EUCTR2014-001713-26-Outside-EU/EEAActive, not recruitingNot Applicable
Immunogenicity and Large-Scale Safety of Tetravalent Dengue Vaccine in Healthy Subjects Aged 2 to 45 Years in Singapore
Sanofi Pasteur SA0 sites1,198 target enrollmentStarted: May 26, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 1,198
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 from 2 to 45 years on the day of inclusion.
- •2. Subject in good health, based on medical h istory and physical examination.
- •3. Provision of informed consent form (and assent form for subjects aged 6 to 12 years) signed by the subject and by the parent(s) or another legally acceptable representative for subjects aged less than 21 years.
- •4. Subject and parent(s)/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.
- •5. For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks before the first vaccination until 4 weeks after the last vaccination.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 503
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 695
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1. Febrile illness (temperature =37.5°C) or moderate or severe acute illness/infection on the day of the first vaccination, according to Investigator judgment.
- •2. For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test on the day of inclusion.
- •3. Breast-feeding woman.
- •4. Known systemic hypersensitivity to any of the components of the trial vaccines (especially egg proteins or neomycin) or h istory of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances.
- •5. Personal or family history of thymic pathology or myasthenia.
- •6. Previous hepatitis A vaccination (for children only).
- •7. Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the past 6 months, or long-term systemic corticosteroid therapy.
- •8. Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
- •9. Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune response.
- •10. Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
- •11. Planned participation in another clinical trial during the 18 coming months.
- •12. Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
- •13. Planned receipt of any vaccine in the 4 weeks following the first trial vaccination.
- •14. Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
- •15. Current or past alcohol abuse or drug addiction that may interfere with the subject’s ability to comply with trial procedures.
- •16. Subject who plans to move to another country within the 18 coming months.
Investigators
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