Trial Outcomes & Findings for Long Term Follow-Up Study 16-20 Years After Hepatitis B Vaccination in Newborns of Mothers Who Were Seropositive for Hepatitis B Envelope Antigen (HBeAg) & Hepatitis B Surface Antigen (HBsAg) (NCT NCT00240539)
NCT ID: NCT00240539
Last Updated: 2016-12-08
Results Overview
Seropositive subjects are subjects with anti-HBs antibody concentration ≥ 3.3 mIU/mL.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
36 participants
Primary outcome timeframe
At Years 16, 17, 18, 19 and 20 after primary vaccination
Results posted on
2016-12-08
Participant Flow
Participant Flow and Baseline measures are given for the year 20 time point in order to account for all subjects participating in this long-term follow-up study. Note that not all subjects returned and participated in each of the intermediate follow-up time points.
Participant milestones
| Measure |
HBsAg(+) & HBeAg(+) 5-dose Group
Newborns of anti-hepatitis B surface antigen positive \[HBsAg(+)\] and hepatitis B envelope antigen positive \[HBeAg(+)\] mothers, who received 5 doses of Engerix™ in the primary study.
|
HBsAg(+) & HBeAg(-) 4-dose Group
Newborns of HBsAg(+) and HBeAg negative \[HBeAg(-)\] mothers, who received 4 doses of Engerix™ in the primary study.
|
HBsAg(+) & HBeAg(+) 4-dose Group
Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
|
HBsAg(-) & HBeAg(-) 4-dose Group
Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
31
|
1
|
|
Overall Study
COMPLETED
|
2
|
2
|
31
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Long Term Follow-Up Study 16-20 Years After Hepatitis B Vaccination in Newborns of Mothers Who Were Seropositive for Hepatitis B Envelope Antigen (HBeAg) & Hepatitis B Surface Antigen (HBsAg)
Baseline characteristics by cohort
| Measure |
HBsAg(+) & HBeAg(+) 5-dose Group
n=2 Participants
Newborns of anti-hepatitis B surface antigen positive \[HBsAg(+)\] and hepatitis B envelope antigen positive \[HBeAg(+)\] mothers, who received 5 doses of Engerix™ in the primary study.
|
HBsAg(+) & HBeAg(-) 4-dose Group
n=2 Participants
Newborns of HBsAg(+) and HBeAg negative \[HBeAg(-)\] mothers, who received 4 doses of Engerix™ in the primary study.
|
HBsAg(+) & HBeAg(+) 4-dose Group
n=31 Participants
Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
|
HBsAg(-) & HBeAg(-) 4-dose Group
n=1 Participants
Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Gender
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Gender
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: At Years 16, 17, 18, 19 and 20 after primary vaccinationPopulation: The analyses were performed on the Long-Term According to protocol (ATP) cohort for immunogenicity. Due to subjects being lost to follow up or eliminated from the ATP cohort for immunogenicity, no data from subjects in HBsAg(+) \& HBeAg(-) 4-dose Group and HBsAg(-) \& HBeAg(-) 4-dose Group were analyzed.
Seropositive subjects are subjects with anti-HBs antibody concentration ≥ 3.3 mIU/mL.
Outcome measures
| Measure |
HBsAg(+) & HBeAg(+) 5-dose Group
n=2 Participants
Newborns of anti-hepatitis B surface antigen positive \[HBsAg(+)\] and hepatitis B envelope antigen positive \[HBeAg(+)\] mothers, who received 5 doses of Engerix™ in the primary study.
|
HBsAg(+) & HBeAg(-) 4-dose Group
Newborns of HBsAg(+) and HBeAg negative \[HBeAg(-)\] mothers, who received 4 doses of Engerix™ in the primary study.
|
HBsAg(+) & HBeAg(+) 4-dose Group
n=25 Participants
Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
|
HBsAg(-) & HBeAg(-) 4-dose Group
Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
|
|---|---|---|---|---|
|
Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies
Year 16 (n= 0, 25)
|
0 subjects
Interval 0.0 to 0.0
|
—
|
22 subjects
Interval 22.7 to 86.7
|
—
|
|
Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies
Year 17 (n= 2, 24)
|
2 subjects
Interval 0.2 to 765.3
|
—
|
21 subjects
Interval 18.8 to 76.0
|
—
|
|
Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies
Year 18 (n= 1, 22)
|
1 subjects
Interval 4.8 to 4.8
|
—
|
20 subjects
Interval 18.9 to 65.7
|
—
|
|
Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies
Year 19 (n= 2, 22)
|
2 subjects
Interval 0.0 to 2932.5
|
—
|
19 subjects
Interval 14.8 to 59.5
|
—
|
|
Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies
Year 20 (n= 2, 25)
|
2 subjects
Interval 4.0 to 14.9
|
—
|
23 subjects
Interval 12.1 to 34.2
|
—
|
PRIMARY outcome
Timeframe: At Years 16, 17, 18,19 and 20 after primary vaccinationPopulation: The analyses were performed on the ATP cohort for immunogenicity. Only subjects positive for HBsAg or anti-HBc markers were tested for HBeAg and anti-HBe markers for Year 17 to Year 20.
