At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Cervarix® in Healthy Female Subjects Aged 9 to 14 Years in Mexico
In Brief
A Phase 3 clinical trial evaluating CYD Dengue Vaccine and Human Papillomavirus Bivalent [Types 16 and 18] Vaccine, Recombinant for Dengue Fever and 2 related conditions. Completed, enrolled 480 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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