Hepatitis BPhase 3NCT02152709
Study of Evaluating Safety and Immunogenicity of 10µg/0.5ml Hepatitis B Vaccine
A Phase 3 study testing 3 dose of 10µg/0.5ml hepatitis B vaccine and 3 dose of 5µg/0.5ml hepatitis B vaccine in people with Hepatitis B, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
Trial summary
The main objective of this study was to evaluate the safety and immunogenicity of 10µg/0.5ml and 5µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside yeast for infants and other age groups. Read more about this study
- Who is it for?
- Ages 1 day to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- 3 dose of 10µg/0.5ml hepatitis B vaccine and 3 dose of 5µg/0.5ml hepatitis B vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,537 participants
- Where
- 1 siteChina
- Study dates
- Nov 2008to Oct 2010
- Phase
- Phase 3
- 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 1 day to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy full-term infant after birth, Apgar score ≥7.
- Guardian signed informed consent.
- Guardian can comply with the requirements of the clinical trial.
- Without administering immunoglobulin during the following period.
- Axillary temperature ≤37.0 ℃.
- More than 1 month old healthy people, without the history of hepatitis B infection.
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- Subjects or their guardians signed informed consent.
- After questioning medical history, physical examination and being judged as healthy subject.
- Without the history of hepatitis B vaccination.
- Subjects or their guardians can comply with requirements of the clinical trail.
- Without other prevention drugs or immunoglobulin administered within two weeks before the clinical trail or during the following period.
- Axillary temperature ≤37.0 ℃.
Who cannot join
- Apgar score of infant after birth <7.
- With nervous system damage after birth, or with the family history of mental illness, epilepsy or encephalopathy.
- With immune system dysfunction.
- With vitamin deficiency.
- With acute febrile diseases, or infectious diseases.
- With congenital malformations, developmental disorders or serious chronic illness.
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- With thrombocytopenia or other coagulation disorders.
- Administered immunoglobulin during the period of the clinical trail, especially administered Hepatitis B immunoglobulin to the infant of Hepatitis B infected mother.
- With endemic disease.
- Participate another clinical trial during the period of the clinical trail.
- Any circumstance that may affect clinical trail evaluation.
- With allergies, seizures, epilepsy, encephalopathy or with family history of mental illness.
- Allergic to any component of the study vaccine.
- With immune system dysfunction.
- Hepatitis B infected people.
- Anti-HBs was positive screened by ELISA kit.
- Either anti-HBs ≥10mIU/ml or HBsAg was positive screened by Radioimmunoassay method.
- With acute febrile diseases or infectious diseases.
- With congenital malformations, developmental disorders or serious chronic illness.
- With thrombocytopenia or other coagulation disorders.
- With the history of severe allergic reactions.
- Administered other prevention drugs or immunoglobulin within two weeks before the clinical trail or during the following period.
- With any acute illness that requires antibiotics or anti-viral treatment within 7 days before the clinical trail.
- With vitamin deficiency.
- With the history of febrile convulsion.
- Axillary temperature ≥38.0 ℃ within 3 days before the clinical trail.
- Participate another clinical trial during the period of the clinical trail.
- Pregnant woman.
- Any circumstance that may affect clinical trail evaluation.
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, Jiangsu, 210009
About this study
Official title: A Phase 3, Randomized, Controlled, and Blinded Clinical Trial to Evaluate Safety and Immunogenicity of 10µg/0.5ml Hepatitis B Vaccine for Infants and Other Age Groups.
The main objective of this study was to evaluate the safety and immunogenicity of 10µg/0.5ml and 5µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside yeast for infants and other age groups.
- Conditions
- Hepatitis B
- Being tested
- 3 dose of 10µg/0.5ml hepatitis B vaccine, 3 dose of 5µg/0.5ml hepatitis B vaccine
- Keywords
- Safety, Immunogenicity, Vaccine, Hepatitis 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.
3 dose of 10µg/0.5ml hepatitis B vaccineBiological
3 dose of 10µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside were administered intramuscular injection at 0, 1, 6 momth interval.
3 dose of 5µg/0.5ml hepatitis B vaccineBiological
3 dose of 5µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside were administered intramuscular injection at 0, 1, 6 momth interval.
| Study group | Role | What they receive |
|---|---|---|
| 10µg/0.5ml hepatitis B vaccine | Experimental | 3 dose of 10µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside.Produced by Beijing Tiantan Biological Products Co., Ltd. Lot number: YHB2008063S1. Receives: Biological: 3 dose of 10µg/0.5ml hepatitis B vaccine |
| 5µg/0.5ml hepatitis B vaccine | Active comparator | 3 dose of 5µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside.Produced by Beijing Tiantan Biological Products Co., Ltd. Lot number:20080603. Receives: Biological: 3 dose of 5µg/0.5ml 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
To analyze the number of subjects with adverse events within 28 days after administered each of hepatitis B vaccine.
Measured: Within 28 days after hepatitis B vaccination
Geometric mean concentration of anti-hepatitis B virus surface antigen antibody
Geometric mean concentration of anti-hepatitis B virus surface antigen antibody was measured by chemiluminescence assay and expressed with mIU/mL.
Measured: The 28th day after whole course of hepatitis B vaccination
Secondary outcomes (2)
The rate of hepatitis B virus perinatal transmission
To analyze the rate of hepatitis B virus perinatal transmission after whole course of hepatitis B vaccination.
