Study of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Subjects in Singapore

Summary

Primary Objectives: * To evaluate safety after each CYD Dengue vaccination in terms of injection site and systemic reactogenicity. * To evaluate the occurrence of Serious Adverse Events (SAEs) throughout the trial period. * To evaluate the humoral immune response to each CYD Dengue serotype after each vaccination in a subset of participants. Secondary Objectives: * To evaluate the persistence of the humoral immune response during 4 years after the last vaccination in a subset of participants.

Timeline

Start

2009-04-07

Primary completion

2014-10

Completion

2014-10-14

Publications

• Results Harenberg A, Begue S, Mamessier A, Gimenez-Fourage S, Ching Seah C, Wei Liang A, Li Ng J, Yun Toh X, Archuleta S, Wilder-Smith A, Shek LP, Wartel-Tram A, Bouckenooghe A, Lang J, Crevat D, Caillet C, Guy B. Persistence of Th1/Tc1 responses one year after tetravalent dengue vaccination in adults and adolescents in Singapore. Hum Vaccin Immunother. 2013 Nov;9(11):2317-25. doi: 10.4161/hv.25562. Epub 2013 Jul 9.
• Leo YS, Wilder-Smith A, Archuleta S, Shek LP, Chong CY, Leong HN, Low CY, Oh ML, Bouckenooghe A, Wartel TA, Crevat D. Immunogenicity and safety of recombinant tetravalent dengue vaccine (CYD-TDV) in individuals aged 2-45 y: Phase II randomized controlled trial in Singapore. Hum Vaccin Immunother. 2012 Sep;8(9):1259-71. doi: 10.4161/hv.21224. Epub 2012 Aug 16.

Drugs

Indications