Trial Outcomes & Findings for Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs (NCT NCT00343915)

NCT ID: NCT00343915

Last Updated: 2019-06-10

Results Overview

A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

267 participants

Primary outcome timeframe

At Month 7

Results posted on

2019-06-10

Participant Flow

All subjects who participated in the primary vaccination study, in which they received either 2 or 3 doses of GSK Biologicals hepatitis B vaccine, and who consented to participate in the long-term follow-up were contacted by the investigators. No additional subjects were recruited during this long-term follow-up study.

Participant milestones

Participant milestones
Measure	2-dose Engerix subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.	3-dose Engerix subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
Primary Study STARTED	258	126
Primary Study COMPLETED	254	123
Primary Study NOT COMPLETED	4	3
Month 30 Follow-up STARTED	179	88
Month 30 Follow-up COMPLETED	179	88
Month 30 Follow-up NOT COMPLETED	0	0
Month 42 Follow-up STARTED	174	84
Month 42 Follow-up COMPLETED	174	84
Month 42 Follow-up NOT COMPLETED	0	0
Month 54 Follow-up STARTED	166	79
Month 54 Follow-up COMPLETED	166	79
Month 54 Follow-up NOT COMPLETED	0	0
Month 66 Follow-up STARTED	158	76
Month 66 Follow-up COMPLETED	158	76
Month 66 Follow-up NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	2-dose Engerix subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.	3-dose Engerix subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
Primary Study Withdrawal by Subject	1	0
Primary Study Lost to Follow-up	2	3
Primary Study Other	1	0

Baseline Characteristics

Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	2-dose Engerix n=258 Participants subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.	3-dose Engerix n=126 Participants subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.	Total n=384 Participants Total of all reporting groups
Age, Continuous	12.9 years STANDARD_DEVIATION 1.23 • n=5 Participants	12.7 years STANDARD_DEVIATION 1.32 • n=7 Participants	12.8 years STANDARD_DEVIATION 1.26 • n=5 Participants
Sex: Female, Male Female	132 Participants n=5 Participants	61 Participants n=7 Participants	193 Participants n=5 Participants
Sex: Female, Male Male	126 Participants n=5 Participants	65 Participants n=7 Participants	191 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Month 7

Population: The ATP cohort for immunogenicity included all evaluable subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw.

A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.

Outcome measures

Outcome measures
Measure	2-dose Engerix n=241 Participants Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.	3-dose Engerix n=113 Participants Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.	233 Subjects	111 Subjects

PRIMARY outcome

Timeframe: At Month 30, Month 42, Month 54 and Month 66

Population: Long Term According-to-Protocol cohort for immunogenicity, including all subjects who returned at the considered follow-up time point and who complied with the protocol.

A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.

Outcome measures

Outcome measures
Measure	2-dose Engerix n=166 Participants Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.	3-dose Engerix n=80 Participants Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody. Month 30 (N=140, 64)	122 Subjects	62 Subjects
Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody. Month 42 (N=166, 80)	139 Subjects	74 Subjects
Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody. Month 54 (N=147, 76)	124 Subjects	72 Subjects
Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody. Month 66 (N=132, 70)	105 Subjects	64 Subjects

PRIMARY outcome

Timeframe: At Month 30, Month 42, Month 54 and Month 66

Population: Long Term According-to-Protocol cohort for immunogenicity, including all subjects who returned at the considered follow-up time point and who complied with the protocol.

Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.

Outcome measures

Outcome measures
Measure	2-dose Engerix n=166 Participants Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.	3-dose Engerix n=80 Participants Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
Antibody Titers Against Hepatitis-B Virus. Month 30 (N=140, 64)	229.0 mIU/mL Interval 162.1 to 323.5	708.3 mIU/mL Interval 409.6 to 1224.8
Antibody Titers Against Hepatitis-B Virus. Month 42 (N=166, 80)	159.7 mIU/mL Interval 118.3 to 215.7	417.9 mIU/mL Interval 267.3 to 653.6
Antibody Titers Against Hepatitis-B Virus. Month 54 (N=147, 76)	123.6 mIU/mL Interval 92.7 to 165.0	277.6 mIU/mL Interval 176.5 to 436.7
Antibody Titers Against Hepatitis-B Virus. Month 66 (N=132, 70)	82.1 mIU/mL Interval 60.7 to 111.0	225.2 mIU/mL Interval 142.6 to 355.9

SECONDARY outcome

Timeframe: At Months 1, 2, 6 and 7

Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.

