Sri Rezeki Hadinegoro, Jose Luis Arredondo-García, Maria Rosario Capeding, Carmen Deseda, Tawee Chotpitayasunondh, Reynaldo Dietze, H I Hj Muhammad Ismail, Humberto Reynales, Kriengsak Limkittikul, Doris Maribel Rivera-Medina, Huu Ngoc Tran, Alain Bouckenooghe, Danaya Chansinghakul, Margarita Cortés, Karen Fanouillere, Remi Forrat, Carina Frago, Sophia Gailhardou, Nicholas Jackson, Fernando Noriega, Eric Plennevaux, T Anh Wartel, Betzana Zambrano, Melanie Saville
BACKGROUND: A candidate tetravalent dengue vaccine is being assessed in three clinical trials involving more than 35,000 children between the ages of 2 and 16 years in Asian-Pacific and Latin American countries. We report the results of long-term follow-up interim analyses and integrated efficacy analyses. METHODS: We are assessing the incidence of hospitalization for virologically confirmed dengue as a surrogate safety end point during follow-up in years 3 to 6 of two phase 3 trials, CYD14 and CYD15, and a phase 2b trial, CYD23/57...
September 24, 2015: New England Journal of Medicine