Hepatitis BPhase 3NCT00289718

Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Month Schedule

A Phase 3 study testing Twinrix™ adult in people with Hepatitis B and Hepatitis A, run by GlaxoSmithKline at 1 site in Belgium.

Completed

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

Official record

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Trial summary

The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 11, 12, 13, 14 and 15 years after subjects received their first dose of a 3 dose vaccination schedule of combined hepatitis A/hepatitis B vaccine. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Hepatitis B, Hepatitis A
What is being tested?: Twinrix™ adult
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteBelgium
Study dates: 1 Nov 2004to 2 Mar 2005
Phase: Phase 3
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects participating in this study should have received three-dose primary vaccination with combined hepatitis A/hepatitis B vaccine in the primary study.
Written informed consent will be obtained from each subject before the blood sampling visit of each year

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

GSK Investigational Site
Ghent, 9000

Other trials in Belgium

About this study

Official title: Long-Term Persistence Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers

This protocol posting deals with objectives \& outcome measures of the extension phase at year 11 to 15.

Read the detailed description

This is a long-term follow-up study at Years 11, 12, 13, 14 and 15 after primary vaccination with GSK Biologicals' hepatitis A/hepatitis B vaccine (three-dose schedule, 3 different lots). To evaluate the long-term antibody persistence, volunteers will be bled at Years 11, 12, 13, 14 and 15 after the first vaccine dose of the primary vaccination course to determine their anti-HAV and anti-HBs antibody concentrations.

No additional subjects will be recruited during the course of this long-term study.

If a subject has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection concentrations at the long-term blood sampling time point (i.e. Years 11, 12, 13, 14 or 15), he/ she will be offered an additional vaccine dose.

Conditions: Hepatitis B, Hepatitis A
Being tested: Twinrix™ adult
Keywords: Combined Hepatitis A and B vaccine, Hepatitis A, Hepatitis B
Medical subject headings: Hepatitis B, Hepatitis A

What participants receive

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

Twinrix™ adultBiological
Intramuscular administration

Study groups in NCT00289718
Study group	Role	What they receive
Twinrix Group	Experimental	Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study. As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up. Receives: Biological: Twinrix™ adult

What is being measured

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

Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
Concentrations given as geometric mean concentration (GMC) expressed as milli-international unit per millilitre (mIU/mL).
Measured: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Solicited local symptoms assessed include pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 swelling was greater than 100 millimeters (mm) i.e. >100mm.
Measured: During the 4-day (Day 0-3) follow-up period after additional HBV vaccination
Number of Subjects Seropositive for Anti-HAV Antibodies
A seropositive subject was defined as a vaccinated subject who had a anti-HAV antibody titres ≥ 33 mIU/ml.
Measured: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration
Concentrations given as GMC expressed as mIU/mL. NOTE: There was a change of assay kit at Year 15 time-point, thus for the sake of bridging, blood samples corresponding to Year 14 were re-tested with ChemiLuminescence ImmunoAssay (CLIA). From Year 11 to Year 14, anti-HBs antibody concentrations were tested with ELISA with cut-off of 3.3 mIU/mL while, Year 14* onwards, anti-HBs antibody concentrations were tested with the CLIA with cut-off of 6.2 mIU/mL.
Measured: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination
Number of Subjects Seropositive for Anti-HB Antibodies
A seropositive subject was defined as a vaccinated subject who had anti-HB antibody titres ≥ 1 mIU/mL.
NOTE: There was a change of assay kit at Year 15 time-point, thus for the sake of bridging, blood samples corresponding to Year 14 were re-tested with ChemiLuminescence ImmunoAssay (CLIA)
Measured: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination
Number of Subjects Seroprotected for Anti-HBs Antibodies.
A seroprotected subject was defined as a subjects with the anti-HBs titres ≥ 10 mIU/mL.
NOTE: There was a change of assay kit at Year 15 time-point, thus for the sake of bridging, blood samples corresponding to Year 14 were re-tested with ChemiLuminescence ImmunoAssay (CLIA)
Measured: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination
Number of Subjects Reporting Serious Adverse Events (SAE)
A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Measured: During the follow-up period after additional vaccination (minimum 30 days)
Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration
Concentrations given as GMC expressed as mIU/mL. If a subject became seronegative (< 10 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.
Measured: Before the additional dose and 1 month after the additional dose
Number of Subjects Reporting Any Solicited General Symptoms.
Solicited general symptoms assessed included fatigue, headache, malaise, nausea, vomiting and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination.
Measured: During the 4-day (Day 0-3) follow-up period after additional HBV vaccination
Number of Subjects Reporting Unsolicited Adverse Events (AE)
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: During the 30-day follow-up period after additional vaccination
Number of Subjects Reporting Serious Adverse Events (SAEs)
A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Measured: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination

