Status:
COMPLETED
A Study of the Immunogenicity and Safety of the 2006-2007 Influenza Vaccine
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Influenza
Orthomyxoviridae Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is designed to generate clinical data as outlined in the Note for Guidance on harmonization requirements for influenza vaccine marketing authorization by the European Medicines Agency. The...
Eligibility Criteria
Inclusion
- Aged at least 18 years on the day of inclusion
- Informed consent form signed
- Able to attend all scheduled visits and to comply with all trial procedures
- For a woman, inability to bear a child or negative urine pregnancy test at Visit 1
- For a woman of child-bearing potential: use of an effective method of contraception or abstinence for at least four weeks prior to vaccination and at least three weeks after vaccination.
Exclusion
- Febrile illness (oral temperature \>=37.5°C) on the day of vaccination
- Breast-feeding
- Participation in another clinical trial in the four weeks preceding the 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
- Systemic hypersensitivity to egg proteins, chick proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
- 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
- Any vaccination in the four weeks preceding the trial vaccination
- Vaccination planned in the three weeks following the trial vaccination
- Vaccination against influenza in the previous six months
- 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 :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00343681
Start Date
July 1 2006
End Date
August 1 2007
Last Update
January 17 2014
Active Locations (2)
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1
Allschwil, Switzerland
2
Edinburgh, United Kingdom