Trial Outcomes & Findings for A Study on the Safety and Immune Response of AS37 Together With Hepatitis B Antigen in Adults Aged 18-45 Years (NCT NCT05561673)

Last Updated: 2026-01-15

Results Overview

Assessed solicited administration site events after vaccination included erythema, pain, and swelling at the injection site. Any = occurrence of the event regardless of intensity grade.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

122 participants

Primary outcome timeframe

Day 1 (day of administration) to Day 14

Results posted on

2026-01-15

Participant Flow

Participant milestones

Participant milestones
Measure	HBs-alum Group Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.	HBs-AS03 Group Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.	HBs-AS04 Group Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.	HBs-AS37B Group Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31.	HBs-AS37A Group Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37A adjuvant system (100 µg), at Day 1 and Day 31.
Overall Study STARTED	25	25	24	25	23
Overall Study COMPLETED	24	23	23	24	23
Overall Study NOT COMPLETED	1	2	1	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	HBs-alum Group Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.	HBs-AS03 Group Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.	HBs-AS04 Group Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.	HBs-AS37B Group Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31.
Overall Study Lost to Follow-up	0	1	0	1
Overall Study Consent withdrawal, not due to (S)AE	0	1	0	0
Overall Study Other	1	0	1	0

Baseline Characteristics

A Study on the Safety and Immune Response of AS37 Together With Hepatitis B Antigen in Adults Aged 18-45 Years

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HBs-alum Group n=25 Participants Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.	HBs-AS03 Group n=25 Participants Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.	HBs-AS04 Group n=24 Participants Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.	HBs-AS37B Group n=25 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31.	HBs-AS37A Group n=23 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37A adjuvant system (100 µg), at Day 1 and Day 31.	Total n=122 Participants Total of all reporting groups
Age, Continuous	35.9 YEARS STANDARD_DEVIATION 5.8 • n=14 Participants	37.5 YEARS STANDARD_DEVIATION 6.4 • n=10 Participants	34.5 YEARS STANDARD_DEVIATION 7.9 • n=24 Participants	38.6 YEARS STANDARD_DEVIATION 6.0 • n=78 Participants	37.3 YEARS STANDARD_DEVIATION 7.7 • n=713 Participants	36.8 YEARS STANDARD_DEVIATION 6.8 • n=82 Participants
Sex: Female, Male Female	11 Participants n=14 Participants	10 Participants n=10 Participants	10 Participants n=24 Participants	10 Participants n=78 Participants	10 Participants n=713 Participants	51 Participants n=82 Participants
Sex: Female, Male Male	14 Participants n=14 Participants	15 Participants n=10 Participants	14 Participants n=24 Participants	15 Participants n=78 Participants	13 Participants n=713 Participants	71 Participants n=82 Participants
Race/Ethnicity, Customized Other Races	2 Participants n=14 Participants	0 Participants n=10 Participants	2 Participants n=24 Participants	2 Participants n=78 Participants	1 Participants n=713 Participants	7 Participants n=82 Participants
Race/Ethnicity, Customized White	23 Participants n=14 Participants	25 Participants n=10 Participants	22 Participants n=24 Participants	23 Participants n=78 Participants	22 Participants n=713 Participants	115 Participants n=82 Participants

PRIMARY outcome

Timeframe: Day 1 (day of administration) to Day 14

Population: The analysis was performed on the Exposed Set (ES), which included all participants who received at least 1 dose of the study intervention. Only participants with solicited administration site events diary card available after dose 1 administration for the specified duration were included in this analysis.

Assessed solicited administration site events after vaccination included erythema, pain, and swelling at the injection site. Any = occurrence of the event regardless of intensity grade.

Outcome measures

Outcome measures
Measure	HBs-alum Group n=25 Participants Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.	HBs-AS03 Group n=25 Participants Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.	HBs-AS04 Group n=24 Participants Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.	HBs-AS37B Group n=25 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31.	HBs-AS37A Group n=23 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37A adjuvant system (100 µg), at Day 1 and Day 31.
Number of Participants With Solicited Administration Site Adverse Events (AEs) After Dose 1 Erythema	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Solicited Administration Site Adverse Events (AEs) After Dose 1 Pain	6 Participants	17 Participants	21 Participants	16 Participants	18 Participants
Number of Participants With Solicited Administration Site Adverse Events (AEs) After Dose 1 Swelling	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 31 (day of administration) to Day 45

Population: The analysis was performed on the ES. Only participants with solicited administration site events diary card available after dose 2 administration for the specified duration were included in this analysis.

Assessed solicited administration site events after vaccination included erythema, pain and swelling at the injection site. Any = occurrence of the event regardless of intensity grade.

Outcome measures

Outcome measures
Measure	HBs-alum Group n=24 Participants Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.	HBs-AS03 Group n=24 Participants Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.	HBs-AS04 Group n=23 Participants Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.	HBs-AS37B Group n=25 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31.	HBs-AS37A Group n=23 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37A adjuvant system (100 µg), at Day 1 and Day 31.
Number of Participants With Solicited Administration Site AEs After Dose 2 Erythema	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Solicited Administration Site AEs After Dose 2 Pain	1 Participants	15 Participants	16 Participants	14 Participants	14 Participants
Number of Participants With Solicited Administration Site AEs After Dose 2 Swelling	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 1 (day of administration) to Day 14

Population: The analysis was performed on the ES. Only participants with solicited systemic events diary card available after dose 1 administration for the specified duration were included in this analysis.

Assessed solicited systemic events included fever (defined as temperature greater than or equal to (\>=) 38.0°C regardless of the location of measurement), fatigue, myalgia, arthralgia, headache, chills, malaise, loss of appetite, nausea, vomiting, and diarrhea.

Outcome measures

Outcome measures
Measure	HBs-alum Group n=25 Participants Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.	HBs-AS03 Group n=25 Participants Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.	HBs-AS04 Group n=24 Participants Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.	HBs-AS37B Group n=25 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31.	HBs-AS37A Group n=23 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37A adjuvant system (100 µg), at Day 1 and Day 31.
Number of Participants With Solicited Systemic AEs After Dose 1 Chills	2 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Solicited Systemic AEs After Dose 1 Diarrhea	3 Participants	2 Participants	4 Participants	0 Participants	2 Participants
Number of Participants With Solicited Systemic AEs After Dose 1 Fatigue	9 Participants	10 Participants	10 Participants	12 Participants	11 Participants
Number of Participants With Solicited Systemic AEs After Dose 1 Headache	8 Participants	9 Participants	8 Participants	10 Participants	10 Participants
Number of Participants With Solicited Systemic AEs After Dose 1 Nausea	6 Participants	0 Participants	3 Participants	1 Participants	1 Participants
Number of Participants With Solicited Systemic AEs After Dose 1 Fever	1 Participants	2 Participants	1 Participants	2 Participants	0 Participants
Number of Participants With Solicited Systemic AEs After Dose 1 Vomiting	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Solicited Systemic AEs After Dose 1 Arthralgia	1 Participants	2 Participants	2 Participants	2 Participants	1 Participants
Number of Participants With Solicited Systemic AEs After Dose 1 Loss of appetite	1 Participants	4 Participants	2 Participants	1 Participants	0 Participants
Number of Participants With Solicited Systemic AEs After Dose 1 Malaise	8 Participants	2 Participants	7 Participants	3 Participants	2 Participants
Number of Participants With Solicited Systemic AEs After Dose 1 Myalgia	8 Participants	6 Participants	14 Participants	7 Participants	9 Participants

PRIMARY outcome

Timeframe: Day 31 (day of administration) to Day 45

Population: The analysis was performed on the ES. Only participants with solicited systemic events diary card available after dose 2 administration for the specified duration were included in this analysis.

Assessed solicited systemic events included fever (defined as temperature \>=38.0°C regardless of the location of measurement), fatigue, myalgia, arthralgia, headache, chills, malaise, loss of appetite, nausea, vomiting, and diarrhea.

Outcome measures

Outcome measures
Measure	HBs-alum Group n=24 Participants Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.	HBs-AS03 Group n=24 Participants Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.	HBs-AS04 Group n=23 Participants Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.	HBs-AS37B Group n=25 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31.	HBs-AS37A Group n=23 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37A adjuvant system (100 µg), at Day 1 and Day 31.
Number of Participants With Solicited Systemic AEs After Dose 2 Arthralgia	2 Participants	3 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Solicited Systemic AEs After Dose 2 Chills	2 Participants	4 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Solicited Systemic AEs After Dose 2 Diarrhea	3 Participants	2 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Solicited Systemic AEs After Dose 2 Fatigue	9 Participants	8 Participants	8 Participants	7 Participants	5 Participants
Number of Participants With Solicited Systemic AEs After Dose 2 Headache	9 Participants	8 Participants	7 Participants	7 Participants	4 Participants
Number of Participants With Solicited Systemic AEs After Dose 2 Loss of appetite	3 Participants	2 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Solicited Systemic AEs After Dose 2 Nausea	2 Participants	1 Participants	3 Participants	1 Participants	2 Participants
Number of Participants With Solicited Systemic AEs After Dose 2 Fever	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Solicited Systemic AEs After Dose 2 Vomiting	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Solicited Systemic AEs After Dose 2 Malaise	6 Participants	7 Participants	1 Participants	3 Participants	2 Participants
Number of Participants With Solicited Systemic AEs After Dose 2 Myalgia	2 Participants	7 Participants	12 Participants	6 Participants	7 Participants

PRIMARY outcome

Timeframe: Day 1 (day of administration) to Day 14

Population: The analysis was performed on the ES. Only participants who experienced solicited administration site events after dose 1 administration for the specified duration were included in this analysis. Here, 'Number of Participants Analyzed' = participants with available data for solicited administration site events at dose 1.

Duration is the number of days in which a participant experienced the symptom within the 14-day solicited follow-up period.

