Status:
COMPLETED
Lot-to-Lot Consistency Study of the Investigational, Inactivated, Split-Virion Influenza Vaccine in Adults
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Orthomyxoviridae Infection
Influenza
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
The primary objective of this trial is to demonstrate the equivalence, in terms of immunogenicity, of three different industrial lots of the investigational vaccine thereby supporting consistency of t...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Aged 18 to 60 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 the first visit.
- Exclusion Criteria :
- 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 4 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 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 trial vaccination.
- Vaccination planned in the 4 weeks following the trial vaccination.
- Previous vaccination against influenza (in the previous 6 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.
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
2256 Patients enrolled
Trial Details
Trial ID
NCT00383539
Start Date
September 1 2006
End Date
December 1 2007
Last Update
January 14 2014
Active Locations (4)
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1
Angers, France, 49000
2
Vilnius, Lithuania, 08117
3
Madrid, Spain, 28041
4
Bath, United Kingdom