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

Information source: Jiangsu Province Centers for Disease Control and Prevention
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis B

Intervention: 3 dose of 10µg/0.5ml hepatitis B vaccine (Biological); 3 dose of 5µg/0.5ml hepatitis B vaccine (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Jiangsu Province Centers for Disease Control and Prevention

Official(s) and/or principal investigator(s):
Fubao Ma, Doctor, Principal Investigator, Affiliation: Jiangsu Provincial Center for Disease Control and Prevention

Summary

The main objective of this study was to evaluate the safety and immunogenicity of 10g/0. 5ml and 5g/0. 5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside yeast for infants and other age groups.

Clinical Details

Official title: A Phase 3, Randomized, Controlled, and Blinded Clinical Trial to Evaluate Safety and Immunogenicity of 10g/0.5ml Hepatitis B Vaccine for Infants and Other Age Groups.

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

Primary outcome:

Number of subjects with adverse events

Geometric mean concentration of anti-hepatitis B virus surface antigen antibody

Secondary outcome:

The rate of hepatitis B virus perinatal transmission

Geometric mean concentration of anti-hepatitis B virus surface antigen antibody after the second dose of hepatitis B vaccination

Eligibility

Minimum age: N/A. Maximum age: 75 Years. Gender(s): Both.

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.

Locations and Contacts

Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu 210009, China
Additional Information

Starting date: November 2008
Last updated: May 28, 2014

Page last updated: August 20, 2015

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