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

Long-Term Follow Up Study at Years 16-20, to Evaluate the Persistence of Immune Response of GlaxoSmithKline Biologicals' Hepatitis B Vaccine in Newborns of HBeAg+ and HBsAg+ Mothers

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00240500
Enrollment
109
Registered
2005-10-18
Start date
2003-10-31
Completion date
2007-11-30
Last updated
2016-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B

Keywords

Long-term follow-up, Hepatitis B antibody persistence

Brief summary

The purpose of this study is to evaluate the persistence of anti-hepatitis B surface antigen (anti-HBs) antibodies 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description

The primary study was designed to evaluate the immunogenicity and protective efficacy of hepatitis B vaccine in newborns of HBeAg+ and HBsAg+ mothers in comparison with a historical control group. The present study is carried out to evaluate the anti-HBs persistence 16-20 years after the first vaccine dose and to further investigate the prevalence and incidence of other hepatitis B markers and the clinical significance of these at all time points from Year 16-20. No additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered.

Interventions

BIOLOGICALEngerix™-B

In the primary study, subjects received HBV (10 milligram) vaccine according to a 0, 1 and 2 month schedule with a booster dose at Month 12. Subjects in the 5-dose vaccination regimen received a booster dose of HBV vaccine at Month 60.

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 20 Years
Healthy volunteers
Yes

Inclusion criteria

* Subjects who had received at least one dose of the study vaccine in the primary study (103860/064) * Written informed consent obtained from each subject before each blood sampling visit

Design outcomes

Primary

MeasureTime frameDescription
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody ConcentrationsYears 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.
Prevalence of Serological Markers for Hepatitis B InfectionYears 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
Clinical Review for Hepatitis B Infection StatusOver 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

Countries

Thailand

Participant flow

Participants by arm

ArmCount
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)
17
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)
20
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)
17
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)
23
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)
29
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)
3
Total109

Baseline characteristics

CharacteristicHBV 5 GroupHBV 2 GroupHBV 1 GroupHBV 4 GroupHBV 3 GroupHBV 6 GroupTotal
Age, Continuous16.5 years
STANDARD_DEVIATION 0.51
16.6 years
STANDARD_DEVIATION 0.5
16.5 years
STANDARD_DEVIATION 0.51
16.4 years
STANDARD_DEVIATION 0.51
16.8 years
STANDARD_DEVIATION 0.44
16.7 years
STANDARD_DEVIATION 0.58
16.6 years
STANDARD_DEVIATION 0.5
Gender
Female
7 Participants9 Participants11 Participants7 Participants18 Participants1 Participants53 Participants
Gender
Male
10 Participants11 Participants6 Participants16 Participants11 Participants2 Participants56 Participants

Outcome results

Primary

Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations

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.

