Hepatitis APhase 4NCT01037114

Long-term Persistence Study in Healthy Adults Previously Vaccinated With Twinrix Adult

A Phase 4 study testing Blood sampling, Engerix-B and Havrix in people with Hepatitis A and Hepatitis B, 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

Search all trials

Trial summary

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Hepatitis A, Hepatitis B
What is being tested?: Blood sampling, Engerix-B and Havrix
Type of treatment: Vaccines, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteBelgium
Study dates: 27 Jan 2010to 28 Feb 2014
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 Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

All subjects must satisfy the following criteria at entry into each of the long-term follow-up visits:
Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
A male or female who received the complete primary vaccination course in the primary study 208127/022.
Written informed consent obtained from the subject.
All subjects must satisfy the following criteria at entry into the challenge dose phase:
Subjects who the investigator believes that they can and will comply with the requirements of the protocol.

Show all 14Show fewer

A male or female who received the complete primary vaccination course in the primary study 208127/022.
Written informed consent obtained from the subject.
Subjects who participated in the LTFU phase of the 208127/022 study and for whom the antibody concentrations were below the cut-off at the last available follow-up time-point.
Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
has practiced adequate contraception for 30 days prior to vaccination, and
has a negative pregnancy test on the day of vaccination, and
has agreed to continue adequate contraception for two months after the administration of the challenge dose.

Who cannot join

The following criteria should be checked before entry into each of the long-term follow-up visits. If any exclusion criterion applies, the subject must not be included in the study:
Use of any investigational or non-registered product within 30 days prior to blood sampling.
Administration of a hepatitis A, hepatitis B or combined hepatitis A and B vaccine outside the study procedures, since the primary study 208127/022.
History of hepatitis A or hepatitis B infection since the primary study 208127/022.
Administration of hepatitis A or hepatitis B immunoglobulins and/or any blood products within three months prior to blood sampling.
The following criteria should be checked before the challenge dose is administered. If any apply, the subject must not be included in the challenge dose phase:

Show all 14Show fewer

Use of any investigational or non-registered product within 30 days prior to study start or planned use during the study.
Administration of a hepatitis A, hepatitis B or combined hepatitis A and B vaccine between the last LTFU visit and the challenge dose visit.
History of hepatitis A or hepatitis B infection between the last LTFU visit and the challenge dose visit.
History of anaphylactic reactions following the administration of vaccines.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
Acute disease and/or fever at the time of enrolment.
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions.

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: An Open Single Centre Study to Evaluate the Long-term Antibody Persistence and Immune Memory Between 16 and 20 Years After the Primary Study HAB-032 (208127/022) in Which Healthy Adults Were Vaccinated With Twinrix Adult Following a Three-dose Schedule.

This study will evaluate the persistence of the immune response to HAV (hepatitis A virus) antigens and HBs (hepatitis B surface) antigens in healthy adults previously vaccinated with Twinrix Adult in the primary study, HAB-032 (208127/022). The subjects will be invited for blood sampling 16, 17, 18, 19 and 20 years after the primary vaccination to evaluate the antibody persistence. For subjects in whom low circulating antibodies are detected, the presence of immune memory against hepatitis A \& B antigens will be investigated by the administration of a challenge dose of the appropriate vaccine (Havrix and/or Engerix-B) at the next planned visit.

No new subjects will be recruited during this study.

Conditions: Hepatitis A, Hepatitis B
Being tested: Blood sampling, Engerix-B, Havrix
Keywords: Hepatitis A and hepatitis B
Medical subject headings: Hepatitis A, Hepatitis B

What participants receive

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

Blood samplingProcedure or surgery
Blood sampling at Year 16, 17, 18, 19 and 20 and at the time of challenge dose administration and 14 days and one month after challenge dose administration (if challenge dose needed).
Engerix-BBiological
Engerix-B will be administered to subjects who are not seroprotected against hepatitis B.
HavrixBiological
Havrix will be administered to subjects who are seronegative for anti-HAV antibodies.

