1. Four-year safety follow-up of the tetravalent dengue vaccine efficacy randomized controlled trials in Asia and Latin America
- Author
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Leilani Sanchez, Ana Paula Perroud, Sophia Gailhardou, Sri Rezeki Hadinegoro, Fernando Noriega, Danaya Chansinghakul, Tram Anh Wartel, Tawee Chotpitayasunondh, Dewa Nyoman Wirawan, D M Rivera Medina, Thelma Laot, José Luis Arredondo-García, Matthew Bonaparte, Humberto Reynales, Kriengsak Limkittikul, Alain Bouckenooghe, Diana Coronel, Carina Frago, M N Chua, M Cortés Supelano, Carmen Deseda, N H Tran, Betzana Zambrano, and Edith Langevin
- Subjects
Male ,Risk ,0301 basic medicine ,Microbiology (medical) ,medicine.medical_specialty ,Asia ,Adolescent ,Long term follow up ,Dengue Vaccines ,Antibodies, Viral ,Serogroup ,Vaccines, Attenuated ,Placebo ,law.invention ,Dengue fever ,Dengue ,03 medical and health sciences ,Randomized controlled trial ,law ,Internal medicine ,Humans ,Medicine ,Viremia ,Child ,Dengue vaccine ,Randomized Controlled Trials as Topic ,business.industry ,General Medicine ,Dengue Virus ,medicine.disease ,Hospitalization ,Latin America ,030104 developmental biology ,Infectious Diseases ,Child, Preschool ,Relative risk ,Hospital admission ,Female ,business ,Dengue disease ,Follow-Up Studies - Abstract
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.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.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 aged9 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 aged9 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.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.
- Published
- 2018