At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Immunogenicity and Safety of a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With Tetravalent Dengue Vaccine in Healthy Toddlers Aged 15 to 18 Months in Mexico
In Brief
A Phase 3 clinical trial evaluating Live, attenuated, recombinant dengue serotype 1, 2, 3, and 4 virus, DTaP IPV//Hib vaccine, and 3 other interventions for Dengue and Dengue Hemorrhagic Fever. Completed, enrolled 720 participants across 4 sites.
Detailed Summary
The aim of the study was to assess whether the second CYD dengue vaccination could be administered concomitantly with the booster vaccination of a pediatric combination vaccine (Pentaxim™) during the same day visit but in 2 different sites of administration. Primary Objective: * To demonstrate the non-inferiority of the antibody response against all antigens (diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type b (Hib)) in participants receiving one booster dose of Pentaxim™ vaccine administered concomitantly with the second dose of CYD dengue vaccine compared to participants receiving one booster dose of Pentaxim™ vaccine administered concomitantly with placebo. Secondary Objectives: * To describe the safety of Pentaxim™ vaccine administered concomitantly with the second dose of CYD dengue vaccine, or administered concomitantly with placebo. * To describe the safety of the CYD dengue vaccine after the second dose of CYD dengue vaccine administered concomitantly with Pentaxim™ vaccine (at Visit 05) or administered alone (at Visit 06). * To describe the safety of the CYD dengue vaccine in all participants after each dose. * To describe the antibody response to each dengue virus serotype (post-Dose 2 and post-Dose 3) after the second dose of CYD dengue vaccine administered concomitantly with Pentaxim vaccine (at Visit 05) or administered alone (at Visit 06). * To describe the antibody response to each dengue virus serotype post-Dose 2 and post-Dose 3.
Study Details
Timeline
Interventions
0.5 mL, subcutaneous at age 9 to 12, 15 to 18 and 21 to 24 months.
0.5 mL, intramuscular
0.5 mL, subcutaneous
0.5 mL, subcutaneous
0.5 mL, intramuscular
0.5 mL, subcutaneous at age 9 to 12, 16 to 19 and 21 to 24 months
0.5 mL, intramuscular
0.5 mL, subcutaneously
0.5 mL, subcutaneous
0.5 mL, intramuscular