Clinical Trial: Study of a Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years in Malaysia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Safety and Immunogenicity of a Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years in Malaysia
Brief Summary:
The purpose of this study is to evaluate the safety and immunogenicity of Phase III lots of the CYD dengue vaccine in a pediatric population in Malaysia.
Primary Objectives:
- To describe the safety (in terms of solicited and unsolicited adverse events) of the CYD dengue vaccine in all subjects after each dose.
- To describe the antibody response to each dengue virus serotype post-Dose 2 and post-Dose 3
Detailed Summary: Healthy participants aged 2 to 11 years will receive 3 vaccinations at pre-determined schedules and will be followed-up for at least 6 months after the last vaccination.
Sponsor: Sanofi
Current Primary Outcome:
- Information concerning the safety of CYD Dengue vaccine following each dose of vaccine [ Time Frame: Up to 6 months post-dose 3 ]Safety parameters: solicited injection site pain, erythema, and swelling; solicited systemic reactions - fever (temperature), headache, malaise, myalgia, and asthenia; and unsolicited adverse events.
- Information on the antibody levels against each of the four parental dengue virus strains of CYD dengue vaccine constructs post Dose 2 and post Dose 3 [ Time Frame: 28 days post dose 2 and 3, respectively. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Sanofi
Dates:
Date Received: December 3, 2010
Date Started: December 2010
Date Completion:
Last Updated: September 18, 2014
Last Verified: September 2014
