Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in Asia: a phase 3, randomised, observer-masked, placebo-controlled trial

Capeding MR 1 , Tran NH 2 , Hadinegoro SR 3 , Ismail HI 4 , Chotpitayasunondh T 5 , Chua MN 6 Show all authors , Luong CQ 2 , Rusmil K 7 , Wirawan DN 8 , Nallusamy R 9 , Pitisuttithum P 10 , Thisyakorn U 11 , Yoon IK 12 , van der Vliet D 13 , Langevin E 14 , Laot T 15 , Hutagalung Y 16 , Frago C 16 , Boaz M 17 , Wartel TA 16 , Tornieporth NG 14 , Saville M 18 , Bouckenooghe A 16 , CYD14 Study Group

Affiliations 

  • 1 Research Institute for Tropical Medicine, Alabang, Muntinlupa City, Philippines
  • 2 Pasteur Institute Ho Chi Minh City, Ho Chi Minh City, Vietnam
  • 3 Department of Child Health, Medical School, University of Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia
  • 4 Pediatric Institute, Kuala Lumpur Hospital, Kuala Lumpur, Malaysia
  • 5 Queen Sirikit National Institute of Child Health, Bangkok, Thailand
  • 6 Chong Hua Hospital, Cebu City Guadalupe Health Center Annex, Guadalupe, Cebu City, Philippines
  • 7 Child Health Department, Hasan Sadikin Hospital-Faculty of Medicine, Padjadjaran University, Bandung, Indonesia
  • 8 Department of Preventive Medicine, School of Medicine, Udayana University, Denpasar, Bali, Indonesia
  • 9 Department of Paediatrics, Penang Hospital, Penang, Malaysia
  • 10 Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, Ratchathewi, Bangkok, Thailand
  • 11 Dengue Project Banpong-Photharam, Faculty of Tropical Medicine, Mahidol University, Ratchathewi, Bangkok, Thailand
  • 12 Department of Virology, US Army Medical Component-Armed Forces Research Institute of Medical Sciences (USAMC-AFRIMS), US Army Medical Component, Bangkok, Thailand
  • 13 Sanofi Pasteur, Marcy-l'Étoile, France. Electronic address: diane.vandervliet@sanofipasteur.com
  • 14 Sanofi Pasteur, Marcy-l'Étoile, France
  • 15 Sanofi Pasteur, Makati City, Philippines
  • 16 Sanofi Pasteur, Singapore, Singapore
  • 17 Sanofi Pasteur, Swiftwater, PA, USA
  • 18 Sanofi Pasteur, Lyon, France
Lancet, 2014 Oct 11;384(9951):1358-65.
PMID: 25018116 DOI: 10.1016/S0140-6736(14)61060-6

Abstract

An estimated 100 million people have symptomatic dengue infection every year. This is the first report of a phase 3 vaccine efficacy trial of a candidate dengue vaccine. We aimed to assess the efficacy of the CYD dengue vaccine against symptomatic, virologically confirmed dengue in children.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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