Who is sponsoring NCT01436396?

NCT01436396 is sponsored by Sanofi Pasteur, a Sanofi Company.

What condition does NCT01436396 study?

NCT01436396 studies Dengue, Dengue Hemorrhagic Fever, Yellow Fever.

What drugs are being tested in NCT01436396?

Interventions: Live, attenuated dengue serotype 1, 2, 3, and 4 virus, Yellow fever vaccine, Measles, mumps, and rubella (MMR) vaccine, Pneumococcal Conjugated Vaccine, Hepatitis A Pediatric Vaccine, Diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae vaccine, Live, attenuated dengue serotype 1, 2, 3, and 4 virus, Yellow Fever Vaccine, Placebo (NaCl), Measles, mumps, and rubella vaccine, Pneumococcal Conjugated Vaccine, Diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae vaccine, Hepatitis A Pediatric Vaccine.

What is the status of NCT01436396?

NCT01436396 is currently COMPLETED.

Last reviewed 2022-03-15 · How we verify

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

NCT01436396 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Sanofi Pasteur, a Sanofi Company
Phase	Phase 3
Status	COMPLETED
Enrolment	792
Start date	2011-09-07
Completion	2013-09-02

Conditions

Dengue
Dengue Hemorrhagic Fever
Yellow Fever

Interventions

Live, attenuated dengue serotype 1, 2, 3, and 4 virus
Yellow fever vaccine
Measles, mumps, and rubella (MMR) vaccine
Pneumococcal Conjugated Vaccine
Hepatitis A Pediatric Vaccine
Diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae vaccine
Live, attenuated dengue serotype 1, 2, 3, and 4 virus
Yellow Fever Vaccine
Placebo (NaCl)
Measles, mumps, and rubella vaccine

Primary outcomes

Percentage of Flavi Virus (FV) Non-immune Participants With Seroconversion Against YF Antigen After Vaccination With Yellow Fever (YF) Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo — 28 days Post-Injection 1
Neutralizing antibodies against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay. Seroconversion was defined as YF antibodies \>=10 (1/dilution \[dil\]) in flavivirus non-immune participants (defined as those with YF antibodies \<10 \[1/dil\] for all serotypes (Serotype 1, 2, 3 and 4) with parental dengue virus strains and for YF virus).

Countries

Colombia, Peru