This study is to evaluate lot-lot consistency of Recombinant Hepatitis E Vaccine (Escherichia Coli) Hecolin®.
This study is a mono-center, randomization, double-blind clinical trial in healthy subjects between 18 to 50. Under the premise of full informed consent, 360 subjects that meet the requirement of clinical trial in the age of 18-50 will be divided into 3 groups and injected 3 consecutive batches of Hecolin® separately. The main outcome measures are the immunogenicity evaluation and safety surveillance after inoculation according to prescribed immunization procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
360
Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
Dongtai City Center for Disease Control and Prevention
Dongtai, Jiangsu, China
Seroconversion rate and GMC of anti-HEV IgG at Month 7.
Measure anti-HEV IgG in serum samples at 7 month to evaluate the immunogenicity of the Hepatitis E vaccine.
Time frame: 7 months
Adverse reactions/events of all subjects
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 7 months
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