ArmMeasureGroupValue (MEAN)
HBV 5 GroupAnti-hepatitis B Surface Antigen (Anti-HBs) Antibody ConcentrationsYear 1787.6 mIU/mL
HBV 5 GroupAnti-hepatitis B Surface Antigen (Anti-HBs) Antibody ConcentrationsYear 1896.2 mIU/mL
HBV 5 GroupAnti-hepatitis B Surface Antigen (Anti-HBs) Antibody ConcentrationsYear 1937.4 mIU/mL
HBV 5 GroupAnti-hepatitis B Surface Antigen (Anti-HBs) Antibody ConcentrationsYear 2046.4 mIU/mL
HBV 2 GroupAnti-hepatitis B Surface Antigen (Anti-HBs) Antibody ConcentrationsYear 1934.5 mIU/mL
HBV 2 GroupAnti-hepatitis B Surface Antigen (Anti-HBs) Antibody ConcentrationsYear 1743.8 mIU/mL
HBV 2 GroupAnti-hepatitis B Surface Antigen (Anti-HBs) Antibody ConcentrationsYear 1863.9 mIU/mL
HBV 2 GroupAnti-hepatitis B Surface Antigen (Anti-HBs) Antibody ConcentrationsYear 2025.8 mIU/mL
HBV 1 GroupAnti-hepatitis B Surface Antigen (Anti-HBs) Antibody ConcentrationsYear 18121.6 mIU/mL
HBV 1 GroupAnti-hepatitis B Surface Antigen (Anti-HBs) Antibody ConcentrationsYear 19108.1 mIU/mL
HBV 1 GroupAnti-hepatitis B Surface Antigen (Anti-HBs) Antibody ConcentrationsYear 17143.4 mIU/mL
HBV 1 GroupAnti-hepatitis B Surface Antigen (Anti-HBs) Antibody ConcentrationsYear 20101.8 mIU/mL
HBV 4 GroupAnti-hepatitis B Surface Antigen (Anti-HBs) Antibody ConcentrationsYear 1734.4 mIU/mL
HBV 4 GroupAnti-hepatitis B Surface Antigen (Anti-HBs) Antibody ConcentrationsYear 1833.1 mIU/mL
HBV 4 GroupAnti-hepatitis B Surface Antigen (Anti-HBs) Antibody ConcentrationsYear 1922.5 mIU/mL
HBV 4 GroupAnti-hepatitis B Surface Antigen (Anti-HBs) Antibody ConcentrationsYear 2020.3 mIU/mL
HBV 3 GroupAnti-hepatitis B Surface Antigen (Anti-HBs) Antibody ConcentrationsYear 1790.9 mIU/mL
HBV 3 GroupAnti-hepatitis B Surface Antigen (Anti-HBs) Antibody ConcentrationsYear 2055.5 mIU/mL
HBV 3 GroupAnti-hepatitis B Surface Antigen (Anti-HBs) Antibody ConcentrationsYear 1962.1 mIU/mL
HBV 3 GroupAnti-hepatitis B Surface Antigen (Anti-HBs) Antibody ConcentrationsYear 1889.1 mIU/mL
HBV 6 GroupAnti-hepatitis B Surface Antigen (Anti-HBs) Antibody ConcentrationsYear 1710.6 mIU/mL
HBV 6 GroupAnti-hepatitis B Surface Antigen (Anti-HBs) Antibody ConcentrationsYear 1819.2 mIU/mL
HBV 6 GroupAnti-hepatitis B Surface Antigen (Anti-HBs) Antibody ConcentrationsYear 2012.8 mIU/mL
HBV 6 GroupAnti-hepatitis B Surface Antigen (Anti-HBs) Antibody ConcentrationsYear 1926.9 mIU/mL
Primary

Clinical Review for Hepatitis B Infection Status

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)

ArmMeasureGroupValue (NUMBER)
HBV 5 GroupClinical Review for Hepatitis B Infection StatusChronic HB carriers among primary study responders0 participants
HBV 5 GroupClinical Review for Hepatitis B Infection StatusChronic HB carriers0 participants
HBV 2 GroupClinical Review for Hepatitis B Infection StatusChronic HB carriers among primary study responders0 participants
HBV 2 GroupClinical Review for Hepatitis B Infection StatusChronic HB carriers1 participants
HBV 1 GroupClinical Review for Hepatitis B Infection StatusChronic HB carriers1 participants
HBV 1 GroupClinical Review for Hepatitis B Infection StatusChronic HB carriers among primary study responders0 participants
HBV 4 GroupClinical Review for Hepatitis B Infection StatusChronic HB carriers among primary study responders0 participants
HBV 4 GroupClinical Review for Hepatitis B Infection StatusChronic HB carriers0 participants
HBV 3 GroupClinical Review for Hepatitis B Infection StatusChronic HB carriers0 participants
HBV 3 GroupClinical Review for Hepatitis B Infection StatusChronic HB carriers among primary study responders0 participants
HBV 6 GroupClinical Review for Hepatitis B Infection StatusChronic HB carriers among primary study responders0 participants
HBV 6 GroupClinical Review for Hepatitis B Infection StatusChronic HB carriers0 participants
Primary

Prevalence of Serological Markers for Hepatitis B Infection

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.