Outcome measures

Outcome measures
Measure	2-dose Engerix n=241 Participants Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.	3-dose Engerix n=113 Participants Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
Antibody Titers Against Hepatitis-B Virus. Month 1 (N=240, 112)	28.8 mIU/mL Interval 16.8 to 49.2	28.7 mIU/mL Interval 9.4 to 87.8
Antibody Titers Against Hepatitis-B Virus. Month 2 (N=240, 113)	17.6 mIU/mL Interval 11.1 to 27.8	29.4 mIU/mL Interval 21.6 to 40.1
Antibody Titers Against Hepatitis-B Virus. Month 6 (N=239, 113)	18.8 mIU/mL Interval 14.7 to 24.1	90.0 mIU/mL Interval 68.6 to 117.9
Antibody Titers Against Hepatitis-B Virus. Month 7 (N=241, 113)	2738.5 mIU/mL Interval 2071.4 to 3620.5	7238.3 mIU/mL Interval 5247.3 to 9984.7

SECONDARY outcome

Timeframe: At Months 1, 2 and 6

A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.

Outcome measures

Outcome measures
Measure	2-dose Engerix n=240 Participants Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.	3-dose Engerix n=113 Participants Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
Number of Subjects Seroprotected for Anti-HBs Antibody. Month 1 (N=240, 112)	31 Subjects	8 Subjects
Number of Subjects Seroprotected for Anti-HBs Antibody. Month 2 (N=240, 113)	27 Subjects	63 Subjects
Number of Subjects Seroprotected for Anti-HBs Antibody. Month 6 (N=239, 113)	63 Subjects	99 Subjects

SECONDARY outcome

Timeframe: During the 4-day (Day 0-3) follow-up period after each vaccination and overall

Population: The ATP cohort for safety included all evaluable subjects, who received at least one dose of study vaccine according to their random assignment, with sufficient data to perform safety analysis, who did not receive a vaccine not specified or forbidden in the protocol.

Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.

Outcome measures

Outcome measures
Measure	2-dose Engerix n=253 Participants Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.	3-dose Engerix n=121 Participants Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain; Dose 1 (N=253, 121)	121 Subjects	44 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain; Dose 1 (N=253, 121)	6 Subjects	3 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness; Dose 1 (N=253, 121)	30 Subjects	10 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness; Dose 1 (N=253, 121)	0 Subjects	1 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling; Dose 1 (N=253, 121)	18 Subjects	8 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling; Dose 1 (N=253, 121)	2 Subjects	2 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain; Dose 2 (N=252, 119)	42 Subjects	38 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain; Dose 2 (N=252, 119)	3 Subjects	2 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness; Dose 2 (N=252, 119)	15 Subjects	15 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness; Dose 2 (N=252, 119)	1 Subjects	0 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling; Dose 2 (N=252, 119)	8 Subjects	5 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling; Dose 2 (N=252, 119)	1 Subjects	0 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain; Dose 3 (N=250, 118)	106 Subjects	35 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain; Dose 3 (N=250, 118)	4 Subjects	1 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness; Dose 3 (N=250, 118)	29 Subjects	11 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness; Dose 3 (N=250, 118)	0 Subjects	0 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling; Dose 3 (N=250, 118)	14 Subjects	6 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling; Dose 3 (N=250, 118)	0 Subjects	0 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain; Across Doses (N=253, 121)	155 Subjects	74 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain; Across Doses (N=253, 121)	8 Subjects	6 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness; Across Doses (N=253, 121)	50 Subjects	28 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness; Across Doses (N=253, 121)	0 Subjects	1 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling; Across Doses (N=253, 121)	27 Subjects	15 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling; Across Doses (N=253, 121)	2 Subjects	2 Subjects

SECONDARY outcome

Timeframe: During the 4-day (Day 0-3) follow-up period after each vaccination and overall

Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, and fever. Any was defined as incidence of the specified symptoms regardless of intensity or relationship to study vaccine. Gastrointestinal symptoms included nausea, vomiting, diarrhea and abdominal pain. Grade 3 fever was defined as fever (axillary temperature) \> 38.5°C. Grade 3 symptoms were defined as symptoms which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the vaccination.

