The purpose of this study is to evaluate the immunogenicity and safety of co-immunization with recombinant human papillomavirus bivalent (Types 16,18) vaccine (Escherichia coli) and Hepatitis E vaccine (Escherichia coli)
Cecolin is the first Chinese domestic human papillomavirus (HPV) vaccine. Cecolin is designed to protect against HPV types 16 and 18, the most common virus types that lead to cervical cancer. Hecolin is the first prophylactic vaccine against hepatitis E virus (HEV). The purpose of this study is to evaluate the immunogenicity and safety of co-immunization with Cecolin and Hecolin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
480
Zhejiang Provincial Center for Disease Control and Prevention
Hanzhou, Zhejiang, China
evaluate the concentration of IgG antibodies to HPV-16
Detect the level of IgG antibodies to HPV-16 at 7 month to determine whether group A is non-inferior to group B
Time frame: At 7 months after first dose
evaluate the concentration of IgG antibodies to HPV-18
Detect the level of IgG antibodies to HPV-18 at 7 month to determine whether group A is non-inferior to group B
Time frame: At 7 months after first dose
evaluate the concentration of IgG antibodies to HEV
detect the level of IgG antibodies to HEV at 7 month to determine whether group A is non-inferior to group C
Time frame: At 7 months after first dose
Local and systematic adverse events/reactions occurred within 7 days after each vaccination
Adverse reactions associated with vaccine will be observed in subjects after vaccination. To evaluate number of adverse events/reactions compared with non-simultane vaccination group.
Time frame: During the 7-day period following each vaccination
Adverse events/reactions occurred within 30 days after each vaccination
To evaluate number of adverse events/reactions compared with non-simultane vaccination group.
Time frame: Within 30 days after any vaccination
Serious adverse events occurred throughout the study
Safety analysis. To evaluate number of SAEs compared with the non-simultane vaccination group
Time frame: Up to 7 months
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