EUCTR2008-001219-39-NLActive, not recruitingPhase 1
Immunogenicity and Safety of the Investigational Inactivated, Split-Virion Influenza Vaccine 15 µg Administered by the Intradermal Route in Comparison with the Intramuscular Reference Vaccine Vaxigrip® in 50 to 59 Years old Adults
Sanofi Pasteur SA0 sites2,740 target enrollmentStarted: June 2, 2008Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 2,740
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1) Aged 50 (from the 50th birthday) to 59 years old (day before the 60th birthday) on the day of inclusion.
- •2) Informed Consent Form signed.
- •3) Able to attend all scheduled visits and to comply with all trial procedures.
- •4) For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) observed for at least 4 weeks prior to the vaccination and at least 4 weeks after the vaccination.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1) For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test.
- •2) Breast-feeding woman.
- •3) 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.
- •4) Febrile illness, i.e. oral temperature = 37.5°C (>37.0°C for Czech) or rectal equivalent temperature =38.0°C (>37.5°C for Czech), on the day of inclusion.
- •5) Participation in another clinical trial in the 4 weeks preceding the trial vaccination.
- •6) Planned participation in another clinical trial during the present trial period.
- •7) 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.
- •8) Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
- •9) Current abuse of alcohol or drug addiction that may interfere with the subject’s ability to comply with trial procedures.
- •10) Receipt of blood or blood-derived products in the past 3 months.
- •11) Any vaccine in the 4 weeks preceding the trial vaccination.
- •12) Planned receipt of any vaccine in the 4 weeks following the trial vaccination.
- •13) Previous vaccination against seasonal or pandemic influenza (in the previous 6 months).
- •14) Previous vaccination with inactivated, split-virion influenza vaccine administered by intradermal route.
- •15) Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
- •16) Known Human Immunodeficiency Virus (HIV), HBs antigen or Hepatitis C seropositivity.
- •17) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
Investigators
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