Study groups in NCT01037114
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 first long-term follow-up NCT00289718 and this long-term follow-up. A challenge dose of the Havrix or Engerix-B vaccines can be administered in this study based on serology results at each time point. Receives: Procedure: Blood sampling; Biological: Engerix-B; Biological: Havrix

What is being measured

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

Number of Subjects Seropositive for Anti-hepatitis A Virus Antibodies (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies and With Anti-HBs Antibody Concentrations >= 10 Milliinternational Units Per Milliliter (mIU/mL)
Seropositivity for anti-HAV antibodies is defined as antibody concentrations >= 15 milliinternational units per milliliter (mIU/mL). Seropositivity for anti-HBs antibodies is defined as antibody concentrations >= 6.2 mIU/mL.
Measured: At Years 16, 17, 18, 19 and 20.
Anti-HAV and Anti-HBs Geometric Mean Concentrations (GMCs)
Concentrations were expressed as GMCs in mIU/mL.
Measured: At Years 16, 17, 18, 19 and 20.

Secondary outcomes (8)

Anti-HBs Concentrations After the Challenge Dose of Engerix-B
Concentration was given in mIU/mL.
Only 1 subject was eligible for the challenge dose of Engerix-B at the Year 16 time point. Therefore the values for this subject are given without a measure of dispersion.
Measured: Before, 14 days and one month (30 days) after the challenge dose of Engerix-B.
Anti-HAV Concentrations After the Challenge Dose of Havrix
Concentration was given in mIU/mL. Only 2 subjects were eligible for the challenge dose of Havrix, one at Year 18 and another at Year 20 time point. Therefore the values for these subject are given without a measure of dispersion.
Measured: Before, 14 days and one month (30 days) after the challenge dose of Havrix.
Number of Subjects With Anamnestic Response to the Challenge Dose of Engerix-B
At Year 16 only 1 subject was eligible for the challenge dose of Engerix-B.
Anti-HBs anamnestic response to the challenge dose was defined as:
- Anti-HBs antibody concentrations >= 10 mIU/mL at one month post-challenge dose in subjects seronegative at the pre-challenge time point.
- At least a 4-fold increase in anti-HBs antibody concentrations, at one month post-challenge dose in subjects seropositive at the pre-challenge time point.
Measured: 30 days after the challenge dose of Engerix-B.
Number of Subjects With Anamnestic Response to the Challenge Dose of Havrix
Anti-HAV anamnestic response to the challenge dose was defined as:
- Anti-HAV antibody concentrations ≥ 15 mIU/mL at one month post-challenge dose, in subjects seronegative at the pre-challenge time point.
- At least a 2-fold increase in anti-HAV antibody concentrations one month after the challenge dose, in subjects having anti-HAV antibody concentrations ≥ 100 mIU/mL at the pre-challenge time point.
- Or at least a 4-fold increase in anti-HAV antibody concentrations one month after the challenge dose, in seropositive subjects having anti-HAV antibody concentrations < 100 mIU/mL at the pre-challenge time-point.
Measured: 30 days after the challenge dose of Havrix.
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
At Year 16, 1 subject was administered a challenge dose of Engerix-B and at Y18 and Y20, 2 subjects were administered a challenge dose of Havrix.
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: 31 days (Days 0-30) after the challenge dose of Engerix-B and Havrix.
Number of Subjects With Serious Adverse Events (SAEs)
Only 1 subject received a challenge dose at Year 16 of Engerix-B.
An SAE is any untoward medical occurrence that: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Measured: During the 31-day (Days 0-30) follow-up period after the Engerix-B challenge dose.
Number of Subjects With Serious Adverse Events (SAEs)
One subject received a challenge dose of Havrix at Year 18 and another at Year 20.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: During the 31-day (Days 0-30) follow-up period after the Havrix challenge dose.
Number of Subjects Reporting SAEs Related to Study Participation or a Concurrent GSK Medication
An SAE is any untoward medical occurrence that: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Measured: Up to Year 20.

