At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Immunogenicity of a Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years in Malaysia
In Brief
A Phase 3 clinical trial evaluating Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus and Placebo: NaCl 0.9% for Dengue Fever and Dengue Hemorrhagic Fever. Completed, enrolled 250 participants across 4 sites.
Detailed Summary
The purpose of this study was to evaluate the safety and immunogenicity of Phase III lots of the CYD dengue vaccine in a pediatric population in Malaysia. Primary Objectives: * To describe the safety (in terms of solicited and unsolicited adverse events) of the CYD dengue vaccine in all participants after each injection. * To describe the antibody response to each dengue virus serotype post-injection 2 and post-injection 3.
Study Details
Timeline
Interventions
0.5 mL (at 0, 6, and 12 months), Subcutaneous suspension
0.5 mL (at 0, 6, and 12 months), Subcutaneous suspension