EUCTR2014-001534-29-Outside-EU/EEAActive, not recruitingNot Applicable
Safety of ChimeriVax™ Dengue Tetravalent Vaccine in Subjects Aged 2 to 45 Years in the Philippines
Sanofi Pasteur SA0 sites126 target enrollmentStarted: May 26, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 126
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 2 to 45 years on the day of inclusion (Scr.)
- •2) Informed consent form signed by the subject and by the parent(s) or another legal representative for subjects under 18 years old (Scr.)
- •3) For a woman, inability to bear a child or negative serum pregnancy test at screening (Scr.)
- •4) Able to attend all scheduled visits and to comply with all trial procedures (Scr.+V01)
- •5) For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination and at least 4 weeks after each vaccination (Scr.+V01)
- •6) For a woman, inability to bear a child or negative urine pregnancy test on the day of the first injection (V01)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 108
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 18
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1) History of thymic pathology (thymoma), thymectomy, or myasthenia (Scr.)
- •2) Breast-feeding (Scr.)
- •3) Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances (Scr.)
- •4) Previous vaccination against typhoïd or flavivirus diseases (including Japanese encephalitis, and yellow fever) (Scr.)
- •5) Current abuse of alcohol or drug addiction that may interfere with the subject’s ability to comply with trial procedures (Scr.)
- •6) Planned participation in another clinical trial during the present trial period (Scr.+V01)
- •7) History of flavivirus infection (confirmed either clinically, serologically or microbiologically) (Scr.+V01)
- •8) 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 (Scr.+V01)
- •9) Chronic illness at a stage that could interfere with trial conduct or completion (Scr.+V01)
- •10) Blood or blood-derived products received in the past three months (Scr.+V01)
- •11) Vaccination planned in the four weeks following any trial vaccination (Scr.+V01)
- •12) Flavivirus vaccination planned during the present trial period (Scr.+V01)
- •13) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent (Scr.+V01)
- •14) Participation in another clinical trial in the four weeks preceding the first trial vaccination (V01)
- •15) Any vaccination in the four weeks preceding the first trial vaccination (V01)
- •16) Human Immunodeficiency Virus (HIV), Hepatitis B (HBsAg) or Hepatitis C Virus (HCV) seropositivity in blood sample taken at Screening (V01)
- •17) Clinically significant laboratory abnormalities (as determined by the Investigator) in blood sample taken at Screening (V01)
Investigators
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