Efficacy and Safety of Dengue Vaccine in Healthy Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00842530
First received: February 11, 2009
Last updated: September 18, 2014
Last verified: September 2014

February 11, 2009
September 18, 2014
February 2009
September 2013   (final data collection date for primary outcome measure)
  • Immunogenicity: To provide information concerning the immunogenicity of Dengue Vaccine [ Time Frame: 28 days post-vaccination 3 ] [ Designated as safety issue: No ]
  • Safety: To provide information concerning the safety after administration of Dengue Vaccine [ 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 NCT00842530 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy and Safety of Dengue Vaccine in Healthy Children
Efficacy and Safety of Dengue Vaccine in Healthy Children Aged 4 to 11 Years in Thailand

There is currently no vaccine against dengue and no specific drug treatment against the disease. This study is aimed at generating information on the protective effect of the vaccine.

Primary Objective To assess the efficacy of dengue vaccine after three injections in children.

Secondary Objective:

To evaluate the reactogenicity of dengue vaccine after each injection in a subgroup of children.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Dengue Virus
  • Dengue Fever
  • Dengue Hemorrhagic Fever
  • Dengue Diseases
  • Biological: Chimeric tetravalent dengue (serotype 1, 2, 3, 4)
    0.5 mL, Subcutaneous
    Other Name: ChimeriVax™
  • Biological: Inactivated Rabies virus vaccine
    0.5 mL, Subcutaneous
    Other Name: Verorab®
  • Experimental: Dengue Vaccine Group
    Intervention: Biological: Chimeric tetravalent dengue (serotype 1, 2, 3, 4)
  • Sham Comparator: Control Vaccine Group
    Intervention: Biological: Inactivated Rabies virus vaccine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4002
February 2014
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria :

  • Aged 4 to 11 years on the day of inclusion.
  • Subject in good health, based on medical history and physical examination.
  • Provision of assent form signed by the subject (for subjects ≥ 7 years old) and informed consent form signed by the parent or another legally acceptable representative.
  • Subject and parent/ legally acceptable representative able to attend all scheduled visits and to comply with all trial procedures.
  • Subject attending one of the schools involved in the trial and living in the Ratchaburi Province.
  • For a female subject of child-bearing potential (girls post-menarche), avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to first vaccination, until at least 4 weeks after the last vaccination.

Exclusion Criteria :

  • Febrile illness (temperature ≥ 37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.
  • For a female subject of child-bearing potential (girls post-menarche), known pregnancy or positive urine pregnancy test on the day of the first trial vaccination.
  • Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
  • Planned participation in another clinical trial during the present trial period.
  • Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy, or long-term systemic corticosteroids therapy.
  • Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances.
  • Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
  • Receipt of blood or blood-derived products in the past 3 months.
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
  • Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
  • Planned receipt of any vaccine in the 4 weeks following the first trial vaccination.e
  • Subject who plans to attend another school (outside the trial area) or move to another city in the coming 30 months.
Both
4 Years to 11 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00842530
CYD23
Yes
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Monitor Sanofi Pasteur Inc.
Sanofi
September 2014

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