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Immunogenicity and Safety of CYD Dengue Vaccine in Healthy Toddlers Aged 12 to 15 Months in the Philippines
The purpose of this study is to investigate the potential for co-administration of the first dose of CYD Dengue vaccine with childhood vaccination. Primary Objectives: * To describe the safety of CYD Dengue vaccine after each dose; first dose given alone or coadministered with childhood vaccines. Secondary Objectives: * To describe the immunogenicity of CYD Dengue vaccine after each dose; first dose given alone or co-administered with childhood vaccines.
Details
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 210 |
| Start date | 2010-01 |
| Completion | 2012-11 |
Conditions
- Dengue Fever
- Dengue Hemorrhagic Fever
Interventions
- Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus
- OKAVAX®:Attenuated live varicella-zoster virus and AVAXIM® 80U: Hepatitis A virus Vaccines
- Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and Childhood vaccines
- Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and NaCl (Placebo)
Primary outcomes
- To provide information concerning the safety in terms of solicited and unsolicited adverse events after primary administration of CYD Dengue vaccine. — 28 days after each Dengue vaccination and entire study duration
Countries
Philippines