Study of a Booster Injection of Pentaxim™ Vaccine Administered With Dengue Vaccine in Healthy Toddlers
Condition: Dengue; Dengue Hemorrhagic Fever
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study was to assess whether the second CYD dengue vaccination could be
      administered concomitantly with the booster vaccination of a pediatric combination vaccine
      (Pentaxim™) during the same day visit but in 2 different sites of administration.

      Primary Objective:

        -  To demonstrate the non-inferiority of the antibody response against all antigens
           (diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type b (Hib)) in
           participants receiving one booster dose of Pentaxim™ vaccine administered concomitantly
           with the second dose of CYD dengue vaccine compared to participants receiving one
           booster dose of Pentaxim™ vaccine administered concomitantly with placebo.

      Secondary Objectives:

        -  To describe the safety of Pentaxim™ vaccine administered concomitantly with the second
           dose of CYD dengue vaccine, or administered concomitantly with placebo.

        -  To describe the safety of the CYD dengue vaccine after the second dose of CYD dengue
           vaccine administered concomitantly with Pentaxim™ vaccine (at Visit 05) or administered
           alone (at Visit 06).

        -  To describe the safety of the CYD dengue vaccine in all participants after each dose.

        -  To describe the antibody response to each dengue virus serotype (post-Dose 2 and
           post-Dose 3) after the second dose of CYD dengue vaccine administered concomitantly with
           Pentaxim vaccine (at Visit 05) or administered alone (at Visit 06).

        -  To describe the antibody response to each dengue virus serotype post-Dose 2 and
           post-Dose 3.
    

Detailed description: 
      Participants required 8 or 9 clinic visits and received a total of 7 injections. The dengue
      post-vaccinal viremia was assessed at Visit 2 from a subset of toddlers. The dengue
      immunogenicity was assessed 28 days after CYD dengue dose 2 and dose 3 from a subset of
      toddlers. Participants were followed-up for safety after each vaccine dose and for 6 months
      after the last dengue vaccination.
    

Intervention name(s): Live, attenuated, recombinant dengue serotype 1, 2, 3, and 4 virus; DTaP IPV//Hib vaccine; Placebo; Measles, mumps, and rubella vaccine; Pneumococcal vaccine; Live, attenuated, recombinant dengue serotype 1, 2, 3, and 4 virus; DTaP IPV//Hib vaccine; Placebo; Measles, mumps, and rubella vaccine; Pneumococcal vaccine
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL, subcutaneous at age 9 to 12, 15 to 18 and 21 to 24 months.; 0.5 mL, intramuscular; 0.5 mL, subcutaneous; 0.5 mL, subcutaneous; 0.5 mL, intramuscular; 0.5 mL, subcutaneous at age 9 to 12, 16 to 19 and 21 to 24 months; 0.5 mL, intramuscular; 0.5 mL, subcutaneously; 0.5 mL, subcutaneous; 0.5 mL, intramuscular
Other intervention name(s): CYD Dengue Vaccine; Pentaxim™; NaCl; Trimovax®; Prevenar®; CYD Dengue Vaccine; Pentaxim™; NaCl; Trimovax®; Prevenar®
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dengue; Dengue Hemorrhagic Fever; CYD Dengue Vaccines; Pentaxim™