Timeline

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

27 Jan 201028 Feb 2014

First posted21 Dec 2009 (estimated)
Study start27 Jan 2010
Primary completion28 Feb 2014
Study completion28 Feb 2014

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 AStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01037114
Sponsor's protocol ID: 112266
Status last verified: Jan 2018
First submitted: 17 Dec 2009
Last updated: 1 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
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

Agrawal A, Kolhapure S, Andani A, Ota MOC, Badur S, Karkada N, Mitra M. Long-Term Persistence of Antibody Response with Two Doses of Inactivated Hepatitis A Vaccine in Children. Infect Dis Ther. 2020 Dec;9(4):785-796. doi: 10.1007/s40121-020-00311-8. Epub 2020 Jul 24.
PubMed 32710245

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

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
RecruitingObservational study
Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy (D-SHIELD)
Hepatitis D
Not yet recruitingPhase 2
A Study of HT-101 and HT-102 in Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B

All Hepatitis A trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Single Centre Study to Evaluate the Long-term Antibody Persistence and Immune Memory Between 16 and 20 Years After the Primary Study HAB-032 (208127/022) in Which Healthy Adults Were Vaccinated With Twinrix Adult Following a Three-dose Schedule.
ClinicalTrials.gov ID: NCT01037114
Acronym / sponsor ID: 112266
Conditions: Hepatitis A, Hepatitis B
Keywords: Hepatitis A and hepatitis B
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 27 Jan 2010 (actual)
Primary completion: 28 Feb 2014 (actual)
Study completion: 28 Feb 2014 (actual)
First posted: 21 Dec 2009 (estimated)
Results: Posted 27 Apr 2011

Clinical summary

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

No new subjects will be recruited during this 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	Procedure: Blood sampling, Biological: Engerix-B, Biological: HavrixSubjects 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 first long-term follow-up NCT00289718 and this long-term follow-up. A challenge dose of the Havrix or Engerix-B vaccines can be administered in this study based on serology results at each time point.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (14 listed)

All subjects must satisfy the following criteria at entry into each of the long-term follow-up visits:
Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
A male or female who received the complete primary vaccination course in the primary study 208127/022.
Written informed consent obtained from the subject.
Subjects who the investigator believes that they can and will comply with the requirements of the protocol.

Key exclusion criteria (14 listed)

The following criteria should be checked before entry into each of the long-term follow-up visits. If any exclusion criterion applies, the subject must not be included in the study:
Use of any investigational or non-registered product within 30 days prior to blood sampling.
Administration of a hepatitis A, hepatitis B or combined hepatitis A and B vaccine outside the study procedures, since the primary study 208127/022.
History of hepatitis A or hepatitis B infection since the primary study 208127/022.
Administration of hepatitis A or hepatitis B immunoglobulins and/or any blood products within three months prior to blood sampling.

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
Blood samplingBlood sampling at Year 16, 17, 18, 19 and 20 and at the time of challenge dose administration and 14 days and one month after challenge dose administration (if challenge dose needed).	Procedure or surgery	Twinrix Group
Engerix-BEngerix-B will be administered to subjects who are not seroprotected against hepatitis B.	Biological	Twinrix Group
HavrixHavrix will be administered to subjects who are seronegative for anti-HAV antibodies.	Biological	Twinrix Group

Primary outcome

Number of Subjects Seropositive for Anti-hepatitis A Virus Antibodies (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies and With Anti-HBs Antibody Concentrations >= 10 Milliinternational Units Per Milliliter (mIU/mL)
Time frame: At Years 16, 17, 18, 19 and 20.
Seropositivity for anti-HAV antibodies is defined as antibody concentrations >= 15 milliinternational units per milliliter (mIU/mL). Seropositivity for anti-HBs antibodies is defined as antibody concentrations >= 6.2 mIU/mL.
Anti-HAV and Anti-HBs Geometric Mean Concentrations (GMCs)
Time frame: At Years 16, 17, 18, 19 and 20.
Concentrations were expressed as GMCs in mIU/mL.

8 secondary outcomes

Anti-HBs Concentrations After the Challenge Dose of Engerix-B
Time frame: Before, 14 days and one month (30 days) after the challenge dose of Engerix-B.
Anti-HAV Concentrations After the Challenge Dose of Havrix
Time frame: Before, 14 days and one month (30 days) after the challenge dose of Havrix.
Number of Subjects With Anamnestic Response to the Challenge Dose of Engerix-B
Time frame: 30 days after the challenge dose of Engerix-B.
Number of Subjects With Anamnestic Response to the Challenge Dose of Havrix
Time frame: 30 days after the challenge dose of Havrix.
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Time frame: 31 days (Days 0-30) after the challenge dose of Engerix-B and Havrix.
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the 31-day (Days 0-30) follow-up period after the Engerix-B challenge dose.
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the 31-day (Days 0-30) follow-up period after the Havrix challenge dose.
Number of Subjects Reporting SAEs Related to Study Participation or a Concurrent GSK Medication
Time frame: Up to Year 20.

