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K Zaman

K Zaman

International Centre for Diarrheal Disease Research, Bangladesh

Title: Methodology, results and lessons-learned from the phase I to IV clinical trials with all three FDA licensed Rotavirus vaccines in Bangladesh

Biography

Biography: K Zaman

Abstract

Safe and effective Rotavirus vaccines are needed to reduce the enormous public health burden associated with Rotavirus illness,
especially in developing countries. Prevention by vaccination is critical for effective control of Rotavirus infection since it cannot be prevented with improvements in water and sanitation. The International Centre for Diarrhoeal Disease Research,Bangladesh (ICDDR, B) has completed several Rotavirus vaccine (RV) trials which ranged from phase I to licensure and post marketing evaluation of the vaccines (phase IV). Three FDA (USA) licensed Rotavirus vaccines were tested and evaluated in these trails: Tetravalent rhesus Rotavirus vaccine (RRV-TV, Rota Shield, Wyeth Lederle), Pentavalent Rotavirus vaccine (PRV,RotaTeq®, Merck & Co.) and monovalent Rotavirusvaccine(Rotarix®,GlaxoSmithKline). The trials were conducted in urban and rural areas and the sample size ranged from few hundreds to several thousands. The safety, immunogenicity, efficacy and effectiveness of the vaccines were evaluated. RV did not interfere with the immunogenicity of oral polio vaccine and measles and rubella vaccine. The efficacy and effectiveness of the vaccines were 40-45%. Inclement weather, difficult transportation,and movement of study participants were some of the challenges identified. Bangladesh Government is actively thinking to introduce RV vaccine into EPI program and adequate cold chain facilities need to be established. Details f the methodology,results, lessons-learned and challenges for successful implementation of these trials will be presented.