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

Hepatitis B Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02152709
• Other study ID #: JSEPI-003
• Status: Completed
• Phase: Phase 3
• First received: May 19, 2014
• Last updated: May 28, 2014
• Start date: November 2008
• Est. completion date: October 2010

Study information

• Verified date: May 2014
• Source: Jiangsu Province Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1537
• Est. completion date: October 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Jiangsu Provincial Center for Disease Control and Prevention	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Jiangsu Province Centers for Disease Control and Prevention	Beijing Tiantan Biological Products Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with adverse events	To analyze the number of subjects with adverse events within 28 days after administered each of hepatitis B vaccine.	Within 28 days after hepatitis B vaccination	Yes
Primary	Geometric mean concentration of anti-hepatitis B virus surface antigen antibody	Geometric mean concentration of anti-hepatitis B virus surface antigen antibody was measured by chemiluminescence assay and expressed with mIU/mL.	The 28th day after whole course of hepatitis B vaccination	No
Secondary	The rate of hepatitis B virus perinatal transmission	To analyze the rate of hepatitis B virus perinatal transmission after whole course of hepatitis B vaccination.	The 28th day after whole course of hepatitis B vaccination	No
Secondary	Geometric mean concentration of anti-hepatitis B virus surface antigen antibody after the second dose 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.	The 28th day after the second of hepatitis B vaccination	No