Evaluating the Immunogenicity and Safety of 9-valent Human Papillomavirus(Type6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine in Chinese Females Aged 9 to 45 Years: A Phase 3, Open-label, Non-randomised Clinical Trial

Who is this study for? Healthy female patients age 9 to 45 years old
What treatments are being studied? 9-valent HPV vaccine
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This phase 3 study will evaluate the immunogenicity and safety of 9-valent HPV recombinant vaccine in Chinese females aged 9 to 45 years

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 9
Maximum Age: 45
Healthy Volunteers: t
View:

• Healthy Chinese females aged 9 to 45 years; Provide legal identification;

• The subject voluntarily agrees to enroll in this study. If the subject is a minor, both the subject and subject's legal guardian should voluntarily agree to enroll in this study and sign an informed consent form;

• Be able to understand the study procedures and promise to participate in regular follow-ups under the requirements;

• Had a negative urine pregnancy test on the day of enrollment, among the subjects of childbearing age; Not in the duration of breast-feeding and no birth plan within 7 months; According to the investigator's judgment that there is no possibility of pregnancy at that time: subjects have taken effective contraception, or asexual life after the last menstrual period, or use IUD, or had undergone ligation; subjects agree to continue take effective contraception such as taking OCS and condom use;

• No fever symptoms on the day of enrollment (aged\> 14 years old, axillary temperature\<37.3°C; aged ≤ 14 years old, axillary temperature\<37.5°C );

• Received all 3 doses of trial vaccination;

• Subjects aged 9 to 19 years at the first stage.

Locations
Other Locations
China
Huakun Lv
RECRUITING
Hangzhou
Contact Information
Primary
Huakun Lv
hklv@cdc.zj.cn
13588458021
Time Frame
Start Date: 2021-05-28
Estimated Completion Date: 2026-05
Participants
Target number of participants: 1200
Treatments
Experimental: 9-valent HPV vaccine
9-valent HPV recombinant vaccine (Hansenula Polymorpha) All subjects aged 9 to 45 years received 3 doses of 9v HPV vaccine at 0,2,6 month scehdule
Sponsors
Collaborators: Chongqing Bovax Biopharmaceutical Co., Ltd.
Leads: Shanghai Bovax Biotechnology Co., Ltd.

This content was sourced from clinicaltrials.gov

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