Clinical Trial: Immunogenicity and Safety of 3-Dose and Booster Dose of Tetravalent Dengue Vaccine in Healthy Subjects 9 to 50 Years of Age

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional



Official Title: Immunogenicity and Safety of Tetravalent Dengue Vaccine Given in 1 , 2 , or 3 Dose Schedules (STAGE I) Followed by a Single Booster Injection of the Same Vaccine (STAGE II) 1 or 2 Years After the Last

Brief Summary:

The aim of the study is to assess the safety of the primary series vaccine schedules and the booster vaccination

Primary Objectives:

  • To demonstrate the non-inferiority of the immune response elicited against each dengue serotype by tetravalent CYD vaccine given as a 2 dose schedule (Placebo 1/CYD Dengue vaccine group) compared to the immune response elicited by CYD vaccine given as a 3 dose schedule (CYD Dengue vaccine group) 28 days post-final vaccination.
  • To demonstrate the non-inferiority of the immune response elicited against each dengue serotype by tetravalent CYD vaccine given as a 1 dose schedule (Placebo 2/CYD Dengue vaccine group) compared to the immune response elicited by CYD vaccine given as a 3 dose schedule (CYD Dengue vaccine group) 28 days post final vaccination.
  • To demonstrate the non-inferiority of the immune response elicited against each dengue serotype 28 days after administration of a single booster dose of tetravalent CYD vaccine

Secondary Objectives:

  • To demonstrate the superiority of the immune response elicited by tetravalent CYD vaccine given as a 2 dose schedule (Placebo 1/CYD Dengue vaccine group) compared to the immune response elicited by CYD vaccine given as a 3 dose schedule (CYD Dengue vaccine group) 28 days post-final vaccination.
  • To demonstrate the superiority of the immune response elicited by tetravalent CYD vaccine given as a 1 dose schedule (Placebo 2/CYD Dengue vaccine group) compared to the immune response elicited by CYD vaccine given as a 3 dose schedule (CYD Dengue vaccine group) 28 days post-final vaccinati