Status:
COMPLETED
Immunogenicity Study of the Influenza Vaccine in Adults
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Orthomyxoviridae Infections
Influenza
Eligibility:
All Genders
18-57 years
Phase:
PHASE2
Brief Summary
All marketed influenza vaccines are injected by the intramuscular (IM) route. This study will test whether an influenza vaccine is effective when injected by a route other than into the muscle. In ord...
Eligibility Criteria
Inclusion
- Aged 18 to 57 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 V01
- For a woman of child-bearing potential: use of an effective method of contraception or abstinence for at least 4 weeks prior to, and at least four weeks after, the first vaccination.
- At Year 1 (Visit 05):
- Addendum to the informed consent form signed and dated by the subject prior to vaccination at Visit 05
- At Year 2 (Visit 07):
- Addendum to the informed consent form signed and dated by the subject prior to vaccination at Visit 07
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 (rectal equivalent temperature \>= 38.0°C) on the day of inclusion
- Breast-feeding
- 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 corticosteroid 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
- Any vaccination in the four weeks preceding the first trial vaccination
- 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 IM 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 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
978 Patients enrolled
Trial Details
Trial ID
NCT00258934
Start Date
September 1 2005
End Date
September 1 2008
Last Update
January 14 2014
Active Locations (4)
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1
Antwerp, Belgium
2
Ghent, Belgium
3
Hamburg, Germany
4
Allschwil, Switzerland