Outcome measures

Outcome measures
Measure	HBs-alum Group n=6 Participants Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.	HBs-AS03 Group n=17 Participants Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.	HBs-AS04 Group n=21 Participants Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.	HBs-AS37B Group n=16 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31.	HBs-AS37A Group n=18 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37A adjuvant system (100 µg), at Day 1 and Day 31.
Duration in Days of Solicited Administration Site AEs After Dose 1	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 3.0	3.0 Days Interval 1.0 to 4.0	2.0 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 2.0

PRIMARY outcome

Timeframe: Day 31 (day of administration) to Day 45

Population: The analysis was performed on the ES. Only participants who experienced solicited administration site events after dose 2 administration for the specified duration were included in this analysis. Here, 'Number of Participants Analyzed' = participants with available data for solicited administration site events at dose 2.

Duration is the number of days in which a participant experienced the symptom within the 14-day solicited follow-up period.

Outcome measures

Outcome measures
Measure	HBs-alum Group n=1 Participants Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.	HBs-AS03 Group n=15 Participants Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.	HBs-AS04 Group n=16 Participants Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.	HBs-AS37B Group n=14 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31.	HBs-AS37A Group n=14 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37A adjuvant system (100 µg), at Day 1 and Day 31.
Duration in Days of Solicited Administration Site AEs After Dose 2	1.0 Days Interval 1.0 to 1.0	2.0 Days Interval 2.0 to 3.0	4.0 Days Interval 2.5 to 5.0	1.5 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0

PRIMARY outcome

Timeframe: Day 1 (day of administration) to Day 14

Population: The analysis was performed on the ES. Only participants who experienced solicited systemic events after dose 1 administration for the specified duration were included in this analysis. Here, 'Number of Participants Analyzed' = participants with available data for solicited systemic events at dose 1.

Duration is the number of days in which a participant experienced the symptom within the 14-day solicited follow-up period.

Outcome measures

Outcome measures
Measure	HBs-alum Group n=9 Participants Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.	HBs-AS03 Group n=10 Participants Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.	HBs-AS04 Group n=14 Participants Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.	HBs-AS37B Group n=12 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31.	HBs-AS37A Group n=11 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37A adjuvant system (100 µg), at Day 1 and Day 31.
Duration in Days of Solicited Systemic AEs After Dose 1 Arthralgia	2.0 Days Interval 2.0 to 2.0	1.5 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 1.0	2.0 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 1.0
Duration in Days of Solicited Systemic AEs After Dose 1 Chills	1.5 Days Interval 1.0 to 2.0	—	—	1.0 Days Interval 1.0 to 1.0	3.0 Days Interval 3.0 to 3.0
Duration in Days of Solicited Systemic AEs After Dose 1 Diarrhea	1.0 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 1.0	1.5 Days Interval 1.0 to 2.0	—	1.0 Days Interval 1.0 to 1.0
Duration in Days of Solicited Systemic AEs After Dose 1 Fatigue	1.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 4.0	1.0 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 2.0
Duration in Days of Solicited Systemic AEs After Dose 1 Headache	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0	1.5 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 1.0
Duration in Days of Solicited Systemic AEs After Dose 1 Loss of appetite	5.0 Days Interval 5.0 to 5.0	1.5 Days Interval 1.0 to 2.0	1.5 Days Interval 1.0 to 2.0	4.0 Days Interval 4.0 to 4.0	—
Duration in Days of Solicited Systemic AEs After Dose 1 Malaise	1.0 Days Interval 1.0 to 2.0	1.5 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 1.0
Duration in Days of Solicited Systemic AEs After Dose 1 Myalgia	1.5 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 4.0	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 2.0
Duration in Days of Solicited Systemic AEs After Dose 1 Nausea	1.0 Days Interval 1.0 to 2.0	—	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 1.0
Duration in Days of Solicited Systemic AEs After Dose 1 Fever	1.0 Days Interval 1.0 to 1.0	2.5 Days Interval 2.0 to 3.0	3.0 Days Interval 3.0 to 3.0	3.0 Days Interval 2.0 to 4.0	—

PRIMARY outcome

Timeframe: Day 31 (day of administration) to Day 45

Population: The analysis was performed on the ES. Only participants who experienced solicited systemic events after dose 2 administration for the specified duration were included in this analysis. Here, 'Number of Participants Analyzed' = participants with available data for solicited systemic events at dose 2.

Duration is the number of days in which a participant experienced the symptom within the 14-day solicited follow-up period.

Outcome measures

Outcome measures
Measure	HBs-alum Group n=9 Participants Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.	HBs-AS03 Group n=8 Participants Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.	HBs-AS04 Group n=12 Participants Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.	HBs-AS37B Group n=7 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31.	HBs-AS37A Group n=7 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37A adjuvant system (100 µg), at Day 1 and Day 31.
Duration in Days of Solicited Systemic AEs After Dose 2 Arthralgia	2.0 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 1.0	5.0 Days Interval 5.0 to 5.0	1.0 Days Interval 1.0 to 1.0
Duration in Days of Solicited Systemic AEs After Dose 2 Chills	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 1.5	—	1.0 Days Interval 1.0 to 1.0	1.5 Days Interval 1.0 to 2.0
Duration in Days of Solicited Systemic AEs After Dose 2 Diarrhea	1.0 Days Interval 1.0 to 2.0	1.5 Days Interval 1.0 to 2.0	2.0 Days Interval 2.0 to 2.0	2.0 Days Interval 2.0 to 2.0	1.0 Days Interval 1.0 to 1.0
Duration in Days of Solicited Systemic AEs After Dose 2 Fatigue	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.5	1.5 Days Interval 1.0 to 4.0	2.0 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 1.0
Duration in Days of Solicited Systemic AEs After Dose 2 Headache	1.0 Days Interval 1.0 to 1.0	1.5 Days Interval 1.0 to 2.5	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 4.0	2.0 Days Interval 1.0 to 3.5
Duration in Days of Solicited Systemic AEs After Dose 2 Loss of appetite	1.0 Days Interval 1.0 to 5.0	2.0 Days Interval 1.0 to 3.0	—	—	1.0 Days Interval 1.0 to 1.0
Duration in Days of Solicited Systemic AEs After Dose 2 Malaise	2.5 Days Interval 2.0 to 3.0	1.0 Days Interval 1.0 to 2.0	3.0 Days Interval 3.0 to 3.0	2.0 Days Interval 1.0 to 6.0	1.5 Days Interval 1.0 to 2.0
Duration in Days of Solicited Systemic AEs After Dose 2 Myalgia	2.5 Days Interval 1.0 to 4.0	2.0 Days Interval 1.0 to 4.0	2.5 Days Interval 1.5 to 3.5	2.0 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 3.0
Duration in Days of Solicited Systemic AEs After Dose 2 Nausea	2.5 Days Interval 2.0 to 3.0	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 1.0	2.0 Days Interval 2.0 to 2.0	1.0 Days Interval 1.0 to 1.0
Duration in Days of Solicited Systemic AEs After Dose 2 Fever	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 1.0	4.0 Days Interval 4.0 to 4.0	1.0 Days Interval 1.0 to 1.0	2.0 Days Interval 2.0 to 2.0
Duration in Days of Solicited Systemic AEs After Dose 2 Vomiting	—	—	—	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 1.0

PRIMARY outcome

Timeframe: Day 1 (day of administration) to Day 31

Population: The analysis was performed on the ES. Only participants with unsolicited AEs after dose 1 administration for the specified duration were included in this analysis.

An unsolicited AE is an AE that was not included in a list of solicited events using a Participant Diary. Unsolicited events must have been spontaneously communicated by a participant who has signed the informed consent. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.

Outcome measures

Outcome measures
Measure	HBs-alum Group n=25 Participants Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.	HBs-AS03 Group n=25 Participants Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.	HBs-AS04 Group n=24 Participants Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.	HBs-AS37B Group n=25 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31.	HBs-AS37A Group n=23 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37A adjuvant system (100 µg), at Day 1 and Day 31.
Number of Participants With Any Unsolicited AEs After Dose 1	7 Participants	2 Participants	6 Participants	4 Participants	5 Participants

PRIMARY outcome

Timeframe: Day 31 (day of administration) to Day 61

Population: The analysis was performed on the ES. Only participants with unsolicited AEs after dose 2 administration for the specified duration were included in this analysis.

Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.

Outcome measures

Outcome measures
Measure	HBs-alum Group n=24 Participants Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.	HBs-AS03 Group n=24 Participants Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.	HBs-AS04 Group n=23 Participants Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.	HBs-AS37B Group n=25 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31.	HBs-AS37A Group n=23 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37A adjuvant system (100 µg), at Day 1 and Day 31.
Number of Participants With Any Unsolicited AEs After Dose 2	5 Participants	7 Participants	6 Participants	6 Participants	6 Participants

PRIMARY outcome

Timeframe: Throughout the entire study period (from Day 1 to Day 361)

Population: The analysis was performed on the ES.

An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or is an abnormal pregnancy outcome. Any = occurrence of the SAE regardless of intensity grade or relation to the study vaccination.

Outcome measures

Outcome measures
Measure	HBs-alum Group n=25 Participants Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.	HBs-AS03 Group n=25 Participants Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.	HBs-AS04 Group n=24 Participants Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.	HBs-AS37B Group n=25 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31.	HBs-AS37A Group n=23 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37A adjuvant system (100 µg), at Day 1 and Day 31.
Number of Participants With Serious AEs (SAEs)	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Throughout the entire study period (from Day 1 to Day 361)

Population: The analysis was performed on the ES.

An MAE is any AE with medically attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any = occurrence of the MAE regardless of intensity grade or relation to the study vaccination.

