Study of Evaluating Safety and Immunogenicity of 10µg/0.5ml Hepatitis B Vaccine

Jiangsu Provincial Center for Disease Control and Prevention

Status and phase: Completed; Phase 3

Conditions: Hepatitis B

Treatments: Biological: 3 dose of 5µg/0.5ml hepatitis B vaccine; Biological: 3 dose of 10µg/0.5ml hepatitis B vaccine

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT02152709

JSEPI-003

Details and patient eligibility

About

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.

Enrollment: 1,537 patients

Sex: All

Ages: 1 day to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (For Infant Group):

• 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 ℃.

Inclusion Criteria (For Other Age Groups):

• 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 (For Infant Group):

• 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.
• 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.

Exclusion Criteria (For Other Age Groups):

• 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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,537 participants in 2 patient groups

10µg/0.5ml hepatitis B vaccine

Experimental group

Description:

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.

Treatment:

Biological: 3 dose of 10µg/0.5ml hepatitis B vaccine

5µg/0.5ml hepatitis B vaccine

Active Comparator group

Description:

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.

Treatment:

Biological: 3 dose of 5µg/0.5ml hepatitis B vaccine