Study of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Subjects in Singapore
Condition: Dengue Fever; Dengue Hemorrhagic Fever; Dengue Virus; Dengue Diseases
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever; Hyperthermia
Intervention: CYD Dengue vaccine; NaCl + influenza virus or hepatitis A vaccine
Intervention description: 0.5 mL, Subcutaneous on Day 0, Months 6 and 12; 0.5 mL, Subcutaneous (Intramuscular - Hepatitis A)
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: An observer-design for the first vaccination and a single-blind design for the second and third vaccination were chosen to minimize the bias of the vaccine evaluation. The Investigator in charge of safety evaluation, the Sponsor, and the participants/parents did not know which vaccine was administrated at the first visit. For the second and third vaccinations, the participants/parents did not know which vaccine was administered.
Enrollment: 1198.0
Sex: All
Minimum age: 2 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dengue virus; Dengue fever; Dengue Hemorrhagic fever; Dengue diseases; Sanofi Pasteur's CYD Dengue Vaccine

Summary:

      Primary Objectives:

        -  To evaluate safety after each CYD Dengue vaccination in terms of injection site and
           systemic reactogenicity.

        -  To evaluate the occurrence of Serious Adverse Events (SAEs) throughout the trial period.

        -  To evaluate the humoral immune response to each CYD Dengue serotype after each
           vaccination in a subset of participants.

      Secondary Objectives:

        -  To evaluate the persistence of the humoral immune response during 4 years after the last
           vaccination in a subset of participants.
    

Eligibility criteria:

        Inclusion Criteria :

          -  Aged from 2 to 45 years on the day of inclusion.

          -  Participant in good health, based on medical history and physical examination.

          -  Provision of informed consent form (and assent form for participants aged 6 to 12
             years) signed by the participant and by the parent(s) or another legally acceptable
             representative for participants aged less than 21 years.

          -  Participants and parent(s)/legally acceptable representative able to attend all
             scheduled visits and comply with all trial procedures.

          -  For a woman of child-bearing potential, avoid becoming pregnant (use of an effective
             method of contraception or abstinence) for at least 4 weeks before the first
             vaccination until 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 the first vaccination, according to Investigator judgment.

          -  For a woman of child-bearing potential, known pregnancy or positive urine pregnancy
             test on the day of inclusion.

          -  Breast-feeding woman.

          -  Known systemic hypersensitivity to any of the components of the trial vaccines
             (especially egg proteins or neomycin) or history of a life-threatening reaction to the
             trial vaccines or to a vaccine containing any of the same substances.

          -  Personal or family history of thymic pathology or myasthenia.

          -  Previous hepatitis A vaccination (for children only).

          -  Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy
             such as anti-cancer chemotherapy or radiation therapy within the past 6 months, or
             long-term systemic corticosteroid therapy.

          -  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 that might interfere
             with the assessment of immune response.

          -  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 18 coming months.

          -  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.

          -  Participant deprived of freedom by an administrative or court order, or in an
             emergency setting, or hospitalized without his/her consent.

          -  Current or past alcohol abuse or drug addiction that may interfere with the
             participants ability to comply with trial procedures.

          -  Participant who plans to move to another country within the 18 coming months.