Outcome measures

Outcome measures
Measure	HBs-alum Group n=25 Participants Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.	HBs-AS03 Group n=25 Participants Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.	HBs-AS04 Group n=24 Participants Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.	HBs-AS37B Group n=25 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31.	HBs-AS37A Group n=23 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37A adjuvant system (100 µg), at Day 1 and Day 31.
Number of Participants With Medically Attended AEs (MAEs)	8 Participants	2 Participants	2 Participants	3 Participants	4 Participants

PRIMARY outcome

Timeframe: Throughout the entire study period (from Day 1 to Day 361)

Population: The analysis was performed on the ES.

An AE is any untoward medical occurrence (an unfavourable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. The AE may or may not be considered related to the study intervention. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for him/her since the date of withdrawal/last contact.

Outcome measures

Outcome measures
Measure	HBs-alum Group n=25 Participants Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.	HBs-AS03 Group n=25 Participants Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.	HBs-AS04 Group n=24 Participants Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.	HBs-AS37B Group n=25 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31.	HBs-AS37A Group n=23 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37A adjuvant system (100 µg), at Day 1 and Day 31.
Number of Participants With AEs Leading to Study Withdrawal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Throughout the entire study period (from Day 1 to Day 361)

Population: The analysis was performed on the ES.

pIMDs are a subset of adverse events that include autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have an autoimmune aetiology. Any = occurrence of the pIMD regardless of intensity grade or relation to the study vaccination.

Outcome measures

Outcome measures
Measure	HBs-alum Group n=25 Participants Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.	HBs-AS03 Group n=25 Participants Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.	HBs-AS04 Group n=24 Participants Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.	HBs-AS37B Group n=25 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31.	HBs-AS37A Group n=23 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37A adjuvant system (100 µg), at Day 1 and Day 31.
Number of Participants With Potential Mediated Immune Diseases (pIMDs)	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: At Day 8 (relative to baseline [pre-vaccination Day 1])

Population: The analysis was performed on the ES. Only participants for whom the specified laboratory data after dose 1 administration were available for the specified timepoint (at Day 8) were included in analysis.

In the analysis were included biochemistry parameters: alanine aminotransferase (ALT), aspartate aminotransferase (AST), bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, white blood cells (WBC).

Outcome measures

Outcome measures
Measure	HBs-alum Group n=25 Participants Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.	HBs-AS03 Group n=25 Participants Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.	HBs-AS04 Group n=24 Participants Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.	HBs-AS37B Group n=25 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31.	HBs-AS37A Group n=23 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37A adjuvant system (100 µg), at Day 1 and Day 31.
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 ALT	-3.04 Mean percent change from baseline Standard Deviation 20.322	-6.69 Mean percent change from baseline Standard Deviation 14.117	-1.13 Mean percent change from baseline Standard Deviation 34.221	8.14 Mean percent change from baseline Standard Deviation 25.853	0.95 Mean percent change from baseline Standard Deviation 15.926
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 AST	4.74 Mean percent change from baseline Standard Deviation 17.106	-5.62 Mean percent change from baseline Standard Deviation 14.509	-1.79 Mean percent change from baseline Standard Deviation 18.626	7.35 Mean percent change from baseline Standard Deviation 24.486	2.28 Mean percent change from baseline Standard Deviation 16.477
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 Bicarbonate	0.52 Mean percent change from baseline Standard Deviation 7.789	-0.19 Mean percent change from baseline Standard Deviation 8.276	3.68 Mean percent change from baseline Standard Deviation 8.491	0.06 Mean percent change from baseline Standard Deviation 10.180	4.16 Mean percent change from baseline Standard Deviation 7.337
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 Blood urea nitrogen	2.60 Mean percent change from baseline Standard Deviation 29.717	-3.03 Mean percent change from baseline Standard Deviation 19.264	1.84 Mean percent change from baseline Standard Deviation 32.456	0.09 Mean percent change from baseline Standard Deviation 25.501	-0.63 Mean percent change from baseline Standard Deviation 15.543
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 Chloride	0.79 Mean percent change from baseline Standard Deviation 1.921	0.23 Mean percent change from baseline Standard Deviation 2.119	-0.11 Mean percent change from baseline Standard Deviation 2.000	-0.33 Mean percent change from baseline Standard Deviation 2.247	-0.24 Mean percent change from baseline Standard Deviation 2.119
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 C Reactive Protein	78.43 Mean percent change from baseline Standard Deviation 349.570	41.16 Mean percent change from baseline Standard Deviation 124.844	129.65 Mean percent change from baseline Standard Deviation 393.365	5.72 Mean percent change from baseline Standard Deviation 57.451	-6.50 Mean percent change from baseline Standard Deviation 45.671
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 Creatinine	0.34 Mean percent change from baseline Standard Deviation 8.164	-2.35 Mean percent change from baseline Standard Deviation 10.278	-2.01 Mean percent change from baseline Standard Deviation 7.209	-0.10 Mean percent change from baseline Standard Deviation 9.989	0.76 Mean percent change from baseline Standard Deviation 9.176
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 Potassium	1.88 Mean percent change from baseline Standard Deviation 8.648	-0.14 Mean percent change from baseline Standard Deviation 8.133	1.91 Mean percent change from baseline Standard Deviation 8.313	2.43 Mean percent change from baseline Standard Deviation 7.932	0.27 Mean percent change from baseline Standard Deviation 6.323
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 Sodium	0.26 Mean percent change from baseline Standard Deviation 1.204	0.18 Mean percent change from baseline Standard Deviation 1.376	0.27 Mean percent change from baseline Standard Deviation 1.438	0.04 Mean percent change from baseline Standard Deviation 1.481	0.19 Mean percent change from baseline Standard Deviation 1.253
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 Eosinophils	20.35 Mean percent change from baseline Standard Deviation 45.285	31.51 Mean percent change from baseline Standard Deviation 76.423	-3.33 Mean percent change from baseline Standard Deviation 46.839	18.15 Mean percent change from baseline Standard Deviation 45.276	12.86 Mean percent change from baseline Standard Deviation 38.767
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 Erythrocytes	-2.06 Mean percent change from baseline Standard Deviation 3.756	-1.01 Mean percent change from baseline Standard Deviation 3.786	-0.67 Mean percent change from baseline Standard Deviation 4.423	0.45 Mean percent change from baseline Standard Deviation 5.160	-0.21 Mean percent change from baseline Standard Deviation 4.384
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 Hemoglobin	-2.17 Mean percent change from baseline Standard Deviation 3.729	-0.94 Mean percent change from baseline Standard Deviation 3.817	-0.60 Mean percent change from baseline Standard Deviation 3.892	0.74 Mean percent change from baseline Standard Deviation 5.156	-0.36 Mean percent change from baseline Standard Deviation 4.075
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 Lymphocytes	8.79 Mean percent change from baseline Standard Deviation 18.849	6.58 Mean percent change from baseline Standard Deviation 23.996	1.25 Mean percent change from baseline Standard Deviation 25.224	7.80 Mean percent change from baseline Standard Deviation 32.898	4.04 Mean percent change from baseline Standard Deviation 15.252
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 Platelets	1.56 Mean percent change from baseline Standard Deviation 10.141	2.84 Mean percent change from baseline Standard Deviation 7.234	5.10 Mean percent change from baseline Standard Deviation 10.605	4.72 Mean percent change from baseline Standard Deviation 10.952	5.67 Mean percent change from baseline Standard Deviation 11.517
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 Monocytes	8.83 Mean percent change from baseline Standard Deviation 23.264	6.20 Mean percent change from baseline Standard Deviation 24.148	7.31 Mean percent change from baseline Standard Deviation 36.121	12.52 Mean percent change from baseline Standard Deviation 35.758	4.98 Mean percent change from baseline Standard Deviation 24.417
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 Neutrophils	2.69 Mean percent change from baseline Standard Deviation 27.341	-2.23 Mean percent change from baseline Standard Deviation 28.410	14.24 Mean percent change from baseline Standard Deviation 38.460	2.03 Mean percent change from baseline Standard Deviation 25.842	4.70 Mean percent change from baseline Standard Deviation 28.444
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 WBC	4.06 Mean percent change from baseline Standard Deviation 16.847	0.88 Mean percent change from baseline Standard Deviation 17.754	7.58 Mean percent change from baseline Standard Deviation 19.074	0.26 Mean percent change from baseline Standard Deviation 21.314	3.53 Mean percent change from baseline Standard Deviation 18.126

PRIMARY outcome

Timeframe: At Day 31 (compared with baseline [prevaccination, Day 1])