ArmMeasureGroupValue (NUMBER)
HBV 5 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, HBsAg Negative100 Percentage of participants (%)
HBV 5 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, HBsAg Positive0 Percentage of participants (%)
HBV 5 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, Anti HBc Negative100 Percentage of participants (%)
HBV 5 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, Anti HBc Positive0 Percentage of participants (%)
HBV 5 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, HBeAg Negative0 Percentage of participants (%)
HBV 5 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, HBeAg Positive0 Percentage of participants (%)
HBV 5 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, Anti HBeAg Negative0 Percentage of participants (%)
HBV 5 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, Anti HBeAg Positive0 Percentage of participants (%)
HBV 5 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, HBsAg Negative100 Percentage of participants (%)
HBV 5 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, HBsAg Positive0 Percentage of participants (%)
HBV 5 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, Anti HBc Negative94.1 Percentage of participants (%)
HBV 5 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, Anti HBc Positive5.9 Percentage of participants (%)
HBV 5 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, HBeAg Negative100 Percentage of participants (%)
HBV 5 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, HBeAg Positive0 Percentage of participants (%)
HBV 5 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, Anti HBeAg Negative100 Percentage of participants (%)
HBV 5 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, Anti HBeAg Positive0 Percentage of participants (%)
HBV 5 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, HBsAg Negative92.9 Percentage of participants (%)
HBV 5 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, HBsAg Positive7.1 Percentage of participants (%)
HBV 5 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, Anti HBc Negative100 Percentage of participants (%)
HBV 5 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, Anti HBc Positive0 Percentage of participants (%)
HBV 5 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, HBeAg Negative100 Percentage of participants (%)
HBV 5 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, HBeAg Positive0 Percentage of participants (%)
HBV 5 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, Anti HBeAg Negative100 Percentage of participants (%)
HBV 5 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, Anti HBeAg Positive0 Percentage of participants (%)
HBV 5 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, HBsAg Negative100 Percentage of participants (%)
HBV 5 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, HBsAg Positive0 Percentage of participants (%)
HBV 5 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, Anti HBc Negative93.7 Percentage of participants (%)
HBV 5 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, Anti HBc Positive6.3 Percentage of participants (%)
HBV 5 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, HBeAg Negative100 Percentage of participants (%)
HBV 5 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, HBeAg Positive0 Percentage of participants (%)
HBV 5 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, Anti HBeAg Negative100 Percentage of participants (%)
HBV 5 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, Anti HBeAg Positive0 Percentage of participants (%)
HBV 2 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, HBsAg Positive5.9 Percentage of participants (%)
HBV 2 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, HBsAg Negative94.1 Percentage of participants (%)
HBV 2 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, Anti HBeAg Positive0 Percentage of participants (%)
HBV 2 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, Anti HBc Positive25 Percentage of participants (%)
HBV 2 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, Anti HBeAg Positive0 Percentage of participants (%)
HBV 2 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, HBeAg Positive0 Percentage of participants (%)
HBV 2 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, Anti HBeAg Negative100 Percentage of participants (%)
HBV 2 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, HBeAg Positive0 Percentage of participants (%)
HBV 2 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, HBeAg Negative100 Percentage of participants (%)
HBV 2 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, HBsAg Positive6.3 Percentage of participants (%)
HBV 2 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, HBsAg Negative93.7 Percentage of participants (%)
HBV 2 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, Anti HBeAg Positive20 Percentage of participants (%)
HBV 2 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, HBeAg Negative100 Percentage of participants (%)
HBV 2 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, Anti HBc Negative76.5 Percentage of participants (%)
HBV 2 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, HBsAg Positive23.5 Percentage of participants (%)
HBV 2 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, HBsAg Negative76.5 Percentage of participants (%)
HBV 2 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, Anti HBc Positive31.3 Percentage of participants (%)
HBV 2 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, HBsAg Negative100 Percentage of participants (%)
HBV 2 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, Anti HBc Positive23.5 Percentage of participants (%)
HBV 2 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, Anti HBeAg Positive0 Percentage of participants (%)
HBV 2 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, Anti HBeAg Negative100 Percentage of participants (%)
HBV 2 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, HBeAg Positive0 Percentage of participants (%)
HBV 2 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, HBeAg Negative100 Percentage of participants (%)
HBV 2 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, HBsAg Positive0 Percentage of participants (%)
HBV 2 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, Anti HBeAg Negative80 Percentage of participants (%)
HBV 2 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, Anti HBeAg Negative100 Percentage of participants (%)
HBV 2 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, HBeAg Negative100 Percentage of participants (%)
HBV 2 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, Anti HBc Positive23.5 Percentage of participants (%)
HBV 2 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, HBeAg Positive0 Percentage of participants (%)
HBV 2 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, Anti HBc Negative75 Percentage of participants (%)
HBV 2 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, Anti HBc Negative68.7 Percentage of participants (%)
HBV 2 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, Anti HBc Negative76.5 Percentage of participants (%)
