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New 11-Valent HPV vaccine aims to block more Cancer-Causing viruses

NCT ID NCT05262010

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 13,500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2022

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Hechi Yizhou District Center for Disease Control and Prevention

    NOT_YET_RECRUITING

    Hechi, Guangxi, 546300, China

  • Hezhou Center for Disease Control and Prevention

    NOT_YET_RECRUITING

    Hezhou, Guangxi, 542899, China

  • Lianyuan Center for Disease Control and Prevention

    RECRUITING

    Lianyuan, Hunan, 417100, China

  • Mianyang Youxian District Center for Disease Control and Prevention

    NOT_YET_RECRUITING

    Mianyang, Sichuan, 621000, China

  • Neijiang Shizhong District Center for Disease Control and Prevention

    NOT_YET_RECRUITING

    Neijiang, Sichuan, 641000, China

  • Qiyang Center for Disease Control and Prevention

    RECRUITING

    Wuxi, Hunan, 426100, China

  • Yongji Center for Disease Control and Prevention

    NOT_YET_RECRUITING

    Yongji, Shanxi, 044500, China

  • Yuanqu Center for Disease Control and Prevention

    NOT_YET_RECRUITING

    Yuncheng, Shanxi, 043700, China

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