135
Participants
Start Date
March 28, 2019
Primary Completion Date
October 7, 2024
Study Completion Date
October 7, 2024
ChAd155-hIi-HBV low dose formulation
Subjects in group A1 receive one dose of ChAd155-hIi-HBV low dose formulation at Day 1, by intramuscular injection in the deltoid of the non-dominant arm.
ChAd155-hIi-HBV high dose formulation
"Subjects in groups B1 and B3 receive one dose of ChAd155-hIi-HBV high dose formulation at Day 1 and Day 113 respectively, by intramuscular injection in the deltoid of the non-dominant arm.~Subjects in groups C1 and C2 receive one dose of ChAd155-hIi-HBV high dose formulation at Day 1 and Day 113 respectively, by intramuscular injection in the deltoid of the dominant arm."
HBc-HBs/AS01B-4 low dose formulation
Subjects in group A1 receive two doses of HBc-HBs/AS01B-4 low dose formulation, one at Day 113 and one at Day 169 and subjects in group A2 receive four doses of the low dose formulation, one dose each at Days 1, 57, 113 and 169, by intramuscular injection in the deltoid of the non-dominant arm.
HBc-HBs/AS01B-4 high dose formulation
Subjects in group B1 receive two doses of HBc-HBs/AS01B-4 high dose formulation, one at Day 113 and one at 169; subjects in group B2 receive four doses, one dose each at Days 1, 57, 113 and 169; subjects in group C1 receive four co-administered doses at Days 1, 57, 113 and 169 and subjects in group C2 receive two co-administered doses at Days 113 and 169, by intramuscular injection in the deltoid of the non-dominant arm.
MVA-HBV low dose formulation
Subjects in group A1 receive one dose of MVA-HBV low dose formulation at Day 57, by intramuscular injection in the deltoid of the non-dominant arm.
MVA-HBV high dose formulation
"Subjects in groups B1 and B3 receive one dose of MVA-HBV high dose formulation at Day 57 and Day 169 respectively, by intramuscular injection in the deltoid of the non-dominant arm.~Subjects in group C1 receive three co-administered doses of the vaccine at Days 57, 113 and 169 and subjects in group C2 receive one co-administered dose of the vaccine at Day 169, by intramuscular injection in the deltoid of the dominant arm."
Placebo
Subjects in group A3 receive four doses of placebo, one each at Days 1, 57, 113 and 169 and subjects in group B3 receive two doses of placebo one each at Days 1 and 57, by intramuscular injection in the deltoid of the non-dominant arm. Subjects in group C2 receive 2 co-administered doses of placebo at Days 1 and 57, by intramuscular injection in the deltoid of the dominant and non-dominant arm.
GSK Investigational Site, Taipei
GSK Investigational Site, Taoyuan District
GSK Investigational Site, Tainan City
GSK Investigational Site, Brussels
GSK Investigational Site, Antwerp
GSK Investigational Site, Edegem
GSK Investigational Site, Ghent
GSK Investigational Site, Bangkok
GSK Investigational Site, Berlin
GSK Investigational Site, Córdoba
GSK Investigational Site, Granada
GSK Investigational Site, Hamburg
GSK Investigational Site, Madrid
GSK Investigational Site, Madrid
GSK Investigational Site, Madrid
GSK Investigational Site, Madrid
GSK Investigational Site, TorrejOn Ardoz Madrid
GSK Investigational Site, Santander
GSK Investigational Site, Taichung
GSK Investigational Site, Taichung
GSK Investigational Site, Seville
GSK Investigational Site, Essen
GSK Investigational Site, Chiang Mai
GSK Investigational Site, Aachen
GSK Investigational Site, Bonn
GSK Investigational Site, Mainz
GSK Investigational Site, Frankfurt
GSK Investigational Site, Strasbourg
GSK Investigational Site, Lyon
GSK Investigational Site, Tübingen
GSK Investigational Site, Clichy
GSK Investigational Site, Créteil
GSK Investigational Site, Pokfulam
GSK Investigational Site, Krakow
GSK Investigational Site, Mysłowice
GSK Investigational Site, Poznan
GSK Investigational Site, Łańcut
GSK Investigational Site, Barcelona
GSK Investigational Site, Barcelona
GSK Investigational Site, Palma de Mallorca
GSK Investigational Site, London
GSK Investigational Site, London
GSK Investigational Site, Nottingham
Lead Sponsor
GlaxoSmithKline
INDUSTRY