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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00386113
Other study ID # 107973
Secondary ID
Status Completed
Phase Phase 2
First received October 9, 2006
Last updated February 22, 2018
Start date October 16, 2006
Est. completion date November 14, 2006

Study information

Verified date February 2018
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date November 14, 2006
Est. primary completion date November 14, 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 67 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Fluarix and adjuvanted influenza vaccine


Locations

Country Name City State
Belgium GSK Investigational Site Gent

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of the safety and reactogenicity of repeated vaccination with adjuvanted influenza vaccine, during 21 days following administration of the vaccine.
Secondary Evaluation of the humoral immune response & cell-mediated immune response 21 days after revaccination with candidate vaccine.
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