Status:
COMPLETED
The Immunogenicity and Safety of 60mcg/30mcg Recombinant Hepatitis B Vaccines in People Who Failed to Respond to Routine Administration of Hepatitis B Vaccines
Lead Sponsor:
Jiangsu Province Centers for Disease Control and Prevention
Collaborating Sponsors:
Shenzhen Kangtai Biological Products Co., LTD
Conditions:
Hepatitis b
Eligibility:
All Genders
16+ years
Phase:
PHASE2
PHASE3
Brief Summary
This study is an expanded Phase 2/Phase 3 clinical trial base on the safety data obtained from the phase 1 clinical trial. The purpose of this study is to further evaluate the immunogenicity and safet...
Detailed Description
The most effective method to prevent hepatitis B virus infection is to receive the vaccination of hepatitis b vaccine to get the protective antibody anti-HBs. Both the blood-derived hepatitis B vaccin...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Filter period: The subjects to receive first 10mcg recombinant hepatitis B vaccines:
- Healthy subjects aged 16 and older as established by medical history and clinical examination
- The subjects or their guardians are able to understand and sign the informed consent
- Had never received the hepatitis B vaccines
- Subjects who can and will comply with the requirements of the protocol
- Revaccination period: The nonresponders to receive first 60mcg recombinant hepatitis B vaccines:
- Healthy subjects aged 16 and older as established by medical history and clinical examination
- The subjects or their guardians are able to understand and sign the informed consent
- After the routine administration of 10mcg hepatitis B vaccines, the peak period levels of anti-HBs is lower than 10mIU/ml
- Subjects with temperature \<37.1°C on axillary setting
- Subjects who can and will comply with the requirements of the protocol
- Exclusion Criteria:
- Filter period: The subjects to receive first 10mcg recombinant hepatitis B vaccines:
- Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
- Family history of seizures or progressive neurological disease
- Family history of congenital or hereditary immunodeficiency
- Women of pregnancy, lactation or about to be pregnant in 60 days
- Autoimmune disease or immunodeficiency
- Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
- Any prior administration of administration of immunoglobulins
- Filter period: The subjects to receive second or/and third 10mcg recombinant hepatitis B vaccines:
- Any reaction or hypersensitivity to the recombinant hepatitis B vaccines after the vaccinations
- Serious adverse reactions to vaccines
- Active infections
- Subjects who want to quit the study
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
- Revaccination period: The nonresponders to receive first 60mcg recombinant hepatitis B vaccines:
- Qualitative test of Anti-HBs, HBsAg or Anti-HBc on serum is positive
- Any reaction or hypersensitivity to the recombinant hepatitis B vaccines after the vaccinations
- Family history of seizures or progressive neurological disease
- Family history of congenital or hereditary immunodeficiency
- Women of pregnancy, lactation or about to be pregnant in 60 days
- Autoimmune disease or immunodeficiency
- Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
- Any prior administration of immunoglobulins, any other vaccines or experimental drugs in the last 7days
- Any active infections and received any antibiotic or anti-virus treatments in the last 7 days
- Had a fever in the last 3 days, with temperature ≥37.1°C
- Participate in another clinical trials
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
- Revaccination period: The nonresponders to receive second or/and third 60mcg recombinant hepatitis B vaccines:
- Any reaction or hypersensitivity to the recombinant hepatitis B vaccines after the vaccinations
- Serious adverse reactions to vaccines
- Active infections
- Subjects who want to quit the study
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
1091 Patients enrolled
Trial Details
Trial ID
NCT01203319
Start Date
November 1 2006
End Date
March 1 2011
Last Update
April 27 2012
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