Outcome measures

Outcome measures
Measure	2-dose Engerix n=253 Participants Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.	3-dose Engerix n=121 Participants Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Gastrointestinal; Dose 1 (N=253, 121)	11 Subjects	3 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fatigue; Dose 1 (N=253, 121)	1 Subjects	1 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Fatigue; Dose 1 (N=253, 121)	29 Subjects	16 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Gastrointestinal; Dose 1 (N=253, 121)	26 Subjects	4 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Gastrointestinal; Dose 1 (N=253, 121)	3 Subjects	0 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Fatigue; Across Doses (N=253, 121)	51 Subjects	30 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Headache; Dose 1 (N=253, 121)	57 Subjects	29 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Headache; Dose 1 (N=253, 121)	0 Subjects	1 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Headache; Dose 1 (N=253, 121)	33 Subjects	15 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Temperature; Dose 1 (N=253, 121)	4 Subjects	2 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Temperature; Dose 1 (N=253, 121)	0 Subjects	0 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Temperature; Dose 1 (N=253, 121)	3 Subjects	2 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Fatigue; Dose 2 (N=252, 119)	37 Subjects	18 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fatigue; Dose 2 (N=252, 119)	2 Subjects	0 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Fatigue; Dose 2 (N=252, 119)	23 Subjects	13 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Gastrointestinal; Dose 2 (N=252, 119)	20 Subjects	7 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Gastrointestinal; Dose 2 (N=252, 119)	0 Subjects	0 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Gastrointestinal; Dose 2 (N=252, 119)	7 Subjects	5 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Headache; Dose 2 (N=252, 119)	24 Subjects	11 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Temperature; Dose 2 (N=252, 119)	5 Subjects	5 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Temperature; Dose 2 (N=252, 119)	1 Subjects	0 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Gastrointestinal; Dose 3 (N=250, 118)	17 Subjects	14 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Headache; Dose 3 (N=250, 118)	36 Subjects	20 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Headache; Dose 3 (N=250, 118)	1 Subjects	1 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Temperature; Dose 3 (N=250, 118)	13 Subjects	9 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Temperature; Dose 3 (N=250, 118)	1 Subjects	0 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Temperature; Dose 3 (N=250, 118)	7 Subjects	5 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Fatigue; Across Doses (N=253, 121)	77 Subjects	46 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fatigue; Across Doses (N=253, 121)	4 Subjects	3 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Gastrointestinal; Across Doses (N=253, 121)	36 Subjects	21 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Gastrointestinal; Across Doses (N=253,121)	6 Subjects	2 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Headache; Across Doses (N=253, 121)	49 Subjects	30 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Temperature; Across Doses (N=253, 121)	17 Subjects	14 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Fatigue; Dose 1 (N=253, 121)	50 Subjects	26 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Headache; Dose 2 (N=252, 119)	40 Subjects	21 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Headache; Dose 2 (N=252, 119)	0 Subjects	0 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Temperature; Dose 2 (N=252, 119)	5 Subjects	4 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Fatigue; Dose 3 (N=250, 118)	49 Subjects	20 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fatigue; Dose 3 (N=250, 118)	3 Subjects	2 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Fatigue; Dose 3 (N=250, 118)	30 Subjects	8 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Gastrointestinal; Dose 3 (N=250, 118)	3 Subjects	2 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Gastrointestinal; Dose 3 (N=250, 118)	6 Subjects	6 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Headache; Dose 3 (N=250, 118)	22 Subjects	12 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Gastrointestinal; Across Doses (N=253,121)	17 Subjects	14 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Headache; Across Doses (N=253, 121)	78 Subjects	46 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Headache; Across Doses (N=253, 121)	1 Subjects	2 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Temperature; Across Doses (N=253, 121)	1 Subjects	0 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Temperature; Across Doses (N=253, 121)	10 Subjects	10 Subjects

SECONDARY outcome

Timeframe: During the 31-day (Day 0-30) follow-up period after each vaccination and overall

Population: Total Cohort included all enrolled (i.e. randomized or vaccinated) subjects who received at least one vaccine dose and for whom data were available. No information regarding AEs was available for 1 subject in each group

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Outcome measures

Outcome measures
Measure	2-dose Engerix n=257 Participants Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.	3-dose Engerix n=125 Participants Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AE). any AE(s)	112 Subjects	54 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AE). grade 3 AE(s)	31 Subjects	15 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AE). related AE(s)	9 Subjects	1 Subjects

SECONDARY outcome

Timeframe: During the entire study period (Month 0 to Month 66)

Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.

