NCT02824198

Immunogenicity and Safety of a Tetravalent Dengue Vaccine Booster Injection in Subjects Who Previously Completed a 3-dose Schedule

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 Singapore

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 14 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The aim of the study was to assess and describe the booster effect of a tetravalent CYD dengue vaccine dose administered about 5 years or more after the completion of a 3-dose vaccination schedule in Singapore. 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 participants from CYD28 trial (participants from Group 1 only). Secondary Objectives: * If the primary objective of non-inferiority achieved: To demonstrate the superiority, in terms of GMTRs, of a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in participants from CYD28 trial (participants from Group 1 only). * To describe the immune responses elicited by the CYD dengue vaccine booster or placebo injection in participants who received three doses of the CYD dengue vaccine in the CYD28 trial in all participants. * To describe the neutralizing antibody levels of each dengue serotype Post Dose 3 (CYD28 participants) and immediately prior to booster or placebo injection in all participants. * To describe the neutralizing antibody persistence 6 months, 1 year and 2 years post booster or placebo injection in all study participants. * To evaluate the safety of booster vaccination with CYD dengue vaccine in all participants.

Detailed description

Healthy adolescents and adults received 3 doses of the tetravalent dengue vaccine 5-6 years earlier in a previous CYD dengue vaccine trial (CYD28 - NCT00880893) received either a booster injection of CYD dengue vaccine or a placebo on Day 0. They were evaluated for safety and antibody persistence of the booster injection up to 2 years post-vaccination.

Conditions

• Dengue Fever
• Dengue Hemorrhagic Fever

Interventions

Type	Name	Description
BIOLOGICAL	CYD Dengue Vaccine (5 dose formulation)	0.5 mL, Subcutaneous
BIOLOGICAL	Placebo, NaCl 0.9%	0.5 mL, Subcutaneous

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-03-18
• Completion: 2019-01-18
• First posted: 2016-07-06
• Last updated: 2022-03-24
• Results posted: 2019-06-14

Locations

3 sites across 1 country: Singapore

Regulatory

• FDA-regulated drug study