drugset / Trial / NCT00993447
Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents in Latin America
RandomizedParallel-groupSingle-blindPrevention
Summary
Primary objectives: * To describe the immune response to each dengue serotype before and after each vaccination with sanofi pasteur's CYD dengue vaccine. * To evaluate the safety of each vaccination with sanofi pasteur's CYD dengue vaccine.
Timeline
- Start
- 2009-10
- Primary completion
- 2011-09
- Completion
- 2012-03
Publications
- Results Villar LA, Rivera-Medina DM, Arredondo-Garcia JL, Boaz M, Starr-Spires L, Thakur M, Zambrano B, Miranda MC, Rivas E, Dayan GH. Safety and immunogenicity of a recombinant tetravalent dengue vaccine in 9-16 year olds: a randomized, controlled, phase II trial in Latin America. Pediatr Infect Dis J. 2013 Oct;32(10):1102-9. doi: 10.1097/INF.0b013e31829b8022.
- 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 | Adacel | Vaccine | 0.5 ml | Intramuscular |