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Tests treatment safety and results for HPV Infections
Official title Immunogenicity and Safety of Quadrivalent HPV Vaccine in Healthy Chinese Female Subjects Aged 9 to 19 Years
ClinicalTrials.gov ID: NCT05027776
What this study is testing
What is 2-doses Group among 9-14 years?
2-doses Group among 9-14 years is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for hpv infections.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase 3 study will evaluate the immunogenicity and safety of Quadrivalent HPV recombinant vaccine in Chinese females aged 9 to 26 years
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 9 to 26, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Had a negative urine pregnancy test on the day of enrollment, among the people of childbearing age; Not in the duration of breast-feeding and no...
- 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;
You likely can't join if
- 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...
- History of diseases related to HPV infection (e.g. genital warts, VIN, VaIN, and related cancers) or history of STDs, including syphilis, gonorrhea...
- Known allergy to any vaccine components or history of severe allergic diseases requiring treatment, including shock, laryngeal edema, urticarial...
- Had primary or acquired immunodeficiency such as HIV, SLE, JRA, etc;
See the full eligibility 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 people of childbearing age; Not in the duration of breast-feeding and no birth plan within 7 months; According to the investigator's judgment that...
- 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...
- 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);
- people 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...
- Receipt of inactivated, RNA, and recombinant vaccines within 14 days, live vaccines within 28 days;
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Mianyang, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 9 years to 26 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mianyang, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.