Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Gardasil®
Condition: Dengue Fever; Dengue Hemorrhagic Fever; Human Papillomavirus Disease
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever; Hyperthermia
Intervention: CYD Dengue Vaccine; CYD Dengue Vaccine; Human Papillomavirus Quadrivalent [Types 6, 11, 16, and 18] Vaccine, Recombinant.
Intervention description: 0.5 mL, SC injection at Day 0, Month 6 and 12, respectively.; 0.5 mL, SC injection at Month 1, 7 and 13, respectively.; 0.5 mL, IM injection at Day 0 and Month 6, respectively.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 528.0
Sex: All
Minimum age: 9 Years
Maximum age: 13 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dengue Fever; Dengue Hemorrhagic Fever; Human Papillomavirus Disease; CYD Dengue Vaccine; Dengvaxia®; Gardasil®

Summary:

      The aim of the study was to assess the safety and immunogenicity of the CYD dengue vaccine
      and Gardasil (Human Papillomavirus Quadrivalent [Types 6, 11, 16, and 18] Vaccine,
      Recombinant) when administered concomitantly or sequentially.

      Primary objectives:

        -  To demonstrate that the humoral immune response (in terms of geometric mean titers
           [GMTs]) to Gardasil after concomitant administration was non-inferior to sequential
           administration with the CYD dengue vaccine measured 28 days after the last dose of
           Gardasil.

        -  To demonstrate that the humoral immune response to the CYD dengue vaccine after
           concomitant administration was non-inferior to sequential administration with Gardasil
           measured 28 days after the last dose of the CYD dengue vaccine.

      Secondary Objectives:

        -  To demonstrate that the humoral immune response (in terms of seroconversion) to Gardasil
           vaccine after concomitant administration was non-inferior to sequential administration
           with the CYD dengue vaccine measured 28 days after the last dose of Gardasil.

        -  To describe the humoral immune response to Gardasil at baseline and after each dose of
           Gardasil in each and any group.

        -  To describe the humoral immune response to the CYD dengue vaccine at baseline and after
           each dose of the CYD dengue vaccine in each and any group.

        -  To describe the safety of Gardasil and the CYD dengue vaccine after each and any dose in
           each group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants aged 9 to 13 years (i.e., from the day of the 9th birthday to the day
             prior to the 14th birthday) on the day of inclusion.

          -  Informed consent form (ICF) or Assent form (AF) had been signed and dated by the
             participant (based on local regulations), and/or ICF had been signed and dated by the
             parent(s) or another legally acceptable representative (and by an independent witness
             if required by local regulations).

          -  Participant (or participant and parent[s] or another legally acceptable
             representative) was (were) able to attend all scheduled visits and complied with all
             trial procedures.

          -  Participant in good health, based on medical history, and physical examination.

        Exclusion Criteria:

          -  Participant was pregnant, or lactating, or of childbearing potential (to be considered
             of non-childbearing potential, a female had to be pre-menarche, surgically sterile, or
             using an effective method of contraception or abstinence from at least 4 weeks prior
             to the first vaccination and 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 vaccine.

          -  Previous vaccination against human papillomavirus (HPV) disease with either the trial
             vaccine or another vaccine.

          -  Receipt of immune globulins, blood or blood-derived products in the past 3 months.

          -  Known or suspected congenital or acquired immunodeficiency (including human
             immunodeficiency virus 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 corticosteroid therapy
             (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).

          -  History of HPV infection, confirmed either clinically, serologically, or
             microbiologically as reported by participant or parent(s) or another 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.

          -  Thrombocytopenia, contraindicating IM vaccination.

          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicating IM vaccination.

          -  Deprived of freedom by an administrative or court order, or in an emergency setting,
             or hospitalized involuntarily.

          -  Current alcohol abuse or drug addiction that, based on investigator's judgment, might
             interfered 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 interfered 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 Hepatitis B, Hepatitis C infection.