Study of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Adacel® in Healthy Subjects
Condition: Dengue Fever; Dengue Hemorrhagic Fever
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever; Hyperthermia
Intervention: CYD Dengue Vaccine; Tdap: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine adsorbed; Tdap: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed
Intervention description: 0.5 milliliter (mL), Subcutaneous at Month 1, 7 and Month 13, respectively; 0.5 mL, intramuscularly (IM) at Month 1.; 0.5 mL, intramuscularly at Day 0.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 688.0
Sex: All
Minimum age: 9 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dengue Fever; Dengue Hemorrhagic Fever; CYD Dengue Vaccine; Dengavaxia®

Summary:

      The aim of the study was to investigate the immunogenicity and safety of CYD dengue vaccine
      and Tetanus Toxoid (T), Reduced Diphtheria Toxoid (D) and Acellular Pertussis Vaccine
      Adsorbed (ap) (Tdap) vaccine when both vaccines were administered concomitantly or
      sequentially.

      Primary Objectives:

        -  To demonstrate the non-inferiority of the humoral immune response to the Tdap booster
           dose concomitantly administered with the first dose of CYD dengue vaccine as compared to
           sequential administration, measured 28 days after Tdap booster dose.

        -  To demonstrate the non-inferiority of the humoral immune response to the first dose of
           CYD dengue vaccine concomitantly administered with Tdap as compared to sequential
           administration, measured 28 days after the first dose of CYD dengue vaccine.

      Secondary Objectives:

        -  To demonstrate the non-inferiority of the humoral immune response of 3 doses of CYD
           dengue vaccine with the first dose concomitantly administered with Tdap as compared to
           sequential administration, measured 28 days after the third dose of CYD dengue vaccine.

        -  To describe the humoral immune response at baseline and 28 days after the first and
           third doses of CYD dengue vaccine, in each and any group.

        -  To describe the humoral immune response of Tdap vaccine at baseline and 28 days after
           concomitant administration with the first dose of CYD dengue vaccine as compared to the
           sequential administration, in each and any group.

        -  To describe the safety of the CYD dengue vaccine and of the Tdap booster dose after each
           and any injection in each group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant aged 9 to 60 years (i.e., from the day of the 9th birthday to the day
             prior to the 61th birthday) on the day of inclusion.

          -  Participant in good health, based on medical history and physical examination.

          -  Informed consent form (ICF) or assent form was signed and dated by the participant
             (based on local regulations), and/or ICF was signed and dated by the parent(s) or
             another legally acceptable representative (and by an independent witness if required
             by local regulations).

          -  For participant aged 9 to 11 years: known (documented) receipt of at least 4 previous
             doses of diphtheria toxoid, tetanus toxoid and acellular pertussis-containing (DTaP)
             vaccines, with the last dose not within the last 5 years prior to enrolment.

        OR For participant aged at least 12 years: known (documented or self-reported) receipt of
        at least 3 previous doses of diphtheria toxoid, tetanus toxoid, and whole cell
        pertussis-containing (DTwP) vaccines, with the last dose not within the last 5 years prior
        to enrolment.

          -  Participant (or participant and parent[s]/legally acceptable representatives) was able
             to attend all scheduled visits and complied with all trial procedures.

        Exclusion Criteria:

          -  Participant was pregnant, or lactating, or of childbearing potential (to be considered
             of non-childbearing potential, a female must be pre-menarche or post-menopausal for at
             least 1 year, surgically sterile, or using an effective method of contraception or
             abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks
             after the last vaccination).

          -  Participation at the time of study enrollment (or in the 4 weeks preceding the first
             trial vaccination) or planned participation during the present trial period in another
             clinical trial investigating a vaccine, drug, medical device, or medical procedure.

          -  Planned receipt of any vaccine in the 4 weeks following any trial vaccination.

          -  Previous vaccination against dengue disease with the trial CYD dengue vaccine.

          -  Receipt of immune globulins, 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 (including human
             immunodeficiency virus (HIV) infection with impaired immune function); or receipt of
             immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within
             the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or
             equivalent for more than 2 consecutive weeks within the past 3 months).

          -  A previous severe reaction to pertussis, diphtheria or tetanus vaccine including
             immediate anaphylaxis, encephalopathy within 7 days or seizure within 3 days of
             receiving the vaccine.

          -  Known systemic hypersensitivity to any of the vaccine components, or history of a
             life-threatening reaction to the vaccine used in the trial or to a vaccine containing
             any of the same substances.

          -  Thrombocytopenia, contraindicating IM vaccination.

          -  Bleeding disorder or receipt of anticoagulants within 3 weeks preceding inclusion,
             which might be a contraindication for IM vaccination, at the discretion of the
             Investigator.

          -  Deprived of freedom by administrative or court order, or in an emergency setting, or
             hospitalized involuntarily.

          -  Current alcohol abuse or drug addiction that, based on Investigator's judgment, may
             interfere with the participant's ability to comply with trial procedures.

          -  Chronic illness that, in the opinion of the Investigator, was at a stage where it
             might interfere with trial conduct or completion.

          -  Identified as an Investigator or employee of the Investigator with direct involvement
             in the proposed study, or identified as an immediate family member (i.e., parent,
             spouse, natural or adopted child) of the Investigator or employee with direct
             involvement in the proposed study.

          -  Self-reported HIV, Hepatitis B, or Hepatitis C infection.

          -  Personal history of Guillain-Barré syndrome.