This phase IV clinical study was designed to evaluate the safety and immunogenicity of the recombinant Hepatitis E vaccine(Hecolin®), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy volunteers aged over 65 years of age at enrollment. The study volunteers will receive the 3 doses of Hecolin® administered intramuscularly according to a 0-1-6 month schedule.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
600
Participants would intramuscularly receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) at 0, 1, 6 month.
Kaihua Center for Disease Control and Prevention
Quzhou, Zhejiang, China
Adverse reactions/events
Measure solicited local adverse reactions within 7 days after each vaccination; Measure solicited systematic adverse reactions within 7 days after each vaccination; Measure unsolicited adverse reactions within 30 days after vaccination; Measure serious adverse events occurred throughout the study
Time frame: up to 10 months
Anti-HEV antibody
Measure anti-HEV antibody in serum samples at 7 month to evaluate the immunogenicity of the Hepatitis E vaccine.
Time frame: 7 months
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