Hepatitis BPhase 4NCT01861613
Seroprevalence of Hepatitis B and Immune Response to Hepatitis B Vaccination in Chinese College Students
A Phase 4 study testing HBV vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20µg/mL/vial, GlaxoSmithKline, Belgium) in people with Hepatitis B and Immune Response, run by Hui Zhuang at 1 site in China.
Trial summary
At present, children less than 15 y of age have been regarded as a key group for hepatitis B immunization in China. However, there is not yet special immunization strategy for population above 15 y of age. Read more about this study
- Who is it for?
- Ages 16 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B, Immune Response, Seroprevalence
- What is being tested?
- HBV vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20µg/mL/vial, GlaxoSmithKline, Belgium)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,040 participants
- Where
- 1 siteChina
- Study dates
- Sep 2009to Nov 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male and female freshmen in one college in Liuzhou city of Guangxi Zhuang Autonomous Region
Who cannot join
- acute illness
- immunocompromised conditions
- renal insufficiency
- pregnancy
- allergic history to HB vaccine or yeast
- positive for any of HBsAg, anti-HBs or anti-HBc
Trial locations and contacts
1 site in 1 country.
About this study
At present, children less than 15 y of age have been regarded as a key group for hepatitis B immunization in China. However, there is not yet special immunization strategy for population above 15 y of age. In this study, we investigated the seroprevalence of hepatitis B and immune response to HB vaccine among Chinese college students to uncover the need on universal mass vaccination or booster immunization only for students with HBV vaccination history against hepatitis B in Chinese college students to inform decision making.
- Conditions
- Hepatitis B, Immune Response, Seroprevalence
- Being tested
- HBV vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20µg/mL/vial, GlaxoSmithKline, Belgium)
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBV vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20µg/mL/vial, GlaxoSmithKline, Belgium)Biological
| Study group | Role | What they receive |
|---|---|---|
| HBV vaccine | Experimental | HBV vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20µg/mL/vial, GlaxoSmithKline, Belgium) Receives: Biological: HBV vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20µg/mL/vial, GlaxoSmithKline, Belgium) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-HBs immune response in participants negative for HB sAg, anti-HBs and anti-HBc
Measured: Anti-HBs was assayed at Month 7
Secondary outcomes (4)
Seroprevalence for HBsAg, anti-HBs and anti-HBc in Chinese college students
Measured: seroprevalence at baseline
Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc
Measured: Anti-HBs immune response at Month 1
Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc
Measured: Anti-HBs immune response at Month 6
Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc
Measured: Anti-HBs immune response at Month 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startSep 2009
- Primary completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- 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
- 2,040 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hui Zhuang
- Sponsor type
- University, hospital or other
- Collaborators
- Guangxi Center for Disease Control and Prevention
- Responsible party
- Sponsor-investigator, Hui Zhuang, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861613
- Sponsor's protocol ID
- PRO-HBV-001
- Status last verified
- May 2013
- First submitted
- 19 May 2013
- Last updated
- 24 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroprevalence of Hepatitis B and Immune Response to Hepatitis B Vaccination in Chinese College Students
- ClinicalTrials.gov ID
- NCT01861613
- Acronym / sponsor ID
- PRO-HBV-001
- Conditions
- Hepatitis B, Immune Response, Seroprevalence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,040 participants (actual)
- Lead sponsor
- Hui ZhuangUniversity, hospital or other
- Collaborators
- Guangxi Center for Disease Control and Prevention
- Study start
- Sep 2009
- Primary completion
- Nov 2011 (actual)
- First posted
- 23 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
At present, children less than 15 y of age have been regarded as a key group for hepatitis B immunization in China. However, there is not yet special immunization strategy for population above 15 y of age. In this study, we investigated the seroprevalence of hepatitis B and immune response to HB vaccine among Chinese college students to uncover the need on universal mass vaccination or booster immunization only for students with HBV vaccination history against hepatitis B in Chinese college students to inform decision making.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HBV vaccine | Experimental | Biological: HBV vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20µg/mL/vial, GlaxoSmithKline, Belgium)HBV vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20µg/mL/vial, GlaxoSmithKline, Belgium) |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Male and female freshmen in one college in Liuzhou city of Guangxi Zhuang Autonomous Region
Key exclusion criteria (6 listed)
- acute illness
- immunocompromised conditions
- renal insufficiency
- pregnancy
- allergic history to HB vaccine or yeast
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 |
|---|---|---|
| HBV vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20µg/mL/vial, GlaxoSmithKline, Belgium) | Biological | HBV vaccine |
Primary outcome
Anti-HBs immune response in participants negative for HB sAg, anti-HBs and anti-HBc
Time frame: Anti-HBs was assayed at Month 7
4 secondary outcomes
Seroprevalence for HBsAg, anti-HBs and anti-HBc in Chinese college students
Time frame: seroprevalence at baseline
Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc
Time frame: Anti-HBs immune response at Month 1
Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc
Time frame: Anti-HBs immune response at Month 6
Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc
Time frame: Anti-HBs immune response at Month 20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 HBV vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20µg/mL/vial, GlaxoSmithKline, Belgium) in people with Hepatitis B and Immune Response, run by Hui Zhuang at 1 site in China.
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 1 inclusion and 6 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 24 May 2013. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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-HBs immune response in participants negative for HB sAg, anti-HBs and anti-HBc (time frame: Anti-HBs was assayed at Month 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2013.