Outcome measures

Outcome measures
Measure	HBs-alum Group n=24 Participants Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.	HBs-AS03 Group n=24 Participants Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.	HBs-AS04 Group n=23 Participants Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.	HBs-AS37B Group n=25 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31.	HBs-AS37A Group n=23 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37A adjuvant system (100 µg), at Day 1 and Day 31.
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 ALT	-2.45 Mean percent change from baseline Standard Deviation 32.837	12.52 Mean percent change from baseline Standard Deviation 81.650	2.94 Mean percent change from baseline Standard Deviation 25.235	5.89 Mean percent change from baseline Standard Deviation 25.561	3.07 Mean percent change from baseline Standard Deviation 27.915
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 AST	-0.60 Mean percent change from baseline Standard Deviation 22.151	0.12 Mean percent change from baseline Standard Deviation 25.394	3.33 Mean percent change from baseline Standard Deviation 31.456	3.21 Mean percent change from baseline Standard Deviation 22.040	4.57 Mean percent change from baseline Standard Deviation 21.930
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 Bicarbonate	0.58 Mean percent change from baseline Standard Deviation 11.020	-2.47 Mean percent change from baseline Standard Deviation 9.490	0.78 Mean percent change from baseline Standard Deviation 10.526	-0.20 Mean percent change from baseline Standard Deviation 9.834	4.65 Mean percent change from baseline Standard Deviation 12.535
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 Blood urea nitrogen	-1.04 Mean percent change from baseline Standard Deviation 17.638	1.42 Mean percent change from baseline Standard Deviation 23.387	-5.65 Mean percent change from baseline Standard Deviation 27.995	-3.27 Mean percent change from baseline Standard Deviation 27.699	3.70 Mean percent change from baseline Standard Deviation 23.551
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 Chloride	0.76 Mean percent change from baseline Standard Deviation 2.430	0.29 Mean percent change from baseline Standard Deviation 2.668	-0.16 Mean percent change from baseline Standard Deviation 1.836	0.09 Mean percent change from baseline Standard Deviation 2.059	0.17 Mean percent change from baseline Standard Deviation 2.022
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 C Reactive Protein	23.07 Mean percent change from baseline Standard Deviation 94.084	37.95 Mean percent change from baseline Standard Deviation 143.597	130.90 Mean percent change from baseline Standard Deviation 518.895	12.48 Mean percent change from baseline Standard Deviation 63.081	77.00 Mean percent change from baseline Standard Deviation 358.139
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 Creatinine	-3.73 Mean percent change from baseline Standard Deviation 8.529	-4.69 Mean percent change from baseline Standard Deviation 9.817	-1.37 Mean percent change from baseline Standard Deviation 7.374	-1.77 Mean percent change from baseline Standard Deviation 9.931	-2.23 Mean percent change from baseline Standard Deviation 9.222
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 Potassium	-1.60 Mean percent change from baseline Standard Deviation 6.867	0.23 Mean percent change from baseline Standard Deviation 7.493	-0.78 Mean percent change from baseline Standard Deviation 7.674	2.46 Mean percent change from baseline Standard Deviation 8.750	-1.54 Mean percent change from baseline Standard Deviation 6.611
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 Sodium	0.18 Mean percent change from baseline Standard Deviation 1.273	0.49 Mean percent change from baseline Standard Deviation 1.486	-0.28 Mean percent change from baseline Standard Deviation 1.113	0.31 Mean percent change from baseline Standard Deviation 1.221	0.13 Mean percent change from baseline Standard Deviation 1.318
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 Eosinophils	61.95 Mean percent change from baseline Standard Deviation 156.721	10.80 Mean percent change from baseline Standard Deviation 47.476	6.13 Mean percent change from baseline Standard Deviation 42.536	43.03 Mean percent change from baseline Standard Deviation 99.613	0.88 Mean percent change from baseline Standard Deviation 44.640
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 Erythrocytes	-2.30 Mean percent change from baseline Standard Deviation 3.813	-0.71 Mean percent change from baseline Standard Deviation 3.877	-1.14 Mean percent change from baseline Standard Deviation 5.730	0.76 Mean percent change from baseline Standard Deviation 4.317	-1.06 Mean percent change from baseline Standard Deviation 5.496
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 Hemoglobin	-1.99 Mean percent change from baseline Standard Deviation 4.925	-0.25 Mean percent change from baseline Standard Deviation 3.795	-0.75 Mean percent change from baseline Standard Deviation 5.168	0.92 Mean percent change from baseline Standard Deviation 4.328	-1.06 Mean percent change from baseline Standard Deviation 4.325
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 Lymphocytes	3.44 Mean percent change from baseline Standard Deviation 15.877	5.02 Mean percent change from baseline Standard Deviation 23.147	4.16 Mean percent change from baseline Standard Deviation 24.245	-0.47 Mean percent change from baseline Standard Deviation 22.632	0.61 Mean percent change from baseline Standard Deviation 17.722
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 Platelets	-4.21 Mean percent change from baseline Standard Deviation 10.893	-1.86 Mean percent change from baseline Standard Deviation 13.771	1.72 Mean percent change from baseline Standard Deviation 10.562	2.92 Mean percent change from baseline Standard Deviation 9.752	0.68 Mean percent change from baseline Standard Deviation 10.344
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 Monocytes	8.76 Mean percent change from baseline Standard Deviation 44.115	9.84 Mean percent change from baseline Standard Deviation 30.487	5.31 Mean percent change from baseline Standard Deviation 30.151	7.75 Mean percent change from baseline Standard Deviation 34.218	9.96 Mean percent change from baseline Standard Deviation 29.752
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 Neutrophils	10.63 Mean percent change from baseline Standard Deviation 43.055	2.47 Mean percent change from baseline Standard Deviation 29.935	8.26 Mean percent change from baseline Standard Deviation 27.070	-0.67 Mean percent change from baseline Standard Deviation 24.740	12.13 Mean percent change from baseline Standard Deviation 32.091
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 WBC	6.65 Mean percent change from baseline Standard Deviation 26.757	2.37 Mean percent change from baseline Standard Deviation 18.732	5.78 Mean percent change from baseline Standard Deviation 20.170	-2.04 Mean percent change from baseline Standard Deviation 18.832	6.17 Mean percent change from baseline Standard Deviation 19.512

PRIMARY outcome

Timeframe: At Day 38 (compared with baseline [pre-vaccination, Day 1])

Population: The analysis was performed on the ES. Only participants for whom the specified laboratory data after dose 2 administration were available for the specified timepoint (at Day 38) were included in analysis.

Outcome measures

Outcome measures
Measure	HBs-alum Group n=23 Participants Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.	HBs-AS03 Group n=23 Participants Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.	HBs-AS04 Group n=22 Participants Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.	HBs-AS37B Group n=25 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31.	HBs-AS37A Group n=23 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37A adjuvant system (100 µg), at Day 1 and Day 31.
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 ALT	-1.70 Mean percent change from baseline Standard Deviation 28.091	-9.56 Mean percent change from baseline Standard Deviation 28.152	8.70 Mean percent change from baseline Standard Deviation 40.893	7.81 Mean percent change from baseline Standard Deviation 24.159	-4.15 Mean percent change from baseline Standard Deviation 19.568
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 AST	1.91 Mean percent change from baseline Standard Deviation 26.199	-7.81 Mean percent change from baseline Standard Deviation 21.151	11.34 Mean percent change from baseline Standard Deviation 41.922	5.63 Mean percent change from baseline Standard Deviation 17.430	-2.19 Mean percent change from baseline Standard Deviation 18.087
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 Bicarbonate	-0.10 Mean percent change from baseline Standard Deviation 11.002	1.04 Mean percent change from baseline Standard Deviation 7.590	4.41 Mean percent change from baseline Standard Deviation 12.016	0.75 Mean percent change from baseline Standard Deviation 9.389	5.04 Mean percent change from baseline Standard Deviation 11.085
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 Blood urea nitrogen	2.83 Mean percent change from baseline Standard Deviation 30.148	-1.73 Mean percent change from baseline Standard Deviation 23.632	2.30 Mean percent change from baseline Standard Deviation 39.154	0.69 Mean percent change from baseline Standard Deviation 28.712	5.34 Mean percent change from baseline Standard Deviation 23.796
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 Chloride	0.39 Mean percent change from baseline Standard Deviation 1.824	-0.18 Mean percent change from baseline Standard Deviation 2.413	-0.96 Mean percent change from baseline Standard Deviation 2.079	-0.46 Mean percent change from baseline Standard Deviation 2.004	0.39 Mean percent change from baseline Standard Deviation 2.058
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 C Reactive Protein	57.03 Mean percent change from baseline Standard Deviation 191.211	131.87 Mean percent change from baseline Standard Deviation 475.577	55.41 Mean percent change from baseline Standard Deviation 110.350	146.04 Mean percent change from baseline Standard Deviation 584.663	3.02 Mean percent change from baseline Standard Deviation 66.364
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 Creatinine	1.18 Mean percent change from baseline Standard Deviation 10.007	-2.71 Mean percent change from baseline Standard Deviation 8.546	-0.25 Mean percent change from baseline Standard Deviation 7.389	0.61 Mean percent change from baseline Standard Deviation 11.670	1.40 Mean percent change from baseline Standard Deviation 9.723
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 Potassium	-0.11 Mean percent change from baseline Standard Deviation 8.188	0.30 Mean percent change from baseline Standard Deviation 10.244	1.76 Mean percent change from baseline Standard Deviation 10.350	1.83 Mean percent change from baseline Standard Deviation 8.246	2.15 Mean percent change from baseline Standard Deviation 7.425
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 Sodium	0.31 Mean percent change from baseline Standard Deviation 0.802	0.32 Mean percent change from baseline Standard Deviation 1.833	-0.03 Mean percent change from baseline Standard Deviation 1.268	0.01 Mean percent change from baseline Standard Deviation 1.225	0.38 Mean percent change from baseline Standard Deviation 1.128
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 Eosinophils	103.21 Mean percent change from baseline Standard Deviation 216.663	64.45 Mean percent change from baseline Standard Deviation 142.771	27.38 Mean percent change from baseline Standard Deviation 65.060	35.67 Mean percent change from baseline Standard Deviation 96.666	6.21 Mean percent change from baseline Standard Deviation 58.498
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 Erythrocytes	-2.59 Mean percent change from baseline Standard Deviation 4.677	-0.54 Mean percent change from baseline Standard Deviation 3.879	0.01 Mean percent change from baseline Standard Deviation 5.660	0.66 Mean percent change from baseline Standard Deviation 4.466	-1.46 Mean percent change from baseline Standard Deviation 5.741
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 Hemoglobin	-1.89 Mean percent change from baseline Standard Deviation 5.602	-0.44 Mean percent change from baseline Standard Deviation 3.530	-0.05 Mean percent change from baseline Standard Deviation 5.064	0.88 Mean percent change from baseline Standard Deviation 4.548	-2.32 Mean percent change from baseline Standard Deviation 3.201
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 Lymphocytes	2.35 Mean percent change from baseline Standard Deviation 22.056	8.61 Mean percent change from baseline Standard Deviation 23.233	15.80 Mean percent change from baseline Standard Deviation 31.316	2.46 Mean percent change from baseline Standard Deviation 25.691	0.10 Mean percent change from baseline Standard Deviation 23.742
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 Platelets	1.41 Mean percent change from baseline Standard Deviation 11.656	5.25 Mean percent change from baseline Standard Deviation 14.869	6.56 Mean percent change from baseline Standard Deviation 11.374	2.33 Mean percent change from baseline Standard Deviation 10.113	3.02 Mean percent change from baseline Standard Deviation 14.577
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 Monocytes	20.33 Mean percent change from baseline Standard Deviation 52.053	5.44 Mean percent change from baseline Standard Deviation 29.929	23.51 Mean percent change from baseline Standard Deviation 31.162	10.00 Mean percent change from baseline Standard Deviation 32.556	10.95 Mean percent change from baseline Standard Deviation 42.691
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 Neutrophils	8.11 Mean percent change from baseline Standard Deviation 39.675	10.17 Mean percent change from baseline Standard Deviation 55.015	12.80 Mean percent change from baseline Standard Deviation 27.430	-5.36 Mean percent change from baseline Standard Deviation 24.208	-3.26 Mean percent change from baseline Standard Deviation 32.341
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 WBC	5.34 Mean percent change from baseline Standard Deviation 24.916	8.19 Mean percent change from baseline Standard Deviation 34.765	12.42 Mean percent change from baseline Standard Deviation 18.141	-3.72 Mean percent change from baseline Standard Deviation 16.095	-3.79 Mean percent change from baseline Standard Deviation 19.528

