Dengue, Dengue Fever, Dengue Hemorrhagic Fever, Dengue Virus
Conditions
Keywords
Dengue, Dengue fever, Dengue hemorrhagic fever, Dengue virus
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 ChimeriVax™ dengue tetravalent vaccine. * To describe the immune response against dengue before and after one injection of ChimeriVax™ dengue tetravalent vaccine
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.
Interventions
BIOLOGICALChimeric dengue serotype (1, 2, 3, 4)
0.5 mL, Subcutaneous, 1 dose
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity: To provide information concerning the immunogenicity of ChimeriVax™ | 28, 60 and 180 days post vaccination |
| Safety: To provide information concerning the safety of ChimeriVax™ | 28 days post-vaccination and entire study duration |
Countries
Australia
Outcome results
None listed