Study of a Novel Tetravalent Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in Latin America
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|ClinicalTrials.gov Identifier: NCT01374516|
Recruitment Status : Unknown
Verified March 2016 by Sanofi ( Sanofi Pasteur, a Sanofi Company ).
Recruitment status was: Active, not recruiting
First Posted : June 16, 2011
Last Update Posted : April 26, 2016
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
|Condition or disease||Intervention/treatment||Phase|
|Dengue Fever Dengue Hemorrhagic Fever Dengue||Biological: Live, attenuated, dengue serotype 1, 2, 3, 4 virus Biological: Placebo: NaCl 0.9% solution||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20869 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy and Safety of a Novel Tetravalent Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in Latin America|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||November 2014|
|Estimated Study Completion Date :||April 2018|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.|