PRIMARY outcome

Timeframe: At Day 61 (compared with baseline [pre-vaccination, Day 1])

Outcome measures

Outcome measures
Measure	HBs-alum Group n=24 Participants Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.	HBs-AS03 Group n=24 Participants Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.	HBs-AS04 Group n=23 Participants Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.	HBs-AS37B Group n=25 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31.	HBs-AS37A Group n=23 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37A adjuvant system (100 µg), at Day 1 and Day 31.
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 ALT	-4.71 Mean percent change from baseline Standard Deviation 27.145	61.39 Mean percent change from baseline Standard Deviation 318.144	12.94 Mean percent change from baseline Standard Deviation 49.927	4.67 Mean percent change from baseline Standard Deviation 36.939	13.83 Mean percent change from baseline Standard Deviation 63.700
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 AST	8.19 Mean percent change from baseline Standard Deviation 43.555	42.91 Mean percent change from baseline Standard Deviation 171.398	18.51 Mean percent change from baseline Standard Deviation 68.383	8.78 Mean percent change from baseline Standard Deviation 47.643	3.47 Mean percent change from baseline Standard Deviation 33.308
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 Bicarbonate	0.66 Mean percent change from baseline Standard Deviation 8.676	-2.36 Mean percent change from baseline Standard Deviation 8.453	3.17 Mean percent change from baseline Standard Deviation 9.880	-3.21 Mean percent change from baseline Standard Deviation 10.373	4.64 Mean percent change from baseline Standard Deviation 12.554
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 Blood urea nitrogen	8.26 Mean percent change from baseline Standard Deviation 26.719	-1.24 Mean percent change from baseline Standard Deviation 32.101	-4.94 Mean percent change from baseline Standard Deviation 21.078	-2.00 Mean percent change from baseline Standard Deviation 25.429	2.60 Mean percent change from baseline Standard Deviation 21.312
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 Chloride	-0.22 Mean percent change from baseline Standard Deviation 2.006	0.48 Mean percent change from baseline Standard Deviation 2.157	0.09 Mean percent change from baseline Standard Deviation 1.691	-0.14 Mean percent change from baseline Standard Deviation 2.311	0.01 Mean percent change from baseline Standard Deviation 1.803
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 C Reactive Protein	64.02 Mean percent change from baseline Standard Deviation 180.495	121.89 Mean percent change from baseline Standard Deviation 432.514	79.61 Mean percent change from baseline Standard Deviation 218.741	91.49 Mean percent change from baseline Standard Deviation 237.304	109.50 Mean percent change from baseline Standard Deviation 512.035
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 Creatinine	2.96 Mean percent change from baseline Standard Deviation 13.010	-1.84 Mean percent change from baseline Standard Deviation 13.034	1.15 Mean percent change from baseline Standard Deviation 11.041	-3.95 Mean percent change from baseline Standard Deviation 8.215	-1.20 Mean percent change from baseline Standard Deviation 7.048
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 Potassium	0.33 Mean percent change from baseline Standard Deviation 9.316	3.34 Mean percent change from baseline Standard Deviation 10.727	-1.88 Mean percent change from baseline Standard Deviation 7.115	1.17 Mean percent change from baseline Standard Deviation 8.379	-0.21 Mean percent change from baseline Standard Deviation 6.832
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 Sodium	-0.35 Mean percent change from baseline Standard Deviation 1.278	0.34 Mean percent change from baseline Standard Deviation 1.881	0.44 Mean percent change from baseline Standard Deviation 1.278	-0.33 Mean percent change from baseline Standard Deviation 1.156	0.25 Mean percent change from baseline Standard Deviation 1.335
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 Eosinophils	20.20 Mean percent change from baseline Standard Deviation 32.608	32.37 Mean percent change from baseline Standard Deviation 59.533	42.38 Mean percent change from baseline Standard Deviation 91.920	57.74 Mean percent change from baseline Standard Deviation 144.539	17.59 Mean percent change from baseline Standard Deviation 63.368
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 Erythrocytes	-0.86 Mean percent change from baseline Standard Deviation 5.037	0.65 Mean percent change from baseline Standard Deviation 5.327	-0.76 Mean percent change from baseline Standard Deviation 5.901	0.51 Mean percent change from baseline Standard Deviation 4.813	-0.63 Mean percent change from baseline Standard Deviation 5.596
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 Hemoglobin	-0.86 Mean percent change from baseline Standard Deviation 6.190	0.49 Mean percent change from baseline Standard Deviation 4.971	-0.85 Mean percent change from baseline Standard Deviation 5.363	0.60 Mean percent change from baseline Standard Deviation 4.671	-1.01 Mean percent change from baseline Standard Deviation 3.466
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 Lymphocytes	6.43 Mean percent change from baseline Standard Deviation 21.692	2.32 Mean percent change from baseline Standard Deviation 18.547	9.74 Mean percent change from baseline Standard Deviation 32.460	-1.74 Mean percent change from baseline Standard Deviation 27.336	4.92 Mean percent change from baseline Standard Deviation 21.356
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 Platelets	-1.29 Mean percent change from baseline Standard Deviation 11.369	2.12 Mean percent change from baseline Standard Deviation 15.566	1.35 Mean percent change from baseline Standard Deviation 12.342	3.77 Mean percent change from baseline Standard Deviation 10.156	3.47 Mean percent change from baseline Standard Deviation 11.839
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 Monocytes	21.95 Mean percent change from baseline Standard Deviation 56.206	12.47 Mean percent change from baseline Standard Deviation 32.131	15.05 Mean percent change from baseline Standard Deviation 30.852	5.66 Mean percent change from baseline Standard Deviation 35.371	15.01 Mean percent change from baseline Standard Deviation 42.423
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 Neutrophils	3.81 Mean percent change from baseline Standard Deviation 33.133	-6.10 Mean percent change from baseline Standard Deviation 40.627	8.68 Mean percent change from baseline Standard Deviation 31.904	4.91 Mean percent change from baseline Standard Deviation 34.720	12.12 Mean percent change from baseline Standard Deviation 42.077
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 WBC	5.16 Mean percent change from baseline Standard Deviation 22.729	-3.20 Mean percent change from baseline Standard Deviation 25.520	9.32 Mean percent change from baseline Standard Deviation 24.511	0.84 Mean percent change from baseline Standard Deviation 24.001	7.14 Mean percent change from baseline Standard Deviation 25.180

PRIMARY outcome

Timeframe: At Day 1 (baseline)

Population: The analysis was performed on the ES. Only participants for whom the specified laboratory data were available for the specified timepoint (Day 1) were included in analysis.

In the analysis were included biochemistry parameters: ALT, AST, bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, WBC. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

Outcome measures

Outcome measures
Measure	HBs-alum Group n=25 Participants Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.	HBs-AS03 Group n=25 Participants Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.	HBs-AS04 Group n=24 Participants Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.	HBs-AS37B Group n=25 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31.	HBs-AS37A Group n=23 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37A adjuvant system (100 µg), at Day 1 and Day 31.
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 ALT · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 ALT · Within	21 Participants	21 Participants	23 Participants	23 Participants	21 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 ALT · Above	4 Participants	4 Participants	1 Participants	2 Participants	2 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 ALT · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 AST · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 AST · Within	22 Participants	24 Participants	24 Participants	25 Participants	22 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 AST · Above	3 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 AST · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Bicarbonate, Day 1 · Below	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Bicarbonate, Day 1 · Within	25 Participants	25 Participants	24 Participants	25 Participants	22 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Bicarbonate, Day 1 · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Bicarbonate, Day 1 · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Blood urea nitrogen · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Blood urea nitrogen · Within	24 Participants	23 Participants	22 Participants	24 Participants	23 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Blood urea nitrogen · Above	1 Participants	2 Participants	2 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Blood urea nitrogen · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Chloride · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Chloride · Within	25 Participants	24 Participants	24 Participants	25 Participants	23 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Chloride · Above	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Chloride · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 C Reactive Protein · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 C Reactive Protein · Within	24 Participants	24 Participants	21 Participants	23 Participants	20 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 C Reactive Protein · Above	1 Participants	1 Participants	3 Participants	2 Participants	3 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 C Reactive Protein · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Creatinine · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Creatinine · Within	24 Participants	22 Participants	22 Participants	23 Participants	23 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Creatinine · Above	1 Participants	3 Participants	2 Participants	2 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Creatinine · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Potassium · Below	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Potassium · Within	25 Participants	25 Participants	23 Participants	25 Participants	23 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Potassium · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Potassium · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Sodium · Below	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Sodium · Within	25 Participants	25 Participants	24 Participants	24 Participants	23 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Sodium · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Sodium · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Eosinophils · Below	1 Participants	1 Participants	1 Participants	3 Participants	2 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Eosinophils · Within	24 Participants	23 Participants	22 Participants	21 Participants	21 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Eosinophils · Above	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Eosinophils · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Erythrocytes · Below	1 Participants	1 Participants	3 Participants	2 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Erythrocytes · Within	24 Participants	24 Participants	21 Participants	22 Participants	22 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Erythrocytes · Above	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Erythrocytes · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Hemoglobin · Below	3 Participants	0 Participants	5 Participants	3 Participants	3 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Hemoglobin · Within	22 Participants	25 Participants	19 Participants	22 Participants	20 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Hemoglobin · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Hemoglobin · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Lymphocytes · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Lymphocytes · Within	25 Participants	25 Participants	24 Participants	25 Participants	23 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Lymphocytes · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Lymphocytes · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Platelets · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Platelets · Within	25 Participants	24 Participants	22 Participants	25 Participants	23 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Platelets · Above	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Platelets · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Monocytes · Below	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Monocytes · Within	25 Participants	25 Participants	24 Participants	25 Participants	22 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Monocytes · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Monocytes · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Neutrophils · Below	1 Participants	1 Participants	2 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Neutrophils · Within	24 Participants	24 Participants	22 Participants	24 Participants	22 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Neutrophils · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 Neutrophils · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 WBC · Below	3 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 WBC · Within	21 Participants	23 Participants	23 Participants	24 Participants	22 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 WBC · Above	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 WBC · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: At Day 8

