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Study of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects
This study has been completed.
Study NCT00730288   Information provided by Sanofi-Aventis
First Received: August 6, 2008   Last Updated: August 7, 2008   History of Changes

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 ]
Same as current
Complete list of historical versions of study NCT00730288 on ClinicalTrials.gov Archive Site
 
 
 
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

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
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
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
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).
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00730288
Medical Monitor, Sanofi Pasteur Inc
CYD10
Sanofi-Aventis
 
Study Director: Medical Monitor Sanofi Pasteur Inc
Sanofi-Aventis
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP