Publication:
Four-year safety follow-up of the tetravalent dengue vaccine efficacy randomized controlled trials in Asia and Latin America

Issued Date

2018-07-01

Resource Type

Article

ISSN

14690691
1198743X

DOI

10.1016/j.cmi.2018.01.018

Other identifier(s)

2-s2.0-85042586862

Rights

Mahidol University

Rights Holder(s)

SCOPUS

Bibliographic Citation

Clinical Microbiology and Infection. Vol.24, No.7 (2018), 755-763

Suggested Citation

J. L. Arredondo-García, S. R. Hadinegoro, H. Reynales, M. N. Chua, D. M. Rivera Medina, T. Chotpitayasunondh, N. H. Tran, C. C. Deseda, D. N. Wirawan, M. Cortés Supelano, C. Frago, E. Langevin, D. Coronel, T. Laot, A. P. Perroud, L. Sanchez, M. Bonaparte, K. Limkittikul, D. Chansinghakul, S. Gailhardou, F. Noriega, T. A. Wartel, A. Bouckenooghe, B. Zambrano Four-year safety follow-up of the tetravalent dengue vaccine efficacy randomized controlled trials in Asia and Latin America. Clinical Microbiology and Infection. Vol.24, No.7 (2018), 755-763. doi:10.1016/j.cmi.2018.01.018 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/46583

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Title

Four-year safety follow-up of the tetravalent dengue vaccine efficacy randomized controlled trials in Asia and Latin America

Author(s)

J. L. Arredondo-García
 S. R. Hadinegoro
 H. Reynales
 M. N. Chua
 D. M. Rivera Medina
 T. Chotpitayasunondh
 N. H. Tran
 C. C. Deseda
 D. N. Wirawan
 M. Cortés Supelano
 C. Frago
 E. Langevin
 D. Coronel
 T. Laot
 A. P. Perroud
 L. Sanchez
 M. Bonaparte
 K. Limkittikul
 D. Chansinghakul
 S. Gailhardou
 F. Noriega
 T. A. Wartel
 A. Bouckenooghe
 B. Zambrano

Other Contributor(s)

Universitas Udayana
 University of Indonesia, RSUPN Dr. Cipto Mangunkusumo
 Sanofi Pasteur SA
 Mahidol University
 Queen Sirikit National Institute of Child Health
 Instituto Nacional de Pediatría
 Sanofi Pasteur
 INVERIME SA
 Institut Pasteur in Ho-Chi-Minh-City
 Caribbean Travel Medicine Clinic
 Caimed SAS
 Sanofi Pasteur
 Sanofi Pasteur
 Sanofi Pasteur
 Sanofi Pasteur
 Sanofi Pasteur
 Sanofi Pasteur
 Chong Hua Hospital
 Sanofi Pasteur

Abstract

© 2018 The Authors 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.

Keyword(s)

Medicine

Availability

URI

https://repository.li.mahidol.ac.th/handle/20.500.14594/46583

Collections

Scopus 2018