Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects
Condition: Dengue Virus; Dengue Fever; Dengue Hemorrhagic Fever; Dengue Disease
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever; Hyperthermia
Intervention: CYD dengue vaccine serotypes (1, 2, 3, 4).; Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide
Intervention description: 0.5 mL, Subcutaneous; Each at 0.5 mL, Subcutaneous, respectively
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: The first and second vaccinations were administered in a blind-observer manner. The third vaccination was planned to be administered in a single-blind manner; however, due to the cancellation of the statistical analysis after the second vaccination, the third vaccination was also administered in a blind- observer manner. To ensure the blind-observer design of the 3 vaccinations, the product was prepared in a separate room whether neither the Investigator nor participant had access.
Enrollment: 180.0
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; Dengue vaccine

Summary:

      This trial evaluated the use of a tetravalent vaccine against dengue.

      Primary objectives:

        -  To describe the humoral immune response to dengue before and after each vaccination with
           tetravalent dengue vaccine in adults, adolescents, and children.

        -  To evaluate the safety of each vaccination with tetravalent dengue vaccine in the 4 age
           cohorts.

        -  To evaluate the persistence of antibodies against dengue during 5 years after the first
           vaccination with tetravalent dengue vaccine in the 4 age cohorts.
    

Eligibility criteria:

        Inclusion Criteria :

          -  Aged 2 to 45 years on the day of inclusion.

          -  Provision of Informed Consent/Assent Form signed by the participant (and/or by the
             parent or another legally acceptable representative for participants <18 years).

          -  Participant (and parent/guardian for participants <18 years) able to attend all
             scheduled visits and to comply with all trial procedures.

          -  For a female participant of child-bearing potential, avoid becoming pregnant (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.

          -  Participant in good health, based on medical history, physical examination and
             laboratory parameters.

        Exclusion Criteria :

          -  Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.

          -  For a female participant of child-bearing potential, known pregnancy or positive serum
             pregnancy test at Screening.

          -  For a female participant of child-bearing potential, known pregnancy or positive urine
             pregnancy test on the day of the first injection.

          -  Breast-feeding female participant.

          -  Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.

          -  Human immunodeficiency virus, hepatitis B, or hepatitis C seropositivity in the blood
             sample taken at screening.

          -  Planned participation in another clinical trial during the first year of the study.

          -  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 corticosteroids therapy.

          -  Known systemic hypersensitivity to any of the vaccine components or history of a
             life-threatening reaction to the trial vaccines or to a vaccine containing any of the
             same substances.

          -  Chronic illness at a stage that could interfere with trial conduct or completion, in
             the opinion of the Investigator.

          -  Current alcohol abuse or drug addiction that may interfere with the participant's
             ability to comply with trial procedures.

          -  Receipt of blood or blood-derived products in the past 3 months that might interfere
             with the assessment of immune response.

          -  Participant deprived of freedom by an administrative or court order, or in an
             emergency setting, or hospitalized without his/her consent.

          -  Laboratory abnormalities of at least moderate severity or clinically significant
             according to the Investigator 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 receipt of any vaccine in the 4 weeks following the first trial vaccination.

          -  Familial atopy medical history (parents, brothers, or sisters).

          -  Previous vaccination with meningococcal A+C or typhoid vaccines within 3 years prior
             to inclusion.

          -  History of meningococcal or typhoid infections (confirmed either clinically,
             serologically or microbiologically).