Vaccination; Complications, Reaction, Serum Clinical Trial
Official title:
Effect of Dose of Hepatitis B Vaccines in Non/Low-response Populations
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.
A randomized clinical study will be conducted to evaluate effects of different doses of
hepatitis B vaccines in low or non-response population in China. 650 low or non-response
subjects after hepatitis B vaccination will be enrolled under the premise of informed
consent. 200 subjects aged 1-17 years will be divided into 3 groups and 450 subjects aged
18-65years will be divided into 4 groups. Group 1/2/3 will receive 3 doses of vaccine on day
0,30 and 180, with 5ug/10ug/20ug HBs-Ag respectively. Group 4 will receive 1 dose of vaccine
with 60ug HBs-Ag, low or nonresponse subjects of which will receive the second dose by an
interval of at least 28 days. All vaccinations will be done by specific study personnel, who
do not take part in the assessment of safety or immunogenicity. Adverse events will be
recorded after vaccination and blood samples were collected at day 30 after each vaccination
for antibody detection.
The clinical program approved by the ethics committee will be performed by the researchers
independently. Inspectors designated by the sponsor will take meticulous on-site audits to
ensure the safety specifications during the whole process of research.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention