Study of a Novel Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 14 Years in Asia
Condition: Dengue; Dengue Fever; Dengue Hemorrhagic Fever
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever; Hyperthermia
Intervention: Live, attenuated, dengue serotype 1, 2, 3, 4 virus; Placebo: Sodium chloride (NaCl) 0.9%
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: 10275.0
Sex: All
Minimum age: 2 Years
Maximum age: 14 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dengue; Dengue fever; Dengue Hemorrhagic Fever; CYD dengue vaccine; Flavivirus

Summary:

      The aim of the trial was to assess the efficacy of the CYD dengue vaccine in preventing
      symptomatic, virologically-confirmed dengue (VCD) cases.

      Primary Objective:

      To assess the efficacy of CYD dengue vaccine after 3 vaccinations at 0, 6, and 12 months in
      preventing symptomatic VCD cases, regardless of the severity, due to any of the four
      serotypes in children aged 2 to 14 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 serious adverse events (SAEs), including SAEs of special
           interest in all participants throughout the trial period.

        -  To describe the occurrence of hospitalized virologically-confirmed dengue (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 to 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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 2 to 14 years on the day of inclusion and resident of the site zone

          -  Participant was 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 attended all scheduled visits and to comply with all trial procedures.

        Exclusion Criteria:

          -  Participant was pregnant, or lactating, or was 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 might interfere with the 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.