Hepatitis BPhase 3NCT00393523

Hepatitis B Vaccine Booster Study (V232-058)(COMPLETED)

A Phase 3 study testing Comparator: Modified Process Hepatitis B Vaccine and Comparator: Comparator: ENGERIX-B in people with Hepatitis B, run by Merck Sharp & Dohme LLC.

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

Who is it for?: Ages 4 to 8 yearsHealthy volunteers can take part
Conditions the study is for: Hepatitis B
What is being tested?: Comparator: Modified Process Hepatitis B Vaccine and Comparator: Comparator: ENGERIX-B
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,478 participants
Where: No sites listed yet
Study dates: Sep 2006to Jun 2008
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 4 to 8 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy Children 4 to 8 years of age
Complete medical records documenting receiving a previous hepatitis B vaccination during the first year of life (for Cohort A and B only)
Complete 3-dose vaccination with either a primary series of RECOMBIVAX HB or a primary series of ENGERIX-B (for Cohort A and B only)

Who cannot join

Birth mother known to be a carrier of hepatitis B virus (Cohort C only)
History of previous hepatitis B vaccine
History of vaccination with any hepatitis B vaccine (Cohort C only)
Known of suspected hypersensitivity to any component of RECOMBIVAX HB or ENGERIX-B (eg aluminum, yeast) recent administration of hepatitis B immune globulin (HBIg), serum immune globulin, or any other blood-derived product
Receipt of investigational drugs or vaccines within 3 months prior to study vaccine or planned within study period
Impairment of immunologic function or recent use of immunomodulatory medications
A Combination of different hepatitis B vaccines used in the primary vaccination series (Cohort A and B only)

About this study

Official title: A Study to Assess the Anamnestic Immune Response 4 to 8 Years After a Primary Vaccination Series With HBVAXPRO

To assess the safety and immunogenicity of a booster dose of hepatitis B vaccine in children who have received a 3-dose primary series of either RECOMBIVAX HB or ENGERIX-B. The primary vaccination series (was given 4 to 8 years prior to study entry and consisted of a licensed hepatitis B vaccine product (either RECOMBIVAX HB or ENGERIX-B). The booster dose given in this study will be either an investigational Merck product (Modified Process Hepatitis B Vaccine) or licensed ENGERIX-B vaccine.

Conditions: Hepatitis B
Being tested: Comparator: Modified Process Hepatitis B Vaccine, Comparator: Comparator: ENGERIX-B
Medical subject headings: Hepatitis B

What participants receive

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

Comparator: Modified Process Hepatitis B VaccineBiological
Single dose 5 µg/0.5ml modified process hepatitis B vaccine
Comparator: Comparator: ENGERIX-BBiological
Single dose 10 µg/0.5ml ENGERIX-B

Study groups in NCT00393523
Study group	Role	What they receive
5 µg Modified Process Hepatitis B Vaccine Booster (Group 1)	Active comparator	Participants had previously received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study. During this study, participants received a 5µg/0.5 ml dose of Modified Process Hepatitis B Vaccine (Booster Dose). Receives: Biological: Comparator: Modified Process Hepatitis B Vaccine
10 µg ENGERIX-B™ Booster (Group 2)	Active comparator	Participants had previously received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study. During this study, participants received a dose of 10µg/per 0.5 ml ENGERIX-B™ (Booster Dose) Receives: Biological: Comparator: Comparator: ENGERIX-B
5 µg Modified Process Hepatitis B Vaccine Booster (Group 3)	Active comparator	Participants had previously received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose) during the first year of life outside of the context of the study. During this study, participants received a 5µg/0.5 ml dose of Modified Process Hepatitis B Vaccine, (Booster Dose). Receives: Biological: Comparator: Modified Process Hepatitis B Vaccine
10 µg ENGERIX-B™ Booster (Group 4)	Active comparator	Participants had previously received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose) during the first year of life outside of the context of the study. During this study, participants received a 10µg/0.5 ml dose of ENGERIX-B™ (Booster Dose). Receives: Biological: Comparator: Comparator: ENGERIX-B
5 µg Modified Process Hepatitis B Vaccine (Group 5)	Experimental	Participants did not receive a prior vaccination with a hepatitis B vaccine. During the study, participants received a 5µg/0.5 ml dose of Modified Process Hepatitis B Vaccine. Receives: Biological: Comparator: Modified Process Hepatitis B Vaccine

