This study is an open, multicenter Phase IV clinical study to evaluate the safety of vaccination with Menhycia®. The study plan is to enroll approximately 3,000 infants at 3 months of age who have not been vaccinated with any epidemic encephalitis vaccine, and to administer a total of 3 doses of Menhycia®, with a minimum of 1 month between doses, and a booster dose of 1 dose of immunization is allowed at 12 months of age.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
3,011
4 doses of vaccine on Day 0, Day30, Day 60 and Month 12
Nanjing Luhe District Center for Disease Control and Prevention Center for Disease Control and Prevention
Nanjing, China
Incidence of localized adverse reactions in subjects
Time frame: Within 7 days after each dose of vaccination
Incidence of systemic adverse reactions in subjects
Time frame: Within 7 days after each dose of vaccination
Incidence of adverse reactions in subjects
Time frame: Within 30 days after each dose of vaccination
Incidence of adverse events in subjects
Time frame: Within 30 days after each dose of vaccination
Incidence of severe adverse events
Time frame: Through study completion, an average of 10 months
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