Trial Outcomes & Findings for Follow-up Study 16-20 Years After Primary Vaccination Against Hepatitis B of Newborns From HBeAg+ & HBsAg+ Mothers (NCT NCT00240500)
NCT ID: NCT00240500
Last Updated: 2016-12-21
Results Overview
During this follow-up study, it was planned to collect data from Year 16 through to Year 20 after primary vaccination. By the time the study protocol was approved, it was too late to collect data on Year 16. Therefore, the table presents mean concentrations expressed in milli-international units/milliliter (mIU/mL) at years 17, 18, 19 and 20.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
109 participants
Primary outcome timeframe
Years 17, 18, 19 and 20.
Results posted on
2016-12-21
Participant Flow
Participant milestones
| Measure |
HBV 5 Group
neonates born to Hepatitis B surface antigen negative (HBsAg-) and Hepatitis B e antigen negative (HBeAg-) mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
|
HBV 2 Group
neonates born to Hepatitis B surface antigen positive (HBsAg+) and Hepatitis B e antigen positive (HBeAg+) mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
|
HBV 1 Group
neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
|
HBV 4 Group
neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
|
HBV 3 Group
neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
|
HBV 6 Group
neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
20
|
17
|
23
|
29
|
3
|
|
Overall Study
COMPLETED
|
16
|
17
|
14
|
19
|
26
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
3
|
4
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Follow-up Study 16-20 Years After Primary Vaccination Against Hepatitis B of Newborns From HBeAg+ & HBsAg+ Mothers
Baseline characteristics by cohort
| Measure |
HBV 5 Group
n=17 Participants
neonates born to Hepatitis B surface antigen negative (HBsAg-) and Hepatitis B e antigen negative (HBeAg-) mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
|
HBV 2 Group
n=20 Participants
neonates born to Hepatitis B surface antigen positive (HBsAg+) and Hepatitis B e antigen positive (HBeAg+) mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
|
HBV 1 Group
n=17 Participants
neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
|
HBV 4 Group
n=23 Participants
neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
|
HBV 3 Group
n=29 Participants
neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
|
HBV 6 Group
n=3 Participants
neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
16.5 years
STANDARD_DEVIATION 0.51 • n=5 Participants
|
16.6 years
STANDARD_DEVIATION 0.5 • n=7 Participants
|
16.5 years
STANDARD_DEVIATION 0.51 • n=5 Participants
|
16.4 years
STANDARD_DEVIATION 0.51 • n=4 Participants
|
16.8 years
STANDARD_DEVIATION 0.44 • n=21 Participants
|
16.7 years
STANDARD_DEVIATION 0.58 • n=8 Participants
|
16.6 years
STANDARD_DEVIATION 0.50 • n=8 Participants
|
|
Gender
Female
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
53 Participants
n=8 Participants
|
|
Gender
Male
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
56 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Years 17, 18, 19 and 20.During this follow-up study, it was planned to collect data from Year 16 through to Year 20 after primary vaccination. By the time the study protocol was approved, it was too late to collect data on Year 16. Therefore, the table presents mean concentrations expressed in milli-international units/milliliter (mIU/mL) at years 17, 18, 19 and 20.