What is being measured

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

Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy
Number of subjects who received a 3-dose primary series of RECOMBIVAX HB™ in infancy and who demonstrated antibodies to hepatitis B surface antigen ≥10 mIU/mL at 4 weeks after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™.
Measured: 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B

Secondary outcomes (1)

Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy
Number of subjects who received a 3-dose primary series of ENGERIX-B ™ in infancy and who demonstrated antibodies to hepatitis B surface antigen ≥10 mIU/mL at 4 weeks after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™.
Measured: 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B

Timeline

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

Sep 2006Jun 2008

First posted27 Oct 2006 (estimated)
Study startSep 2006
Primary completionJun 2008
Study completionJun 2008

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 Merck Sharp & Dohme LLCThe 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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 1,478 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00393523
Sponsor's protocol ID: V232-058
Other IDs: 2006_040
Status last verified: Mar 2017
First submitted: 25 Oct 2006
Last updated: 12 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

Diez-Domingo J, Flores SA, Martin JC, Klopfer SO, Schodel FP, Bhuyan PK. A randomized, multicenter, open-label clinical trial to assess the anamnestic immune response 4 to 8 years after a primary hepatitis B vaccination series. Pediatr Infect Dis J. 2010 Oct;29(10):972-4. doi: 10.1097/INF.0b013e3181f1b3b6.
PubMed 20724955

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?

Official record

Active, not recruitingPhase 1/2
A Clinical Study of HT-101 and/or HT-102 in Patients With Chronic Hepatitis B Virus Infection
Chronic Hepatitis B
Active, not recruitingPhase 2
A Clinical Study of HT-101 and HT-102 in Patients With Chronic Hepatitis B Virus Infection
Chronic Hepatitis B
Not yet recruitingPhase 1
Phase Ia/Ib Trial of SCTA02A Injection in Healthy Adults and Patients With Chronic Hepatitis B
Hepatitis B
Recruiting
HIV/HBV/HCV Triple Screening in Primary Care
HIV, HBV (Hepatitis B Virus)
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C

All Hepatitis B trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Assess the Anamnestic Immune Response 4 to 8 Years After a Primary Vaccination Series With HBVAXPRO
ClinicalTrials.gov ID: NCT00393523
Acronym / sponsor ID: V232-058
Conditions: Hepatitis B
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,478 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Sep 2006
Primary completion: Jun 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 27 Oct 2006 (estimated)
Results: Posted 12 Oct 2009

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 5

Arm	Type	Receives
5 µg Modified Process Hepatitis B Vaccine Booster (Group 1)	Active comparator	Biological: Comparator: Modified Process Hepatitis B VaccineParticipants had previously received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study. During this study, participants received a 5µg/0.5 ml dose of Modified Process Hepatitis B Vaccine (Booster Dose).
10 µg ENGERIX-B™ Booster (Group 2)	Active comparator	Biological: Comparator: Comparator: ENGERIX-BParticipants had previously received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study. During this study, participants received a dose of 10µg/per 0.5 ml ENGERIX-B™ (Booster Dose)
5 µg Modified Process Hepatitis B Vaccine Booster (Group 3)	Active comparator	Biological: Comparator: Modified Process Hepatitis B VaccineParticipants had previously received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose) during the first year of life outside of the context of the study. During this study, participants received a 5µg/0.5 ml dose of Modified Process Hepatitis B Vaccine, (Booster Dose).
10 µg ENGERIX-B™ Booster (Group 4)	Active comparator	Biological: Comparator: Comparator: ENGERIX-BParticipants had previously received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose) during the first year of life outside of the context of the study. During this study, participants received a 10µg/0.5 ml dose of ENGERIX-B™ (Booster Dose).
5 µg Modified Process Hepatitis B Vaccine (Group 5)	Experimental	Biological: Comparator: Modified Process Hepatitis B VaccineParticipants did not receive a prior vaccination with a hepatitis B vaccine. During the study, participants received a 5µg/0.5 ml dose of Modified Process Hepatitis B Vaccine.