Tested markers were hepatitis B surface antigen (HBsAg), antibody to hepatitis B core antigen (anti-HBc), hepatitis B envelope antigen (HBeAg) and antibody to hepatitis B envelope antigen (anti-HBe).
Outcome measures
| Measure |
HBsAg(+) & HBeAg(+) 5-dose Group
n=2 Participants
Newborns of anti-hepatitis B surface antigen positive \[HBsAg(+)\] and hepatitis B envelope antigen positive \[HBeAg(+)\] mothers, who received 5 doses of Engerix™ in the primary study.
|
HBsAg(+) & HBeAg(-) 4-dose Group
Newborns of HBsAg(+) and HBeAg negative \[HBeAg(-)\] mothers, who received 4 doses of Engerix™ in the primary study.
|
HBsAg(+) & HBeAg(+) 4-dose Group
n=25 Participants
Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
|
HBsAg(-) & HBeAg(-) 4-dose Group
Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
|
|---|---|---|---|---|
|
Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus
HBsAg [Year 16] (n= 1, 25)
|
0 subjects
|
—
|
0 subjects
|
—
|
|
Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus
HBsAg [Year 17] (n= 2, 25)
|
0 subjects
|
—
|
1 subjects
|
—
|
|
Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus
HBsAg [Year 18] (n= 1, 22)
|
0 subjects
|
—
|
0 subjects
|
—
|
|
Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus
HBsAg [Year 19] (n= 1, 22)
|
0 subjects
|
—
|
2 subjects
|
—
|
|
Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus
HBsAg [Year 20] (n= 2, 25)
|
0 subjects
|
—
|
2 subjects
|
—
|
|
Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus
Anti-HBc [Year 16] (n= 1, 25)
|
1 subjects
|
—
|
4 subjects
|
—
|
|
Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus
Anti-HBc [Year 17] (n= 2, 25)
|
1 subjects
|
—
|
3 subjects
|
—
|
|
Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus
Anti-HBc [Year 18] (n= 1, 22)
|
1 subjects
|
—
|
2 subjects
|
—
|
|
Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus
Anti-HBc [Year 19] (n= 2, 22)
|
1 subjects
|
—
|
2 subjects
|
—
|
|
Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus
Anti-HBc [Year 20] (n= 2, 25)
|
1 subjects
|
—
|
3 subjects
|
—
|
|
Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus
HBeAg [Year 16] (n= 1, 23)
|
0 subjects
|
—
|
0 subjects
|
—
|
|
Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus
HBeAg [Year 17] (n= 1, 3)
|
0 subjects
|
—
|
0 subjects
|
—
|
|
Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus
HBeAg [Year 18] (n= 1, 2)
|
0 subjects
|
—
|
0 subjects
|
—
|
|
Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus
HBeAg [Year 19] (n= 1, 4)
|
0 subjects
|
—
|
0 subjects
|
—
|
|
Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus
HBeAg [Year 20] (n= 1, 5)
|
0 subjects
|
—
|
0 subjects
|
—
|
|
Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus
Anti-HBe [Year 16] (n= 1, 23)
|
1 subjects
|
—
|
0 subjects
|
—
|
|
Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus
Anti-HBe [Year 17] (n= 1, 4)
|
1 subjects
|
—
|
1 subjects
|
—
|
|
Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus
Anti-HBe [Year 18] (n= 1, 2)
|
1 subjects
|
—
|
0 subjects
|
—
|
|
Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus
Anti-HBe [Year 19] (n= 1, 4)
|
0 subjects
|
—
|
0 subjects
|
—
|
|
Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus
Anti-HBe [Year 20] (n= 1, 5)
|
1 subjects
|
—
|
0 subjects
|
—
|
PRIMARY outcome
Timeframe: From year 16 through to year 20* Chronic HBV infection: HBsAg+ and anti-HBc+ at more than 2 consecutive time points. * Clinical HBV infection: Serologically confirmed, symptomatic HBV infection, and all HBV markers negative at consecutive time point.
Outcome measures
| Measure |
HBsAg(+) & HBeAg(+) 5-dose Group
n=2 Participants
Newborns of anti-hepatitis B surface antigen positive \[HBsAg(+)\] and hepatitis B envelope antigen positive \[HBeAg(+)\] mothers, who received 5 doses of Engerix™ in the primary study.
|
HBsAg(+) & HBeAg(-) 4-dose Group
n=2 Participants
Newborns of HBsAg(+) and HBeAg negative \[HBeAg(-)\] mothers, who received 4 doses of Engerix™ in the primary study.
|
HBsAg(+) & HBeAg(+) 4-dose Group
n=31 Participants
Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
|
HBsAg(-) & HBeAg(-) 4-dose Group
n=1 Participants
Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
|
|---|---|---|---|---|
|
Number of Subjects With Chronic and With Clinical HBV Infection
Chronic HBV infection
|
0 subjects
|
0 subjects
|
1 subjects
|
0 subjects
|
|
Number of Subjects With Chronic and With Clinical HBV Infection
Clinical HBV infection
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
Adverse Events
HBsAg(+) & HBeAg(+) 5-dose Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HBsAg(+) & HBeAg(-) 4-dose Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HBsAg(+) & HBeAg(+) 4-dose Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HBsAg(-) & HBeAg(-) 4-dose 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