학술논문
Four-year safety follow-up of the tetravalent dengue vaccine efficacy randomized controlled trials in Asia and Latin America.
Document Type
Academic Journal
Author
Arredondo-García JL; Instituto Nacional de Pediatria, México DF, Mexico.; Hadinegoro SR; Department of Child Health, Cipto Mangunkusumo Hospital, Medical School, University of Indonesia, Jakarta, Indonesia.; Reynales H; Centro de Atención e Investigación Médica-CAIMED, Bogotá, Colombia.; Chua MN; Department of Paediatrics, Chong Hua Hospital, Cebu City, Philippines.; Rivera Medina DM; Inversiones en Investigación Médica, INVERIME SA, Tegucigalpa, Honduras.; Chotpitayasunondh T; Department of Paediatrics, Queen Sirikit National Institute of Child Health, Bangkok, Thailand.; Tran NH; Infectious Diseases Department, Institut Pasteur in Ho-Chi-Minh-City, Ho-Chi-Minh-City, Viet Nam.; Deseda CC; Caribbean Travel Medicine Clinic, San Juan, Puerto Rico.; Wirawan DN; Department of Preventive Medicine, School of Medicine, Udayana University, Denpasar, Bali, Indonesia.; Cortés Supelano M; Sanofi Pasteur, Bogota, Colombia.; Frago C; Sanofi Pasteur, Singapore, Singapore.; Langevin E; Sanofi Pasteur, Marcy-l'Étoile, France.; Coronel D; Sanofi Pasteur, Mexico City, Mexico.; Laot T; Sanofi Pasteur, Taguig, Philippines.; Perroud AP; Sanofi Pasteur, São Paulo, Brazil.; Sanchez L; Sanofi Pasteur, Taguig, Philippines.; Bonaparte M; Sanofi Pasteur, Swiftwater, PA, USA.; Limkittikul K; Faculty of Tropical Medicine, Mahidol University, Thailand.; Chansinghakul D; Sanofi Pasteur, Bangkok, Thailand.; Gailhardou S; Sanofi Pasteur, Lyon, France.; Noriega F; Sanofi Pasteur, Swiftwater, PA, USA.; Wartel TA; Sanofi Pasteur, Marcy-l'Étoile, France.; Bouckenooghe A; Sanofi Pasteur, Singapore, Singapore.; Zambrano B; Sanofi Pasteur, Montevideo, Uruguay. Electronic address: betzana.zambrano@sanofi.com.
Source
Publisher: Elsevier Country of Publication: England NLM ID: 9516420 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1469-0691 (Electronic) Linking ISSN: 1198743X NLM ISO Abbreviation: Clin Microbiol Infect Subsets: MEDLINE
Subject
Language
English
Abstract
Objective: Our objective was to describe the risk of hospital admission for virologically confirmed dengue (VCD) and the risk of clinically severe hospitalized VCD occurring up to 4 years after the first dose (years 1 to 4) in three randomized clinical trials comparing tetravalent dengue vaccine with placebo.
Methods: The relative risks (RR) for hospitalized VCD from first dose to year 4 were estimated by year and age-group in individual and combined studies.
Results: Overall, from Year 1 to Year 4, 233 and 228 participants had at least one episode of hospitalized VCD in the vaccinated (n = 22 603) and placebo (n = 11 301) groups, respectively (RR = 0.511, 95% CI 0.42-0.62). Among these, 48 and 47 cases, respectively, were classified as clinically severe. In children aged ≥9 years, 88 and 136 participants had at least one episode of hospitalized VCD in the vaccinated (n = 17 629) and placebo (n = 8821) groups, respectively (RR = 0.324; 95% CI 0.24-0.43). In vaccinated participants aged <9 years, particularly in those aged 2-5 years, there were more hospitalized VCD cases compared with the control participants in Year 3 but not in Year 4. The overall RR in those aged <9 years for Year 1 to Year 4 was 0.786 (95% CI 0.60-1.03), with a higher protective effect in the 6-8 year olds than in the 2-5 year olds.
Conclusions: The overall benefit-risk remained positive in those aged ≥9 years up to year 4, although the protective effect was lower in years 3 and 4 than in years 1 and 2.
(Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.)
Methods: The relative risks (RR) for hospitalized VCD from first dose to year 4 were estimated by year and age-group in individual and combined studies.
Results: Overall, from Year 1 to Year 4, 233 and 228 participants had at least one episode of hospitalized VCD in the vaccinated (n = 22 603) and placebo (n = 11 301) groups, respectively (RR = 0.511, 95% CI 0.42-0.62). Among these, 48 and 47 cases, respectively, were classified as clinically severe. In children aged ≥9 years, 88 and 136 participants had at least one episode of hospitalized VCD in the vaccinated (n = 17 629) and placebo (n = 8821) groups, respectively (RR = 0.324; 95% CI 0.24-0.43). In vaccinated participants aged <9 years, particularly in those aged 2-5 years, there were more hospitalized VCD cases compared with the control participants in Year 3 but not in Year 4. The overall RR in those aged <9 years for Year 1 to Year 4 was 0.786 (95% CI 0.60-1.03), with a higher protective effect in the 6-8 year olds than in the 2-5 year olds.
Conclusions: The overall benefit-risk remained positive in those aged ≥9 years up to year 4, although the protective effect was lower in years 3 and 4 than in years 1 and 2.
(Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.)