Study of Evaluating Safety and Immunogenicity of 10µg/0.5ml Hepatitis B Vaccine
NCT ID: NCT02152709
Last Updated: 2014-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1537 participants
INTERVENTIONAL
2008-11-30
2010-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Immunogenicity and Safety of 60mcg/30mcg Recombinant Hepatitis B Vaccines in People Who Failed to Respond to Routine Administration of Hepatitis B Vaccines
NCT01203319
Clinical Trial of Recombinant Hepatitis B Vaccine (Hansenula Polymorpha, 10μg)
NCT04075201
A Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of the Third Generation Hepatitis B Vaccine
NCT02692170
Modified Process Hepatitis B Vaccine in Healthy Neonates (V232-056)
NCT00322361
Study on New Strategies for Hepatitis B Virus Immunization
NCT06515938
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
10µg/0.5ml hepatitis B vaccine
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.
3 dose of 10µg/0.5ml hepatitis B vaccine
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.
5µg/0.5ml hepatitis B vaccine
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.
3 dose of 5µg/0.5ml hepatitis B vaccine
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
3 dose of 10µg/0.5ml hepatitis B vaccine
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 vaccine
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
* 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 ℃.
Exclusion Criteria
* 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.
* 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.
1 Day
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Beijing Tiantan Biological Products Co., Ltd.
INDUSTRY
Jiangsu Province Centers for Disease Control and Prevention
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Fubao Ma, Doctor
Role: PRINCIPAL_INVESTIGATOR
Jiangsu Provincial Center for Disease Control and Prevention
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, Jiangsu, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
JSEPI-003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.