HepatitisPhase 4NCT02764671
Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Neonates
A Phase 4 study testing 10μg/0.5ml recombinant hepatitis B vaccine in people with Hepatitis and Hepatitis B, run by Shenzhen Kangtai Biological Products Co., LTD at 2 sites in China.
Trial summary
The purpose of this study is to further evaluate the immunogenicity and safety of 10μg/0.5ml Recombinant Hepatitis B Vaccines(Saccharomyces Cerevisiae) in the Healthy Neonates. Read more about this study
- Who is it for?
- Ages Up to 24 hoursHealthy volunteers can take part
- Conditions the study is for
- Hepatitis, Hepatitis B, Liver Diseases
- What is being tested?
- 10μg/0.5ml recombinant hepatitis B vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 2 sitesChina
- Study dates
- May 2015to Sep 2020
- 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 Up to 24 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects who are healthy full-term infants after birth, Apgar score ≥8;
- Subjects with a birth weight ≥ 2500g;
- Subjects' guardians are able to understand and sign informed consent;
- Subjects who can and will comply with the requirements of the protocol.
Who cannot join
- Family history of eclampsia, epilepsy and encephalopathy;
- Subjects' birth mother had immune system dysfunction, or history of organ transplantation or blood dialysis;
- Subjects' parents had a medical history of allergic to any ingredient of the vaccine, including supplementary material and formaldehyde;
- Subjects' parents had a medical history of allergic to combined hepatitis A and B vaccine(HAB) or hepatitis B vaccine;
- Subjects had serious acute and chronic diseases;
- with temperature ≧37.1℃;
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Gaozhou District Center for Disease Control and Prevention
Maoming, Guangdong
Huang Zhuhang, Master, +86-020-36271871, jade_lyy@126.com
- Recruiting
Xinxing District Center for Disease Control and Prevention
Yunfu, Guangdong
Huang Zhuhang, master, +86-020-36271871, jade_lyy@126.com
About this study
Official title: The Safety and Immunogenicity of 10μg/0.5ml Recombinant Hepatitis B Vaccines(Saccharomyces Cerevisiae) in the Healthy Neonates
The purpose of this study is to further evaluate the immunogenicity and safety of 10μg/0.5ml Recombinant Hepatitis B Vaccines(Saccharomyces Cerevisiae) in the Healthy Neonates.
- Conditions
- Hepatitis, Hepatitis B, Liver Diseases, Digestive System Diseases
- Being tested
- 10μg/0.5ml recombinant hepatitis B vaccine
- Keywords
- recombinant hepatitis B vaccine, safety, immunogenicity
- Medical subject headings
- Hepatitis, Hepatitis B, Liver Diseases, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10μg/0.5ml recombinant hepatitis B vaccineBiological
5000 participants who are healthy neonates receive 10μg/0.5ml recombinant hepatitis B vaccine on day 0, 30 and 60.
| Study group | Role | What they receive |
|---|---|---|
| 10μg/0.5ml recombinant HBV vaccine | Experimental | 5000 participants who are healthy neonates receive 10μg/0.5ml recombinant hepatitis B vaccine on day 0, 30 and 60. Receives: Biological: 10μg/0.5ml recombinant hepatitis B vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events
Measured: Within 30 days after hepatitis B vaccination
Secondary outcomes (4)
Geometric mean titer of anti-hepatitis B virus surface antigen antibody
Geometric mean titer of anti-hepatitis B virus surface antigen antibody was measured by chemiluminescence assay and expressed with mIU/mL.
Measured: The 30th day after whole course of hepatitis B vaccination
Geometric mean titer of anti-hepatitis B virus surface antigen antibody
Geometric mean titer of anti-hepatitis B virus surface antigen antibody was measured by chemiluminescence assay and expressed with mIU/mL.
Measured: The 1th year after whole course of hepatitis B vaccination
Geometric mean titer of anti-hepatitis B virus surface antigen antibody
Geometric mean titer of anti-hepatitis B virus surface antigen antibody was measured by chemiluminescence assay and expressed with mIU/mL.
