Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Gardasil® in Healthy Subjects Aged 9 to 13 Years in Malaysia

Detailed 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.

Study Details

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Interventions