Last updated: 11/03/2018 07:46:13
Study to evaluate reactogenicity and immunogenicity of revaccination with adjuvanted influenza vaccine in elderly Adults
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Evaluate reactogenicity & immunogenicity of adjuvanted influenza vaccine in elderly adults previously vaccinated with the same candidate vaccine. Fluarix™ administered in young & elderly adults will be used as reference
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
200
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Influenza
Product
GSK576389A
Collaborators
Not applicable
Study date(s)
October 2006 to December 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- The subjects must be healthy adults ages 18-40 years or >/= 65 years previously vaccinated with either Fluarix or the adjuvanted vaccine.
- 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
Inclusion and exclusion criteria
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
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2006-12-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
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