Outcome measures
| Measure |
HBV 5 Group
n=17 Participants
neonates born to Hepatitis B surface antigen negative (HBsAg-) and Hepatitis B e antigen negative (HBeAg-) mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
|
HBV 2 Group
n=20 Participants
neonates born to Hepatitis B surface antigen positive (HBsAg+) and Hepatitis B e antigen positive (HBeAg+) mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
|
HBV 1 Group
n=17 Participants
neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
|
HBV 4 Group
n=23 Participants
neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
|
HBV 3 Group
n=29 Participants
neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
|
HBV 6 Group
n=3 Participants
neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
|
|---|---|---|---|---|---|---|
|
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations
Year 17
|
87.6 mIU/mL
Interval 27.6 to 278.2
|
43.8 mIU/mL
Interval 22.0 to 87.4
|
143.4 mIU/mL
Interval 39.2 to 523.9
|
34.4 mIU/mL
Interval 12.3 to 95.8
|
90.9 mIU/mL
Interval 45.8 to 180.3
|
10.6 mIU/mL
Interval 0.4 to 251.0
|
|
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations
Year 18
|
96.2 mIU/mL
Interval 37.8 to 244.8
|
63.9 mIU/mL
Interval 32.2 to 126.6
|
121.6 mIU/mL
Interval 31.8 to 465.0
|
33.1 mIU/mL
Interval 15.2 to 72.2
|
89.1 mIU/mL
Interval 43.8 to 181.3
|
19.2 mIU/mL
Interval 0.0 to 2615400000.0
|
|
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations
Year 19
|
37.4 mIU/mL
Interval 14.8 to 94.4
|
34.5 mIU/mL
Interval 20.6 to 57.7
|
108.1 mIU/mL
Interval 30.6 to 382.8
|
22.5 mIU/mL
Interval 11.7 to 43.6
|
62.1 mIU/mL
Interval 30.7 to 125.6
|
26.9 mIU/mL
Interval 2.0 to 363.6
|
|
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations
Year 20
|
46.4 mIU/mL
Interval 19.6 to 109.8
|
25.8 mIU/mL
Interval 14.4 to 46.3
|
101.8 mIU/mL
Interval 28.7 to 361.7
|
20.3 mIU/mL
Interval 10.2 to 40.6
|
55.5 mIU/mL
Interval 30.1 to 102.1
|
12.8 mIU/mL
Interval 0.0 to 7642461.0
|
PRIMARY outcome
Timeframe: Years 17, 18, 19 and 20.It was initially planned to collect data from Year 16 through to Year 20 after primary vaccination. By the time the study protocol was approved, it was too late to collect data on Year 16. Only the subjects positive for HBsAg or anti Hepatitis B core antigen (anti-HBc) were tested for HBeAg \& anti-HBe
Outcome measures
| Measure |
HBV 5 Group
n=17 Participants
neonates born to Hepatitis B surface antigen negative (HBsAg-) and Hepatitis B e antigen negative (HBeAg-) mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
|
HBV 2 Group
n=20 Participants
neonates born to Hepatitis B surface antigen positive (HBsAg+) and Hepatitis B e antigen positive (HBeAg+) mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
|
HBV 1 Group
n=17 Participants
neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
|
HBV 4 Group
n=23 Participants
neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
|
HBV 3 Group
n=29 Participants
neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
|
HBV 6 Group
n=3 Participants
neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
|
|---|---|---|---|---|---|---|
|
Prevalence of Serological Markers for Hepatitis B Infection
Year 19, HBsAg Positive
|
7.1 Percentage of participants (%)
|
5.9 Percentage of participants (%)
|
0 Percentage of participants (%)
|
15 Percentage of participants (%)
|
17.9 Percentage of participants (%)
|
25 Percentage of participants (%)
|
|
Prevalence of Serological Markers for Hepatitis B Infection
Year 19, Anti HBc Negative
|
100 Percentage of participants (%)
|
76.5 Percentage of participants (%)
|
78.6 Percentage of participants (%)
|
95 Percentage of participants (%)
|
100 Percentage of participants (%)
|
100 Percentage of participants (%)
|
|
Prevalence of Serological Markers for Hepatitis B Infection
Year 19, Anti HBc Positive
|
0 Percentage of participants (%)
|
23.5 Percentage of participants (%)
|
21.4 Percentage of participants (%)
|
5 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
|
Prevalence of Serological Markers for Hepatitis B Infection
Year 17, HBsAg Negative
|
100 Percentage of participants (%)
|
93.7 Percentage of participants (%)
|
100 Percentage of participants (%)
|
100 Percentage of participants (%)
