Phase 3 Endometrial Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Chinese women aged 20 to 45 years old who can provide legal identification and have a history of sexual activity
• People who fully understand what the study involves, including the risks and benefits, and are willing to sign a consent form
• People who are able to read, understand, and fill in study forms such as diary cards, and are able to attend follow-up visits as required
• People who have either never had cervical cancer screening, or have had screening with normal results
• People whose urine pregnancy test is negative at the time of enrolment, who are not breastfeeding, and who do not plan to become pregnant for 7 months after joining the study (which covers 1 month after the last vaccination)
• People who have been using effective contraception for at least 2 weeks before joining and agree to continue using effective contraception for 7 months after enrolment — accepted methods include the pill, injections, implants, slow-release hormonal contraceptives, hormone patches, intrauterine devices (IUDs), sterilisation, abstinence, male condoms, diaphragms, or cervical caps (note: rhythm method, withdrawal, and emergency contraception are not accepted)
• People with an underarm body temperature below 37.3°C at the time of their visit
• People who agree, before any visit that involves gynaecological sample collection, to avoid sexual intercourse (including anal, vaginal, or genital contact of any kind) for 48 hours beforehand, and to avoid vaginal rinsing, cleaning, or use of vaginal medications or preparations for 72 hours beforehand

Who may not be able to join:

• People who have previously received a commercially available HPV vaccine, plan to receive one during the study, or have previously taken part in an HPV vaccine clinical trial and received a vaccine or placebo
• People with a previous positive HPV test result
• People with a history of abnormal cervical cell results, including squamous intraepithelial lesions, certain types of atypical cells, cervical pre-cancerous changes (CIN), cervical cancer in situ, or abnormal cervical biopsy results
• People with a past history of diseases affecting the anal or genital area, such as genital warts, vulvar or vaginal pre-cancerous changes, or vulvar, vaginal, or anal cancer
• People who have had a full hysterectomy (complete removal of the uterus) or radiotherapy to the pelvic area
• People with cervical weakness or an abnormal cervical structure identified during routine gynaecological examination
• People with a past history of sexually transmitted infections such as syphilis, gonorrhoea, chancroid, venereal lymphogranuloma, or granuloma inguinale, or who have visible genital warts
• People with a personal history of seizures or convulsions, or a family history of mental illness
• People who have taken part in other gynaecology-related clinical trials within the past 6 months, or who have used or plan to use other experimental or unregistered drugs or vaccines within the past 3 months
• People with a history of severe allergic reactions requiring medical treatment, such as anaphylactic shock, severe throat swelling, allergic purpura, or serious skin reactions — or a known severe allergy to any ingredient in the study vaccine (including histidine, polysorbate, aluminium phosphate, sodium borate, amorphous aluminium phosphate sulphate adjuvant, or water for injection)
• People who have received immunoglobulin or blood products within 3 months before the first dose, or who plan to receive such products within 7 months of joining the study
• People who currently have or have been diagnosed with a condition that affects the immune system, such as congenital or acquired immune deficiency, HIV infection, lymphoma, leukaemia, lupus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune conditions
• People who have received immune-suppressing treatments in the month before the first dose — such as high-dose steroid medications taken by mouth or injection over an extended period — or who plan to receive such treatment within the next 7 months
• People who do not have a spleen, or whose spleen does not function normally
• People with serious complications related to liver, kidney, or heart and blood vessel disease, diabetes, or a malignant (cancerous) tumour
• People with low platelet counts or any blood clotting disorders that may make muscle injections unsafe
• People who have received an inactivated or recombinant vaccine within 14 days before joining the study, or a live attenuated vaccine within 28 days before joining
• People who have had an acute illness, a flare-up of a chronic illness, or have used fever-reducing, pain-relieving, or anti-allergy medications (such as paracetamol, ibuprofen, aspirin, loratadine, or cetirizine) within 3 days before vaccination
• People who are currently pregnant at the time of the first dose, or whose pregnancy ended less than 6 weeks before the first dose
• People who have had a fever (underarm temperature at or above 37.3°C) in the 24 hours before the first vaccination
• People who are menstruating at the time of their visit
• People found to have severe acute vaginitis or purulent cervicitis (visible pus-like discharge) during gynaecological examination
• People whose blood pressure before the first dose is at or above 140/90 mmHg
• People in whom genital warts are suspected, or in whom pre-cancerous or cancerous changes of the vulva, vagina, or cervix are suspected based on symptoms or examination findings, at the time of the first dose
• People who may be unable to follow the study procedures, comply with the study agreement, or who plan to permanently move away from the study region before the study is completed
• People whom the study investigators consider unsuitable to participate for any other reason that could affect their safety or wellbeing in the trial

Important: Always verify eligibility with the trial site directly before applying.