drugset / Trial / NCT01187433
Study of CYD Dengue Vaccine in Healthy Children and Adolescents in South America
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The purpose of this study is to generate immunogenicity and safety data in preparation for efficacy studies in Latin America. Primary Objectives: * To describe the immune response to dengue viruses before and after each vaccination with CYD dengue vaccine. * To evaluate the safety of each vaccination with CYD dengue vaccine.
Timeline
- Start
- 2010-08
- Primary completion
- 2012-10
- Completion
- 2012-12
Publications
- Results Dayan GH, Garbes P, Noriega F, Izoton de Sadovsky AD, Rodrigues PM, Giuberti C, Dietze R. Immunogenicity and safety of a recombinant tetravalent dengue vaccine in children and adolescents ages 9-16 years in Brazil. Am J Trop Med Hyg. 2013 Dec;89(6):1058-1065. doi: 10.4269/ajtmh.13-0304. Epub 2013 Nov 4.
- Coronel D, Garcia-Rivera EJ, Rivera DM, Arredondo-Garcia JL, Dietze R, Perroud AP, Cortes M, Bonaparte M, Wang H, Pagnon A, Jantet-Blaudez F, Penalosa LAR, Dayan G, Zambrano B, DiazGranados CA, Noriega F. Immune Response Persistence and Safety of a Booster Dose of the Tetravalent Dengue Vaccine in Adolescents and Adults Who Previously Completed the 3-dose Schedule 4-5 Years Earlier in Latin America: A Randomized Placebo-controlled Trial. Pediatr Infect Dis J. 2020 Oct;39(10):961-968. doi: 10.1097/INF.0000000000002830.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CYD-TDV | Vaccine | 0.5 ml | Subcutaneous |
| Comparator | Meningococcal A+C vaccine | Vaccine | 0.5 ml | Intramuscular |
| Comparator | tetanus toxoid | Vaccine | 0.5 ml | Intramuscular |