Status:
COMPLETED
Study of Inactivated, Split-Virion Influenza Vaccine Compared With the Reference Vaccine Vaxigrip® in the Elderly
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Orthomyxoviridae Infection
Influenza
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief Summary
Vaccination against influenza is a high priority for the elderly population who present the highest morbidity and mortality rate. However, due to their weak antibody response an improvement of the imm...
Eligibility Criteria
Inclusion
- Aged over 60 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 or rectal equivalent temperature ≥ 38.0°C) on the day of inclusion.
- 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 6 months, or long-term systemic corticosteroids therapy.
- Unstable chronic illness (defined as illness requiring hospitalization or a clinically significant change in medication in the 12 weeks prior to inclusion) 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 3 months.
- Any vaccination in the 4 weeks preceding the first trial vaccination.
- Vaccination planned in the 4 weeks following the first trial vaccination.
- Previous vaccination against influenza (in the previous 6 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 :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
3707 Patients enrolled
Trial Details
Trial ID
NCT00383526
Start Date
September 1 2006
End Date
September 1 2009
Last Update
January 14 2014
Active Locations (4)
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1
Antwerp, Belgium, 2060
2
Angers, France, 49000
3
Genova, Italy, 16132
4
Vilnius, Lithuania, LT-08117