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Protocol Summaries: H1N1 Pandemic Influenza Vaccine

GSK
Study ID
   Phase    Title Status
113440 phase 2 A study to evaluate the safety and immunogenicity of A/California/7/2009 (H1N1)v-like vaccines GSK2340273A and GSK2340274A in adults aged 18 years and older Completed
113456 phase 3 Safety and immunogenicity study of GSK Biologicals’ influenza vaccine GSK2340272A in adults aged 18 to 60 years Completed
113459 phase 3 Safety and immunogenicity study of GSK Biologicals’ influenza vaccine GSK2340272A in adults aged 18 years and above Completed
113462 phase 2 Safety and immunogenicity study of GSK Biologicals’ pandemic influenza candidate vaccine (GSK2340272A) in children aged 6 to 35 months Completed
113480 phase 3 A study to evaluate the safety, immunogenicity, and relative efficacy of A/California/7/2009 (H1N1)v-like vaccines GSK2340274A and GSK2340273A in adults aged 18 years and older Completed
113482 phase 2 A study to evaluate the safety and immunogenicity of A/California/7/2009 (H1N1)v-like vaccines GSK2340274A and GSK2340273A in children 6 months to less than 9 years of age Completed
113483 phase 1 A study to evaluate immune responses following A/California/7/2009 (H1N1)v-like virus vaccination given 4 months following seasonal influenza vaccination in adults 19 to 40 years of age Completed
113519 phase 2 Immunogenicity and safety study of GSK Biologicals’ influenza candidate vaccine GSK2340274A Completed
113525 phase 2 Immunogenicity, safety and reactogenicity of GSK Biologicals’ influenza GSK2340272A and Fluarix™ 2009-2010 vaccines when co-administered in elderly subjects aged 61 years and older Completed
113528 phase 3 Safety and immunogenicity study of GSK Biologicals’ pandemic influenza candidate vaccine (GSK2340272A) in children aged 3 to 17 years Completed
113535 phase 3 Immunological equivalence between GSK2340272A and GSK2340274A influenza vaccines in adults aged 18 to 60 years Completed
113536 phase 2 A study to evaluate the safety and immunogenicity of an A/California/7/2009 (H1N1)v-like vaccine GSK2340274A or GSK2340273A co-administered with trivalent inactivated seasonal influenza vaccine in adults 19 to 40 years of age. Completed
113572 phase 3 Immunogenicity and safety of GSK Biologicals’ pandemic influenza candidate vaccine GSK2340272A Completed
113574 phase 2 Safety and Immunogenicity Study of GSK Biologicals' Influenza Vaccine GSK2340272A in Adults Aged 18 to 60 Years Completed
113585 phase 4 Post-Authorization Safety Study (PASS) of GlaxoSmithKline Biologicals’ pandemic influenza vaccine (GSK2340272A) in the United Kingdom (UK) Completed
113629 phase 2 Safety and immunogenicity study of GSK Biologicals’ pandemic influenza candidate vaccine (GSK2340272A) in children aged 8 to 12 weeks Completed
113630 phase 3 Safety and immunogenicity study of GSK Biologicals’ influenza vaccine GSK2340272A in adults aged 18 years and above Completed
113638 phase 3 Safety and immunogenicity study of GSK Biologicals’ pandemic influenza candidate vaccine (GSK2340272A) in children aged 3 to 17 years Completed
113809 phase 3 Immunological non-inferiority between two process-manufactured influenza vaccines in adults aged 18 to 60 years Completed
113810 phase 3 Safety and immunogenicity study of GSK Biologicals’ pandemic influenza candidate vaccine (GSK2340272A) in children aged 3 to 9 years Terminated
113847 phase 2 Safety and immunogenicity study of GSK Biologicals’ pandemic influenza (H1N1) candidate vaccine (GSK2340274A) in Japanese children aged 6 months to 17 years Completed
113866 phase 3 Safety and immunogenicity study of GSK Biologicals’ influenza vaccine GSK2340272A in adults aged 18 to 60 years Completed
113883 phase 2 Safety and immunogenicity study of GSK Biologicals’ pandemic influenza (H1N1) candidate vaccine (GSK2340274A) in children aged 10 to less than 18 years Completed
113924 phase 2 Immunogenicity and safety study of GSK Biologicals’ pandemic influenza (H1N1) candidate vaccine GSK2340274A in adults 18 to 64 years of age Withdrawn
114000 phase 3 A study to evaluate the safety and efficacy of A/California/7/2009 (H1N1)v-like vaccines GSK2340274A and GSK2340273A in children aged 6 months to less than 10 years of age Completed
114270 phase 4 Immunogenicity and safety study of GSK Biologicals’ influenza vaccine Arepanrix™ (GSK2340274A) in adults 65 years of age or older Completed
114451 phase 4 Immunogenicity and Safety Study of GSK Biologicals' Seasonal (2010-2011) Influenza Vaccine Fluarix™ in Children Previously Vaccinated With GSK Biologicals' H1N1 Vaccine Pandemrix™ Completed
114454 phase 3 Immunogenicity and safety of FluarixTM/ Influsplit SSW® 2010/2011 or Pandemrix TM Terminated
114495 phase 2 An observer-blind safety and immunogenicity study of GSK Biologicals’ A/California/7/2009 (H1N1)v-like vaccines GSK234074A and GSK234072A in children 3 to less than 10 years old Completed
116602 phase 4 Risk of solid organ transplant rejection following vaccination with Pandemrix™ in the United Kingdom Active not recruiting
Flu-Pan-Meta-Analysis-201109 n\a Integrated summary of the safety of AS03-adjuvanted monovalent H5N1 and H1N1 vaccines in adults 18 years of age and older Completed