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Efficacy and Safety of Dengue Vaccine in Healthy Children Aged 4 to 11 Years in Thailand
The primary objective of the study was to assess the efficacy of CYD dengue vaccine after three injections in preventing symptomatic virologically-confirmed dengue (VCD) cases, regardless of the severity, due to any of the four serotypes in children aged 4 to 11 years at the time of inclusion. Secondary objectives included to assess: * Vaccine efficacy against severe VCD cases * Vaccine efficacy against VCD cases following at least two injections with CYD dengue vaccine * Immune response to CYD dengue vaccine * Safety profile of CYD dengue vaccine. Safety assessments include solicited reactions within 7 or 14 days after each injection, unsolicited adverse events within 28 days after each injection, and serious adverse events during the study period. Other objectives included: * Vaccine efficacy against VCD cases following at least one injection with CYD dengue vaccine * Vaccine efficacy against VCD cases due to each serotype * Participants with clinical signs and symptoms for VCD
Details
| Lead sponsor | Sanofi Pasteur, a Sanofi Company |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 4002 |
| Start date | 2009-02 |
| Completion | 2014-02 |
Conditions
- Dengue Virus
- Dengue Fever
- Dengue Hemorrhagic Fever
- Dengue Diseases
Interventions
- CYD Dengue Vaccine
- Inactivated rabies virus vaccine
- Placebo
Primary outcomes
- Number of Symptomatic Virologically-Confirmed Dengue (VCD) Cases During the Active Phase Post-dose 3 Following Inj. With Either CYD Dengue Vaccine or a Placebo — 28 days Post-Inj. 3 up to the end of Active Phase (up to 13 months Post-Inj. 3, i.e. up to 25 months)
Symptomatic VCD cases were defined as acute febrile illness with fever lasting for at least 1 day (temperature \>= 37.5 degree Celsius (°C) measured at least twice with an interval of at least 4 hours), confirmed by reverse transcriptase-polymerase chain reaction and/or dengue non-structural protein-1 (NS1) enzyme-linked immunosorbent assay antigen test, and occurring more than 28 days after the third injection. Vaccine efficacy was reported as density incidence (cases/100 person-years at risk). Density incidence was defined as the number of VCD cases divided by the cumulative person-years at risk.
Countries
Thailand