Outcome measures

Outcome measures
Measure	2-dose Engerix n=257 Participants Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.	3-dose Engerix n=125 Participants Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
Number of Subjects With Serious Adverse Events (SAEs)	4 Subjects	1 Subjects

SECONDARY outcome

Timeframe: At Month 30, Month 42, Month 54 & Month 66

Population: LT total cohort included all subjects who were included in the total cohort in the primary study and returned at the considered follow-up time point.

erious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.

Outcome measures

Outcome measures
Measure	2-dose Engerix n=179 Participants Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.	3-dose Engerix n=88 Participants Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
Number of Subjects With Serious Adverse Events (SAEs). Month 30 (N=179, 88)	0 Participants	0 Participants
Number of Subjects With Serious Adverse Events (SAEs). Month 42 (N=174, 84)	0 Participants	0 Participants
Number of Subjects With Serious Adverse Events (SAEs). Month 54 (N=166, 79)	0 Participants	0 Participants
Number of Subjects With Serious Adverse Events (SAEs). Month 66 (N=158, 76)	0 Participants	0 Participants

Adverse Events

2-dose Engerix

Serious events: 4 serious events

Other events: 155 other events

Deaths: 0 deaths

3-dose Engerix

Serious events: 1 serious events

Other events: 74 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	2-dose Engerix n=257 participants at risk subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.	3-dose Engerix n=125 participants at risk subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
Injury, poisoning and procedural complications Injury	0.39% 1/257 • Serious adverse events: during the entire study period (Month 0-66), Solicited local and general symptoms: During the 4-day (Days 0-3) post vaccination period and unsolicited adverse events: up to Month 7.Non-serious adverse events were not assessed during the long term follow-up period (Month 30-66). The total number of participants at risk is the number of participants with at least one documented dose. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.80% 1/125 • Serious adverse events: during the entire study period (Month 0-66), Solicited local and general symptoms: During the 4-day (Days 0-3) post vaccination period and unsolicited adverse events: up to Month 7.Non-serious adverse events were not assessed during the long term follow-up period (Month 30-66). The total number of participants at risk is the number of participants with at least one documented dose. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Arthritis	0.39% 1/257 • Serious adverse events: during the entire study period (Month 0-66), Solicited local and general symptoms: During the 4-day (Days 0-3) post vaccination period and unsolicited adverse events: up to Month 7.Non-serious adverse events were not assessed during the long term follow-up period (Month 30-66). The total number of participants at risk is the number of participants with at least one documented dose. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/125 • Serious adverse events: during the entire study period (Month 0-66), Solicited local and general symptoms: During the 4-day (Days 0-3) post vaccination period and unsolicited adverse events: up to Month 7.Non-serious adverse events were not assessed during the long term follow-up period (Month 30-66). The total number of participants at risk is the number of participants with at least one documented dose. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Ileitis	0.39% 1/257 • Serious adverse events: during the entire study period (Month 0-66), Solicited local and general symptoms: During the 4-day (Days 0-3) post vaccination period and unsolicited adverse events: up to Month 7.Non-serious adverse events were not assessed during the long term follow-up period (Month 30-66). The total number of participants at risk is the number of participants with at least one documented dose. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/125 • Serious adverse events: during the entire study period (Month 0-66), Solicited local and general symptoms: During the 4-day (Days 0-3) post vaccination period and unsolicited adverse events: up to Month 7.Non-serious adverse events were not assessed during the long term follow-up period (Month 30-66). The total number of participants at risk is the number of participants with at least one documented dose. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Infection bacterial	0.39% 1/257 • Serious adverse events: during the entire study period (Month 0-66), Solicited local and general symptoms: During the 4-day (Days 0-3) post vaccination period and unsolicited adverse events: up to Month 7.Non-serious adverse events were not assessed during the long term follow-up period (Month 30-66). The total number of participants at risk is the number of participants with at least one documented dose. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/125 • Serious adverse events: during the entire study period (Month 0-66), Solicited local and general symptoms: During the 4-day (Days 0-3) post vaccination period and unsolicited adverse events: up to Month 7.Non-serious adverse events were not assessed during the long term follow-up period (Month 30-66). The total number of participants at risk is the number of participants with at least one documented dose. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.

Other adverse events

Additional Information

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GlaxoSmithKline

Phone: 866-435-7343

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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 centres of a multi-centre trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
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