New 9-Valent HPV vaccine aims to block more Cancer-Causing viruses
NCT ID NCT04537156
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 3 trial tests a 9-valent HPV vaccine in over 9,000 healthy women aged 18-45. The vaccine targets nine HPV types linked to cervical cancer and genital warts. Researchers compare it to an existing 2-valent vaccine to see if it provides broader protection. The goal is to prevent persistent infections, precancerous lesions, and related diseases.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 9-valent human papillomavirus (HPV) vaccine
- What this could lead to
- If successful, this vaccine could prevent more types of HPV infections, reducing cases of cervical cancer and genital warts in women.
- What could go wrong
- This is a large Phase 3 trial, but results are not yet published. The vaccine may not prove superior to the existing bivalent vaccine, and long-term protection is still being studied.
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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9,327 people
The number who actually took part.
- Started
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Sep 2020
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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: 1. Female aged between 18 and 45 years at the first vaccination; 2. Be able to understand and comply with the request of the protocol(e.g. biological specimen collection, diary card entry and attend regular follow-up), and sign written informed consent; 3. Women who agree to use effective contraception within 8 months after the first vaccination, or women who have undergone tubal ligation, benign subtotal hysterectomy, benign ovarian tumor removal, or postmenopausal women; 4. The number of sexual partners so far less than four; 5. Have intact cervix and have no history of physical or surgical treatment; 6. No previous history of sexually transmitted diseases (including syphilis, gonorrhea, chancroid, venereal lymphogranuloma, groin granuloma, etc.); 7. No previous history of abnormal cervical screening results or cervical intraepithelial neoplasia (CIN), and no abnormality in gynecological examination; 8. Sexual intercourse has occurred. Exclusion Criteria: 1. Participants with acute cervicitis and acute lower genital tract infection, or with obvious condyloma; 2. Participants during menstruation, or have vaginal medication, sexual behavior (including anal, vaginal or external genital contact, regardless of the sex of parterner) within two days (48 hours) before the visit, which may affect gynecological examinations and specimens collection. 3. Axillary temperature \> 37.0℃; 4. Participants who have positive urine pregnancy test, or are pregnant or breastfeeding; 5. Have used other investigational or unregistered products (drugs or vaccines) within 30 days before receiving the research vaccine or have participated in another clinical research in the past two years, or plan to use other research or unregistered products or participate in other research during the research period; 6. Long-term use (more than 14 continuous days) of immunosuppressors and other Immunoregulatory agents or systemic corticosteroids (Except intranasal steroid, the use of low dose topical, ophthalmic and inhaled steroid preparations will be permitted.) 6 months prior to vaccination. 7. Administration of immunoglobulin and/or blood products 3 months prior to vaccination or intending to use them during the study. 8. Administration of inactivated vaccine within 14 days before vaccination or live vaccine within 21 days; 9. Fever (Axillary temperature \>38.0℃) 3 days prior to vaccination or system administration of antibiotics or antiviral agents (Anti-flu agents include but are not limited to Tamiflu, Tamiflu, Symmetrel and Flumadine) 5 days prior to vaccination. 10. Have received other HPV vaccines or participated in clinical research related to HPV or cervical cancer previously; 11. Immunodeficiency disease, primary disease of important viscera, cancer and autoimmune disease (including systemic lupus erythematosus, rheumatoid arthritis, asplenia or splenectomy due to any condition, and other autoimmune diseases that investigators believe may influence the immune response). 12. History of severe allergy (e.g., anaphylaxis, generalized urticaria, dyspnea, angioedema, and other significant reaction) to any previous vaccines, or allergy to any of the components of investigational vaccine. 13. Asthma, which has been unstable for the past two years and requires emergency treatment, hospitalization, oral or intravenous corticosteroids; 14. Suffered from a serious medical illness; 15. Self-report past coagulation disorders or abnormal coagulation function; 16. Epilepsy, excluding febrile epilepsy under 2 years of age, alcoholic epilepsy 3 years prior to abstinence or simple epilepsy that did not require treatment in the past 3 years; 17. According to the judgement of investigator, various medical, psychological, social, vocational or other factors that are not suitable for participating in the clinical trial.
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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.
Contacts and locations
Locations
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Jiangsu Provincial Centre for Disease Control and Prevention
Nanjing, Jiangsu, 210009, China
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Sichuan Provincial Centre for Disease Control and Prevention
Chengdu, Sichuan, 610041, China
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Other studies related to the condition(s) this trial covers.
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