Immunogenicity of Two Dosages of Inactivated, Split-Virion Influenza Vaccine Given by an Alternate Route in the Elderly
NCT ID: NCT00296829
Last Updated: 2014-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
1080 participants
INTERVENTIONAL
2006-01-31
2007-02-28
Brief Summary
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Primary Objective:
To demonstrate and compare the immune response of two dosages of influenza vaccine administered by an alternate route to the intramuscular administration of the vaccine.
Secondary Objectives:
* To compare the immune response 21 days after vaccination between each investigational group versus intramuscular group for each influenza strain.
* To describe the safety profile after the vaccination in each study group
* To describe the compliance of the two dosages of the vaccine administered by the alternate route with the European Medicine Agency.
Observational Objectives:
* To describe the safety profile during the 21-day period following an intramuscular revaccination in each group and the possibility of any reaction at the first injection site.
* To describe the pain at the injection site with a Visual Analog Scale and the acceptability of the injection using a questionnaire in each group.
* To describe the leakage appearing at the injection site immediately after the alternate route injection and to explore the relationship with immunogenicity.
* To evaluate the cellular mediated immune response in a subset of subjects.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Interventions
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Inactivated, split-virion influenza vaccine
Eligibility Criteria
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Inclusion Criteria
* Informed consent form signed
* Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria
* Febrile illness (oral temperature \>= 37.5°C equivalent rectal temperature \>= 38.0°C) on the day of inclusion
* Any vaccination or participation in another clinical trial in the four weeks preceding the first trial vaccination
* Planned participation in another clinical trial during the present trial period
* Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding six months, or long-term systemic corticosteroids therapy
* Chronic illness at a stage that could interfere with trial conduct or completion
* Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures
* Blood or blood-derived products received in the past three months
* Vaccination planned in the four weeks following the first trial vaccination
* Previous vaccination against influenza (in the previous six months) with the trial vaccine or another vaccine
* Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
* Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
60 Years
85 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Sanofi Pasteur, a Sanofi Company
Locations
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Adelaide, , Australia
Carina Heights, , Australia
Inala, , Australia
Kippa-Ring, , Australia
Victoria, , Australia
Victoria, , Australia
Victoria, , Australia
Westmead, , Australia
Auckland, , New Zealand
Dunedin, , New Zealand
Hamilton, , New Zealand
Countries
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References
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Holland D, Booy R, De Looze F, Eizenberg P, McDonald J, Karrasch J, McKeirnan M, Salem H, Mills G, Reid J, Weber F, Saville M. Intradermal influenza vaccine administered using a new microinjection system produces superior immunogenicity in elderly adults: a randomized controlled trial. J Infect Dis. 2008 Sep 1;198(5):650-8. doi: 10.1086/590434.
Related Links
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Related Info
Other Identifiers
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GID16
Identifier Type: -
Identifier Source: org_study_id
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