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

  • STATUS
    Recruiting
  • End date
    Sep 29, 2026
  • participants needed
    1348
  • sponsor
    Shanghai Bovax Biotechnology Co., Ltd.
Updated on 10 March 2022
hpv vaccine
recombinant vaccine
lab tests
Accepts healthy volunteers

Summary

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

Description

This is a singel-center study (protocol 4-HPV-3002) in which women are planned to receive q-HPV vaccine. Study participation will last approximately 60 months and involves a total of nine or eleven scheduled visits.

This study will also assess whether the immunogenicity of the q-HPV vaccine given 2-dose schedule in 9-14 year old girls is noninferior to that in young women, aged 20-26, receiving 3 doses, and 3 doses in 9-19 year old girls is noninferior to that in young women receiving 3 doses, while assessing the safety of this vaccine.

Details
Condition HPV Infections, Cervical Cancer Stage IIa, Vaginal Cancer, Genital Wart, CIN1, CIN2, CIN3
Treatment 2-doses Group among 9-14 years, 3-doses Group among 9-19 years, 3-doses Group among 20-26 years
Clinical Study IdentifierNCT05027776
SponsorShanghai Bovax Biotechnology Co., Ltd.
Last Modified on10 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

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
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
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
History of epilepsy and convulsions (except fever convulsions in children under 5 years of age)
Subjects with existing infectious diseases such as TB, viral hepatitis, and/or HIV infection; or existing liver or kidney conditions, CVDs, and malignancy
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)
With prohibitive contraindications such as Thrombocytopenia or coagulopathy
Asplenic, functionally asplenic, or splenectomy caused by any condition
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 month 0 to month 7;
Receipt of immune globulin or blood-related products within 3 months; or plan to receive such products during this study period(month 0 to month 7)
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, RNA, and recombinant vaccines within 14 days, live vaccines within 28 days
Subjects with existing mental illness, History of mental illness, or Family History
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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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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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