Immunobridging Study of 9-valent Human Papillomavirus Recombinant Vaccine in Chinese Females Aged 9 to 19 Years

  • STATUS
    Recruiting
  • End date
    May 7, 2026
  • participants needed
    1200
  • sponsor
    Shanghai Bovax Biotechnology Co., Ltd.
Updated on 7 March 2022
human papillomavirus
hpv vaccine
recombinant vaccine
human papilloma virus vaccine
lab tests
Accepts healthy volunteers

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

Description

This study (protocol 9-HPV-3003) is an immunogenicity and safety study in the subjects (9-19 years of age) who received the 9-valent HPV recombinant vaccine compared with the subjects (20-45 years of age). In this study, we will assess whether the immunogenicity of the 9-valent HPV vaccine given 3-dose schedule in the subjects (9-19 years of age) in noninferior to that in the subjects (20-45 years of age) receiving 3 doses, while assessing the safety of this vaccine.

Details
Condition HPV Infections, Cervical Cancer, Vulvar Cancer, Vaginal Cancer, CIN1, CIN2, CIN 3, VaIN1, VaIN2, VaIN3, Genital Wart, VIN 1, VIN 2, VIN 3, AIS
Treatment 9-valent HPV vaccine
Clinical Study IdentifierNCT04895020
SponsorShanghai Bovax Biotechnology Co., Ltd.
Last Modified on7 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Inclusion Criteria for the first stage
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 )
Inclusion Criteria for the second stage
Received all 3 doses of trial vaccination
Subjects aged 9 to 19 years at the first stage

Exclusion Criteria

Received marketed HPV vaccine or plan to receive marketed HPV vaccine during this study period or have enrolled in HPV vaccine clinical trials
History of positive test to HPV, history of cervical cancer (e.g. abnormal screening test results, abnormal cervical biopsy results, including CIN, AIS, and cervical cancer) or history of hysterectomy (vaginal or abdominal radical hysterectomy), or history of pelvic radiotherapy; History of genital diseases related to HPV infection (e.g. uterine peristalsis, VIN, VAIN, AIN, and related cancers); History of STDs, including syphilis, gonorrhea, genital herpes, Mycoplasma genitalium, Lymphgranuloma Venereum, granuloma inguinale, etc
Known allergy to any vaccine components or history of severe allergic diseases requiring treatment, including shock, laryngeal edema, urticarial, Henoch-Schonlein purpura, Arthus reaction, etc
Had primary or acquired immunodeficiency such as HIV, SLE, JRA, etc. or received immunosuppressive treatment within one month before study such as long-term glucocorticoid use(≥2mg per kg per day, lasted more than two wks), or plan to receive such treatment from day 0 to month 7 after the last dose
Had chronic diseases or congenital malformations, which might interfere with the process and completion of this study, such as Down Syndrome, heart diseases, liver diseases, chronic diabetes complications, and malignant tumor
Enrolling or plan to enroll in other clinical trials (drug or vaccine)
Had infectious diseases such as TB, viral hepatitis, and/or HIV infection
Had convulsions, epilepsy, encephalopathy, and mental illness or family history
With prohibitive contraindications such as Thrombocytopenia or coagulopathy
Asplenic, functionally asplenic, or splenectomy caused by any condition
Within 3 days prior to vaccination, have an acute disease or are in the acute attack of a chronic disease or have used antipyretic, analgesic and anti-allergic drugs (such as: acetaminophen, ibuprofen, aspirin, loratadine, ceti Rizine, etc.)
Receipt of inactivated or recombinant vaccines within 14 days, live vaccines within 28 days
Receipt of immune globulin or blood-related products within 3 months; or plan to receive such products during this study period
Had fever symptoms within 24 hours on the first day (aged> 14 years old, axillary temperature ≥ 37.3°C; aged ≤ 14 years old, axillary temperature ≥37.5°C )
Untreated/uncontrolled hypertension before vaccination (aged 9 to 17 years: systolic BP>120mmHg and/or diastolic BP>80mmHg; aged more than 18 years: Systolic BP≥140mmHg and/or diastolic BP ≥90mmHg)
Plan to permanently relocate from the area before the end of the study or leave the local area for a long time during the study visit (affecting the scheduled visit time)
According to the investigator's judgment, the subject has any condition may interfere with process of evaluation or participating in this study cannot guarantee the object's maximum benefit
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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