Status:
COMPLETED
Immunogenicity of Two Dosages of Inactivated, Split-Virion Influenza Vaccine Given by an Alternate Route in the Elderly
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Orthomyxoviridae Infection
Influenza
Eligibility:
All Genders
60-85 years
Phase:
PHASE2
Brief Summary
All marketed influenza vaccines are injected by the intramuscular route. This study will test whether an influenza vaccine is effective when injected by other route than into the muscle. In order to p...
Eligibility Criteria
Inclusion
- Aged 60 to 85 years on the day of inclusion
- Informed consent form signed
- Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion
- Systemic hypersensitivity to egg proteins, chick proteins, or any of the vaccine components, in particular, neomycin, formaldehyde, and octoxinol 9, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
February 1 2007
Estimated Enrollment :
1080 Patients enrolled
Trial Details
Trial ID
NCT00296829
Start Date
January 1 2006
End Date
February 1 2007
Last Update
January 14 2014
Active Locations (11)
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1
Adelaide, Australia, 5000
2
Carina Heights, Australia, QLD 4152
3
Inala, Australia, QLD 4077
4
Kippa-Ring, Australia, QLD 4021