Trial Outcomes & Findings for LT F-up Study 16-20 Yrs After Vaccine Dose of Hepatitis B With/Without HBIg in Newborns to HBeAg+ Mothers (NCT NCT00240526)
NCT ID: NCT00240526
Last Updated: 2016-12-07
Results Overview
Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL). Note: At Year 15 and 16, a commercial ELISA was used. From Year 17 to Year 20, anti-HBs antibody concentrations were tested with a validated in-house assay with cut-off 3.3mIU/mL.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
79 participants
Primary outcome timeframe
At Years 15, 16, 17, 18, 19 and 20
Results posted on
2016-12-07
Participant Flow
The baseline characteristics are given for the Year 15 time point. Therefore the number of participants in the Engerix-3D Group is 21, as in the Year 15 participant flow data.
Participant milestones
| Measure |
Engerix 4D + HBIg Group
Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
|
Engerix 3D + HBIg Group
Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
|
Engerix 4D
Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, 6 and 60.
|
Engerix 3D Group
Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, and 6
|
|---|---|---|---|---|
|
Year 15
STARTED
|
19
|
19
|
14
|
21
|
|
Year 15
COMPLETED
|
19
|
19
|
14
|
21
|
|
Year 15
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Year 16
STARTED
|
17
|
19
|
16
|
22
|
|
Year 16
COMPLETED
|
17
|
19
|
16
|
22
|
|
Year 16
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Year 17
STARTED
|
19
|
17
|
13
|
20
|
|
Year 17
COMPLETED
|
19
|
17
|
13
|
20
|
|
Year 17
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Year 18
STARTED
|
16
|
17
|
14
|
20
|
|
Year 18
COMPLETED
|
16
|
17
|
14
|
20
|
|
Year 18
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Year 19
STARTED
|
17
|
16
|
12
|
18
|
|
Year 19
COMPLETED
|
17
|
16
|
12
|
18
|
|
Year 19
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Year 20
STARTED
|
19
|
17
|
13
|
20
|
|
Year 20
COMPLETED
|
19
|
17
|
13
|
20
|
|
Year 20
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
LT F-up Study 16-20 Yrs After Vaccine Dose of Hepatitis B With/Without HBIg in Newborns to HBeAg+ Mothers
Baseline characteristics by cohort
| Measure |
Engerix 4D + HBIg Group
n=19 Participants
Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
|
Engerix 3D + HBIg Group
n=19 Participants
Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
|
Engerix 4D
n=14 Participants
Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, 6 and 60.
|
Engerix 3D Group
n=21 Participants
Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, and 6
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
14.5 years
STANDARD_DEVIATION 0.51 • n=5 Participants
|
14.7 years
STANDARD_DEVIATION 0.45 • n=7 Participants
|
14.6 years
STANDARD_DEVIATION 0.50 • n=5 Participants
|
14.5 years
STANDARD_DEVIATION 0.51 • n=4 Participants
|
14.6 years
STANDARD_DEVIATION 0.49 • n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: At Years 15, 16, 17, 18, 19 and 20Population: Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on subjects with available data at the specified time-points
Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL). Note: At Year 15 and 16, a commercial ELISA was used. From Year 17 to Year 20, anti-HBs antibody concentrations were tested with a validated in-house assay with cut-off 3.3mIU/mL.
Outcome measures
| Measure |
Engerix 4D + HBIg Group
n=17 Participants
Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
|
Engerix 3D + HBIg Group
n=15 Participants
Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
|
Engerix 4D
n=12 Participants
Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, 6 and 60.
|
Engerix 3D Group
n=17 Participants
Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, and 6
|
|---|---|---|---|---|
|
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA).
Year 15 (N=17;15;12;17)
|
118.6 mIU/mL
Interval 53.4 to 263.1
|
14.8 mIU/mL
Interval 6.8 to 32.0
|
142.8 mIU/mL
Interval 30.4 to 669.4
|
24.2 mIU/mL
Interval 10.0 to 58.7
|
|
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA).
Year 16 (N=15;13;12;16)
|
119.3 mIU/mL
Interval 50.0 to 284.7
|
14.1 mIU/mL
Interval 6.8 to 29.4
|
134.3 mIU/mL
Interval 30.1 to 599.8
|
22.9 mIU/mL
Interval 9.7 to 54.1
|
|
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA).
Year 17 (N=17;13;11;13)
|
140.0 mIU/mL
Interval 67.2 to 291.9
|
8.2 mIU/mL
Interval 3.9 to 17.1
|
70.2 mIU/mL
Interval 14.3 to 344.1
|
17.0 mIU/mL
Interval 6.7 to 43.3
|
|
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA).
