A Study on the Safety and Immune Response of AS37 Together With Hepatitis B Antigen in Adults Aged 18-45 Years - Trial NCT05561673
Access comprehensive clinical trial information for NCT05561673 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by GlaxoSmithKline and is currently Recruiting. The study focuses on Hepatitis B. Target enrollment is 150 participants.
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Study Focus
GSK's Hepatitis B vaccine adjuvanted with aluminum hydroxide
Interventional
combination product
Sponsor & Location
GlaxoSmithKline
Timeline & Enrollment
Phase 1/2
Oct 04, 2022
Aug 05, 2024
Primary Outcome
Percentage of participants with solicited administration site events,Percentage of participants with solicited administration site events,Percentage of participants with solicited systemic events,Percentage of participants with solicited systemic events,Duration of solicited administration site events,Duration of solicited administration site events,Duration of solicited systemic events,Duration of solicited systemic events,Percentage of participants with any unsolicited adverse events (AEs),Percentage of participants with any unsolicited adverse events (AEs),Percentage of participants with serious AEs (SAEs),Percentage of participants with medically attended AEs (MAEs),Percentage of participants with AEs leading to study withdrawal,Percentage of participants with potential mediated immune diseases (pIMDs),Percentage of participants with changes from baseline (pre-vaccination, Day 1) in haematology and biochemistry parameters at Day 8,Percentage of participants with changes from baseline (pre-vaccination, Day 1) in haematology and biochemistry parameters at Day 31,Percentage of participants with changes from baseline (pre-vaccination, Day 1) in haematology and biochemistry parameters at Day 38,Percentage of participants with changes from baseline (pre-vaccination, Day 1) in haematology and biochemistry parameters at Day 61,Percentage of participants with abnormal haematology and biochemistry laboratory parameter values at Day 1,Percentage of participants with abnormal haematology and biochemistry laboratory parameter values at Day 8,Percentage of participants with abnormal haematology and biochemistry laboratory parameter values at Day 31,Percentage of participants with abnormal haematology and biochemistry laboratory parameter values at Day 38,Percentage of participants with abnormal haematology and biochemistry laboratory parameter values at Day 61
Summary
This study is conducted to assess the 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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05561673
Non-Device Trial