Study to Evaluate Reactogenicity and Immunogenicity of Revaccination With Adjuvanted Influenza Vaccine in Elderly

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00386113
• Date of registration: 09/10/2006
• Primary sponsor: GlaxoSmithKline
• Public title: Study to Evaluate Reactogenicity and Immunogenicity of Revaccination With Adjuvanted Influenza Vaccine in Elderly
• Scientific 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.
• Date of first enrolment: October 2006
• Target sample size: 83
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00386113
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Countries of recruitment

Belgium

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion 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



Age minimum: 67 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Influenza

Intervention(s)

Biological: Fluarix and adjuvanted influenza vaccine

Primary Outcome(s)

Evaluation of the safety and reactogenicity of repeated vaccination with adjuvanted influenza vaccine, during 21 days following administration of the vaccine.

Secondary Outcome(s)

Evaluation of the humoral immune response & cell-mediated immune response 21 days after revaccination with candidate vaccine.

Secondary ID(s)

107973

Source(s) of Monetary Support

Please refer to primary and secondary sponsors