|
96.3 Percentage of participants (%)
|
100 Percentage of participants (%)
|
|
Prevalence of Serological Markers for Hepatitis B Infection
Year 17, HBsAg Positive
|
0 Percentage of participants (%)
|
6.3 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
3.7 Percentage of participants (%)
|
0 Percentage of participants (%)
|
|
Prevalence of Serological Markers for Hepatitis B Infection
Year 17, Anti HBc Negative
|
100 Percentage of participants (%)
|
68.7 Percentage of participants (%)
|
78.6 Percentage of participants (%)
|
100 Percentage of participants (%)
|
100 Percentage of participants (%)
|
100 Percentage of participants (%)
|
|
Prevalence of Serological Markers for Hepatitis B Infection
Year 17, Anti HBc Positive
|
0 Percentage of participants (%)
|
31.3 Percentage of participants (%)
|
21.4 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
|
Prevalence of Serological Markers for Hepatitis B Infection
Year 17, HBeAg Negative
|
0 Percentage of participants (%)
|
100 Percentage of participants (%)
|
100 Percentage of participants (%)
|
0 Percentage of participants (%)
|
100 Percentage of participants (%)
|
0 Percentage of participants (%)
|
|
Prevalence of Serological Markers for Hepatitis B Infection
Year 17, HBeAg Positive
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
|
Prevalence of Serological Markers for Hepatitis B Infection
Year 17, Anti HBeAg Negative
|
0 Percentage of participants (%)
|
80 Percentage of participants (%)
|
100 Percentage of participants (%)
|
0 Percentage of participants (%)
|
100 Percentage of participants (%)
|
0 Percentage of participants (%)
|
|
Prevalence of Serological Markers for Hepatitis B Infection
Year 17, Anti HBeAg Positive
|
0 Percentage of participants (%)
|
20 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
|
Prevalence of Serological Markers for Hepatitis B Infection
Year 18, HBsAg Negative
|
100 Percentage of participants (%)
|
100 Percentage of participants (%)
|
100 Percentage of participants (%)
|
100 Percentage of participants (%)
|
96.4 Percentage of participants (%)
|
100 Percentage of participants (%)
|
|
Prevalence of Serological Markers for Hepatitis B Infection
Year 18, HBsAg Positive
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
3.6 Percentage of participants (%)
|
0 Percentage of participants (%)
|
|
Prevalence of Serological Markers for Hepatitis B Infection
Year 18, Anti HBc Negative
|
94.1 Percentage of participants (%)
|
75 Percentage of participants (%)
|
71.4 Percentage of participants (%)
|
100 Percentage of participants (%)
|
100 Percentage of participants (%)
|
100 Percentage of participants (%)
|
|
Prevalence of Serological Markers for Hepatitis B Infection
Year 18, Anti HBc Positive
|
5.9 Percentage of participants (%)
|
25 Percentage of participants (%)
|
28.6 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
|
Prevalence of Serological Markers for Hepatitis B Infection
Year 18, HBeAg Negative
|
100 Percentage of participants (%)
|
100 Percentage of participants (%)
|
100 Percentage of participants (%)
|
0 Percentage of participants (%)
|
100 Percentage of participants (%)
|
0 Percentage of participants (%)
|
|
Prevalence of Serological Markers for Hepatitis B Infection
Year 18, HBeAg Positive
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
|
Prevalence of Serological Markers for Hepatitis B Infection
Year 18, Anti HBeAg Negative
|
100 Percentage of participants (%)
|
100 Percentage of participants (%)
|
100 Percentage of participants (%)
|
0 Percentage of participants (%)
|
100 Percentage of participants (%)
|
0 Percentage of participants (%)
|
|
Prevalence of Serological Markers for Hepatitis B Infection
Year 18, Anti HBeAg Positive
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
|
Prevalence of Serological Markers for Hepatitis B Infection
Year 19, HBsAg Negative
|
92.9 Percentage of participants (%)
|
94.1 Percentage of participants (%)
|
100 Percentage of participants (%)
|
85 Percentage of participants (%)
|
82.1 Percentage of participants (%)
|
75 Percentage of participants (%)
|
|
Prevalence of Serological Markers for Hepatitis B Infection
Year 19, HBeAg Negative
|
100 Percentage of participants (%)
|
100 Percentage of participants (%)
