine in Elderly
Official Title
A Phase II, Open, Controlled Study to Evaluate the Reactogenicity and the Immunogenicity of GlaxoSmithKline Biologicals' Adjuvanted Influenza Vaccine in Elderly Adults Previously Vaccinated With Either Fluarix™ or the Adjuvanted Vaccine.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
October 16, 2006 (Actual)
Primary Completion Date
November 14, 2006 (Actual)
Study Completion Date
November 14, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
Since influenza vaccines are normally administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profile of adjuvanted influenza vaccine need to be re-evaluated after repeated vaccine administration. In this study, subjects previously vaccinated with Fluarix or the influenza adjuvanted vaccine, will receive a booster dose with the 2006-2007 season's formulations of either Fluarix or the adjuvanted vaccine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, improved vaccine, elderly
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Fluarix and adjuvanted influenza vaccine
Primary Outcome Measure Information:
Title
Evaluation of the safety and reactogenicity of repeated vaccination with adjuvanted influenza vaccine, during 21 days following administration of the vaccine.
Secondary Outcome Measure Information:
Title
Evaluation of the humoral immune response & cell-mediated immune response 21 days after revaccination with candidate vaccine.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The subjects must be healthy elderly >/= 67 years and previously vaccinated with Fluarix or the adjuvanted vaccine.
Exclusion Criteria:
Subjects will be excluded if they take/have taken chronically high doses of immunosuppressants or other immunemodifying drugs within six months before vaccination, or immunoglobulins or blood products within three months before vaccination, or any investigational product within 30 days before vaccination, have a history of influenza infection since previous vaccination, or if subjects have acute or chronic clinically significant disease or an immunosuppressive/deficient condition, or have contra-indications to influenza vaccination
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate Reactogenicity and Immunogenicity of Revaccination With Adjuvanted Influenza Vaccine in Elderly
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