Hepatitis BPhase 4NCT00240526

LT F-up Study 16-20 Yrs After Vaccine Dose of Hepatitis B With/Without HBIg in Newborns to HBeAg+ Mothers

A Phase 4 study testing Engerix™ -B and Hepatitis B immunoglobulin (HBIg) in people with Hepatitis B, run by GlaxoSmithKline at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To evaluate the persistence of anti-HBs antibodies up to 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. Read more about this study

Who is it for?: Ages 16 to 20 yearsHealthy volunteers can take part
Conditions the study is for: Hepatitis B
What is being tested?: Engerix™ -B and Hepatitis B immunoglobulin (HBIg)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 79 participants
Where: 1 siteThailand
Study dates: Oct 2003to Mar 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 to 20 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

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

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

Thailand1 site

GSK Investigational Site
Bangkok, 10330

Other trials in Thailand

About this study

Official title: Comparative Study of the Immunogenicity and Protective Efficacy of GlaxoSmithKline Biologicals' Rec-DNA Hepatitis B Vaccine With or Without Hepatitis B Immunoglobulins (HBIg) in Newborns of HBeAg+ Mothers.

No additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered.

Read the detailed description

The primary study was to evaluate the reactogenicity, immunogenicity and protective efficacy of a hepatitis B vaccine in healthy neonates of HBeAg positive mothers if administered with or without a dose of HBIg at birth. The current study describes the long term follow up of these subjects between Y16 and 20 after primary vaccination.

Conditions: Hepatitis B
Being tested: Engerix™ -B, Hepatitis B immunoglobulin (HBIg)
Keywords: Hepatitis B immunoglobulin, Hepatitis B antibody persistence
Medical subject headings: Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Engerix™ -BBiological
3 (Groups A and C) or 4 (Groups B and D) intramuscular injections during the primary study
Hepatitis B immunoglobulin (HBIg)Biological
1 intramuscular injections at birth (primary study)

Study groups in NCT00240526
Study group	Role	What they receive
Engerix 4D + HBIg Group	Experimental	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. Receives: Biological: Engerix™ -B; Biological: Hepatitis B immunoglobulin (HBIg)
Engerix 3D + HBIg Group	Experimental	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. Receives: Biological: Engerix™ -B; Biological: Hepatitis B immunoglobulin (HBIg)
Engerix 4D	Experimental	Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60. Receives: Biological: Engerix™ -B
Engerix 3D Group	Experimental	Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6. Receives: Biological: Engerix™ -B

What is being measured

The primary outcome is the main question the study is designed to answer.

Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA).
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.
Measured: At Years 15, 16, 17, 18, 19 and 20
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by ChemiLuminescence ImmunoAssay (CLIA).
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.
Measured: At Years 19 and 20
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA).
Anti-hepatitis B surface antigen (anti-HBs) antibody cut-off values assessed include 1.0 and 10 mIU/mL.
Measured: At Years 15, 16, 17, 18, 19 and 20
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)
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.
Measured: At Years 19 and 20
Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection
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).
Measured: At Years 15, 16, 17, 18, 19 and 20
Number of Subjects With Different Hepatitis B Infection Statuses
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
Measured: Over the entire follow up period (Final assessment of clinical significance was analyzed after the Year 20 time point)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2003Mar 2010

First posted18 Oct 2005 (estimated)
Study startOct 2003
Primary completionMar 2010
Study completionMar 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hepatitis BStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00240526
Sponsor's protocol ID: 100450
Status last verified: Oct 2016
First submitted: 13 Oct 2005
Last updated: 7 Dec 2016
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

Poovorawan Y, Chongsrisawat V, Theamboonlers A, Leroux-Roels G, Crasta PD, Hardt K. Persistence and immune memory to hepatitis B vaccine 20 years after primary vaccination of Thai infants, born to HBsAg and HBeAg positive mothers. Hum Vaccin Immunother. 2012 Jul;8(7):896-904. doi: 10.4161/hv.19989. Epub 2012 Jul 1.
PubMed 22777097