HBV 1 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, Anti HBeAg Positive0 Percentage of participants (%)
HBV 1 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, Anti HBeAg Negative100 Percentage of participants (%)
HBV 1 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, Anti HBeAg Positive0 Percentage of participants (%)
HBV 1 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, Anti HBeAg Positive0 Percentage of participants (%)
HBV 1 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, HBsAg Negative100 Percentage of participants (%)
HBV 1 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, HBsAg Positive0 Percentage of participants (%)
HBV 1 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, HBeAg Negative100 Percentage of participants (%)
HBV 1 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, Anti HBc Negative71.4 Percentage of participants (%)
HBV 1 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, Anti HBc Positive28.6 Percentage of participants (%)
HBV 1 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, HBeAg Negative100 Percentage of participants (%)
HBV 1 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, HBeAg Positive0 Percentage of participants (%)
HBV 1 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, Anti HBeAg Negative100 Percentage of participants (%)
HBV 1 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, HBeAg Positive0 Percentage of participants (%)
HBV 1 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, HBeAg Positive0 Percentage of participants (%)
HBV 1 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, HBsAg Negative100 Percentage of participants (%)
HBV 1 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, HBsAg Positive0 Percentage of participants (%)
HBV 1 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, Anti HBc Negative78.6 Percentage of participants (%)
HBV 1 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, Anti HBc Positive21.4 Percentage of participants (%)
HBV 1 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, HBeAg Negative100 Percentage of participants (%)
HBV 1 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, HBeAg Positive0 Percentage of participants (%)
HBV 1 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, Anti HBeAg Negative100 Percentage of participants (%)
HBV 1 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, Anti HBeAg Negative100 Percentage of participants (%)
HBV 1 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, Anti HBeAg Positive0 Percentage of participants (%)
HBV 1 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, HBsAg Negative92.9 Percentage of participants (%)
HBV 1 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, HBsAg Positive7.1 Percentage of participants (%)
HBV 1 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, Anti HBc Negative78.6 Percentage of participants (%)
HBV 1 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, HBsAg Negative100 Percentage of participants (%)
HBV 1 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, HBsAg Positive0 Percentage of participants (%)
HBV 1 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, Anti HBc Negative78.6 Percentage of participants (%)
HBV 1 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, Anti HBc Positive21.4 Percentage of participants (%)
HBV 1 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, Anti HBc Positive21.4 Percentage of participants (%)
HBV 1 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, HBeAg Negative100 Percentage of participants (%)
HBV 4 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, HBsAg Negative85 Percentage of participants (%)
HBV 4 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, HBeAg Positive0 Percentage of participants (%)
HBV 4 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, Anti HBc Negative100 Percentage of participants (%)
HBV 4 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, HBeAg Positive0 Percentage of participants (%)
HBV 4 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, Anti HBc Negative100 Percentage of participants (%)
HBV 4 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, HBsAg Positive0 Percentage of participants (%)
HBV 4 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, Anti HBc Positive0 Percentage of participants (%)
HBV 4 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, Anti HBeAg Negative100 Percentage of participants (%)
HBV 4 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, HBsAg Positive15 Percentage of participants (%)
HBV 4 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, Anti HBeAg Positive0 Percentage of participants (%)
HBV 4 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, Anti HBeAg Negative100 Percentage of participants (%)
HBV 4 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, HBsAg Negative100 Percentage of participants (%)
HBV 4 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, HBeAg Negative0 Percentage of participants (%)
HBV 4 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, Anti HBeAg Positive0 Percentage of participants (%)
HBV 4 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, HBsAg Positive0 Percentage of participants (%)
HBV 4 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, Anti HBc Negative95 Percentage of participants (%)
HBV 4 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, Anti HBeAg Negative0 Percentage of participants (%)
HBV 4 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, HBsAg Negative100 Percentage of participants (%)
HBV 4 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, HBeAg Positive0 Percentage of participants (%)
HBV 4 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, HBsAg Negative78.9 Percentage of participants (%)
HBV 4 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, Anti HBc Positive0 Percentage of participants (%)
HBV 4 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, HBeAg Negative100 Percentage of participants (%)
HBV 4 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, HBeAg Positive0 Percentage of participants (%)
HBV 4 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, HBeAg Negative100 Percentage of participants (%)
HBV 4 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, Anti HBc Positive0 Percentage of participants (%)
HBV 4 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, HBsAg Positive21.1 Percentage of participants (%)
HBV 4 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, Anti HBeAg Positive0 Percentage of participants (%)
HBV 4 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, HBeAg Negative0 Percentage of participants (%)
HBV 4 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, Anti HBc Positive5 Percentage of participants (%)
HBV 4 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, Anti HBeAg Positive0 Percentage of participants (%)
HBV 4 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, Anti HBeAg Negative0 Percentage of participants (%)
HBV 4 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, Anti HBc Negative100 Percentage of participants (%)
