Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years
Condition: Dengue Virus; Dengue Fever; Dengue Hemorrhagic Fever; Dengue Diseases
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever; Hyperthermia
Intervention: CYD Dengue Vaccine Serotypes 1, 2, 3, and 4; Pneumococcal polysaccharide vaccine
Intervention description: 0.5 mL, Subcutaneous (SC); 0.5 mL, SC
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The observer-blind design was implemented. 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 any potential bias, the control group used the same route and schedule as the study vaccine.
Enrollment: 300.0
Sex: All
Minimum age: 2 Years
Maximum age: 11 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dengue virus; Dengue fever; Dengue Hemorrhagic fever; Dengue diseases; Dengue vaccine

Summary:

      The aim of the trial was to evaluate the use of a tetravalent vaccine, CYD dengue vaccine,
      against dengue disease.

      Primary Objectives:

        -  To describe the humoral immune response to dengue before and after each vaccination with
           dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years)
           previously vaccinated with yellow fever (YF) vaccine.

        -  To evaluate the safety of each vaccination with dengue vaccine in two age cohorts of
           children (6 to 11 years and 2 to 5 years).

        -  To describe viremia after the first and second vaccinations with dengue vaccine in a
           subgroup of 130 randomized participants (100 participants in Dengue Vaccine Group and 30
           participants in Control Group) in two age cohorts of children (6 to 11 years and 2 to 5
           years).
    

Eligibility criteria:

        Inclusion Criteria :

          -  Aged 2 to 11 years on the day of inclusion.

          -  Participant in good health, based on medical history, physical examination and
             laboratory parameters.

          -  Provision of Assent Form signed by the participants (for participants >=8 years old)
             and Informed Consent Form signed by the parents or another legally acceptable
             representative (and by an independent witness for illiterate parent[s]).

          -  Participant and parents/legally acceptable representative able to attend all scheduled
             visits and to comply with all trial procedures.

          -  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.

          -  Documented receipt of yellow fever vaccine since at least one month before the first
             vaccination.

        Exclusion Criteria :

          -  Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.

          -  For a female participant of child-bearing potential (girls post-menarche), known
             pregnancy.

          -  For a female participant of child-bearing potential (girls post-menarche), known
             pregnancy or positive pregnancy test in blood sample taken at Screening.

          -  Participation in another clinical trial investigating a vaccine, drug, medical device,
             or a medical procedure in the 4 weeks preceding the first trial vaccination.

          -  Planned participation in another clinical trial during the trial.

          -  Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy
             such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months,
             or long-term systemic corticosteroids therapy.

          -  Known systemic hypersensitivity to any of the vaccines components or history of a
             life-threatening reaction to the trial vaccines or to a vaccine containing any of the
             same substances.

          -  Systemic hypersensitivity to YF vaccine or history of a life-threatening reaction to
             YF vaccine.

          -  Chronic illness at a stage that could interfere with trial conduct or completion, in
             the opinion of the Investigator.

          -  Current or past alcohol abuse or drug addiction that may interfere with the
             participant's ability to comply with trial procedures.

          -  Receipt of any blood or blood-derived products in the past 3 months, that might
             interfere with the assessment of immune response.

          -  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.

          -  Human Immunodeficiency Virus, hepatitis B antigen, or hepatitis C seropositivity in
             blood sample taken at Screening.

          -  Clinically significant laboratory abnormalities (as determined by the Investigator) in
             blood sample taken at Screening.

          -  Known previous vaccination with pneumococcal polysaccharide vaccine.