Timeline

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

1 Nov 20042 Mar 2005

First posted10 Feb 2006 (estimated)
Study start1 Nov 2004
Primary completion2 Mar 2005
Study completion2 Mar 2005

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 (3)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 3
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00289718
Sponsor's protocol ID: 100556 (Y11)
Other IDs: 100557 (Y12), 100558 (Y13), 100559 (Y14), 100560 (Y15)
Status last verified: Nov 2016
First submitted: 9 Feb 2006
Last updated: 15 Feb 2018
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

Van Damme P, Leroux-Roels G, Law B, Diaz-Mitoma F, Desombere I, Collard F, Tornieporth N, Van Herck K. Long-term persistence of antibodies induced by vaccination and safety follow-up, with the first combined vaccine against hepatitis A and B in children and adults. J Med Virol. 2001 Sep;65(1):6-13.
PubMed 11505437
Van Damme P, Leroux-Roels G, Crasta P, Messier M, Jacquet JM, Van Herck K. Antibody persistence and immune memory in adults, 15 years after a three-dose schedule of a combined hepatitis A and B vaccine. J Med Virol. 2012 Jan;84(1):11-7. doi: 10.1002/jmv.22264. Epub 2011 Nov 3.
PubMed 22052690
Van Herck K, Leroux-Roels G, Van Damme P, Srinivasa K, Hoet B. Ten-year antibody persistence induced by hepatitis A and B vaccine (Twinrix) in adults. Travel Med Infect Dis. 2007 May;5(3):171-5. doi: 10.1016/j.tmaid.2006.07.003. Epub 2006 Sep 20.
PubMed 17448944

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

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Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long-Term Persistence Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers
ClinicalTrials.gov ID: NCT00289718
Acronym / sponsor ID: 100556 (Y11)
Conditions: Hepatitis B, Hepatitis A
Keywords: Combined Hepatitis A and B vaccine, Hepatitis A, Hepatitis B
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 1 Nov 2004
Primary completion: 2 Mar 2005 (actual)
Study completion: 2 Mar 2005 (actual)
First posted: 10 Feb 2006 (estimated)
Results: Posted 26 Aug 2010

Clinical summary

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

This protocol posting deals with objectives \& outcome measures of the extension phase at year 11 to 15.

Detailed description

No additional subjects will be recruited during the course of this long-term study.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Twinrix Group	Experimental	Biological: Twinrix™ adultSubjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study. As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Subjects participating in this study should have received three-dose primary vaccination with combined hepatitis A/hepatitis B vaccine in the primary study.
Written informed consent will be obtained from each subject before the blood sampling visit of each year

Key exclusion criteria (0 listed)

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
Twinrix™ adultIntramuscular administration	Biological	Twinrix Group

Primary outcome

Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
Time frame: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination
Concentrations given as geometric mean concentration (GMC) expressed as milli-international unit per millilitre (mIU/mL).
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Time frame: During the 4-day (Day 0-3) follow-up period after additional HBV vaccination
Solicited local symptoms assessed include pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 swelling was greater than 100 millimeters (mm) i.e. >100mm.
Number of Subjects Seropositive for Anti-HAV Antibodies
Time frame: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination
A seropositive subject was defined as a vaccinated subject who had a anti-HAV antibody titres ≥ 33 mIU/ml.
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration
Time frame: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination
Concentrations given as GMC expressed as mIU/mL. NOTE: There was a change of assay kit at Year 15 time-point, thus for the sake of bridging, blood samples corresponding to Year 14 were re-tested with ChemiLuminescence ImmunoAssay (CLIA). From Year 11 to Year 14, anti-HBs antibody concentrations were tested with ELISA with cut-off of 3.3 mIU/mL while, Year 14* onwards, anti-HBs antibody concentrations were tested with the CLIA with cut-off of 6.2 mIU/mL.
Number of Subjects Seropositive for Anti-HB Antibodies
Time frame: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination
A seropositive subject was defined as a vaccinated subject who had anti-HB antibody titres ≥ 1 mIU/mL. NOTE: There was a change of assay kit at Year 15 time-point, thus for the sake of bridging, blood samples corresponding to Year 14 were re-tested with ChemiLuminescence ImmunoAssay (CLIA)
Number of Subjects Seroprotected for Anti-HBs Antibodies.
Time frame: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination
A seroprotected subject was defined as a subjects with the anti-HBs titres ≥ 10 mIU/mL. NOTE: There was a change of assay kit at Year 15 time-point, thus for the sake of bridging, blood samples corresponding to Year 14 were re-tested with ChemiLuminescence ImmunoAssay (CLIA)
Number of Subjects Reporting Serious Adverse Events (SAE)
Time frame: During the follow-up period after additional vaccination (minimum 30 days)
A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration
Time frame: Before the additional dose and 1 month after the additional dose
Concentrations given as GMC expressed as mIU/mL. If a subject became seronegative (< 10 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.
Number of Subjects Reporting Any Solicited General Symptoms.
Time frame: During the 4-day (Day 0-3) follow-up period after additional HBV vaccination
Solicited general symptoms assessed included fatigue, headache, malaise, nausea, vomiting and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination.
Number of Subjects Reporting Unsolicited Adverse Events (AE)
Time frame: During the 30-day follow-up period after additional vaccination
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time frame: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination
A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.

