RecruitingPhase 3

Immunogenicity and Safety of Quadrivalent HPV Vaccine in Healthy Chinese Female Subjects Aged 9 to 19 Years

China1,348 participantsStarted 2021-09-15

Plain-language summary

This phase 3 study will evaluate the immunogenicity and safety of Quadrivalent HPV recombinant vaccine in Chinese females aged 9 to 26 years

Age range9 Years – 26 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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;

✕. 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.;

Primary immunogenicity outcome

Timeframe: At month 8

NCT IDNCT05027776

SponsorShanghai Bovax Biotechnology Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11-22

Ting Huang

Who can participate

Age range9 Years – 26 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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;

✕. 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.;