We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2024 for:    hepatitis b
Previous Study | Return to List | Next Study

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02152709
First Posted: June 2, 2014
Last Update Posted: June 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Beijing Tiantan Biological Products Co., Ltd
Information provided by (Responsible Party):
Jiangsu Province Centers for Disease Control and Prevention
  Purpose
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.

Condition Intervention Phase
Hepatitis B Biological: 3 dose of 10µg/0.5ml hepatitis B vaccine Biological: 3 dose of 5µg/0.5ml hepatitis B vaccine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Jiangsu Province Centers for Disease Control and Prevention:

Primary Outcome 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 Outcome 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.


Enrollment: 1537
Study Start Date: November 2008
Study Completion Date: October 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152709


Locations
China, Jiangsu
Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, Jiangsu, China, 210009
Sponsors and Collaborators
Jiangsu Province Centers for Disease Control and Prevention
Beijing Tiantan Biological Products Co., Ltd
Investigators
Principal Investigator: Fubao Ma, Doctor Jiangsu Provincial Center for Disease Control and Prevention
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jiangsu Province Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT02152709     History of Changes
Other Study ID Numbers: JSEPI-003
First Submitted: May 19, 2014
First Posted: June 2, 2014
Last Update Posted: June 2, 2014
Last Verified: May 2014

Keywords provided by Jiangsu Province Centers for Disease Control and Prevention:
Safety
Immunogenicity
Vaccine
Hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs