New 9-Valent HPV vaccine aims to shield chinese women from more Cancer-Causing strains
NCT ID NCT03998254
First seen Jun 26, 2026 · Last updated Sep 02, 2026 · Updated 3 times
Summary
This phase 3 study tests a 9-valent HPV vaccine (V503) in 6,000 Chinese women aged 20-45 to see if it prevents persistent infection and cervical disease from five additional HPV types compared to the current 4-valent vaccine. Participants receive either the new vaccine or Gardasil, and researchers track infections, immune response, and side effects over time.
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 HPV vaccine (V503)
- What this could lead to
- If successful, this vaccine could prevent infections and cervical precancers caused by nine HPV types in Chinese women.
- What could go wrong
- This is a late-stage trial, but results may not apply to all populations. Side effects like injection-site pain or fever are possible.
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 6,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2019
- Expected to finish
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Nov 2029
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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20 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 * Healthy * Has not had sex with males or has had sex with males and used effective contraception with no failures since the first day of the participant's last menstrual period through Day 1 * Agrees to use effective contraception if has sex with a male partner during study * Has had sexual intercourse with male partners, and has had 1 to 4 male and/or female sexual partners Exclusion Criteria * History of a positive test for HPV * History of an abnormal Pap test result showing ASC-US, atypical squamous cells - cannot exclude HSIL (high grade squamous intraepithelial lesion \[(ASC-H)\], low-grade squamous intraepithelial lesion (LSIL), HSIL), or atypical glandular cells * History of an abnormal cervical biopsy result showing CIN, adenocarcinoma in situ or cervical cancer * History of or clinical evidence at the Day 1 gynecologic examination of HPV-related anogenital diseases (e.g., genital warts, VIN, VaIN, AIN, vulvular cancer, vaginal cancer or anal cancer * Does not have an intact cervix uteri or has more than one cervix uteri * Is pregnant * Known allergy to any vaccine component, including aluminum, yeast, or Benzonase™ (nuclease, Nycomed™ \[used to remove residual nucleic acids from this and other vaccines\]) * History of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension or shock) that required medical intervention * Has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections * Currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune condition * Has had a splenectomy * Is expecting to donate eggs during Day 1 through Month 7 of the study * Plans to receive during Day 1 through Month 7 of the study, is receiving or has received within 12 months prior to enrollment the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (Arava™), tumor necrosis factor (TNF)-α antagonists, monocolonal antibody therapies (including rituximab \[Rituxan™\]), intravenous gamma globulin (IVIG), antilymphocyte sera, or other therapy known to interfere with the immune response. With regard to systemic corticosteroids, a participant will be excluded if she is currently receiving steroid therapy, has recently (defined as within 2 weeks of enrollment) received such therapy, or has received 2 or more courses of high dose corticosteroids (orally or parenterally) lasting at least 1 week within 12 months prior to enrollment. Participants using inhaled, nasal, or topical corticosteroids are considered eligible for the study. * Plans to receive during Day 1 through Month 7 of the study, is receiving or has received within the 6 months prior to the Day 1 vaccination any immune globulin product (including RhoGAM™) or blood derived product other than IVIG * Has received a marketed HPV vaccine, or has participated in an HPV vaccine clinical study and has received either active agent or placebo * Concurrently enrolled in clinical studies of investigational agents or studies involving collection of cervical specimens * User of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence at the discretion of the investigator. Alcohol abusers are defined as those who drink despite recurrent social, interpersonal, and/or legal problems as a result of alcohol use
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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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Lingchuan Center for Disease Control and Prevention ( Site 0002)
Guilin, Guangxi, 541200, China
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Mianyang Center for Disease Control and Prevention ( Site 0005)
Mianyang, Sichuan, 621000, China
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Quanzhou Center for Disease Control and Prevention ( Site 0001)
Guilin, Guangxi, 541500, China
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Santai County Center for Disease Control and Prevention ( Site 0006)
Mianyang, Sichuan, 621100, China
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Xiangyuan Center for Disease Control and Prevention ( Site 0003)
Changzhi, Shanxi, 046299, China
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Yanhu Center for Disease Control and Prevention of Yuncheng ( Site 0004)
Yuncheng, Shanxi, 044000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A new strategy to prevent cervical cancer: community follow-up for HPV shots
- Broader HPV shield: could a 9-Type vaccine strengthen protection after the 2-Type shot?
- Can a daily supplement help the body clear HPV?
- Could a Light-Activated cream replace surgery for cervical precancer?
- Enzyme-HPV link in cervical disease explored
- HPV vaccine shows promise for chinese women and girls in large trial