Clinical Trial: Study of a Booster Dose of a Tetravalent Dengue Vaccine in Subjects Who Previously Completed the 3-dose Schedule

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



Official Title: Immunogenicity and Safety of a Tetravalent Dengue Vaccine Given as a Booster Injection in Adolescents and Adults Who Previously Completed the 3-dose Schedule in a Study Conducted in Latin America

Brief Summary:

The aim of the study is to assess and describe the booster effect of a CYD dengue vaccine dose administered 4 to 5 years after the completion of a 3-dose vaccination schedule.

Primary Objective

- To demonstrate the non-inferiority, in terms of geometric mean of titer ratios (GMTRs), of a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in subjects from previous CYD dengue vaccine trials.

Secondary Objectives:

  • If the primary objective of non-inferiority is achieved: To demonstrate the superiority, in terms of GMTRs, of a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in subjects from previous CYD dengue vaccine trials.
  • To describe the immune responses elicited by a CYD dengue vaccine booster and placebo injection in subjects who received 3 doses of the CYD dengue vaccine in previous CYD dengue vaccine trials.
  • To describe the neutralizing Ab levels of each dengue serotype post-dose 3 (previous CYD dengue vaccine trials' subjects) and immediately prior to booster or placebo injection in all subjects.
  • To describe the neutralizing Ab persistence 6 months, 1 year, and 2 years post booster or placebo injection in all subjects.
  • To evaluate the safety of booster vaccination with the CYD dengue vaccine in all subjects.