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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
210
0.5 mL, Subcutaneous
0.5 mL, Subcutaneous and 0.5 mL, Intravascular
0.5 mL, Subcutaneous and 0.5 mL, Subcutaneous
Unnamed facility
San Pablo, Philippines
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
To provide information concerning the immunogenicity of CYD Dengue vaccine after each dose of primary vaccination.
Time frame: Day 28 after each Dengue vaccination
To provide information concerning the immunogenicity of childhood vaccines after primary vaccination.
Time frame: Day 28 after post-vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
0.5 mL Subcutaneous and 0.5 mL Subcutaneous