Population: The analysis was performed on the ES. Only participants for whom the specified laboratory data were available for the specified timepoint (Day 8) were included in analysis.

In the analysis were included biochemistry parameters: alanine aminotransferase (ALT), aspartate transaminase (AST), bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, white blood cells (WBC).Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

Outcome measures

Outcome measures
Measure	HBs-alum Group n=25 Participants Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.	HBs-AS03 Group n=25 Participants Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.	HBs-AS04 Group n=24 Participants Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.	HBs-AS37B Group n=25 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31.	HBs-AS37A Group n=23 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37A adjuvant system (100 µg), at Day 1 and Day 31.
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 ALT · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 ALT · Within	23 Participants	22 Participants	22 Participants	22 Participants	21 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 ALT · Above	2 Participants	3 Participants	2 Participants	3 Participants	2 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 ALT · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 AST · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 AST · Within	24 Participants	24 Participants	24 Participants	24 Participants	23 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 AST · Above	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 AST · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Bicarbonate · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Bicarbonate · Within	24 Participants	25 Participants	24 Participants	25 Participants	23 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Bicarbonate · Above	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Bicarbonate · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Blood urea nitrogen · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Blood urea nitrogen · Within	25 Participants	22 Participants	23 Participants	25 Participants	22 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Blood urea nitrogen · Above	0 Participants	3 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Blood urea nitrogen · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Chloride · Below	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Chloride · Within	25 Participants	25 Participants	23 Participants	25 Participants	22 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Chloride · Above	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Chloride · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 C Reactive Protein · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 C Reactive Protein · Within	23 Participants	24 Participants	21 Participants	24 Participants	21 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 C Reactive Protein · Above	2 Participants	1 Participants	3 Participants	1 Participants	2 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 C Reactive Protein · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Creatinine · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Creatinine · Within	23 Participants	23 Participants	24 Participants	24 Participants	20 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Creatinine · Above	2 Participants	2 Participants	0 Participants	1 Participants	3 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Creatinine · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Potassium · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Potassium · Within	24 Participants	25 Participants	23 Participants	24 Participants	23 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Potassium · Above	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Potassium · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Sodium · Below	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Sodium · Within	25 Participants	25 Participants	24 Participants	25 Participants	22 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Sodium · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Sodium · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Eosinophils · Below	2 Participants	0 Participants	1 Participants	2 Participants	2 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Eosinophils · Within	22 Participants	24 Participants	23 Participants	21 Participants	19 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Eosinophils · Above	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Eosinophils · Missing	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Erythrocytes · Below	1 Participants	0 Participants	2 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Erythrocytes · Within	23 Participants	25 Participants	22 Participants	23 Participants	21 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Erythrocytes · Above	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Erythrocytes · Missing	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Hemoglobin · Below	4 Participants	0 Participants	5 Participants	1 Participants	3 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Hemoglobin · Within	20 Participants	25 Participants	19 Participants	24 Participants	19 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Hemoglobin · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Hemoglobin · Missing	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Lymphocytes · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Lymphocytes · Within	24 Participants	25 Participants	24 Participants	24 Participants	22 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Lymphocytes · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Lymphocytes · Missing	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Platelets · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Platelets · Within	24 Participants	23 Participants	22 Participants	25 Participants	22 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Platelets · Above	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Platelets · Missing	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Monocytes · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Monocytes · Within	24 Participants	25 Participants	24 Participants	24 Participants	22 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Monocytes · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Monocytes · Missing	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Neutrophils · Below	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Neutrophils · Within	23 Participants	24 Participants	22 Participants	24 Participants	21 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Neutrophils · Above	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 Neutrophils · Missing	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 WBC · Below	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 WBC · Within	22 Participants	24 Participants	23 Participants	24 Participants	20 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 WBC · Above	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 WBC · Missing	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: At Day 31

Population: The analysis was performed on the ES. Only participants for whom the specified laboratory data were available for the specified timepoint (Day 31) were included in analysis.

Outcome measures

Outcome measures
Measure	HBs-alum Group n=24 Participants Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.	HBs-AS03 Group n=24 Participants Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.	HBs-AS04 Group n=23 Participants Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.	HBs-AS37B Group n=25 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31.	HBs-AS37A Group n=23 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37A adjuvant system (100 µg), at Day 1 and Day 31.
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Sodium · Within	24 Participants	23 Participants	22 Participants	24 Participants	21 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Sodium · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Sodium · Missing	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Eosinophils · Below	0 Participants	0 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Eosinophils · Within	23 Participants	23 Participants	22 Participants	21 Participants	22 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Eosinophils · Above	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Eosinophils · Missing	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Erythrocytes · Below	0 Participants	1 Participants	5 Participants	1 Participants	2 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Erythrocytes · Within	24 Participants	23 Participants	18 Participants	23 Participants	21 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Erythrocytes · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Erythrocytes · Missing	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Hemoglobin · Below	3 Participants	1 Participants	5 Participants	2 Participants	4 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Hemoglobin · Within	21 Participants	23 Participants	17 Participants	22 Participants	19 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Hemoglobin · Above	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Hemoglobin · Missing	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Lymphocytes · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Lymphocytes · Within	24 Participants	24 Participants	23 Participants	24 Participants	23 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Lymphocytes · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Lymphocytes · Missing	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Platelets · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Platelets · Within	23 Participants	23 Participants	22 Participants	24 Participants	22 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Platelets · Above	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Platelets · Missing	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Monocytes · Below	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Monocytes · Within	23 Participants	24 Participants	23 Participants	24 Participants	23 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Monocytes · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Monocytes · Missing	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Neutrophils · Below	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Neutrophils · Within	24 Participants	23 Participants	23 Participants	23 Participants	20 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Neutrophils · Above	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Neutrophils · Missing	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 WBC · Below	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 WBC · Within	22 Participants	22 Participants	23 Participants	22 Participants	21 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 WBC · Above	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 WBC · Missing	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 ALT · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 ALT · Within	19 Participants	19 Participants	22 Participants	21 Participants	22 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 ALT · Above	5 Participants	5 Participants	1 Participants	3 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 ALT · Missing	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 AST · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 AST · Within	22 Participants	23 Participants	21 Participants	24 Participants	23 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 AST · Above	2 Participants	1 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 AST · Missing	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Bicarbonate · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Bicarbonate · Within	24 Participants	24 Participants	23 Participants	24 Participants	23 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Bicarbonate · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Bicarbonate · Missing	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Blood urea nitrogen · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Blood urea nitrogen · Within	23 Participants	21 Participants	22 Participants	23 Participants	20 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Blood urea nitrogen · Above	1 Participants	3 Participants	1 Participants	1 Participants	3 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Blood urea nitrogen · Missing	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Chloride · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Chloride · Within	24 Participants	24 Participants	23 Participants	23 Participants	22 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Chloride · Above	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Chloride · Missing	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 C Reactive Protein · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 C Reactive Protein · Within	22 Participants	23 Participants	17 Participants	25 Participants	20 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 C Reactive Protein · Above	2 Participants	1 Participants	6 Participants	0 Participants	3 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 C Reactive Protein · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Creatinine · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Creatinine · Within	24 Participants	22 Participants	23 Participants	22 Participants	22 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Creatinine · Above	0 Participants	2 Participants	0 Participants	2 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Creatinine · Missing	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Potassium · Below	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Potassium · Within	24 Participants	23 Participants	23 Participants	22 Participants	23 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Potassium · Above	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Potassium · Missing	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 Sodium · Below	0 Participants	1 Participants	1 Participants	0 Participants	2 Participants

PRIMARY outcome

Timeframe: At Day 38

Population: The analysis was performed on the ES. Only participants for whom the specified laboratory data were available for the specified timepoint (Day 38) were included in analysis.

