Clinical trial NCT02152709: Study of Evaluating Safety and Immunogenicity of 10µg/0.5ml Hepatitis B Vaccine
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Keywords: Safety
Immunogenicity
Vaccine
Hepatitis B
Lead sponsor: Jiangsu Province Centers for Disease Control and Prevention
Sponsor class: NETWORK
Collaborators: name: Beijing Tiantan Biological Products Co., Ltd.
First posted: 2014-06-02
Enrollment: 1537
Sex: ALL
Minimum age (years): 1
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Number of subjects with adverse events
timeFrame: Within 28 days after hepatitis B vaccination
measure: Geometric mean concentration of anti-hepatitis B virus surface antigen antibody
timeFrame: The 28th day after whole course of hepatitis B vaccination
Secondary outcomes:
measure: The rate of hepatitis B virus perinatal transmission
timeFrame: The 28th day after whole course of hepatitis B vaccination
measure: Geometric mean concentration of anti-hepatitis B virus surface antigen antibody after the second dose of hepatitis B vaccination
timeFrame: The 28th day after the second of hepatitis B vaccination
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Provincial Center for Disease Control and Prevention
state: Jiangsu
Study officials:
affiliation: Jiangsu Provincial Center for Disease Control and Prevention
name: Fubao Ma, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kang G, Ma F, Chen H, Yang Y, Guo S, Wang Z, Liang X, Li L, Cui F, Zhang L. Efficacy of antigen dosage on the hepatitis B vaccine response in infants born to hepatitis B-uninfected and hepatitis B-infected mothers. Vaccine. 2015 Aug 7;33(33):4093-9. doi: 10.1016/j.vaccine.2015.06.081. Epub 2015 Jul 3.