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
Intervention: 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 description: 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
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: An observer-blind design was chosen since the products were visually different. For the second dose of CYD dengue vaccine, the person who administered the injections knew which product was administered while the subject/parent and Investigator were blinded. The first and third doses of CYD dengue vaccine were administered according to an open-label procedure. A placebo dose was administered at Month 7(Group 1) and concomitantly with Pentaxim vaccine at Month 6 (Group 2) to maintain the blind.
Enrollment: 720.0
Sex: All
Minimum age: 9 Months
Maximum age: 12 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dengue; Dengue Hemorrhagic Fever; CYD Dengue Vaccines; Pentaxim™

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 9 to 12 months on the day of inclusion.

          -  Born at full term of pregnancy (>= 37 weeks) and with a birth weight >= 2.5 kg.

          -  Participant in good health, based on medical history and physical examination.

          -  Documentation of completion of the primary vaccination series with Pentaxim vaccine
             with the 3 doses received between 2 and 8 months of age.

          -  Informed consent form had been signed and dated by both parents or other legally
             acceptable representative (and by 2 mandatory witnesses as required by local
             regulations).

          -  Participant and parent/guardian attended all scheduled visits and 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 any trial vaccination.

          -  Previous vaccination against flavivirus diseases, measles, mumps, rubella, previous
             booster vaccination against pneumococcal diseases, diphtheria, tetanus, pertussis, Hib
             and/or polio.

          -  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 months; or long-term systemic corticosteroid therapy (prednisone or
             equivalent for more than 2 consecutive weeks within the past 3 months).

          -  Personal seropositivity for human immunodeficiency virus (HIV) or hepatitis C as
             reported by the parent(s)/legally acceptable representative.

          -  History of pertussis and/or Hib infection as reported by the parent(s)/legally
             acceptable representative.

          -  Known systemic hypersensitivity to any of the vaccine components, or history of a
             life-threatening reaction to the vaccines used in the trial or to a vaccine containing
             any of the same substances.

          -  History of contraindication to the receipt of vaccines containing components of
             Pentaxim vaccine (diphtheria toxoid, tetanus toxoid, pertussis toxoid, filamentous
             hemagglutinin, polyribosylribitol phosphate [PRP] and polio) or of measles, mumps and
             rubella vaccine and of pneumococcal vaccine.

          -  Thrombocytopenia, as reported by the parent(s)/legally acceptable representative.

          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicating intramuscular vaccination.

          -  History of central nervous system disorder or disease, including seizures.

          -  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 site 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.