Year 18 (N=14;14;10;13)
|
82.3 mIU/mL
Interval 32.1 to 211.3
|
10.8 mIU/mL
Interval 6.5 to 17.9
|
56.5 mIU/mL
Interval 11.7 to 271.8
|
26.1 mIU/mL
Interval 10.7 to 63.3
|
|
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA).
Year 19 (N=13;12;8;11)
|
103.3 mIU/mL
Interval 38.9 to 274.7
|
9.5 mIU/mL
Interval 4.0 to 22.8
|
84.9 mIU/mL
Interval 12.0 to 600.2
|
19.9 mIU/mL
Interval 7.4 to 53.7
|
|
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA).
Year 20 (N=13;13;6;12)
|
73.9 mIU/mL
Interval 26.6 to 205.4
|
14.3 mIU/mL
Interval 6.7 to 30.6
|
297.1 mIU/mL
Interval 46.0 to 1919.5
|
16.3 mIU/mL
Interval 7.2 to 36.9
|
PRIMARY outcome
Timeframe: At Years 19 and 20Population: Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on subjects with available data at the specified time-points
Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL). Note: There was a change of assay kit at Year 19 time-point, thus for the sake of bridging, blood samples corresponding to Year 19 were re-tested with new CLIA. At Year 19 and 20, anti-HBs antibody concentrations tested with the CLIA with cut-off 6.2 mIU/mL.
Outcome measures
| Measure |
Engerix 4D + HBIg Group
n=16 Participants
Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
|
Engerix 3D + HBIg Group
n=13 Participants
Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
|
Engerix 4D
n=7 Participants
Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, 6 and 60.
|
Engerix 3D Group
n=13 Participants
Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, and 6
|
|---|---|---|---|---|
|
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by ChemiLuminescence ImmunoAssay (CLIA).
YEAR 19 (N=14;12;6;11)
|
60.1 mIU/mL
Interval 26.7 to 135.5
|
5.8 mIU/mL
Interval 3.3 to 10.0
|
159.0 mIU/mL
Interval 32.6 to 776.5
|
11.7 mIU/mL
Interval 5.0 to 27.4
|
|
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by ChemiLuminescence ImmunoAssay (CLIA).
YEAR 20 (N=16;13;7;13)
|
44.0 mIU/mL
Interval 18.3 to 105.9
|
5.1 mIU/mL
Interval 3.1 to 8.6
|
83.5 mIU/mL
Interval 16.2 to 431.7
|
9.5 mIU/mL
Interval 4.3 to 21.2
|
PRIMARY outcome
Timeframe: At Years 15, 16, 17, 18, 19 and 20Population: Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on subjects with available data at the specified time-points
Anti-hepatitis B surface antigen (anti-HBs) antibody cut-off values assessed include 1.0 and 10 mIU/mL.
Outcome measures
| Measure |
Engerix 4D + HBIg Group
n=17 Participants
Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
|
Engerix 3D + HBIg Group
n=15 Participants
Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
|
Engerix 4D
n=12 Participants
Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, 6 and 60.
|
Engerix 3D Group
n=17 Participants
Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, and 6
|
|---|---|---|---|---|
|
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA).
Year 19 (≥ 10 mIU/mL) (N=14;12;8;11)
|
12 subjects
|
3 subjects
|
6 subjects
|
6 subjects
|
|
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA).
Year 15 (≥ 1.0 mIU/mL) (N=17;15;12;17)
|
17 subjects
|
7 subjects
|
10 subjects
|
11 subjects
|
|
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA).
Year 15 (≥ 10 mIU/mL) (N=17;15;12;17)
|
16 subjects
|
4 subjects
|
9 subjects
|
7 subjects
|
|
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA).
Year 16 (≥ 1.0 mIU/mL) (N=15;13;12;16)
|
15 subjects
|
9 subjects
|
12 subjects
|
11 subjects
|
|
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA).
Year 16 (≥ 10 mIU/mL) (N=15;13;12;16)
|
14 subjects
|
6 subjects
|
10 subjects
|
8 subjects
|
|
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA).
Year 17 (≥ 1.0 mIU/mL) (N=17;13;11;13)
|
15 subjects
|
7 subjects
|
11 subjects
|
10 subjects
|
|
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA).
Year 17 (≥ 10 mIU/mL) (N=17;13;11;13)
|
15 subjects
|
2 subjects
|
9 subjects
|
5 subjects
|
|
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA).
Year 18 (≥ 1.0 mIU/mL) (N=14;14;10;13)
|
14 subjects
|
7 subjects
|
10 subjects
|
8 subjects
|
|
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA).
Year 18 (≥ 10 mIU/mL) (N=14;14;10;13)
|
13 subjects
|
3 subjects
|
7 subjects
|
7 subjects
|
|
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA).
Year 19 (≥ 1.0 mIU/mL) (N=14;12;8;11)
|
13 subjects
|
7 subjects
|
8 subjects
|
8 subjects
|
|
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA).
Year 20 (≥ 1.0 mIU/mL) (N=13;13;6;12)
|
13 subjects
|
9 subjects
|
5 subjects
|
10 subjects
|
|
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA).
Year 20 (≥ 10 mIU/mL) (N=13;13;6;12)
|
11 subjects
|
5 subjects
|
5 subjects
|
6 subjects
|
PRIMARY outcome
Timeframe: At Years 19 and 20Population: Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on subjects with available data at the specified time-points
Anti-hepatitis B surface antigen (anti-HBs) antibody cut-off values assessed include 1.0 and 10 mIU/mL. Note: Missing CLIA anti-HBs concentrations, for subjects with ELISA results available, are estimated by multiple imputations and GMCs and number of subjects were adjusted for these imputations.
Outcome measures
| Measure |
Engerix 4D + HBIg Group
n=16 Participants
Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
|
Engerix 3D + HBIg Group
n=13 Participants
Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
|
Engerix 4D
n=7 Participants
Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, 6 and 60.
|
Engerix 3D Group
n=13 Participants
Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, and 6
|
|---|---|---|---|---|
|
Adjusted Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values as Measured by ChemiLuminescence ImmunoAssay (CLIA)
Year 19 (≥ 1.0 mIU/mL) (N=14;12;6;11)
|
13.0 Subjects
|
4.2 Subjects
|
6.0 Subjects
|
7.0 Subjects
|
|
Adjusted Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values as Measured by ChemiLuminescence ImmunoAssay (CLIA)
Year 19 (≥ 10 mIU/mL) (N=14;12;6;11)
|
12.0 Subjects
|
3.9 Subjects
|
5.0 Subjects
|
4.0 Subjects
|
|
Adjusted Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values as Measured by ChemiLuminescence ImmunoAssay (CLIA)
Year 20 (≥ 1.0 mIU/mL) (N=16;13;7;13)
|
13.1 Subjects
|
5.4 Subjects
|
6.0 Subjects
|
6.3 Subjects
|
|
Adjusted Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values as Measured by ChemiLuminescence ImmunoAssay (CLIA)
Year 20 (≥ 10 mIU/mL) (N=16;13;7;13)
|
12.2 Subjects
|
2.1 Subjects
|
5.0 Subjects
|
5.8 Subjects
|
PRIMARY outcome
Timeframe: At Years 15, 16, 17, 18, 19 and 20Population: Analysis was performed on the Long Term Total Cohort (LT total cohort) on subjects with available data for the specified marker.
Serological markers for hepatitis B infection assessed are hepatitis B surface antigen (HBsAg), antibodies to hepatitis B core antigen (anti-HBc), hepatitis B e antigen (HBeAg) and antibodies to hepatitis B e antigen (anti-HBe).
Outcome measures
| Measure |
Engerix 4D + HBIg Group
n=19 Participants
Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
|
Engerix 3D + HBIg Group
n=19 Participants
Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
|
Engerix 4D
n=16 Participants
Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, 6 and 60.
