Full name
A first-time-in Human (FTIH), Phase I/II, Randomized, Multi-centric, Single-blind, Controlled Dose-escalation Study to Evaluate the Reactogenicity, Safety, Immunogenicity and Efficacy of GSK Biologicals' HBV Viral Vector Vaccines Given in a Prime-boost Schedule With Sequential or Co-administration of Adjuvanted Proteins Therapeutic Vaccine (GSK3528869A) in Chronic Hepatitis B Patients (18-65 Years Old) Well Controlled Under Nucleo(s)Tide Analogue (NA) Therapy
NCT Number
NCT03866187
Geography
Non-US
Locations
Belgium, France, Germany, Hong Kong, Poland, Spain, Taiwan, Thailand, United Kingdom
Primary Endpoints
- Number of subjects reporting solicited local adverse events (AEs). Within 7 days after each vaccination (from day of vaccination to 6 days after vaccination)
- Number of subjects reporting solicited general AEs. Within 7 days after each vaccination (from day of vaccination to 6 days after vaccination)
- Number of subjects reporting unsolicited AEs. Within 30 days after each vaccination (from day of vaccination to 29 days after vaccination)
- Number of subjects with hematological, biochemical or urinalysis laboratory abnormalities. Within 30 days after each vaccination (from day of vaccination to 29 days after vaccination)
- Number of subjects reporting serious adverse events (SAEs). From Day 1 up to Day 337 (6 months after last dose)
- Number of subjects reporting potential immune-mediated diseases (pIMDs). From Day 1 up to Day 337 (six months after the last dose)
- Number of subjects reporting liver-disease-related (LDR) AEs. From Day 1 up to Day 337 (six months after the last dose)
- Number of subjects reporting any hematological adverse events of specific interest (AESIs). From Day 1 up to Day 337 (six months after last dose)
- Number of subjects reporting medically-attended adverse events (MAEs). From Day 1 up to Day 337 (six months after the last dose)
External Link
https://clinicaltrials.gov/study/NCT03866187
Order
4
Disease
Version
Phase
1/2