Immunogenicity and Safety of Quadrivalent HPV Vaccine in Healthy Chinese Female Subjects Aged 9 to 19 Years
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age9-26
SponsorShanghai Bovax Biotechnology Co., Ltd.
About this trial
This phase 3 study will evaluate the immunogenicity and safety of Quadrivalent HPV recombinant vaccine in Chinese females aged 9 to 26 years
Eligibility criteria
Qualifiers
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 );
Disqualifiers
Received marketed HPV vaccine or plan to receive marketed HPV vaccine during this study period or have enrolled in HPV vaccine clinical trials;
Enrolling or plan to enroll in other clinical trials (drug or vaccine);
History of positive test to HPV, history of cervical cancer (e.g. abnormal screening test results, abnormal cervical biopsy results, including CIN, LSIL, and cervical cancer) or history of pelvic radiotherapyherpes;
History of diseases related to HPV infection (e.g. genital warts, VIN, VaIN, and related cancers) or history of STDs, including syphilis, gonorrhea, genital herpes, Mycoplasma genitalium, Lymphgranuloma Venereum, granuloma inguinale, etc.;
Trial design
Treatments tested in this trial
- 2-doses Group among 9-14 years
- 3-doses Group among 9-19 years
- 3-doses Group among 20-26 years
Treatment groups
1,348 Participants
are divided into 3 treatment groupsSponsors and collaborators
Shanghai Bovax Biotechnology Co., Ltd.
Lead sponsor
Chongqing Bovax Biopharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov