Study of a Novel Tetravalent Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in Latin America
Condition: Dengue Fever; Dengue Hemorrhagic Fever; Dengue
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever; Hyperthermia
Intervention: Live, attenuated, dengue serotype 1, 2, 3, 4 virus; Placebo: (NaCl) 0.9% solution
Intervention description: 0.5 mL, Subcutaneous; 0.5 mL, Subcutaneous
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20869.0
Sex: All
Minimum age: 9 Years
Maximum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dengue Virus; Dengue fever; Dengue Hemorrhagic Fever; CYD dengue vaccine; Flavivirus; Dengue Disease

Summary:

      The aim of the study was to assess the efficacy of Sanofi Pasteur's CYD dengue vaccine in
      preventing symptomatic virologically-confirmed dengue cases for dengue-endemic areas of Latin
      America.

      Primary Objective:

      To assess the efficacy of CYD dengue vaccine after 3 vaccinations at 0, 6, and 12 months in
      preventing symptomatic virologically-confirmed dengue (VCD) cases, regardless of the
      severity, due to any of the four serotypes in children and adolescents aged 9 to 16 years at
      the time of inclusion.

      Secondary Objectives:

        -  To describe the efficacy of CYD dengue vaccine in preventing symptomatic VCD cases after
           the third dose to the end of the Active Phase, after at least 1 dose, and after 2 doses.

        -  To describe the occurrence of hospitalized VCD cases and the occurrence of severe
           (clinically severe or as per World Health Organization (WHO) criteria) VCD cases,
           throughout the Surveillance Expansion Period (SEP) and throughout the trial (from Day 0
           until the end of the study).

        -  To describe the antibody response to each dengue serotype after Dose 2, after Dose 3,
           and 1 and 5 years after Dose 3.

        -  To describe the occurrence of serious adverse events (SAEs), including SAEs of special
           interest in all participants throughout the trial period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 9 to 16 years on the day of inclusion and resident of the site zone

          -  Participant in good health, based on medical history and physical examination

          -  Assent form or informed consent form has been signed and dated by the participant
             (based on local regulations), and informed consent form has been signed and dated by
             the parent(s) or another legally acceptable representative (and by an independent
             witness if required by local regulations)

          -  Participant was able to attend all scheduled visits and comply with all trial
             procedures.

        Exclusion Criteria:

          -  Participant was pregnant, or lactating, or of childbearing potential (to be considered
             of non-childbearing potential, a female must be pre-menarche for at least 1 year,
             surgically sterile, or using an effective method of contraception or abstinence from
             at least 4 weeks prior to the first vaccination until at least 4 weeks after the last
             vaccination).

          -  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 present trial period

          -  Self-reported 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 corticosteroids therapy (prednisone or
             equivalent for more than 2 consecutive weeks within the past 3 months)

          -  Self-reported seropositivity for Human Immunodeficiency Virus (HIV) infection

          -  Self-reported systemic hypersensitivity to any of the vaccine components, or history
             of a life-threatening reaction to the vaccine used in the trial or to a vaccine
             containing any of the same substances

          -  Chronic illness that, in the opinion of the Investigator, is at a stage where it might
             interfere with trial conduct or completion

          -  Receipt of blood or blood-derived products in the past 3 months, which might interfere
             with assessment of the immune response

          -  Planned receipt of any vaccine in the 4 weeks following any trial vaccination

          -  Deprived of freedom by administrative or court order, or in an emergency setting, or
             hospitalized involuntarily

          -  Current alcohol abuse or drug addiction that may interfere with the participant's
             ability to comply with trial procedures

          -  Identified as a site employee 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, as well as a family member (i.e., immediate, husband,
             wife and their children, adopted or natural) of the site employees or the
             Investigator.