Immunogenicity and Safety of CYD Dengue Vaccine in Healthy Toddlers Aged 12 to 15 Months in the Philippines
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Dengue Fever
- Sponsor
- Sanofi
- Enrollment
- 210
- Primary Endpoint
- To provide information concerning the safety in terms of solicited and unsolicited adverse events after primary administration of CYD Dengue vaccine.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
To provide information concerning the safety in terms of solicited and unsolicited adverse events after primary administration of CYD Dengue vaccine.
Time Frame: 28 days after each Dengue vaccination and entire study duration
Secondary Outcomes
- 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)