Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Cervarix®
Condition: Dengue Fever; Dengue Hemorrhagic Fever; Human Papillomavirus Disease
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever; Hyperthermia
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study was to investigate the immunogenicity and safety of CYD dengue vaccine
      and Cervarix when administered concomitantly or sequentially in healthy female participants
      aged 9-14 years of age.

      Primary objectives:

        -  To demonstrate that the humoral immune response (in terms of geometric mean titers
           [GMTs]) to Cervarix after concomitant administration with the CYD dengue vaccine is
           non-inferior to the humoral immune response (in terms of GMTs) after sequential
           administration with the CYD dengue vaccine measured 28 days after the last dose of
           Cervarix.

        -  To demonstrate that the humoral immune response (in terms of GMTs) to the CYD dengue
           vaccine after concomitant administration with Cervarix is non-inferior to the humoral
           immune response (in terms of GMTs) to the CYD dengue vaccine after sequential
           administration with Cervarix 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 Cervarix
           after concomitant administration with the CYD dengue vaccine is non-inferior to the
           humoral immune response (in terms of seroconversion) to Cervarix sequential
           administration with the CYD dengue vaccine measured 28 days after the last dose of
           Cervarix.

        -  To describe the humoral immune response to Cervarix at baseline and after each dose of
           Cervarix 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 Cervarix and CYD dengue vaccine after each and any dose in
           each group.
    

Detailed description: 
      Participants received 3 doses of the CYD dengue vaccine and 2 doses of Cervarix administered
      either concomitantly or sequentially. Due to a protocol amendment, only previously dengue
      exposed participants (seropositive for dengue before vaccination) were eligible to complete
      the vaccination schedule and be assessed for CYD immunogenicity and human papilloma virus
      (HPV) immunogenicity. Dengue unexposed participants (seronegative for dengue before
      vaccination) did not receive the third CYD dengue vaccine injection, but were followed for
      safety up to 6 months after the last injection.

      Safety assessments included solicited reactions within 7 or 14 days after each injection,
      unsolicited adverse events within 28 days after each injection, and serious adverse events
      during the study period. All participants were included in the assessment of safety up to 6
      months after the last injection.
    

Intervention name(s): CYD Dengue Vaccine; CYD Dengue Vaccine; Human Papillomavirus Bivalent [Types 16 and 18] Vaccine, Recombinant; Human Papillomavirus Bivalent [Types 16 and 18] Vaccine, Recombinant
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL, SC at Day 0, Months 6 and 12; 0.5 mL, SC at Months 1, 7, and 13; 0.5 mL, IM at Day 0 and Month 6; 0.5 mL, IM at Day 0 and Month 6
Other intervention name(s): Dengvaxia®; Dengvaxia®; Cervarix®; Cervarix®
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Dengue Fever; Dengue Hemorrhagic Fever; Human Papillomavirus Disease; CYD Dengue Vaccine; Dengvaxia®; Cervarix®