NCT01411241

Study of a Booster Injection of Pentaxim™ Vaccine Administered With Dengue Vaccine in Healthy Toddlers

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 720 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 9 Months – 12 Months
• Healthy volunteers: Accepted

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.

Detailed description

Participants required 8 or 9 clinic visits and received a total of 7 injections. The dengue post-vaccinal viremia was assessed at Visit 2 from a subset of toddlers. The dengue immunogenicity was assessed 28 days after CYD dengue dose 2 and dose 3 from a subset of toddlers. Participants were followed-up for safety after each vaccine dose and for 6 months after the last dengue vaccination.

Conditions

• Dengue
• Dengue Hemorrhagic Fever

Interventions

Type	Name	Description
BIOLOGICAL	Live, attenuated, recombinant dengue serotype 1, 2, 3, and 4 virus	0.5 mL, subcutaneous at age 9 to 12, 15 to 18 and 21 to 24 months.
BIOLOGICAL	DTaP IPV//Hib vaccine	0.5 mL, intramuscular
BIOLOGICAL	Placebo	0.5 mL, subcutaneous
BIOLOGICAL	Measles, mumps, and rubella vaccine	0.5 mL, subcutaneous
BIOLOGICAL	Pneumococcal vaccine	0.5 mL, intramuscular
BIOLOGICAL	Live, attenuated, recombinant dengue serotype 1, 2, 3, and 4 virus	0.5 mL, subcutaneous at age 9 to 12, 16 to 19 and 21 to 24 months
BIOLOGICAL	DTaP IPV//Hib vaccine	0.5 mL, intramuscular
BIOLOGICAL	Placebo	0.5 mL, subcutaneously
BIOLOGICAL	Measles, mumps, and rubella vaccine	0.5 mL, subcutaneous
BIOLOGICAL	Pneumococcal vaccine	0.5 mL, intramuscular

Timeline

• Start date: 2011-07-18
• Primary completion: 2014-02-04
• Completion: 2014-04-01
• First posted: 2011-08-08
• Last updated: 2022-03-25
• Results posted: 2019-07-29

Locations

4 sites across 1 country: Mexico