Results and safety

Results posted to the registry on 26 Aug 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
Twinrix Group	51	51

Primary outcome: Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration

Time frame: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination. Geometric mean (95% Confidence Interval). Unit: mIU/mL

Measure	Twinrix Group n = 33
Year 11 (N=33)	369.1 (273.8 to 497.7)
Year 12 (N=33)	323.5 (233.8 to 447.7)
Year 13 (N=32)	293.7 (214.8 to 401.8)
Year 14 (N=30)	298.2 (217.0 to 409.6)
Year 15 (N=29)	274.4 (200.9 to 374.7)

Population analysed: Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity, on subjects with available data for the defined timepoint

Primary outcome: Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.

Time frame: During the 4-day (Day 0-3) follow-up period after additional HBV vaccination. Number. Unit: subjects

Measure	Twinrix Group n = 1
Pain	1
Redness	0
Swelling	0

Population analysed: Analysis was performed on the Long Term Total cohort, on subjects who received an additional vaccine dose. Only 1 subject received an additional dose.

Primary outcome: Number of Subjects Seropositive for Anti-HAV Antibodies

Time frame: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination. Number. Unit: Subjects

Measure	Twinrix Group n = 33
Year 11 (N=33)	33
Year 12 (N=33)	33
Year 13 (N=32)	32
Year 14 (N=30)	30
Year 15 (N=29)	29

Population analysed: Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity, on subjects with available data for the defined timepoint

Primary outcome: Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration

Time frame: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination. Geometric mean (95% Confidence Interval). Unit: mIU/mL

Measure	Twinrix Group n = 33
Year 11 (N=33)	123.6 (76.1 to 200.9)
Year 12 (N=33)	150.3 (92.9 to 243.0)
Year 13 (N=32)	77.8 (48.7 to 124.4)
Year 14 (N=30)	71.7 (45.5 to 113.1)
Year 14* (N=28)	95.3 (54.1 to 168.1)
Year 15 (N=29)	79.2 (45.7 to 137.3)

Population analysed: Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity, on subjects with available data for the defined timepoint

Adverse events

Time frame: Serious Adverse Events (SAEs):Up to Year 15 and after additional HBV vaccination;Solicited local and general symptoms:During the 4-day follow-up period post additional dose;Unsolicited AEs:During the 30-day follow-up period post additional dose.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Twinrix Group	1 of 1 (100%)	1 of 1 (100%)	0 of 1

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). The table shows updated results following complete retesting and reanalysis

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 11505437Van Damme P, Leroux-Roels G, Law B, Diaz-Mitoma F, Desombere I, Collard F, Tornieporth N, Van Herck K. Long-term persistence of antibodies induced by vaccination and safety follow-up, with the first combined vaccine against hepatitis A and B in children and adults. J Med Virol. 2001 Sep;65(1):6-13.
Background: PubMed 22052690Van Damme P, Leroux-Roels G, Crasta P, Messier M, Jacquet JM, Van Herck K. Antibody persistence and immune memory in adults, 15 years after a three-dose schedule of a combined hepatitis A and B vaccine. J Med Virol. 2012 Jan;84(1):11-7. doi: 10.1002/jmv.22264. Epub 2011 Nov 3.
Background: PubMed 17448944Van Herck K, Leroux-Roels G, Van Damme P, Srinivasa K, Hoet B. Ten-year antibody persistence induced by hepatitis A and B vaccine (Twinrix) in adults. Travel Med Infect Dis. 2007 May;5(3):171-5. doi: 10.1016/j.tmaid.2006.07.003. Epub 2006 Sep 20.
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.

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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 3 study testing Twinrix™ adult in people with Hepatitis B and Hepatitis A, run by GlaxoSmithKline at 1 site in Belgium.

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 0 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 15 Feb 2018. 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 Belgium. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 26 Aug 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 A Virus (Anti-HAV) Antibody Concentration (time frame: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination). The study lists 11 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 NCT00289718, which also lists 3 linked publications.

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 15 Feb 2018.