| August 6, 2008 |
| August 7, 2008 |
| August 2006 |
| August 2007 (final data collection date for primary outcome measure) |
- Immunogenicity:
To provide information concerning the immunogenicity of ChimeriVax™ [ Time Frame: 28, 60 and 180 days post vaccination ] [ Designated as safety issue: No ]
- Safety:
To provide information concerning the safety of ChimeriVax™ [ Time Frame: 28 days post-vaccination and entire study duration ] [ Designated as safety issue: Yes ]
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| Same as current |
| Complete list of historical versions of study NCT00730288 on ClinicalTrials.gov Archive Site |
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| Study of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects |
| Safety of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects Previously Immunised With an Investigational Dengue or Yellow Fever Vaccine |
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 ChimeriVax™ dengue tetravalent vaccine.
- To describe the immune response against dengue before and after one injection of ChimeriVax™ dengue tetravalent vaccine
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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. |
| Phase II |
| Interventional |
| Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
- Dengue
- Dengue Fever
- Dengue Hemorrhagic Fever
- Dengue Virus
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| Biological: Chimeric dengue serotype (1, 2, 3, 4) |
- Experimental: Received monovalent Vero dengue vaccine in Study DIV12
- Experimental: Received Yellow fever vaccine in Study DIV12
- Experimental: Flavivirus-naive subjects
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| Completed |
| 35 |
| January 2008 |
| August 2007 (final data collection date for primary outcome measure) |
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).
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| Both |
| 18 Years to 40 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| Australia |
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| NCT00730288 |
| Medical Monitor, Sanofi Pasteur Inc |
| CYD10 |
| Sanofi-Aventis |
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| Study Director: |
Medical Monitor |
Sanofi Pasteur Inc |
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| Sanofi-Aventis |
| August 2008 |