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B

All Hepatitis B trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Study of the Immunogenicity and Protective Efficacy of GlaxoSmithKline Biologicals' Rec-DNA Hepatitis B Vaccine With or Without Hepatitis B Immunoglobulins (HBIg) in Newborns of HBeAg+ Mothers.
ClinicalTrials.gov ID: NCT00240526
Acronym / sponsor ID: 100450
Conditions: Hepatitis B
Keywords: Hepatitis B immunoglobulin, Hepatitis B antibody persistence
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 79 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Oct 2003
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 18 Oct 2005 (estimated)
Results: Posted 15 Jul 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

No additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Engerix 4D + HBIg Group	Experimental	Biological: Engerix™ -B, Biological: Hepatitis B immunoglobulin (HBIg)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	Experimental	Biological: Engerix™ -B, Biological: Hepatitis B immunoglobulin (HBIg)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	Experimental	Biological: Engerix™ -BSubjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
Engerix 3D Group	Experimental	Biological: Engerix™ -BSubjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6.

Who may qualify

Ages: 16 to 20 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Engerix™ -B3 (Groups A and C) or 4 (Groups B and D) intramuscular injections during the primary study	Biological	Engerix 3D + HBIg Group, Engerix 3D Group, Engerix 4D, Engerix 4D + HBIg Group
Hepatitis B immunoglobulin (HBIg)1 intramuscular injections at birth (primary study)	Biological	Engerix 3D + HBIg Group, Engerix 4D + HBIg Group

Primary outcome

Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA).
Time frame: At Years 15, 16, 17, 18, 19 and 20
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.
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by ChemiLuminescence ImmunoAssay (CLIA).
Time frame: At Years 19 and 20
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.
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA).
Time frame: At Years 15, 16, 17, 18, 19 and 20
Anti-hepatitis B surface antigen (anti-HBs) antibody cut-off values assessed include 1.0 and 10 mIU/mL.
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)
Time frame: At Years 19 and 20
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.
Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection
Time frame: At Years 15, 16, 17, 18, 19 and 20
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).
Number of Subjects With Different Hepatitis B Infection Statuses
Time frame: Over the entire follow up period (Final assessment of clinical significance was analyzed after the Year 20 time point)
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

Results and safety

Results posted to the registry on 15 Jul 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Engerix 4D + HBIg Group	19	19
Engerix 3D + HBIg Group	19	19
Engerix 4D	14	14
Engerix 3D Group	21	21

Primary outcome: Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA).

Time frame: At Years 15, 16, 17, 18, 19 and 20. Geometric mean (95% Confidence Interval). Unit: mIU/mL

Measure	Engerix 4D + HBIg Group n = 17	Engerix 3D + HBIg Group n = 15	Engerix 4D n = 12	Engerix 3D Group n = 17
Year 15 (N=17;15;12;17)	118.6 (53.4 to 263.1)	14.8 (6.8 to 32.0)	142.8 (30.4 to 669.4)	24.2 (10.0 to 58.7)
Year 16 (N=15;13;12;16)	119.3 (50.0 to 284.7)	14.1 (6.8 to 29.4)	134.3 (30.1 to 599.8)	22.9 (9.7 to 54.1)
Year 17 (N=17;13;11;13)	140.0 (67.2 to 291.9)	8.2 (3.9 to 17.1)	70.2 (14.3 to 344.1)	17.0 (6.7 to 43.3)
Year 18 (N=14;14;10;13)	82.3 (32.1 to 211.3)	10.8 (6.5 to 17.9)	56.5 (11.7 to 271.8)	26.1 (10.7 to 63.3)
Year 19 (N=13;12;8;11)	103.3 (38.9 to 274.7)	9.5 (4.0 to 22.8)	84.9 (12.0 to 600.2)	19.9 (7.4 to 53.7)
Year 20 (N=13;13;6;12)	73.9 (26.6 to 205.4)	14.3 (6.7 to 30.6)	297.1 (46.0 to 1919.5)	16.3 (7.2 to 36.9)

Population analysed: 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

Primary outcome: Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by ChemiLuminescence ImmunoAssay (CLIA).