Who may qualify

Ages: 4 to 8 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Healthy Children 4 to 8 years of age
Complete medical records documenting receiving a previous hepatitis B vaccination during the first year of life (for Cohort A and B only)
Complete 3-dose vaccination with either a primary series of RECOMBIVAX HB or a primary series of ENGERIX-B (for Cohort A and B only)

Key exclusion criteria (7 listed)

Birth mother known to be a carrier of hepatitis B virus (Cohort C only)
History of previous hepatitis B vaccine
History of vaccination with any hepatitis B vaccine (Cohort C only)
Known of suspected hypersensitivity to any component of RECOMBIVAX HB or ENGERIX-B (eg aluminum, yeast) recent administration of hepatitis B immune globulin (HBIg), serum immune globulin, or any other blood-derived product
Receipt of investigational drugs or vaccines within 3 months prior to study vaccine or planned within study period

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
Comparator: Modified Process Hepatitis B VaccineSingle dose 5 µg/0.5ml modified process hepatitis B vaccine	Biological	5 µg Modified Process Hepatitis B Vaccine (Group 5), 5 µg Modified Process Hepatitis B Vaccine Booster (Group 1), 5 µg Modified Process Hepatitis B Vaccine Booster (Group 3)
Comparator: Comparator: ENGERIX-BSingle dose 10 µg/0.5ml ENGERIX-B	Biological	10 µg ENGERIX-B™ Booster (Group 2), 10 µg ENGERIX-B™ Booster (Group 4)

Primary outcome

Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy
Time frame: 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B
Number of subjects who received a 3-dose primary series of RECOMBIVAX HB™ in infancy and who demonstrated antibodies to hepatitis B surface antigen ≥10 mIU/mL at 4 weeks after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™.

1 secondary outcome

Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy
Time frame: 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B

Results and safety

Results posted to the registry on 12 Oct 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Modified Process Hepatitis B Vaccine Booster (Group 1)	376	364
ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)	375	366
Modified Process Hepatitis B Vaccine Booster (Group 3)	353	349
ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)	354	348
Modified Process Hepatitis B Vaccine (Group 5)	20	19

Primary outcome: Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy

Time frame: 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B. Number. Unit: Participants

Measure	Modified Process Hepatitis B Vaccine Booster (Group 1) n = 340	ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2) n = 333
Value	323	305

Modified Process Hepatitis B Vaccine Booster (Group 1): Seroprotection rate (SPR): 95.0 (95.2% CI 92.1 to 97.1), p <0.001, Hochberg's step up
Modified Process Hepatitis B Vaccine Booster (Group 1): Seroprotection rate (SPR): 95.0 (97.6% CI 91.6 to 97.3), p <0.001, Hochberg's step up
ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2): Seroprotection rate (SPR): 91.6 (95.2% CI 88.0 to 94.4), p = 0.19, Hochberg's step up

Population analysed: Per-protocol population (defined as the subjects that completed the study as defined by the protocol). Subjects were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Modified Process Hepatitis B Vaccine Booster (Group 1)	0 of 369 (0%)	214 of 369 (58%)	Not reported
ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)	0 of 368 (0%)	192 of 368 (52.2%)	Not reported
Modified Process Hepatitis B Vaccine Booster (Group 3)	0 of 344 (0%)	198 of 344 (57.6%)	Not reported
ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)	2 of 342 (0.6%)	194 of 342 (56.7%)	Not reported
Modified Process Hepatitis B Vaccine (Group 5)	0 of 19 (0%)	9 of 19 (47.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20724955Diez-Domingo J, Flores SA, Martin JC, Klopfer SO, Schodel FP, Bhuyan PK. A randomized, multicenter, open-label clinical trial to assess the anamnestic immune response 4 to 8 years after a primary hepatitis B vaccination series. Pediatr Infect Dis J. 2010 Oct;29(10):972-4. doi: 10.1097/INF.0b013e3181f1b3b6.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

Related trials for Hepatitis B

Active, not recruitingPhase 1/2
A Clinical Study of HT-101 and/or HT-102 in Patients With Chronic Hepatitis B Virus Infection
Chronic Hepatitis B
Active, not recruitingPhase 2
A Clinical Study of HT-101 and HT-102 in Patients With Chronic Hepatitis B Virus Infection
Chronic Hepatitis B
Not yet recruitingPhase 1
Phase Ia/Ib Trial of SCTA02A Injection in Healthy Adults and Patients With Chronic Hepatitis B
Hepatitis B
Recruiting
HIV/HBV/HCV Triple Screening in Primary Care
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RecruitingObservational study
Evaluation of Patients With Liver Disease
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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.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Comparator: Modified Process Hepatitis B Vaccine and Comparator: Comparator: ENGERIX-B in people with Hepatitis B, run by Merck Sharp & Dohme LLC.

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 3 inclusion and 7 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 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

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 12 Oct 2009). 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?

Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy (time frame: 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B). 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 NCT00393523, 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 12 Apr 2017.