Outcome measures

Outcome measures
Measure	HBs-alum Group n=24 Participants Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.	HBs-AS03 Group n=23 Participants Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.	HBs-AS04 Group n=22 Participants Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.	HBs-AS37B Group n=25 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31.	HBs-AS37A Group n=23 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37A adjuvant system (100 µg), at Day 1 and Day 31.
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 ALT · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 ALT · Within	19 Participants	21 Participants	20 Participants	23 Participants	22 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 ALT · Above	4 Participants	2 Participants	2 Participants	2 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 ALT · Missing	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 AST · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 AST · Within	22 Participants	22 Participants	22 Participants	24 Participants	23 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 AST · Above	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 AST · Missing	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Bicarbonate · Below	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Bicarbonate · Within	21 Participants	22 Participants	21 Participants	25 Participants	21 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Bicarbonate · Above	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Bicarbonate · Missing	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Blood urea nitrogen · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Blood urea nitrogen · Within	23 Participants	22 Participants	20 Participants	24 Participants	22 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Blood urea nitrogen · Above	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Blood urea nitrogen · Missing	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Chloride · Below	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Chloride · Within	22 Participants	23 Participants	22 Participants	25 Participants	22 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Chloride · Above	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Chloride · Missing	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 C Reactive Protein · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 C Reactive Protein · Within	19 Participants	20 Participants	17 Participants	24 Participants	21 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 C Reactive Protein · Above	4 Participants	3 Participants	5 Participants	1 Participants	2 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 C Reactive Protein · Missing	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Creatinine · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Creatinine · Within	22 Participants	21 Participants	21 Participants	25 Participants	21 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Creatinine · Above	1 Participants	2 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Creatinine · Missing	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Potassium · Below	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Potassium · Within	23 Participants	23 Participants	20 Participants	25 Participants	22 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Potassium · Above	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Potassium · Missing	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Sodium · Below	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Sodium · Within	23 Participants	22 Participants	22 Participants	25 Participants	22 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Sodium · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Sodium · Missing	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Eosinophils · Below	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Eosinophils · Within	21 Participants	21 Participants	22 Participants	24 Participants	22 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Eosinophils · Above	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Eosinophils · Missing	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Erythrocytes · Below	1 Participants	0 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Erythrocytes · Within	22 Participants	23 Participants	21 Participants	23 Participants	22 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Erythrocytes · Above	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Erythrocytes · Missing	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Hemoglobin · Below	3 Participants	1 Participants	6 Participants	2 Participants	5 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Hemoglobin · Within	20 Participants	22 Participants	16 Participants	23 Participants	18 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Hemoglobin · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Hemoglobin · Missing	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Lymphocytes · Below	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Lymphocytes · Within	22 Participants	22 Participants	21 Participants	25 Participants	22 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Lymphocytes · Above	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Lymphocytes · Missing	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Platelets · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Platelets · Within	23 Participants	23 Participants	20 Participants	25 Participants	22 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Platelets · Above	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Platelets · Missing	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Monocytes · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Monocytes · Within	22 Participants	23 Participants	21 Participants	25 Participants	23 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Monocytes · Above	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Monocytes · Missing	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Neutrophils · Below	3 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Neutrophils · Within	18 Participants	19 Participants	22 Participants	23 Participants	23 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Neutrophils · Above	1 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 Neutrophils · Missing	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 WBC · Below	3 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 WBC · Within	19 Participants	19 Participants	21 Participants	24 Participants	23 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 WBC · Above	1 Participants	2 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 WBC · Missing	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: At Day 61

Population: The analysis was performed on the ES. Only participants for whom the specified laboratory data were available for the specified timepoint (Day 61) were included in analysis.

Outcome measures

Outcome measures
Measure	HBs-alum Group n=24 Participants Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.	HBs-AS03 Group n=24 Participants Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.	HBs-AS04 Group n=23 Participants Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.	HBs-AS37B Group n=25 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31.	HBs-AS37A Group n=23 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37A adjuvant system (100 µg), at Day 1 and Day 31.
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Bicarbonate · Within	24 Participants	23 Participants	23 Participants	23 Participants	22 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 ALT · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 ALT · Within	21 Participants	20 Participants	21 Participants	23 Participants	20 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 ALT · Above	3 Participants	4 Participants	2 Participants	2 Participants	3 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 ALT · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 AST · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 AST · Within	21 Participants	21 Participants	22 Participants	24 Participants	22 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 AST · Above	3 Participants	3 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 AST · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Bicarbonate · Below	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Bicarbonate · Above	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Bicarbonate · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Blood urea nitrogen · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Blood urea nitrogen · Within	23 Participants	22 Participants	21 Participants	25 Participants	23 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Blood urea nitrogen · Above	1 Participants	2 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Blood urea nitrogen · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Chloride · Below	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Chloride · Within	24 Participants	23 Participants	22 Participants	25 Participants	22 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Chloride · Above	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Chloride · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 C Reactive Protein · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 C Reactive Protein · Within	20 Participants	21 Participants	17 Participants	24 Participants	20 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 C Reactive Protein · Above	4 Participants	3 Participants	5 Participants	1 Participants	3 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 C Reactive Protein · Missing	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Creatinine · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Creatinine · Within	23 Participants	21 Participants	22 Participants	24 Participants	22 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Creatinine · Above	1 Participants	3 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Creatinine · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Potassium · Below	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Potassium · Within	23 Participants	21 Participants	22 Participants	24 Participants	23 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Potassium · Above	1 Participants	3 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Potassium · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Sodium · Below	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Sodium · Within	24 Participants	23 Participants	23 Participants	25 Participants	21 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Sodium · Above	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Sodium · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Eosinophils · Below	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Eosinophils · Within	21 Participants	23 Participants	22 Participants	24 Participants	22 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Eosinophils · Above	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Eosinophils · Missing	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Erythrocytes · Below	1 Participants	1 Participants	4 Participants	3 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Erythrocytes · Within	22 Participants	23 Participants	19 Participants	21 Participants	23 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Erythrocytes · Above	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Erythrocytes · Missing	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Hemoglobin · Below	4 Participants	1 Participants	5 Participants	4 Participants	3 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Hemoglobin · Within	19 Participants	23 Participants	18 Participants	21 Participants	20 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Hemoglobin · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Hemoglobin · Missing	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Lymphocytes · Below	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Lymphocytes · Within	23 Participants	24 Participants	23 Participants	25 Participants	22 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Lymphocytes · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Lymphocytes · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Platelets · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Platelets · Within	22 Participants	22 Participants	21 Participants	24 Participants	23 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Platelets · Above	0 Participants	2 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Platelets · Missing	2 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Monocytes · Below	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Monocytes · Within	23 Participants	24 Participants	23 Participants	24 Participants	23 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Monocytes · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Monocytes · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Neutrophils · Below	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Neutrophils · Within	21 Participants	23 Participants	22 Participants	22 Participants	23 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Neutrophils · Above	2 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 Neutrophils · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 WBC · Below	1 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 WBC · Within	20 Participants	21 Participants	23 Participants	22 Participants	22 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 WBC · Above	2 Participants	1 Participants	0 Participants	2 Participants	1 Participants
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 WBC · Missing	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At Day 1, Day 31, Day 61 and Day 361

Population: The analysis was performed on the Per-Protocol set (PPS), which included all participants who received all doses as per protocol, had immunogenicity results post-dose, complied with dosing/blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only participants with data available for GMC of anti-HBs antibody concentration at the specified timepoints were included in the analysis.

Anti-HBs antibody concentration was measured as GMC and expressed in milli international units per milliliter (mIU/mL).

Outcome measures

Outcome measures
Measure	HBs-alum Group n=25 Participants Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.	HBs-AS03 Group n=24 Participants Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.	HBs-AS04 Group n=23 Participants Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.	HBs-AS37B Group n=24 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31.	HBs-AS37A Group n=23 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37A adjuvant system (100 µg), at Day 1 and Day 31.
Geometric Mean Concentration (GMC) of Anti-HBs Antibody Concentrations Day 1	3.4 mIU/mL Interval 3.0 to 3.8	3.1 mIU/mL Interval 3.1 to 3.1	3.1 mIU/mL Interval 3.1 to 3.1	3.1 mIU/mL Interval 3.1 to 3.1	3.1 mIU/mL Interval 3.1 to 3.1
Geometric Mean Concentration (GMC) of Anti-HBs Antibody Concentrations Day 31	7.7 mIU/mL Interval 3.0 to 20.0	204.9 mIU/mL Interval 62.8 to 668.4	8.3 mIU/mL Interval 3.4 to 20.2	22.0 mIU/mL Interval 10.4 to 46.6	95.2 mIU/mL Interval 27.6 to 327.5
Geometric Mean Concentration (GMC) of Anti-HBs Antibody Concentrations Day 61	40.3 mIU/mL Interval 14.3 to 113.1	7193.0 mIU/mL Interval 4062.5 to 12735.8	86.3 mIU/mL Interval 41.1 to 181.0	401.3 mIU/mL Interval 212.0 to 759.8	1574.2 mIU/mL Interval 600.6 to 4125.7
Geometric Mean Concentration (GMC) of Anti-HBs Antibody Concentrations Day 361	1055.9 mIU/mL Interval 359.2 to 3103.7	3211.8 mIU/mL Interval 2252.4 to 4579.7	41.4 mIU/mL Interval 18.9 to 90.6	153.2 mIU/mL Interval 81.6 to 287.7	586.3 mIU/mL Interval 242.2 to 1419.4

SECONDARY outcome

Timeframe: At Day 31, Day 61 and Day 361

Population: The analysis was performed on the PPS. Only participants that seroconverted for anti-HBs and had data available at the specified timepoints were included in the analysis.

A participant who seroconverted for anti-HBs is defined as a participant with an anti-HBs antibody concentration higher than (\>) 6.2 mIU/mL.

