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

Summary

The aim of the study was 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 participants from CYD13 - NCT00993447 and CYD30 - NCT01187433 trials (participants from Group 1 only). Secondary Objectives: * If the primary objective of non-inferiority was 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 CYD13 and CYD30 trials. * To describe the immune responses elicited by a CYD dengue vaccine booster and placebo injection in participants who received 3 doses of the CYD dengue vaccine in the CYD13 and CYD30 trials in all participants. * To describe the neutralizing antibody levels of each dengue serotype post-dose 3 (CYD13 and CYD30 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 participants. * To evaluate the safety of booster vaccination with the CYD dengue vaccine in all participants.

Timeline

Start

2016-04-14

Primary completion

2016-11-23

Completion

2018-10-28

Publications

• Coronel D, Garcia-Rivera EJ, Rivera M, Arredondo-Garcia JL, Dietze R, Perroud AP, Cortes M, Bonaparte M, Zhao J, Tila M, Jackson N, Zambrano B, Noriega F. Dengue Vaccine Booster in Healthy Adolescents and Adults in Latin America: Evaluation 4-5 Years After a Primary 3-Dose Schedule. Pediatr Infect Dis J. 2019 May;38(5):e90-e95. doi: 10.1097/INF.0000000000002286.

Drugs

Indications