|
100 Percentage of participants (%)
|
100 Percentage of participants (%)
|
80 Percentage of participants (%)
|
100 Percentage of participants (%)
|
|
Prevalence of Serological Markers for Hepatitis B Infection
Year 19, HBeAg Positive
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
20 Percentage of participants (%)
|
0 Percentage of participants (%)
|
|
Prevalence of Serological Markers for Hepatitis B Infection
Year 19, Anti HBeAg Negative
|
100 Percentage of participants (%)
|
100 Percentage of participants (%)
|
100 Percentage of participants (%)
|
100 Percentage of participants (%)
|
100 Percentage of participants (%)
|
100 Percentage of participants (%)
|
|
Prevalence of Serological Markers for Hepatitis B Infection
Year 19, Anti HBeAg Positive
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
|
Prevalence of Serological Markers for Hepatitis B Infection
Year 20, HBsAg Negative
|
100 Percentage of participants (%)
|
76.5 Percentage of participants (%)
|
92.9 Percentage of participants (%)
|
78.9 Percentage of participants (%)
|
84.6 Percentage of participants (%)
|
100 Percentage of participants (%)
|
|
Prevalence of Serological Markers for Hepatitis B Infection
Year 20, HBsAg Positive
|
0 Percentage of participants (%)
|
23.5 Percentage of participants (%)
|
7.1 Percentage of participants (%)
|
21.1 Percentage of participants (%)
|
15.4 Percentage of participants (%)
|
0 Percentage of participants (%)
|
|
Prevalence of Serological Markers for Hepatitis B Infection
Year 20, Anti HBc Negative
|
93.7 Percentage of participants (%)
|
76.5 Percentage of participants (%)
|
78.6 Percentage of participants (%)
|
100 Percentage of participants (%)
|
100 Percentage of participants (%)
|
100 Percentage of participants (%)
|
|
Prevalence of Serological Markers for Hepatitis B Infection
Year 20, Anti HBc Positive
|
6.3 Percentage of participants (%)
|
23.5 Percentage of participants (%)
|
21.4 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
|
Prevalence of Serological Markers for Hepatitis B Infection
Year 20, HBeAg Negative
|
100 Percentage of participants (%)
|
100 Percentage of participants (%)
|
100 Percentage of participants (%)
|
100 Percentage of participants (%)
|
100 Percentage of participants (%)
|
0 Percentage of participants (%)
|
|
Prevalence of Serological Markers for Hepatitis B Infection
Year 20, HBeAg Positive
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
|
Prevalence of Serological Markers for Hepatitis B Infection
Year 20, Anti HBeAg Negative
|
100 Percentage of participants (%)
|
100 Percentage of participants (%)
|
100 Percentage of participants (%)
|
100 Percentage of participants (%)
|
100 Percentage of participants (%)
|
0 Percentage of participants (%)
|
|
Prevalence of Serological Markers for Hepatitis B Infection
Year 20, Anti HBeAg Positive
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
PRIMARY outcome
Timeframe: Over the entire 4 year follow up period (17 - 20 years)Chronic hepatitis B (HB) carrier is defined as positive for anti-HBc AND HBsAg at two or more consecutive time points
Outcome measures
| Measure |
HBV 5 Group
n=17 Participants
neonates born to Hepatitis B surface antigen negative (HBsAg-) and Hepatitis B e antigen negative (HBeAg-) mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
|
HBV 2 Group
n=20 Participants
neonates born to Hepatitis B surface antigen positive (HBsAg+) and Hepatitis B e antigen positive (HBeAg+) mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
|
HBV 1 Group
n=17 Participants
neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
|
HBV 4 Group
n=23 Participants
neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
|
HBV 3 Group
n=29 Participants
neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
|
HBV 6 Group
n=3 Participants
neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
|
|---|---|---|---|---|---|---|
|
Clinical Review for Hepatitis B Infection Status
Chronic HB carriers
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Clinical Review for Hepatitis B Infection Status
Chronic HB carriers among primary study responders
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
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