Measured: The 2th year after whole course of hepatitis B vaccination
Geometric mean titer of anti-hepatitis B virus surface antigen antibody
Geometric mean titer of anti-hepatitis B virus surface antigen antibody was measured by chemiluminescence assay and expressed with mIU/mL.
Measured: The 3th year after whole course of hepatitis B vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startMay 2015
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatitisStudies 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
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Kangtai Biological Products Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guangdong Provincial Institute of Biological Products And Materia Medica
- Responsible party
- Sponsor
- Investigators
- Zheng Huizhen, master, Principal investigator, Guangdong Center for Disease Prevention and Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764671
- Sponsor's protocol ID
- KT0012
- Status last verified
- May 2016
- First submitted
- 4 May 2016
- Last updated
- 6 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Immunogenicity of 10μg/0.5ml Recombinant Hepatitis B Vaccines(Saccharomyces Cerevisiae) in the Healthy Neonates
- ClinicalTrials.gov ID
- NCT02764671
- Acronym / sponsor ID
- KT0012
- Conditions
- Hepatitis, Hepatitis B, Liver Diseases, Digestive System Diseases
- Keywords
- recombinant hepatitis B vaccine, safety, immunogenicity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Shenzhen Kangtai Biological Products Co., LTDIndustry (pharma, biotech, devices)
- Collaborators
- Guangdong Provincial Institute of Biological Products And Materia Medica
- Study start
- May 2015
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 6 May 2016 (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.
The purpose of this study is to further evaluate the immunogenicity and safety of 10μg/0.5ml Recombinant Hepatitis B Vaccines(Saccharomyces Cerevisiae) in the Healthy Neonates.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 10μg/0.5ml recombinant HBV vaccine | Experimental | Biological: 10μg/0.5ml recombinant hepatitis B vaccine5000 participants who are healthy neonates receive 10μg/0.5ml recombinant hepatitis B vaccine on day 0, 30 and 60. |
Who may qualify
- Ages
- Up to 24 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Subjects who are healthy full-term infants after birth, Apgar score ≥8;
- Subjects with a birth weight ≥ 2500g;
- Subjects' guardians are able to understand and sign informed consent;
- Subjects who can and will comply with the requirements of the protocol.
Key exclusion criteria (7 listed)
- Family history of eclampsia, epilepsy and encephalopathy;
- Subjects' birth mother had immune system dysfunction, or history of organ transplantation or blood dialysis;
- Subjects' parents had a medical history of allergic to any ingredient of the vaccine, including supplementary material and formaldehyde;
- Subjects' parents had a medical history of allergic to combined hepatitis A and B vaccine(HAB) or hepatitis B vaccine;
- Subjects had serious acute and chronic diseases;
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 |
|---|---|---|
| 10μg/0.5ml recombinant hepatitis B vaccine5000 participants who are healthy neonates receive 10μg/0.5ml recombinant hepatitis B vaccine on day 0, 30 and 60. | Biological | 10μg/0.5ml recombinant HBV vaccine |
Primary outcome
Number of subjects with adverse events
Time frame: Within 30 days after hepatitis B vaccination
4 secondary outcomes
Geometric mean titer of anti-hepatitis B virus surface antigen antibody
Time frame: The 30th day after whole course of hepatitis B vaccination
Geometric mean titer of anti-hepatitis B virus surface antigen antibody
Time frame: The 1th year after whole course of hepatitis B vaccination
Geometric mean titer of anti-hepatitis B virus surface antigen antibody
Time frame: The 2th year after whole course of hepatitis B vaccination
Geometric mean titer of anti-hepatitis B virus surface antigen antibody
Time frame: The 3th year after whole course of hepatitis B vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2016.
Related trials for Hepatitis
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
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
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
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.
Zheng Huizhen, master principal investigator
Guangdong Center for Disease Prevention and Control
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 10μg/0.5ml recombinant hepatitis B vaccine in people with Hepatitis and Hepatitis B, run by Shenzhen Kangtai Biological Products Co., LTD at 2 sites 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 4 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: status not confirmed, as of the sponsor's last update on 6 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huang Zhuhang, master (+86-020-36271871, jade_lyy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with adverse events (time frame: Within 30 days after hepatitis B vaccination). 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 6 May 2016.