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

Overview

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Participant)
  • Study Primary Completion Date: March 2010

Interventions

  • Biological: 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.
  • Biological: 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.

Arms, Groups and Cohorts

  • Experimental: 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.
  • Active Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Number of subjects with adverse events
    • Time Frame: 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
    • Time Frame: 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 Measures

  • The rate of hepatitis B virus perinatal transmission
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 1 Day

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Jiangsu Province Centers for Disease Control and Prevention
  • Collaborator
    • Beijing Tiantan Biological Products Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Fubao Ma, Doctor, Principal Investigator, Jiangsu Provincial Center for Disease Control and Prevention

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