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Follow-up Study 16-20 Years After Primary Vaccination Against Hepatitis B of Newborns From HBeAg+ & HBsAg+ Mothers

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ClinicalTrials.gov Identifier: NCT00240500
Recruitment Status : Completed
First Posted : October 18, 2005
Results First Posted : May 1, 2009
Last Update Posted : December 21, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Hepatitis B
Intervention Biological: Engerix™-B
Enrollment 109
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HBV 5 Group HBV 2 Group HBV 1 Group HBV 4 Group HBV 3 Group HBV 6 Group
Hide Arm/Group Description 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) 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) 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) 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) 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) 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)
Period Title: Overall Study
Started 17 20 17 23 29 3
Completed 16 17 14 19 26 2
Not Completed 1 3 3 4 3 1
Arm/Group Title HBV 5 Group HBV 2 Group HBV 1 Group HBV 4 Group HBV 3 Group HBV 6 Group Total
Hide Arm/Group Description 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) 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) 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) 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) 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) 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 of all reporting groups
Overall Number of Baseline Participants 17 20 17 23 29 3 109
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 20 participants 17 participants 23 participants 29 participants 3 participants 109 participants
16.5  (0.51) 16.6  (0.5) 16.5  (0.51) 16.4  (0.51) 16.8  (0.44) 16.7  (0.58) 16.6  (0.50)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 20 participants 17 participants 23 participants 29 participants 3 participants 109 participants
Female
7
  41.2%
9
  45.0%
11
  64.7%
7
  30.4%
18
  62.1%
1
  33.3%
53
  48.6%
Male
10
  58.8%
11
  55.0%
6
  35.3%
16
  69.6%
11
  37.9%
2
  66.7%
56
  51.4%
1.Primary Outcome
Title Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations
Hide Description 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.
Time Frame Years 17, 18, 19 and 20.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HBV 5 Group HBV 2 Group HBV 1 Group HBV 4 Group HBV 3 Group HBV 6 Group
Hide Arm/Group Description:
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)
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)
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)
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)
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)
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 Number of Participants Analyzed 17 20 17 23 29 3
Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
Year 17
87.6
(27.6 to 278.2)
43.8
(22.0 to 87.4)
143.4
(39.2 to 523.9)
34.4
(12.3 to 95.8)
90.9
(45.8 to 180.3)
10.6
(0.4 to 251.0)
Year 18
96.2
(37.8 to 244.8)
63.9
(32.2 to 126.6)
121.6
(31.8 to 465.0)
33.1
(15.2 to 72.2)
89.1
(43.8 to 181.3)
19.2
(0.0 to 2615400000)
Year 19
37.4
(14.8 to 94.4)
34.5
(20.6 to 57.7)
108.1
(30.6 to 382.8)
22.5
(11.7 to 43.6)
62.1
(30.7 to 125.6)
26.9
(2.0 to 363.6)
Year 20
46.4
(19.6 to 109.8)
25.8
(14.4 to 46.3)
101.8
(28.7 to 361.7)
20.3
(10.2 to 40.6)
55.5
(30.1 to 102.1)
12.8
(0.0 to 7642461)
2.Primary Outcome
Title Prevalence of Serological Markers for Hepatitis B Infection
Hide Description 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
Time Frame Years 17, 18, 19 and 20.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HBV 5 Group HBV 2 Group HBV 1 Group HBV 4 Group HBV 3 Group HBV 6 Group
Hide Arm/Group Description:
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)
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)
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)
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)
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)
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 Number of Participants Analyzed 17 20 17 23 29 3
Measure Type: Number
Unit of Measure: Percentage of participants (%)
Year 17, HBsAg Negative 100 93.7 100 100 96.3 100
Year 17, HBsAg Positive 0 6.3 0 0 3.7 0
Year 17, Anti HBc Negative 100 68.7 78.6 100 100 100
Year 17, Anti HBc Positive 0 31.3 21.4 0 0 0
Year 17, HBeAg Negative 0 100 100 0 100 0
Year 17, HBeAg Positive 0 0 0 0 0 0
Year 17, Anti HBeAg Negative 0 80 100 0 100 0
Year 17, Anti HBeAg Positive 0 20 0 0 0 0
Year 18, HBsAg Negative 100 100 100 100 96.4 100
Year 18, HBsAg Positive 0 0 0 0 3.6 0
Year 18, Anti HBc Negative 94.1 75 71.4 100 100 100
Year 18, Anti HBc Positive 5.9 25 28.6 0 0 0
Year 18, HBeAg Negative 100 100 100 0 100 0
Year 18, HBeAg Positive 0 0 0 0 0 0
Year 18, Anti HBeAg Negative 100 100 100 0 100 0
Year 18, Anti HBeAg Positive 0 0 0 0 0 0
Year 19, HBsAg Negative 92.9 94.1 100 85 82.1 75
Year 19, HBsAg Positive 7.1 5.9 0 15 17.9 25
Year 19, Anti HBc Negative 100 76.5 78.6 95 100 100
Year 19, Anti HBc Positive 0 23.5 21.4 5 0 0
Year 19, HBeAg Negative 100 100 100 100 80 100
Year 19, HBeAg Positive 0 0 0 0 20 0
Year 19, Anti HBeAg Negative 100 100 100 100 100 100
Year 19, Anti HBeAg Positive 0 0 0 0 0 0
Year 20, HBsAg Negative 100 76.5 92.9 78.9 84.6 100
Year 20, HBsAg Positive 0 23.5 7.1 21.1 15.4 0
Year 20, Anti HBc Negative 93.7 76.5 78.6 100 100 100
Year 20, Anti HBc Positive 6.3 23.5 21.4 0 0 0
Year 20, HBeAg Negative 100 100 100 100 100 0
Year 20, HBeAg Positive 0 0 0 0 0 0
Year 20, Anti HBeAg Negative 100 100 100 100 100 0
Year 20, Anti HBeAg Positive 0 0 0 0 0 0
3.Primary Outcome
Title Clinical Review for Hepatitis B Infection Status
Hide Description Chronic hepatitis B (HB) carrier is defined as positive for anti-HBc AND HBsAg at two or more consecutive time points
Time Frame Over the entire 4 year follow up period (17 - 20 years)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HBV 5 Group HBV 2 Group HBV 1 Group HBV 4 Group HBV 3 Group HBV 6 Group
Hide Arm/Group Description:
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)
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)
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)
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)
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)
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 Number of Participants Analyzed 17 20 17 23 29 3
Measure Type: Number
Unit of Measure: participants
Chronic HB carriers 0 1 1 0 0 0
Chronic HB carriers among primary study responders 0 0 0 0 0 0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00240500     History of Changes
Other Study ID Numbers: 100448
First Submitted: October 13, 2005
First Posted: October 18, 2005
Results First Submitted: October 30, 2008
Results First Posted: May 1, 2009
Last Update Posted: December 21, 2016