Results and safety

Results posted to the registry on 27 Apr 2011, 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	49	49

Primary outcome: Number of Subjects Seropositive for Anti-hepatitis A Virus Antibodies (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies and With Anti-HBs Antibody Concentrations >= 10 Milliinternational Units Per Milliliter (mIU/mL)

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

Measure	Twinrix Group n = 28
anti-HAV >= 15 mIU/mL [at Year 16] (N=28)	28
anti-HBs >= 6.2 mIU/mL [at Year 16] (N=28)	27
anti-HBs >= 10 mIU/mL [at Year 16] (N=28)	27
anti-HAV >= 15 mIU/mL [at Year 17] (N=27)	26
anti-HBs >= 6.2 mIU/mL [at Year 17] (N=27)	25
anti-HBs >= 10 mIU/mL [at Year 17] (N=27)	25
anti-HAV >= 15 mIU/mL [at Year 18] (N=25)	25
anti-HBs >= 6.2 mIU/mL [at Year 18] (N=25)	23

Population analysed: The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at a particular blood sampling time point, who were included in the ATP analysis for the primary study and who did not receive hepatitis A or B vaccination that was not specified in the protocol.

Primary outcome: Anti-HAV and Anti-HBs Geometric Mean Concentrations (GMCs)

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

Measure	Twinrix Group n = 28
anti-HAV [at Year 16] (N=28)	262.5 (189.9 to 362.9)
anti-HBs [at Year 16] (N=28)	79.9 (45.2 to 141.0)
anti-HAV [at Year 17] (N=27)	369.4 (257.9 to 529.1)
anti-HBs [at Year 17] (N=27)	71.7 (39.6 to 129.8)
anti-HAV [at Year 18] (N=25)	237.7 (163.7 to 345.4)
anti-HBs [at Year 18] (N=25)	61.3 (36.8 to 102.3)
anti-HAV [at Year 19] (N=25)	234.3 (159.0 to 345.5)
anti-HBs [at Year 19] (N=25)	59.7 (35.1 to 101.4)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: SAEs: During the 31-day (Days 0 to 30) follow-up period after the challenge dose and from the beginning of the long term follow-up to Year 20; Unsolicited symptoms: During the 31-day (Days 0 to 30) follow-up period after the challenge dose.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Twinrix Group	0 of 49 (0%)	1 of 3 (33.3%)	0 of 49

Limitations and caveats (from the sponsor): A decrease in specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody(10-100 mIU/mL).The tables show updated results following complete retesting/reanalysis for Y16-18.Y19 \& 20 results were only analyzed by CLIA.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32710245Agrawal A, Kolhapure S, Andani A, Ota MOC, Badur S, Karkada N, Mitra M. Long-Term Persistence of Antibody Response with Two Doses of Inactivated Hepatitis A Vaccine in Children. Infect Dis Ther. 2020 Dec;9(4):785-796. doi: 10.1007/s40121-020-00311-8. Epub 2020 Jul 24.
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 A

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
RecruitingObservational study
Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy (D-SHIELD)
Hepatitis D
Not yet recruitingPhase 2
A Study of HT-101 and HT-102 in Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B

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 Blood sampling, Engerix-B and Havrix in people with Hepatitis A and Hepatitis B, 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 14 inclusion and 14 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 1 Feb 2019. 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 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 27 Apr 2011). 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?

Number of Subjects Seropositive for Anti-hepatitis A Virus Antibodies (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies and With Anti-HBs Antibody Concentrations >= 10 Milliinternational Units Per Milliliter (mIU/mL) (time frame: At Years 16, 17, 18, 19 and 20.). The study lists 2 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 NCT01037114, 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 1 Feb 2019; AzTrials last refreshed its copy on 6 Nov 2026.