NCT01436396

Study of Yellow Fever Vaccine Administered With Tetravalent Dengue Vaccine in Healthy Toddlers

Immunogenicity and Safety of Yellow Fever Vaccine (Stamaril®) Administered Concomitantly With Tetravalent Dengue Vaccine in Healthy Toddlers at 12-13 Months of Age in Colombia and Peru

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 792 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 12 Months – 13 Months
• Healthy volunteers: Accepted

Summary

The study was designed to evaluate whether the first CYD dengue vaccination can be administered concomitantly with Stamaril® yellow fever vaccine during the same day and visit, but at 2 different sites of administration. Primary Objective: * To demonstrate the non-inferiority of the immune response against Yellow Fever (YF) in flavivirus (FV) non-immune subjects at baseline receiving one dose of Stamaril vaccine administered concomitantly with the first dose of CYD dengue vaccine compared to participants receiving one dose of Stamaril vaccine concomitantly with placebo. Secondary Objectives: * To assess the non-inferiority of YF immune response 28 days post-Stamaril vaccination based on seroconversion rates regardless of the FV status of participants at baseline. * To describe the YF immune response 28 days post-Stamaril vaccination in both groups. * To describe the antibody (Ab) response to each dengue virus serotype 28 days post CYD dengue vaccine (Visit \[V\] 05 and V07), following CYD dengue vaccine Dose 1 and Dose 2 from Group 2 versus following CYD dengue vaccine Dose 2 and Dose 3 for Group 1 (effect of YF vaccination). * To describe the safety of Stamaril vaccine administered concomitantly with the first dose of CYD dengue vaccine, or Stamaril administered concomitantly with placebo. * To describe the safety of CYD dengue vaccine after the first dose of CYD dengue vaccine administered concomitantly with Stamaril vaccine or CYD vaccine administered alone. * To describe the safety of the CYD dengue vaccine in all participants after each dose.

Detailed description

All participants received a total of 9 injections during the study. Vaccine immunogenicity assessments for dengue neutralizing antibodies was performed in a randomized subset of participants. All participants were followed-up for safety during the study and for 6 months after the last CYD dengue vaccination.

Conditions

• Dengue
• Dengue Hemorrhagic Fever
• Yellow Fever

Interventions

Type	Name	Description
BIOLOGICAL	Live, attenuated dengue serotype 1, 2, 3, and 4 virus	0.5 mL, subcutaneous at age 12, 18, and 24 months
BIOLOGICAL	Yellow fever vaccine	0.5 mL subcutaneous in the deltoid at age 12 to 13 months.
BIOLOGICAL	Measles, mumps, and rubella (MMR) vaccine	0.5 mL, subcutaneous at age 12 to 13 months.
BIOLOGICAL	Pneumococcal Conjugated Vaccine	0.5 mL, intramuscular at age 13 to 14 months
BIOLOGICAL	Hepatitis A Pediatric Vaccine	0.5 mL, intramuscular at age 13 to 14 months and 25 to 26 months
BIOLOGICAL	Diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae vaccine	0.5 mL, intramuscular at age 19 to 20 months
BIOLOGICAL	Live, attenuated dengue serotype 1, 2, 3, and 4 virus	0.5 mL, subcutaneous at age 18 to 19 and 24 to 25 months
BIOLOGICAL	Yellow Fever Vaccine	0.5 mL, subcutaneous at age 12 to 13 months
BIOLOGICAL	Placebo (NaCl)	0.5 mL, subcutaneous at age 12 to 13 months
BIOLOGICAL	Measles, mumps, and rubella vaccine	0.5 mL, subcutaneous at age 13 to 14 months
BIOLOGICAL	Pneumococcal Conjugated Vaccine	0.5 mL, intramuscular at age 13 to 14 months
BIOLOGICAL	Diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae vaccine	0.5 mL, intramuscular at age 19 to 20 months
BIOLOGICAL	Hepatitis A Pediatric Vaccine	0.5 mL, intramuscular at age 13 to 14 months and 25 to 26 months

Timeline

• Start date: 2011-09-07
• Primary completion: 2013-09-01
• Completion: 2013-09-02
• First posted: 2011-09-19
• Last updated: 2022-03-25
• Results posted: 2019-07-29

Locations

2 sites across 2 countries: Colombia, Peru