Efficacy and Safety of Dengue Vaccine in Healthy Children
Condition: Dengue Virus; Dengue Fever; Dengue Hemorrhagic Fever; Dengue Diseases
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever; Hyperthermia
Intervention: CYD Dengue Vaccine; Inactivated rabies virus vaccine; Placebo
Intervention description: 0.5 mL, Subcutaneous; 0.5 mL, Subcutaneous; Sodium chloride 0.9%
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: The observer-blind design was chosen since the products have different appearances and could be recognized. The person who performed vaccinations knew which product was administered while neither the participant nor the Investigator in charge of safety evaluation knew which product was injected. To maintain the blind and minimize the potential bias, the control group used the same route and schedule as the study vaccine.
Enrollment: 4002.0
Sex: All
Minimum age: 4 Years
Maximum age: 11 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dengue virus; Dengue fever; Dengue hemorrhagic fever; Dengue diseases; Dengue vaccine

Summary:

      The primary objective of the study was to assess the efficacy of CYD dengue vaccine after
      three injections in preventing symptomatic virologically-confirmed dengue (VCD) cases,
      regardless of the severity, due to any of the four serotypes in children aged 4 to 11 years
      at the time of inclusion.

      Secondary objectives included to assess:

        -  Vaccine efficacy against severe VCD cases

        -  Vaccine efficacy against VCD cases following at least two injections with CYD dengue
           vaccine

        -  Immune response to CYD dengue vaccine

        -  Safety profile of CYD dengue vaccine. Safety assessments include solicited reactions
           within 7 or 14 days after each injection, unsolicited adverse events within 28 days
           after each injection, and serious adverse events during the study period.

      Other objectives included:

        -  Vaccine efficacy against VCD cases following at least one injection with CYD dengue
           vaccine

        -  Vaccine efficacy against VCD cases due to each serotype

        -  Participants with clinical signs and symptoms for VCD
    

Eligibility criteria:

        Inclusion Criteria :

          -  Aged 4 to 11 years on the day of inclusion.

          -  Participant in good health, based on medical history and physical examination.

          -  Provision of assent form signed by the participants (for participants >= 7 years old)
             and informed consent form signed by the parent or another legally acceptable
             representative.

          -  Participant and parent/ legally acceptable representative able to attend all scheduled
             visits and to comply with all trial procedures.

          -  Participant attended one of the schools involved in the trial and living in the
             Ratchaburi Province.

          -  For a female participant 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 participant 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.

          -  Participant 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

          -  Participant who plans to attend another school (outside the trial area) or move to
             another city in the coming 30 months.