|
Engerix 3D Group
n=22 Participants
Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, and 6
|
|---|---|---|---|---|
|
Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection
Year 20 HBsAg (N=19;17;12;20)
|
6 subjects
|
5 subjects
|
4 subjects
|
12 subjects
|
|
Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection
Year 19 HBsAg (N=17;16;12;18)
|
4 subjects
|
3 subjects
|
3 subjects
|
5 subjects
|
|
Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection
Year 19 Anti-HBc (N=17;16;12;18)
|
4 subjects
|
5 subjects
|
2 subjects
|
9 subjects
|
|
Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection
Year 19 HBeAg (N=8;7;5;10)
|
0 subjects
|
0 subjects
|
0 subjects
|
2 subjects
|
|
Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection
Year 19 Anti-HBe (N=8;7;5;10)
|
1 subjects
|
1 subjects
|
0 subjects
|
3 subjects
|
|
Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection
Year 15 HBsAg (N=19;19;14;21)
|
0 subjects
|
1 subjects
|
0 subjects
|
3 subjects
|
|
Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection
Year 15 Anti-HBc (N=19;19;14;21)
|
4 subjects
|
7 subjects
|
1 subjects
|
9 subjects
|
|
Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection
Year 15 HBeAg (N=4;7;1;8)
|
0 subjects
|
1 subjects
|
0 subjects
|
1 subjects
|
|
Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection
Year 15 Anti-HBe (N=4;7;1;8)
|
1 subjects
|
1 subjects
|
0 subjects
|
3 subjects
|
|
Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection
Year 16 HBsAg (N=16;17;16;22)
|
2 subjects
|
0 subjects
|
2 subjects
|
5 subjects
|
|
Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection
Year 16 Anti-HBc (N=16;17;16;22)
|
4 subjects
|
5 subjects
|
1 subjects
|
9 subjects
|
|
Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection
Year 16 HBeAg (N=6;5;3;11)
|
1 subjects
|
1 subjects
|
0 subjects
|
3 subjects
|
|
Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection
Year 16 Anti-HBe (N=6;5;3;11)
|
0 subjects
|
1 subjects
|
0 subjects
|
2 subjects
|
|
Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection
Year 17 HBsAg (N=19;17;13;19)
|
6 subjects
|
0 subjects
|
3 subjects
|
6 subjects
|
|
Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection
Year 17 Anti-HBc (N=19;17;13;20)
|
5 subjects
|
5 subjects
|
1 subjects
|
8 subjects
|
|
Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection
Year 17 HBeAg (N=9;5;4;10)
|
0 subjects
|
0 subjects
|
0 subjects
|
1 subjects
|
|
Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection
Year 17 Anti-HBe (N=9;5;4;10)
|
1 subjects
|
0 subjects
|
0 subjects
|
3 subjects
|
|
Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection
Year 18 HBsAg (N=16;17;14;20)
|
3 subjects
|
1 subjects
|
3 subjects
|
5 subjects
|
|
Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection
Year 18 Anti-HBc (N=16;17;14;20)
|
5 subjects
|
6 subjects
|
1 subjects
|
8 subjects
|
|
Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection
Year 18 HBeAg (N=8;7;4;10)
|
0 subjects
|
0 subjects
|
0 subjects
|
1 subjects
|
|
Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection
Year 18 Anti-HBe (N=8;7;4;10)
|
1 subjects
|
1 subjects
|
0 subjects
|
2 subjects
|
|
Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection
Year 20 Anti-HBc (N=19;17;12;20)
|
5 subjects
|
7 subjects
|
2 subjects
|
8 subjects
|
|
Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection
Year 20 HBeAg (N=8;7;6;14)
|
1 subjects
|
0 subjects
|
0 subjects
|
1 subjects
|
|
Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection
Year 20 Anti-HBe (N=10;9;6;15)
|
1 subjects
|
0 subjects
|
0 subjects
|
3 subjects
|
PRIMARY outcome
Timeframe: Over the entire follow up period (Final assessment of clinical significance was analyzed after the Year 20 time point)Population: Analysis was performed on the Long Term Total Cohort (LT total cohort). The maximum amount of subjects who have participated in any of the time points in this study has been given as number of participants analyzed.
Categories hepatitis B (HB) infection: 1. Chronic infection: HBsAg and anti-HBc pos (pos) in more than two consecutive samples 2. False positive: single HB marker (HBsAg, HBeAg, anti-HBc) pos + all other markers negative (neg) in one sample. Consecutive time points all neg. 3. Possible subclinical breakthrough infection: One or more HB markers pos in one or more consecutive samples. 4. Isolated natural booster: \>4-fold increase of anti-HBs concentrations if \<100 mIU/mL at previous sample OR \>2- fold increase of anti-HBs concentrations if \>=100 mIU/mL at previous sample + other markers neg
Outcome measures
| Measure |
Engerix 4D + HBIg Group
n=19 Participants
Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
|
Engerix 3D + HBIg Group
n=19 Participants
Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
|
Engerix 4D
n=16 Participants
Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, 6 and 60.
|
Engerix 3D Group
n=22 Participants
Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, and 6
|
|---|---|---|---|---|
|
Number of Subjects With Different Hepatitis B Infection Statuses
Chronic HB infection
|
0 subjects
|
0 subjects
|
0 subjects
|
4 subjects
|
|
Number of Subjects With Different Hepatitis B Infection Statuses
False positive
|
5 subjects
|
5 subjects
|
9 subjects
|
10 subjects
|
|
Number of Subjects With Different Hepatitis B Infection Statuses
Possible subclinical breakthrough HB infection
|
9 subjects
|
12 subjects
|
4 subjects
|
10 subjects
|
|
Number of Subjects With Different Hepatitis B Infection Statuses
Isolated natural booster
|
8 subjects
|
8 subjects
|
9 subjects
|
7 subjects
|
Adverse Events
Engerix 4D + HBIg Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Engerix 3D + HBIg Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Engerix 4D
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Engerix 3D Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
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