Study on the Immunogenicity and Safety of Co-immunization With Recombinant Human Papillomavirus 16/18 Bivalent Vaccine and Hepatitis E Vaccine
Status: Unknown
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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)
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 25
Healthy Volunteers: t
View:
• Female, aged between 18 and 25 years (including 18 and 25 years) on the day of enrollment
• Judged as healthy and eligible for vaccination by the investigators through a self- reported medical history and some physical examinations
• Willing to participate in this study and sign informed consent form
• Able to understand this study information and willing to comply with all study requirements
• Axillary temperature ≤37.0 °C
• Negative urine pregnancy test
Locations
Other Locations
China
Zhejiang Provincial Center for Disease Control and Prevention
Hanzhou
Time Frame
Start Date: 2021-10-25
Completion Date: 2023-06-10
Participants
Target number of participants: 480
Treatments
Experimental: Group A
Participants in this arm will be simultaneously administrated with HPV and HEV vaccine. The immunization schedule is 0,1,6 months.
Active_comparator: Group B
Participants in this arm will be administrated with HPV vaccine. The immunization schedule is 0,1,6 months.
Active_comparator: Group C
Participants in this arm will be administrated with HEV vaccine. The immunization schedule is 0,1,6 months.
Related Therapeutic Areas
Sponsors
Leads: Xiamen Innovax Biotech Co., Ltd
Collaborators: Zhejiang Provincial Center for Disease Control and Prevention