A Study of Dengue Vaccine in Healthy Toddlers Aged 12 to 15 Months in the Philippines
- Conditions
- Dengue FeverDengue Hemorrhagic Fever
- Registration Number
- NCT01064141
- Lead Sponsor
- Sanofi
- Brief Summary
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.
- Detailed Description
Participants will be enrolled in a 3-step enrollment and randomized to 1 of 4 treatment groups. Groups 1 and 2 will receive 5 vaccinations, and Groups 3 and 4 will received 6 vaccinations (childhood vaccines or placebo co-administered with the first dose of CYD Dengue vaccine in 2 separate arms). All toddlers will receive a pentavalent acellular pertussis combination vaccine or Combo (PENTAXIM®), planned approximately 10 months after enrollment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 210
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method To provide information concerning the immunogenicity of CYD Dengue vaccine after each dose of primary vaccination. Day 28 after each Dengue vaccination To provide information concerning the immunogenicity of childhood vaccines after primary vaccination. Day 28 after post-vaccination