Hepatitis B
Conditions
Keywords
Safety, Immunogenicity, Vaccine, Hepatitis B
Brief 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.
Interventions
BIOLOGICAL3 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.
BIOLOGICAL3 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.
Sponsors
Beijing Tiantan Biological Products Co., Ltd.
Jiangsu Province Centers for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
1 Days to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with adverse events | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The rate of hepatitis B virus perinatal transmission | The 28th day after whole course of hepatitis B vaccination | To analyze the rate of hepatitis B virus perinatal transmission 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 | The 28th day after the second 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. |
Countries
China
Outcome results
None listed