Status:
COMPLETED
Study of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects
Lead Sponsor:
Sanofi
Conditions:
Dengue
Dengue Fever
Eligibility:
All Genders
18-40 years
Phase:
PHASE2
Brief Summary
To evaluate effect of previous flavivirus exposure on the safety and immunogenicity of the ChimeriVax™ dengue tetravalent vaccine Primary Objectives: * To describe the safety of one injection of Chi...
Detailed Description
This study will evaluate a dengue tetravalent vaccine formulation in subjects aged 18 to 40 years and previously immunised with a dengue or YF vaccine.
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Aged 18 to 40 years on the day of inclusion.
- Informed consent form signed.
- For a woman, inability to bear a child or negative serum pregnancy test.
- Completed the one-year follow-up of Study DIV12.
- Able to attend all scheduled visits and to comply with all trial procedures.
- For a woman of child-bearing potential: use of an effective method of contraception or abstinence for at least four weeks prior to vaccination and at least four weeks after vaccination.
- Exclusion Criteria :
- History of thymic pathology (thymoma), thymectomy, or myasthenia gravis.
- Breast-feeding.
- 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.
- Previous flavivirus vaccination, e.g. Japanese encephalitis or yellow fever.
- Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.
- Planned participation in another clinical trial during the present trial period.
- History of flavivirus infection (confirmed either clinically, serologically or microbiologically).
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding six months, or long-term systemic corticosteroids therapy.
- Chronic illness at a stage that could interfere with trial conduct or completion.
- Blood or blood-derived products received in the past three months.
- Vaccination planned in the four weeks following the trial vaccination.
- Flavivirus vaccination planned during the present trial period.
- Planned travel during the present trial period to areas with high dengue endemicity.
- Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalised without his/her consent.
- Participation in another clinical trial in the four weeks preceding the trial vaccination.
- Any vaccination in the four weeks preceding the trial vaccination.
- Human Immunodeficiency Virus (HIV), Hepatitis B (Ag HBs) or Hepatitis C (HC) seropositivity in blood sample taken at screening.
- Laboratory abnormalities considered clinically significant upon the Investigator's judgement in blood sample taken at screening.
- Positive flavivirus serological test in blood sample taken at screening (for Controls only).
Exclusion
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00730288
Start Date
August 1 2006
End Date
January 1 2008
Last Update
February 27 2018
Active Locations (1)
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1
Adelaide, Australia