HBV 3 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, Anti HBeAg Negative100 Percentage of participants (%)
HBV 3 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, Anti HBc Positive0 Percentage of participants (%)
HBV 3 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, HBsAg Negative96.3 Percentage of participants (%)
HBV 3 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, Anti HBeAg Positive0 Percentage of participants (%)
HBV 3 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, HBsAg Positive3.6 Percentage of participants (%)
HBV 3 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, HBeAg Negative100 Percentage of participants (%)
HBV 3 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, HBeAg Negative100 Percentage of participants (%)
HBV 3 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, Anti HBc Positive0 Percentage of participants (%)
HBV 3 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, HBeAg Negative80 Percentage of participants (%)
HBV 3 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, HBsAg Positive3.7 Percentage of participants (%)
HBV 3 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, HBeAg Positive0 Percentage of participants (%)
HBV 3 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, Anti HBc Positive0 Percentage of participants (%)
HBV 3 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, Anti HBeAg Negative100 Percentage of participants (%)
HBV 3 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, HBsAg Positive17.9 Percentage of participants (%)
HBV 3 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, Anti HBeAg Negative100 Percentage of participants (%)
HBV 3 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, Anti HBeAg Positive0 Percentage of participants (%)
HBV 3 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, HBeAg Positive20 Percentage of participants (%)
HBV 3 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, HBeAg Positive0 Percentage of participants (%)
HBV 3 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, HBsAg Negative96.4 Percentage of participants (%)
HBV 3 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, Anti HBc Negative100 Percentage of participants (%)
HBV 3 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, Anti HBc Negative100 Percentage of participants (%)
HBV 3 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, Anti HBc Positive0 Percentage of participants (%)
HBV 3 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, Anti HBeAg Positive0 Percentage of participants (%)
HBV 3 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, Anti HBeAg Negative100 Percentage of participants (%)
HBV 3 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, Anti HBc Negative100 Percentage of participants (%)
HBV 3 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, HBsAg Negative82.1 Percentage of participants (%)
HBV 3 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, HBsAg Negative84.6 Percentage of participants (%)
HBV 3 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, HBeAg Negative100 Percentage of participants (%)
HBV 3 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, Anti HBeAg Positive0 Percentage of participants (%)
HBV 3 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, HBsAg Positive15.4 Percentage of participants (%)
HBV 3 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, Anti HBc Negative100 Percentage of participants (%)
HBV 3 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, HBeAg Positive0 Percentage of participants (%)
HBV 6 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, Anti HBeAg Positive0 Percentage of participants (%)
HBV 6 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, Anti HBc Negative100 Percentage of participants (%)
HBV 6 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, HBsAg Negative75 Percentage of participants (%)
HBV 6 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, HBsAg Positive25 Percentage of participants (%)
HBV 6 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, Anti HBc Negative100 Percentage of participants (%)
HBV 6 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, HBeAg Positive0 Percentage of participants (%)
HBV 6 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, HBsAg Positive0 Percentage of participants (%)
HBV 6 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, Anti HBc Negative100 Percentage of participants (%)
HBV 6 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, Anti HBc Positive0 Percentage of participants (%)
HBV 6 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, HBeAg Negative100 Percentage of participants (%)
HBV 6 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, HBsAg Negative100 Percentage of participants (%)
HBV 6 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, HBeAg Positive0 Percentage of participants (%)
HBV 6 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, HBeAg Positive0 Percentage of participants (%)
HBV 6 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, HBeAg Negative0 Percentage of participants (%)
HBV 6 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, Anti HBeAg Negative100 Percentage of participants (%)
HBV 6 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 19, Anti HBeAg Positive0 Percentage of participants (%)
HBV 6 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, Anti HBeAg Positive0 Percentage of participants (%)
HBV 6 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, Anti HBc Positive0 Percentage of participants (%)
HBV 6 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, HBsAg Negative100 Percentage of participants (%)
HBV 6 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, Anti HBeAg Negative0 Percentage of participants (%)
HBV 6 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, HBsAg Positive0 Percentage of participants (%)
HBV 6 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, Anti HBeAg Positive0 Percentage of participants (%)
HBV 6 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, Anti HBc Positive0 Percentage of participants (%)
HBV 6 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, HBsAg Negative100 Percentage of participants (%)
HBV 6 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, Anti HBc Negative100 Percentage of participants (%)
HBV 6 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, Anti HBeAg Negative0 Percentage of participants (%)
HBV 6 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, HBeAg Negative0 Percentage of participants (%)
HBV 6 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 20, HBeAg Negative0 Percentage of participants (%)
HBV 6 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, Anti HBc Positive0 Percentage of participants (%)
HBV 6 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, HBeAg Positive0 Percentage of participants (%)
HBV 6 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 17, HBsAg Positive0 Percentage of participants (%)
HBV 6 GroupPrevalence of Serological Markers for Hepatitis B InfectionYear 18, Anti HBeAg Negative0 Percentage of participants (%)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026