Dengue Fever Clinical Trial
Official title:
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.
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. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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