HPV vaccine shows promise for chinese women and girls in large trial
NCT ID NCT03903562
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed Phase 3 study tested a 9-valent HPV vaccine in nearly 2,000 healthy Chinese females aged 9 to 45. The goal was to see if the vaccine triggers a strong immune response and is safe. Participants received three doses, and researchers measured antibody levels over five years, especially in younger participants. The results could support broader use of this vaccine in China to help prevent HPV infections and related cancers.
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 could confirm that the 9-valent HPV vaccine is safe and produces a strong immune response in Chinese females aged 9-45, supporting its use to prevent HPV infections and related cancers.
- What could go wrong
- This is a completed Phase 3 trial, so results are already in. However, the study only measured immune response, not actual prevention of infection or cancer. Long-term effectiveness and real-world impact still need further study.
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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1,990 people
The number who actually took part.
- Started
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Apr 2019
- Finished
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Feb 2025
- 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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9 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 * Participant is a Chinese female judged to be in good physical health based on medical history and physical examination * Not a woman of childbearing potential (WOCBP) or if of WOCBP, has not had sex with males or has had sex with males and used effective contraception since the first day of participant's last menstrual period through Day 1. And the participant understands and agrees that during the Day 1 through Month 7 period, she should not have sexual intercourse with males without effective contraception, and that the use of the rhythm method, withdrawal, and emergency contraception are not acceptable methods * Has a lifetime history of 0 to 4 male and/or female sexual partners at the time of enrollment. Male partner is defined as someone with whom the participant has penile penetrative sexual intercourse. Female partner is defined as someone who has contacted, either by penetrative (with fingers or other objects) or non-penetrative means, the participant's genitalia during sexual activity Exclusion Criteria * Known allergy to any vaccine component, including aluminum, yeast, or BENZONASE™ (nuclease, Nycomed™). An allergy to vaccine components is defined as an allergic reaction that met the criteria for serious adverse event * History of severe allergic reaction (e.g. swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention * Known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections * Has a fever (defined as an axillary temperature ≥37.1°C) within 24 hours prior to the Day 1 vaccination * Has any history of abnormal Pap test showing squamous intraepithelial lesion (SIL) or atypical squamous cells - undetermined significance (ASC-US), atypical squamous cells - cannot exclude HSIL (ASC-H), atypical glandular cells, or biopsy showing cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ or cervical cancer * History of external genital wart, vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), vulvar cancer or vaginal cancer * History of a positive test for HPV * Currently immunocompromised or has been diagnosed as having 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 * History of splenectomy * Donated blood within 1 week prior to the Day 1 vaccination, or intends to donate during Day 1 through Month 7 of the study * Expecting to donate eggs during Day 1 through Month 7 of the study * Pregnant * Receiving or has received in the year prior to Day 1 vaccination the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (Arava™), tumor necrosis factor (TNF)-α antagonists, monoclonal 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 Day 1 vaccination) received such therapy, or has received 2 or more courses of corticosteroids (orally or parenterally) lasting at least 1 week in duration in the year prior to Day 1 vaccination. Participants using inhaled, nasal or topical corticosteroids are considered eligible for the study * Has received immune globulin product (including RhoGAM™ or blood-derived product other than IVIG within 6 months prior to Day 1 vaccination, or plans to receive any such product during Day 1 through Month 7 of the study * Has received a marketed HPV vaccine, or has participated in an HPV vaccine clinical trial and has received either active agent or placebo * Has received inactivated or recombinant vaccines within 14 days prior to Day 1 vaccination or has received live vaccines within 21 days prior to Day 1 vaccination * Concurrently enrolled in clinical studies of interventional agents * A user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence. 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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Kaihua country Center for Disease Control and Prevention ( Site 0002)
Quzhou, Zhejiang, 324300, China
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Shaoxing keqiao center for disease prevention and control ( Site 0001)
Shaoxing, Zhejiang, 312030, 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
- New 9-Valent HPV vaccine aims to shield chinese women from more Cancer-Causing strains