Study of a Novel Tetravalent Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in Latin America
The aim of the study is to assess the efficacy of sanofi pasteur's CYD dengue vaccine in preventing symptomatic virologically-confirmed dengue cases for dengue-endemic areas of Latin America.
To assess the efficacy of CYD dengue vaccine after 3 vaccinations at 0, 6, and 12 months in preventing symptomatic virologically-confirmed dengue cases, regardless of the severity, due to any of the four serotypes in children and adolescents aged 9 to 16 years at the time of inclusion.
To describe the occurrence of serious adverse events (SAEs), including SAEs of special interest in all subjects throughout the trial period.
To describe the efficacy of CYD dengue vaccine after each dose in:
- Preventing symptomatic virologically-confirmed dengue cases due to any of the four serotypes
- Preventing symptomatic dengue cases, either virologically-confirmed or probable based on serological criteria, due to any of the four serotypes
|Dengue Fever Dengue Hemorrhagic Fever Dengue||Biological: Live, attenuated, dengue serotype 1, 2, 3, 4 virus Biological: Placebo: NaCl 0.9% solution||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Efficacy and Safety of a Novel Tetravalent Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in Latin America|
- Information on the symptomatic virologically confirmed dengue cases occurring > 28 days after Dose 3 (during the active phase) in terms of (i) Acute febrile illness and (ii) Virologically confirmed [ Time Frame: 28 Days post last vaccination ]Acute febrile illness is temperature ≥ 38°C on at least 2 consecutive days
- Information on the occurrence of serious adverse events (SAEs), including SAEs of special interest in all subjects throughout the trial period [ Time Frame: Day 0 up to 12 months post vaccination ]
- Information on the efficacy of CYD dengue vaccine in preventing symptomatic dengue cases either virologically confirmed or probable based on serological criteria due to any of the four serotypes after each dose. [ Time Frame: 28 Days after each vaccination ]
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||April 2018|
|Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Experimental: CYD Dengue Vaccine Group
Participants will receive a dose of CYD dengue vaccine at 0, 6, and 12 months, respectively.
Biological: Live, attenuated, dengue serotype 1, 2, 3, 4 virus
0.5 mL, Subcutaneous
Other Name: CYD Dengue Vaccine
Placebo Comparator: Control Group
Participants will receive a dose of placebo vaccine at 0, 6, and 12 months, respectively.
Biological: Placebo: NaCl 0.9% solution
0.5 mL, Subcutaneous
Participants will be randomized to either receive a total of 3 injections of CYD dengue vaccine or a placebo at 0, 6, and 12 months, respectively.
A subset of participants from each country will also be evaluated for reactogenicity and immunogenicity to enable the generation of country-specific data on reactogenicity, immunogenicity, and baseline dengue and yellow fewer antibody levels.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01374516
|Fortaleza, CE, Brazil, 60430 270|
|Vitória, ES, Brazil, 29040 09|
|Goiania, GO, Brazil, 74675 020|
|Campo Grande, MS, Brazil, 79074 460|
|Natal, RN, Brazil, 59025 600|
|Aguazul, Casanare, Colombia|
|Yopal, Casanare, Colombia|
|Girardot, Cundinamarca, Colombia|
|Acacias, Meta, Colombia|
|Armenia, Quindío, Colombia|
|Calarcá, Quindío, Colombia|
|La Tebaida, Quindío, Colombia|
|Montenegro, Quindío, Colombia|
|Bucaramanga, Santander, Colombia|
|Tegucigalpa, Municipalidad del Distrito Central, Honduras|
|Temixco, Morelos, Mexico|
|Municipio de Cd. Mante, Tamaulipas, Mexico|
|Veracruz Puerto, Veracruz, Mexico|
|Tizimin, Yucatán, Mexico|
|Valladolid, Yucatán, Mexico|
|Guayama, Puerto Rico, 00784|
|San Juan, Puerto Rico, 00918|
|Study Director:||Medical Director||Sanofi Pasteur Inc.|