Time frame: At Years 19 and 20. Geometric mean (95% Confidence Interval). Unit: mIU/mL

Measure	ENGERIX 4D + HBIG GROUP n = 16	ENGERIX 3D + HBIG GROUP n = 13	ENGERIX 4D n = 7	ENGERIX 3D GROUP n = 13
YEAR 19 (N=14;12;6;11)	60.1 (26.7 to 135.5)	5.8 (3.3 to 10.0)	159.0 (32.6 to 776.5)	11.7 (5.0 to 27.4)
YEAR 20 (N=16;13;7;13)	44.0 (18.3 to 105.9)	5.1 (3.1 to 8.6)	83.5 (16.2 to 431.7)	9.5 (4.3 to 21.2)

Population analysed: 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

Primary outcome: Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA).

Time frame: At Years 15, 16, 17, 18, 19 and 20. Number. Unit: subjects

Measure	Engerix 4D + HBIg Group n = 17	Engerix 3D + HBIg Group n = 15	Engerix 4D n = 12	Engerix 3D Group n = 17
Year 15 (≥ 1.0 mIU/mL) (N=17;15;12;17)	17	7	10	11
Year 15 (≥ 10 mIU/mL) (N=17;15;12;17)	16	4	9	7
Year 16 (≥ 1.0 mIU/mL) (N=15;13;12;16)	15	9	12	11
Year 16 (≥ 10 mIU/mL) (N=15;13;12;16)	14	6	10	8
Year 17 (≥ 1.0 mIU/mL) (N=17;13;11;13)	15	7	11	10
Year 17 (≥ 10 mIU/mL) (N=17;13;11;13)	15	2	9	5
Year 18 (≥ 1.0 mIU/mL) (N=14;14;10;13)	14	7	10	8
Year 18 (≥ 10 mIU/mL) (N=14;14;10;13)	13	3	7	7

Population analysed: 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

Primary outcome: 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)

Time frame: At Years 19 and 20. Number. Unit: Subjects

Measure	ENGERIX 4D + HBIG GROUP n = 16	ENGERIX 3D + HBIG GROUP n = 13	ENGERIX 4D n = 7	ENGERIX 3D GROUP n = 13
Year 19 (≥ 1.0 mIU/mL) (N=14;12;6;11)	13.0	4.2	6.0	7.0
Year 19 (≥ 10 mIU/mL) (N=14;12;6;11)	12.0	3.9	5.0	4.0
Year 20 (≥ 1.0 mIU/mL) (N=16;13;7;13)	13.1	5.4	6.0	6.3
Year 20 (≥ 10 mIU/mL) (N=16;13;7;13)	12.2	2.1	5.0	5.8

Population analysed: 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

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Engerix 4D + HBIg Group	0 of 0	0 of 0	Not reported
Engerix 3D + HBIg Group	0 of 0	0 of 0	Not reported
Engerix 4D	0 of 0	0 of 0	Not reported
Engerix 3D Group	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). Additional tables have been generated following partial retesting and reanalysis of the results at Years 19 and 20.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22777097Poovorawan Y, Chongsrisawat V, Theamboonlers A, Leroux-Roels G, Crasta PD, Hardt K. Persistence and immune memory to hepatitis B vaccine 20 years after primary vaccination of Thai infants, born to HBsAg and HBeAg positive mothers. Hum Vaccin Immunother. 2012 Jul;8(7):896-904. doi: 10.4161/hv.19989. Epub 2012 Jul 1.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Related trials for Hepatitis B

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Engerix™ -B and Hepatitis B immunoglobulin (HBIg) in people with Hepatitis B, run by GlaxoSmithKline at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). (time frame: At Years 15, 16, 17, 18, 19 and 20). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00240526, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2016.