Dose of Hepatitis B Vaccines in Non/Low-response Populations
Effect of Dose of Hepatitis B Vaccines in Non/Low-response Populations
1 other identifier
interventional
537
1 country
2
Brief Summary
An interventional study will be performed in subjects aged 1-65 years old to evaluate effects of different doses of hepatitis B vaccines in low or non-response population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2011
Shorter than P25 for not_applicable
2 active sites
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
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 23, 2012
CompletedFirst Posted
Study publicly available on registry
March 27, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedJuly 10, 2013
July 1, 2013
7 months
March 23, 2012
July 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Seroconversion rates of different doses of vaccines the levels of HBs-Ab after vaccination
describe the levels of HBs-Ab after each vaccination and compare the percentages of adverse events in all groups
day 30 after each vaccination
Study Arms (4)
HepB 5ug
EXPERIMENTALreceive the vaccine with 5ug HBsAg
HepB 10ug
EXPERIMENTALreceive the vaccine with 10ug HBsAg
HepB 20ug
EXPERIMENTALreceive the vaccine with 20ug HBsAg
HepB 60ug
EXPERIMENTALreceive the vaccine with 60ug HBsAg
Interventions
hepatitis B vaccine with 5ug,10ug,20ug,60ug HBsAg
Eligibility Criteria
You may qualify if:
- aged 1-65 years old
- male or non-pregnant female volunteers
- provide written informed consents before joining the trial
- clinically healthy as determined by: medical history inquiring and physical examination
- negative for HBsAg,HBsAb,HBcAb,HBeAg,HBeAb within the past 1 year
You may not qualify if:
- No history of hepatitis B vaccine
- receipt of immunoglobulin within the past 1 month
- allergic to any ingredient of vaccine
- history of serious side effects, such as allergies, hives, breathing difficulties, angioedema or abdominal pain
- severe acute and chronic diseases
- autoimmune disease or immune deficiency
- axillary temperature \> 37.0 ℃ over the time of vaccination
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wu Jianglead
- Beijing Municipal Science & Technology Commissioncollaborator
Study Sites (2)
Xicheng Centers For Disease Prevention & Control
Xicheng District, Beijing Municipality, 100011, China
Chifeng Centers For Disease Prevention & Control
Chifeng, Inner Mongolia, 024000, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
jiang wu, Bachelor
Beijing Centers for Disease Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Department of Immunization & Prevention
Study Record Dates
First Submitted
March 23, 2012
First Posted
March 27, 2012
Study Start
August 1, 2011
Primary Completion
March 1, 2012
Study Completion
June 1, 2012
Last Updated
July 10, 2013
Record last verified: 2013-07