Outcome measures

Outcome measures
Measure	HBs-alum Group n=24 Participants Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.	HBs-AS03 Group n=22 Participants Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.	HBs-AS04 Group n=23 Participants Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.	HBs-AS37B Group n=22 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31.	HBs-AS37A Group n=23 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37A adjuvant system (100 µg), at Day 1 and Day 31.
Percentage of Participants Who Seroconverted for Anti-HBs Day 361	95.2 Percentage of participants Interval 76.2 to 99.9	100 Percentage of participants Interval 82.4 to 100.0	72.7 Percentage of participants Interval 49.8 to 89.3	100 Percentage of participants Interval 83.2 to 100.0	100 Percentage of participants Interval 85.2 to 100.0
Percentage of Participants Who Seroconverted for Anti-HBs Day 61	75.0 Percentage of participants Interval 53.3 to 90.2	100 Percentage of participants Interval 83.9 to 100.0	87.0 Percentage of participants Interval 66.4 to 97.2	100 Percentage of participants Interval 84.6 to 100.0	100 Percentage of participants Interval 83.9 to 100.0
Percentage of Participants Who Seroconverted for Anti-HBs Day 31	16.7 Percentage of participants Interval 4.7 to 37.4	95.5 Percentage of participants Interval 77.2 to 99.9	21.7 Percentage of participants Interval 7.5 to 43.7	59.1 Percentage of participants Interval 36.4 to 79.3	81.0 Percentage of participants Interval 58.1 to 94.6

SECONDARY outcome

Timeframe: At Day 31, Day 61 and Day 361

Population: The analysis was performed on the PPS. Only participants that were seroprotected for anti-HBs and had data available at the specified timepoints were included in the analysis.

A participant seroprotected for anti-HBs is defined as a participant with an anti-HBs antibody concentration \>10 mIU/mL.

Outcome measures

Outcome measures
Measure	HBs-alum Group n=24 Participants Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.	HBs-AS03 Group n=22 Participants Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.	HBs-AS04 Group n=23 Participants Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.	HBs-AS37B Group n=22 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31.	HBs-AS37A Group n=23 Participants Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37A adjuvant system (100 µg), at Day 1 and Day 31.
Percentage of Participants Seroprotected for Anti-HBs Day 31	16.7 Percentage of participants Interval 4.7 to 37.4	95.5 Percentage of participants Interval 77.2 to 99.9	21.7 Percentage of participants Interval 7.5 to 43.7	59.1 Percentage of participants Interval 36.4 to 79.3	81.0 Percentage of participants Interval 58.1 to 94.6
Percentage of Participants Seroprotected for Anti-HBs Day 61	62.5 Percentage of participants Interval 40.6 to 81.2	100 Percentage of participants Interval 83.9 to 100.0	87.0 Percentage of participants Interval 66.4 to 97.2	100 Percentage of participants Interval 84.6 to 100.0	100 Percentage of participants Interval 83.9 to 100.0
Percentage of Participants Seroprotected for Anti-HBs Day 361	95.2 Percentage of participants Interval 76.2 to 99.9	100 Percentage of participants Interval 82.4 to 100.0	72.7 Percentage of participants Interval 49.8 to 89.3	100 Percentage of participants Interval 83.2 to 100.0	100 Percentage of participants Interval 85.2 to 100.0

Adverse Events

HBs-alum Group

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

HBs-AS03 Group

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

HBs-AS04 Group

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

HBs-AS37B Group

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

HBs-AS37A Group

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	HBs-alum Group n=25 participants at risk Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.	HBs-AS03 Group n=25 participants at risk Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.	HBs-AS04 Group n=24 participants at risk Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.	HBs-AS37B Group n=25 participants at risk Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31.	HBs-AS37A Group n=23 participants at risk Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37A adjuvant system (100 µg), at Day 1 and Day 31.
Infections and infestations Anal abscess	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/24 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.0% 1/25 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)

Other adverse events

Other adverse events
Measure	HBs-alum Group n=25 participants at risk Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.	HBs-AS03 Group n=25 participants at risk Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.	HBs-AS04 Group n=24 participants at risk Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.	HBs-AS37B Group n=25 participants at risk Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31.	HBs-AS37A Group n=23 participants at risk Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37A adjuvant system (100 µg), at Day 1 and Day 31.
General disorders Fatigue	60.0% 15/25 • Number of events 18 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	56.0% 14/25 • Number of events 18 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	50.0% 12/24 • Number of events 18 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	56.0% 14/25 • Number of events 19 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	47.8% 11/23 • Number of events 16 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
General disorders Administration site pain	28.0% 7/25 • Number of events 7 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	80.0% 20/25 • Number of events 32 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	91.7% 22/24 • Number of events 37 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	72.0% 18/25 • Number of events 30 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	91.3% 21/23 • Number of events 32 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
General disorders Malaise	40.0% 10/25 • Number of events 14 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	28.0% 7/25 • Number of events 9 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	33.3% 8/24 • Number of events 8 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	16.0% 4/25 • Number of events 6 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	17.4% 4/23 • Number of events 4 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
General disorders Chills	16.0% 4/25 • Number of events 4 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	16.0% 4/25 • Number of events 4 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/24 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.0% 1/25 • Number of events 2 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	13.0% 3/23 • Number of events 3 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
General disorders Pyrexia	8.0% 2/25 • Number of events 2 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	8.0% 2/25 • Number of events 3 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.2% 1/24 • Number of events 2 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	8.0% 2/25 • Number of events 3 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.3% 1/23 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
General disorders Injection site inflammation	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/24 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.0% 1/25 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
General disorders Swelling face	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.2% 1/24 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
General disorders Vaccination site discomfort	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.0% 1/25 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/24 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Musculoskeletal and connective tissue disorders Myalgia	40.0% 10/25 • Number of events 10 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	44.0% 11/25 • Number of events 13 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	62.5% 15/24 • Number of events 28 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	36.0% 9/25 • Number of events 13 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	56.5% 13/23 • Number of events 16 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Musculoskeletal and connective tissue disorders Arthralgia	12.0% 3/25 • Number of events 3 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	20.0% 5/25 • Number of events 5 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	12.5% 3/24 • Number of events 3 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	12.0% 3/25 • Number of events 3 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	8.7% 2/23 • Number of events 2 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.0% 1/25 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.2% 1/24 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.0% 1/25 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/24 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.0% 1/25 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.3% 1/23 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	4.0% 1/25 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/24 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.2% 1/24 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Nervous system disorders Headache	52.0% 13/25 • Number of events 17 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	48.0% 12/25 • Number of events 17 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	41.7% 10/24 • Number of events 15 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	52.0% 13/25 • Number of events 18 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	52.2% 12/23 • Number of events 17 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Gastrointestinal disorders Diarrhea	20.0% 5/25 • Number of events 6 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	16.0% 4/25 • Number of events 4 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	20.8% 5/24 • Number of events 5 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.0% 1/25 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	13.0% 3/23 • Number of events 3 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Gastrointestinal disorders Nausea	28.0% 7/25 • Number of events 8 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.0% 1/25 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	20.8% 5/24 • Number of events 6 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.0% 1/25 • Number of events 2 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	8.7% 2/23 • Number of events 3 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Gastrointestinal disorders Vomiting	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/24 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.0% 1/25 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.3% 1/23 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Gastrointestinal disorders Abdominal pain	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.0% 1/25 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/24 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Gastrointestinal disorders Gingival pain	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.2% 1/24 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Infections and infestations Nasopharyngitis	4.0% 1/25 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	12.0% 3/25 • Number of events 3 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.2% 1/24 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	12.0% 3/25 • Number of events 3 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	8.7% 2/23 • Number of events 2 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Infections and infestations Tonsillitis	4.0% 1/25 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.2% 1/24 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Infections and infestations Upper respiratory tract infection	4.0% 1/25 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/24 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.0% 1/25 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Infections and infestations Bacterial vaginosis	4.0% 1/25 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/24 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Infections and infestations COVID-19	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.2% 1/24 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Infections and infestations Cervicitis	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.2% 1/24 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Infections and infestations Chronic sinusitis	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/24 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.3% 1/23 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Infections and infestations Fungal foot infection	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.2% 1/24 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Infections and infestations Fungal skin infection	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.2% 1/24 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Infections and infestations Gastroenteritis viral	4.0% 1/25 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/24 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Infections and infestations Lower respiratory tract infection	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/24 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.3% 1/23 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Infections and infestations Oral herpes	4.0% 1/25 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/24 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Infections and infestations Pharyngitis streptococcal	4.0% 1/25 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/24 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Infections and infestations Rhinitis	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.2% 1/24 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Infections and infestations Viral infection	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/24 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.3% 1/23 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Infections and infestations Viral upper respiratory tract infection	4.0% 1/25 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/24 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Metabolism and nutrition disorders Decreased appetite	16.0% 4/25 • Number of events 4 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	20.0% 5/25 • Number of events 6 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	8.3% 2/24 • Number of events 2 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.0% 1/25 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.3% 1/23 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Metabolism and nutrition disorders Increased appetite	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.2% 1/24 • Number of events 2 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Injury, poisoning and procedural complications Skin laceration	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.0% 1/25 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/24 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	8.7% 2/23 • Number of events 2 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Injury, poisoning and procedural complications Arthropod sting	4.0% 1/25 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/24 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Injury, poisoning and procedural complications Contusion	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.2% 1/24 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Injury, poisoning and procedural complications Tendon injury	4.0% 1/25 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/24 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Respiratory, thoracic and mediastinal disorders Cough	4.0% 1/25 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/24 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.0% 1/25 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.2% 1/24 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Respiratory, thoracic and mediastinal disorders Throat irritation	4.0% 1/25 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/24 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Investigations Blood potassium increased	4.0% 1/25 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/24 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Investigations C-reactive protein increased	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.2% 1/24 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Investigations Liver function test abnormal	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.0% 1/25 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/24 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Cardiac disorders Palpitations	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/24 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.3% 1/23 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Eye disorders Lacrimation increased	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/24 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.0% 1/25 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Psychiatric disorders Depression	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.0% 1/25 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/24 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Renal and urinary disorders Dysuria	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.2% 1/24 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
Vascular disorders Hypertension	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/25 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/24 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	4.0% 1/25 • Number of events 1 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)	0.00% 0/23 • Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER