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.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,537
- 试验地点
- 1
- 主要终点
- Number of subjects with adverse events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 1 Day 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(For Infant Group):
- •Healthy full-term infant after birth, Apgar score ≥
- •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 ℃.
排除标准
- •(For Infant Group):
- •Apgar score of infant after birth <
- •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.
研究组 & 干预措施
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.
干预措施: 3 dose of 10µg/0.5ml hepatitis B vaccine (Biological)
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.
干预措施: 3 dose of 5µg/0.5ml hepatitis B vaccine (Biological)
结局指标
主要结局
Number of subjects with adverse events
时间窗: 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
时间窗: 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.
次要结局
- The rate of hepatitis B virus perinatal transmission(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(The 28th day after the second of hepatitis B vaccination)