clinical trial · NCT05561673
A Study on the Safety and Immune Response of AS37 Together With Hepatitis B Antigen in Adults Aged 18-45 Years
GlaxoSmithKline·phase1·completed·n = 122
Hepatitis BGSK's Hepatitis B vaccine adjuvanted with aluminum hydroxideGSK's HBsAg candidate vaccine adjuvanted with GSK's AS03 adjuvant systemGSK's Hepatitis B vaccine adjuvanted with GSK's AS04 adjuvant systemGSK's HBsAg (20 μg) vaccine adjuvanted with GSK's AS37B adjuvant system (50 μg)GSK's HBsAg (20 μg) vaccine adjuvanted with GSK's AS37A adjuvant system (100 μg)
brief summary
This study is conducted to assess safety and immunogenicity of GSK's HBsAg vaccine adjuvanted with GSK's AS37 adjuvant system in healthy, HBs naïve, adults aged 18-45 years and to differentiate GSK's AS37 adjuvant system from other approved adjuvant systems and from an aluminum-based adjuvant.
started
Oct 4, 2022
primary completion
Nov 29, 2024
completion
Nov 29, 2024
last updated
Jan 15, 2026
official title
A Phase I/IIa, Open-label, Randomised, Controlled, Multi-country, Dose-escalation Study to Assess the Safety and Immunogenicity of AS37 in Combination With the Hepatitis B Surface Antigen (HBsAg), According to a 0-1 Month Schedule, in Healthy, HBs naïve, Adults Aged 18-45 Years
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol