Clinical Trial: A Study of Dengue Vaccine in Healthy Toddlers Aged 12 to 15 Months in the Philippines
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Immunogenicity and Safety of CYD Dengue Vaccine in Healthy Toddlers Aged 12 to 15 Months in the Philippines
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 Summary: 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.
Sponsor: Sanofi
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Sanofi
Dates:
Date Received: February 5, 2010
Date Started: January 2010
Date Completion:
Last Updated: February 5, 2013
Last Verified: February 2013