Study of a Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years in Malaysia
Condition: Dengue Fever; Dengue Hemorrhagic Fever
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever; Hyperthermia
Intervention: Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus; Placebo: NaCl 0.9%
Intervention description: 0.5 mL (at 0, 6, and 12 months), Subcutaneous suspension; 0.5 mL (at 0, 6, and 12 months), Subcutaneous suspension
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 250.0
Sex: All
Minimum age: 2 Years
Maximum age: 11 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dengue fever; Dengue hemorrhagic fever; CYD dengue vaccine

Summary:

      The purpose of this study was to evaluate the safety and immunogenicity of Phase III lots of
      the CYD dengue vaccine in a pediatric population in Malaysia.

      Primary Objectives:

        -  To describe the safety (in terms of solicited and unsolicited adverse events) of the CYD
           dengue vaccine in all participants after each injection.

        -  To describe the antibody response to each dengue virus serotype post-injection 2 and
           post-injection 3.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 2 to 11 years on the day of inclusion

          -  Assent form was signed and dated by the participant (for participants ≥ 7 years) and
             informed consent form was signed and dated by the parent(s) or another legally
             accepted representative, and by an independent witness if the two parents or legally
             accepted representative were illiterate

          -  Participant and parent/legally accepted representative were able to attend all
             scheduled visits to comply with all trial procedures

          -  Participants in good health, based on medical history and physical examination

          -  For a female participant of childbearing potential, use of an effective method of
             contraception or abstinence for at least 4 weeks prior to the first vaccination, until
             at least 4 weeks after the last vaccination

        Exclusion Criteria:

          -  Known pregnancy, or a positive urine pregnancy test (for female participant of
             child-bearing potential only)

          -  Participation in another clinical trial investigating a vaccine, drug, medical device,
             or medical procedure in the 4 weeks preceding the first trial vaccination

          -  Planned participation in another clinical trial during the present trial period

          -  Planned receipt of any vaccine in the 4 weeks following the trial first vaccination,
             except for pandemic influenza vaccination

          -  Receipt of blood or blood-derived products in the past 3 months, which might interfere
             with assessment of the immune response

          -  Known or suspected congenital or acquired immunodeficiency; or receipt of
             immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within
             the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or
             equivalent for more than 2 consecutive weeks within the past 3 months)

          -  Seropositivity for human immunodeficiency virus (HIV) reported by the parent/legally
             acceptable representative

          -  Known systemic hypersensitivity to any of the vaccine components, or history of a
             life-threatening reaction to the vaccine(s) used in the trial or to a vaccine
             containing any of the same substances

          -  Chronic illness that, in the opinion of the investigator, was at a stage where it
             might interfere with trial conduct or completion

          -  Participants who plan to move to another country/region within the 18 coming months

          -  Identified as a child (adopted or natural) of the Investigator or of site employees of
             the Investigator or study center, with direct involvement in the proposed study or
             other studies under the direction of that Investigator or study center.