New 11-Valent HPV vaccine aims to block more Cancer-Causing viruses
NCT ID NCT05262010
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 3 trial is testing an 11-valent HPV vaccine in 13,500 Chinese women aged 18-45. The vaccine targets 11 types of HPV linked to cervical cancer and genital warts. Participants receive three shots over six months and are monitored for several years to see if the vaccine prevents precancerous lesions. The goal is to show the vaccine is safe and effective.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 11-valent recombinant human papillomavirus vaccine
- What this could lead to
- If successful, this vaccine could protect against 11 types of HPV, potentially preventing most cervical cancers and genital warts in women.
- What could go wrong
- This is a large Phase 3 trial, but results are not yet available. The vaccine may not be as effective as hoped, and side effects are possible. It is also only being tested in Chinese women, so results may not apply to other populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 13,500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2022
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: \- non-gynecological related 1. \*Chinese women with a history of sexual life who are 18-45 years old at the time of enrollment and can provide legal identification; 2. \*Axillary body temperature \<37.3℃ on the day of enrollment; 3. The subjects themselves have the ability to understand the clinical trial and voluntarily sign the informed consent; 4. Subjects have the ability to read, understand, and fill out research application forms such as diary cards/contact cards, and promise to follow the research requirements participate in follow-up visits; 5. No previous HPV vaccination history, no commercially available HPV vaccine during the study period (about 6 years after enrollment) plan of; 6. The subject has a negative urine pregnancy test on the day before vaccination. \- Gynecology related 7. \*Effective contraception was taken from day 1 of last menstrual cycle to day 0 of the study, and no childbearing within 7 months after enrollment plan. 8. \*Before the gynecological visit and within 48 hours before any subsequent visit that includes a gynecological sample collection: asexual life (including same-sex or opposite-sex anal, vaginal or genital contact), unwashed/washed vagina (Except for normal bathing outside the vagina), no vaginal drugs or preparations are used. Exclusion Criteria: First dose exclusion criteria: (Visits may be rescheduled if the criteria described in the "\*" option are met at screening) \- Non-gynecological related 1. \* Those with abnormal blood pressure (systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg) on physical examination before vaccination; 2. \*3 months prior to vaccination or planned to receive any immune globulin or blood products within 7 months of enrollment; 3. \*Received any vaccine within 14 days prior to vaccination, or received live vaccine within 28 days; 4. \*3 days before vaccination, suffering from acute febrile illness (body temperature ≥38.5℃) or using antipyretic, analgesic and antiallergic drugs (eg: acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.); 5. History of severe allergies/conditions requiring medical intervention (e.g. Anaphylactic shock, anaphylactic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local allergic necrosis(Arthus reaction) etc.); 6. Immunocompromised or diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia Blood disease, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammation STD or other autoimmune disease; 7. 1 month before vaccination or plan to receive immunosuppressive therapy within 7 months after enrollment, such as oral administration for more than 2 consecutive weeks Oral or injectable systemic corticosteroid therapy (≥2 mg/kg/day or ≥20 mg/day prednisone or equivalent to prednisone) amount); however, topical medications (such as ointments, eye drops, inhalers, or nasal sprays) are not limited; 8. Previous splenectomy or impaired spleen function; 9. Those with previous or current severe liver, kidney and cardiovascular diseases, complicated diabetes, and malignant tumors; 10. Have a history of epilepsy, convulsions, mental illness or a family history of mental illness; 11. Suffering from thrombocytopenia or any coagulation disorder that can become a contraindication to intramuscular injection; 12. Participate in other clinical studies (drugs, vaccines and medical devices) within 3 months before vaccination or during the planned study period; 13. The investigator believes that the subject has any other factors that are not suitable for participating in the clinical trial (such as: poor compliance or planning Permanent relocation from the area before the study is completed, etc.). \- Gynecology related 14. \*Pregnant, breastfeeding, or within 6 weeks of pregnancy at the time of the first dose of the vaccine; 15. \*The subject is in the menstrual period; 16. \*Acute lower genital tract infection (such as acute vulvitis/vaginitis/cervicitis, etc.) found by the naked eye during gynecological examination; 17. Previous history of abnormal cervical cancer screening or lesions (including HPV DNA positive, squamous intraepithelial lesion (SIL)or atypical squamous cells of undetermined significance (ASC-US), atypical squamous epithelial cells - excluding high-grade squamous cells Intraepithelial lesions (ASC-H), atypical glandular cells (AGC) or with cervical intraepithelial neoplasia (CIN),Adenocarcinoma in situ (AIS) or cervical cancer, etc.); 18. Past or current anal and genital diseases (such as vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, genital warts,vulvar cancer, vaginal cancer and anal cancer, etc.); 19. Previous hysterectomy or pelvic radiation therapy or severe cervical/vaginal dysplasia. Exclusion criteria for 2nd and 3rd dose vaccination: If any of the following occurs, the investigator will terminate the subject's vaccination with the investigational vaccine. * Meet the first dose exclusion criteria 5, 6, 7, 8, 9, 12; * Any other reasons that, in the judgment of the investigator, warrant discontinuation of the investigational vaccination.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hechi Yizhou District Center for Disease Control and Prevention
NOT_YET_RECRUITINGHechi, Guangxi, 546300, China
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Hezhou Center for Disease Control and Prevention
NOT_YET_RECRUITINGHezhou, Guangxi, 542899, China
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Lianyuan Center for Disease Control and Prevention
RECRUITINGLianyuan, Hunan, 417100, China
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Mianyang Youxian District Center for Disease Control and Prevention
NOT_YET_RECRUITINGMianyang, Sichuan, 621000, China
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Neijiang Shizhong District Center for Disease Control and Prevention
NOT_YET_RECRUITINGNeijiang, Sichuan, 641000, China
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Qiyang Center for Disease Control and Prevention
RECRUITINGWuxi, Hunan, 426100, China
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Yongji Center for Disease Control and Prevention
NOT_YET_RECRUITINGYongji, Shanxi, 044500, China
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Yuanqu Center for Disease Control and Prevention
NOT_YET_RECRUITINGYuncheng, Shanxi, 043700, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a daily supplement help the body fight off HPV?
- At-Home HPV tests could save lives of women with HIV
- New immune therapy aims to train body to clear HPV
- Could a tiny HPV shot still protect? small study tests lower dose
- New Self-Sampling and digital colposcopy could speed up cervical cancer detection
- Tailored radiation beams aim to outsmart aggressive throat cancer