Study of Evaluating Safety and Immunogenicity of 10µg/0.5ml Hepatitis B Vaccine
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.
1 other identifier
interventional
1,537
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 19, 2014
CompletedFirst Posted
Study publicly available on registry
June 2, 2014
CompletedJune 2, 2014
May 1, 2014
1.3 years
May 19, 2014
May 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Secondary Outcomes (2)
The rate of hepatitis B virus perinatal transmission
The 28th day 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
The 28th day after the second of hepatitis B vaccination
Study Arms (2)
10µg/0.5ml hepatitis B vaccine
EXPERIMENTAL3 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.
5µg/0.5ml hepatitis B vaccine
ACTIVE COMPARATOR3 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.
Interventions
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 made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside were administered intramuscular injection at 0, 1, 6 momth interval.
Eligibility Criteria
You may qualify if:
- 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 ℃.
- 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 ℃.
You may not qualify if:
- 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.
- 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.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, Jiangsu, 210009, China
Related Publications (1)
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.
PMID: 26144895DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fubao Ma, Doctor
Jiangsu Provincial Center for Disease Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2014
First Posted
June 2, 2014
Study Start
November 1, 2008
Primary Completion
March 1, 2010
Study Completion
October 1, 2010
Last Updated
June 2, 2014
Record last verified: 2014-05