Evaluating the Immunogenicity and Safety of Quadrivalent Human Papillomavirus Recombinant Vaccine (Type 6, 11, 16, 18) in Healthy Chinese Female Subjects Aged 9 to 26 Years: A Phase 3, Open-label, Non-randomized Clinical Trial

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 Quadrivalent HPV recombinant vaccine in Chinese females aged 9 to 26 years

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 9
Maximum Age: 26
Healthy Volunteers: t
View:

• Healthy Chinese females aged 9 to 26 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;

• 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 );

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

Locations
Other Locations
China
Center for Disease Control and Prevention
RECRUITING
Mianyang
Contact Information
Primary
Ting Huang
cocoht@163.com
86-13330993324
Backup
Ji Zhang
20079460@qq.com
86-(028)85586087
Time Frame
Start Date: 2021-09-15
Estimated Completion Date: 2026-09-29
Participants
Target number of participants: 1348
Treatments
Experimental: Experimental: 2-doses Group
Subjects aged 9-14 years, received 2 doses of q-HPV vaccine, which was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 6-month schedule.
Experimental: Experimental: 3-doses Group
Subjects aged 9-19 years, received 3 doses of q-HPV vaccine, which was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 2,6-month schedule.
Active_comparator: Acitve Group
Subjects aged 20-26 years, received 3 doses of q-HPV vaccine, which was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 2,6-month schedule.
Sponsors
Collaborators: Chongqing Bovax Biopharmaceutical Co., Ltd.
Leads: Shanghai Bovax Biotechnology Co., Ltd.

This content was sourced from clinicaltrials.gov

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