J L Arredondo-García1, S R Hadinegoro2, H Reynales3, M N Chua4, D M Rivera Medina5, T Chotpitayasunondh6, N H Tran7, C C Deseda8, D N Wirawan9, M Cortés Supelano10, C Frago11, E Langevin12, D Coronel13, T Laot14, A P Perroud15, L Sanchez14, M Bonaparte16, K Limkittikul17, D Chansinghakul18, S Gailhardou19, F Noriega16, T A Wartel12, A Bouckenooghe11, B Zambrano20. 1. Instituto Nacional de Pediatria, México DF, Mexico. 2. Department of Child Health, Cipto Mangunkusumo Hospital, Medical School, University of Indonesia, Jakarta, Indonesia. 3. Centro de Atención e Investigación Médica-CAIMED, Bogotá, Colombia. 4. Department of Paediatrics, Chong Hua Hospital, Cebu City, Philippines. 5. Inversiones en Investigación Médica, INVERIME SA, Tegucigalpa, Honduras. 6. Department of Paediatrics, Queen Sirikit National Institute of Child Health, Bangkok, Thailand. 7. Infectious Diseases Department, Institut Pasteur in Ho-Chi-Minh-City, Ho-Chi-Minh-City, Viet Nam. 8. Caribbean Travel Medicine Clinic, San Juan, Puerto Rico. 9. Department of Preventive Medicine, School of Medicine, Udayana University, Denpasar, Bali, Indonesia. 10. Sanofi Pasteur, Bogota, Colombia. 11. Sanofi Pasteur, Singapore, Singapore. 12. Sanofi Pasteur, Marcy-l'Étoile, France. 13. Sanofi Pasteur, Mexico City, Mexico. 14. Sanofi Pasteur, Taguig, Philippines. 15. Sanofi Pasteur, São Paulo, Brazil. 16. Sanofi Pasteur, Swiftwater, PA, USA. 17. Faculty of Tropical Medicine, Mahidol University, Thailand. 18. Sanofi Pasteur, Bangkok, Thailand. 19. Sanofi Pasteur, Lyon, France. 20. Sanofi Pasteur, Montevideo, Uruguay. Electronic address: betzana.zambrano@sanofi.com.
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.
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.
Authors: Marcos A Espinal; Jon K Andrus; Barbara Jauregui; Stephen Hull Waterman; David Michael Morens; Jose Ignacio Santos; Olaf Horstick; Lorraine Ayana Francis; Daniel Olson Journal: Am J Public Health Date: 2019-01-24 Impact factor: 9.308
Authors: Long Hoang Nguyen; Bach Xuan Tran; Cuong Duy Do; Chi Linh Hoang; Thao Phuong Nguyen; Trang Thi Dang; Giang Thu Vu; Tung Thanh Tran; Carl A Latkin; Cyrus S Ho; Roger Cm Ho Journal: Patient Prefer Adherence Date: 2018-09-26 Impact factor: 2.711