Study of Yellow Fever Vaccine Administered With Tetravalent Dengue Vaccine in Healthy Toddlers
Condition: Dengue; Dengue Hemorrhagic Fever; Yellow Fever
MeSH terms: Dengue; Yellow Fever; Hemorrhagic Fevers, Viral; Severe Dengue; Fever; Hyperthermia
Intervention: Live, attenuated dengue serotype 1, 2, 3, and 4 virus; Yellow fever vaccine; Measles, mumps, and rubella (MMR) vaccine; Pneumococcal Conjugated Vaccine; Hepatitis A Pediatric Vaccine; Diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae vaccine; Live, attenuated dengue serotype 1, 2, 3, and 4 virus; Yellow Fever Vaccine; Placebo (NaCl); Measles, mumps, and rubella vaccine; Pneumococcal Conjugated Vaccine; Diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae vaccine; Hepatitis A Pediatric Vaccine
Intervention description: 0.5 mL, subcutaneous at age 12, 18, and 24 months; 0.5 mL subcutaneous in the deltoid at age 12 to 13 months.; 0.5 mL, subcutaneous at age 12 to 13 months.; 0.5 mL, intramuscular at age 13 to 14 months; 0.5 mL, intramuscular at age 13 to 14 months and 25 to 26 months; 0.5 mL, intramuscular at age 19 to 20 months; 0.5 mL, subcutaneous at age 18 to 19 and 24 to 25 months; 0.5 mL, subcutaneous at age 12 to 13 months; 0.5 mL, subcutaneous at age 12 to 13 months; 0.5 mL, subcutaneous at age 13 to 14 months; 0.5 mL, intramuscular at age 13 to 14 months; 0.5 mL, intramuscular at age 19 to 20 months; 0.5 mL, intramuscular at age 13 to 14 months and 25 to 26 months
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: To ensure that objective safety data were obtained, the trial was designed using an observer-blind methodology since the products were visually different and may be recognized. For first trial vaccination (V01), the person who administered the injections knew which products were administered while either the participant or parent nor the Investigator in charge of safety evaluation knew which products were administered.
Enrollment: 792.0
Sex: All
Minimum age: 12 Months
Maximum age: 13 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dengue; Dengue Hemorrhagic Fever; CYD Dengue Vaccines; Yellow Fever; Stamaril®; Flavivirus Infections

Summary:

      The study was designed to evaluate whether the first CYD dengue vaccination can be
      administered concomitantly with Stamaril® yellow fever vaccine during the same day and visit,
      but at 2 different sites of administration.

      Primary Objective:

        -  To demonstrate the non-inferiority of the immune response against Yellow Fever (YF) in
           flavivirus (FV) non-immune subjects at baseline receiving one dose of Stamaril vaccine
           administered concomitantly with the first dose of CYD dengue vaccine compared to
           participants receiving one dose of Stamaril vaccine concomitantly with placebo.

      Secondary Objectives:

        -  To assess the non-inferiority of YF immune response 28 days post-Stamaril vaccination
           based on seroconversion rates regardless of the FV status of participants at baseline.

        -  To describe the YF immune response 28 days post-Stamaril vaccination in both groups.

        -  To describe the antibody (Ab) response to each dengue virus serotype 28 days post CYD
           dengue vaccine (Visit [V] 05 and V07), following CYD dengue vaccine Dose 1 and Dose 2
           from Group 2 versus following CYD dengue vaccine Dose 2 and Dose 3 for Group 1 (effect
           of YF vaccination).

        -  To describe the safety of Stamaril vaccine administered concomitantly with the first
           dose of CYD dengue vaccine, or Stamaril administered concomitantly with placebo.

        -  To describe the safety of CYD dengue vaccine after the first dose of CYD dengue vaccine
           administered concomitantly with Stamaril vaccine or CYD vaccine administered alone.

        -  To describe the safety of the CYD dengue vaccine in all participants after each dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 12 to 13 months on the day of inclusion.

          -  Born at full term of pregnancy (>=37 weeks) and with a birth weight >=2.5 kg as
             reported by the parent/legally acceptable representative.

          -  Participant in good health, based on medical history and physical examination.

          -  Participant had completed his/her vaccination schedule according to the official
             immunization calendar of Colombia and/or Peru, respectively.

          -  Informed consent form had been signed and dated by the parent(s) or other legally
             acceptable representative (and by 2 independent witnesses if required by local
             regulations).

          -  Participant and parent/legally acceptable representative/tutor able to attend all
             scheduled visits and to comply with all trial procedures.

        Exclusion Criteria:

          -  Participation in another clinical trial investigating a vaccine, drug, medical device,
             or medical procedure in the 4 weeks preceding the first trial vaccination.

          -  Planned participation in another clinical trial during the present trial period.

          -  Planned receipt of any vaccine in the 4 weeks following first trial vaccination.

          -  Previous vaccination against YF, hepatitis A, or measles, mumps and rubella.

          -  Receipt of blood or blood-derived products in the past 3 months which might interfere
             with assessment of the immune response.

          -  Known or suspected congenital or acquired immunodeficiency; or receipt of
             immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within
             the preceding 6 weeks or long-term systemic corticosteroid therapy (prednisone or
             equivalent for more than 2 consecutive weeks within the past 3 months).

          -  Personal known seropositivity for human immunodeficiency virus (HIV) as reported by
             the parent/legally acceptable representative.

          -  History of previous maternal vaccination against YF as reported by the parent/legally
             acceptable representative.

          -  Personal history of YF or dengue infection/disease as reported by the parent/legally
             acceptable representative.

          -  Known systemic hypersensitivity to any of the vaccine components of the vaccines that
             were used in the trial, or history of a life-threatening reaction to the vaccines used
             in the trial or to vaccines containing any of the same substances.

          -  History of contraindication to receipt of vaccines containing components of Stamaril®
             (yellow fever vaccine), measles, mumps and rubella vaccine, hepatitis A vaccine,
             pneumococcal conjugated vaccine or of diphtheria (D) toxoid, tetanus (T) toxoid,
             pertussis toxoid (PT), filamentous hemagglutinin (FHA), polyribosylribitol phosphate
             (PRP) and polio or other diphtheria, tetanus and pertussis vaccine (e.g., DTwP).

          -  Thrombocytopenia, as reported by the parent/legally acceptable representative.

          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicating intramuscular (IM) vaccination.

          -  History of central nervous system disorder or disease, including seizures.

          -  Personal history of thymic pathology (e.g., thymoma), and/or thymectomy.

          -  Chronic illness that, in the opinion of the Investigator, is at a stage where it might
             interfere with trial conduct or completion.

          -  Identified as a child (adopted or natural) of the Investigator or of employees 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.