Influenza
Conditions
Keywords
Influenza,, improved vaccine,, influenza disease, elderly
Brief summary
Since influenza vaccines are normally administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profiles of the adjuvanted influenza vaccine need to be re-evaluated after repeated vaccine administration. In this study, subjects enrolled in a previous study will receive a booster dose with the 2006-2007 season's formulations of Fluarix or the adjuvanted vaccine.
Interventions
BIOLOGICALFluarix
BIOLOGICALadjuvanted influenza vaccine
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* The subjects must be healthy adults ages 18-40 years or \>/= 65 years previously vaccinated with either Fluarix or the adjuvanted vaccine.
Exclusion criteria
* Subjects will be excluded if they take/have taken chronically high doses of immunosuppressants or other immune modifying 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 * Women who are pregnant * Subjects who have an acute or chronic clinically significant disease or an immunosuppressive/deficient condition, or have contra-indications to influenza vaccination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the safety and reactogenicity of repeated vaccination with adjuvanted influenza vaccine during the 21 days following administration of the vaccine | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the humoral immune response and cell-mediated immune response 21 days after revaccination with candidate vaccine | — |
Countries
Belgium
Outcome results
None listed