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
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      All participants received a total of 9 injections during the study. Vaccine immunogenicity
      assessments for dengue neutralizing antibodies was performed in a randomized subset of
      participants. All participants were followed-up for safety during the study and for 6 months
      after the last CYD dengue vaccination.
    

Intervention name(s): 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 type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 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
Other intervention name(s): CYD Dengue Vaccine; Stamaril®; MMR vaccine; DTaP IPV//Hib Vaccine; CYD dengue vaccine; Stamaril®; NaCl 0.9%; MMR vaccine; DTaP IPV//Hib Vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dengue; Dengue Hemorrhagic Fever; CYD Dengue Vaccines; Yellow Fever; Stamaril®; Flavivirus Infections