Measured: The 28th day after whole course of hepatitis B vaccination
Geometric mean concentration of anti-hepatitis B virus surface antigen antibody after the second dose of hepatitis B vaccination
Geometric mean concentration of anti-hepatitis B virus surface antigen antibody was measured by chemiluminescence assay and expressed with mIU/mL.
Measured: The 28th day after the second 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 posted2 Jun 2014 (estimated)
- Study startNov 2008
- Primary completionMar 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,537 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Collaborators
- Beijing Tiantan Biological Products Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Fubao Ma, Doctor, Principal investigator, Jiangsu Province Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152709
- Sponsor's protocol ID
- JSEPI-003
- Status last verified
- May 2014
- First submitted
- 19 May 2014
- Last updated
- 2 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kang G, Ma F, Chen H, Yang Y, Guo S, Wang Z, Liang X, Li L, Cui F, Zhang L. Efficacy of antigen dosage on the hepatitis B vaccine response in infants born to hepatitis B-uninfected and hepatitis B-infected mothers. Vaccine. 2015 Aug 7;33(33):4093-9. doi: 10.1016/j.vaccine.2015.06.081. Epub 2015 Jul 3.
PubMed 26144895
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Controlled, and Blinded Clinical Trial to Evaluate Safety and Immunogenicity of 10µg/0.5ml Hepatitis B Vaccine for Infants and Other Age Groups.
- ClinicalTrials.gov ID
- NCT02152709
- Acronym / sponsor ID
- JSEPI-003
- Conditions
- Hepatitis B
- Keywords
- Safety, Immunogenicity, Vaccine, Hepatitis B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,537 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Collaborators
- Beijing Tiantan Biological Products Co., Ltd.
- Study start
- Nov 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 2 Jun 2014 (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 main objective of this study was to evaluate the safety and immunogenicity of 10µg/0.5ml and 5µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside yeast for infants and other age groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10µg/0.5ml hepatitis B vaccine | Experimental | Biological: 3 dose of 10µg/0.5ml hepatitis B vaccine3 dose of 10µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside.Produced by Beijing Tiantan Biological Products Co., Ltd. Lot number: YHB2008063S1. |
| 5µg/0.5ml hepatitis B vaccine | Active comparator | Biological: 3 dose of 5µg/0.5ml hepatitis B vaccine3 dose of 5µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside.Produced by Beijing Tiantan Biological Products Co., Ltd. Lot number:20080603. |
Who may qualify
- Ages
- 1 day to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Healthy full-term infant after birth, Apgar score ≥7.
- Guardian signed informed consent.
- Guardian can comply with the requirements of the clinical trial.
- Without administering immunoglobulin during the following period.
- Axillary temperature ≤37.0 ℃.
Key exclusion criteria (29 listed)
- Apgar score of infant after birth <7.
- With nervous system damage after birth, or with the family history of mental illness, epilepsy or encephalopathy.
- With immune system dysfunction.
- With vitamin deficiency.
- With acute febrile diseases, or infectious 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 |
|---|---|---|
| 3 dose of 10µg/0.5ml hepatitis B vaccine3 dose of 10µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside were administered intramuscular injection at 0, 1, 6 momth interval. | Biological | 10µg/0.5ml hepatitis B vaccine |
| 3 dose of 5µg/0.5ml hepatitis B vaccine3 dose of 5µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside were administered intramuscular injection at 0, 1, 6 momth interval. | Biological | 5µg/0.5ml hepatitis B vaccine |
Primary outcome
Number of subjects with adverse events
Time frame: Within 28 days after hepatitis B vaccination
To analyze the number of subjects with adverse events within 28 days after administered each of hepatitis B vaccine.
Geometric mean concentration of anti-hepatitis B virus surface antigen antibody
Time frame: The 28th day after whole course of hepatitis B vaccination
Geometric mean concentration of anti-hepatitis B virus surface antigen antibody was measured by chemiluminescence assay and expressed with mIU/mL.
2 secondary outcomes
The rate of hepatitis B virus perinatal transmission
Time frame: The 28th day after whole course of hepatitis B vaccination
Geometric mean concentration of anti-hepatitis B virus surface antigen antibody after the second dose of hepatitis B vaccination
Time frame: The 28th day after the second of hepatitis B vaccination
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 2 Jun 2014.
- Derived from this study: PubMed 26144895Kang G, Ma F, Chen H, Yang Y, Guo S, Wang Z, Liang X, Li L, Cui F, Zhang L. Efficacy of antigen dosage on the hepatitis B vaccine response in infants born to hepatitis B-uninfected and hepatitis B-infected mothers. Vaccine. 2015 Aug 7;33(33):4093-9. doi: 10.1016/j.vaccine.2015.06.081. Epub 2015 Jul 3.
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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.
Fubao Ma, Doctor principal investigator
Jiangsu Province Centers for Disease Control and Prevention
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 3 dose of 10µg/0.5ml hepatitis B vaccine and 3 dose of 5µg/0.5ml hepatitis B vaccine in people with Hepatitis B, run by Jiangsu Province Centers for Disease Control and Prevention 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 12 inclusion and 29 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 2 Jun 2014. 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 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?
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?
Number of subjects with adverse events (time frame: Within 28 days after hepatitis B vaccination). 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 NCT02152709, 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 2 Jun 2014.