A Phase Ⅲ Study to Evaluate the Efficacy, Immunogenicity, Safety of Quadrivalent HPV Recombinant … (NCT05584332) | Clinical Trial Compass
TerminatedPhase 3
A Phase â…¢ Study to Evaluate the Efficacy, Immunogenicity, Safety of Quadrivalent HPV Recombinant Vaccine in Chinese Healthy Females
Stopped: Strategic adjustment
China3,131 participantsStarted 2022-12-09
Plain-language summary
This study is designed to evaluate the vaccine efficacy, immunogenicity and safety of the 4-valent Human Papillomavirus (Types 6, 11, 16, and 18) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 18-45 Years .
Who can participate
Age range18 Years – 45 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Chinese women aged 18-45 who can provide legal identification and had a sexual life history;
✓. The subject fully understands the study procedures, understands the risks and benefits associated related this study, and voluntarily signs the informed consent;
✓. Subjects are able to read, understand and fill in application forms such as diary CARDS and contact CARDS, and participate in regular follow-up visits according to the study protocol;
✓. \*axillary's temperature \<37.3℃ on the day of enrollment;
✓. Subjects have not received any form of cervical cancer screening, or have been received but the results are normal;
✓. \*0 days before the gynecological visit, no sex within 48 hours, no flushing or vaginal cleaning within 72 hours, no use of vaginal drugs or preparations;
✓. When the subjects were enrolled, the urine pregnancy test was negative (sensitivity was 25mIU/ml β-HCG), they were not in the lactation period, had no family planning from Day 0 to 30 days after receiving the third dose of the vaccine. Agree to continue to use effective contraception (including: oral contraceptives, injectable or embedded contraceptives, sustained-release topical contraceptives, hormone patches, intrauterine devices (IUDs), sterilization, abstinence, condoms (men), diaphragms, cervical caps, etc.) from the day of enrollment to 30 days after the third season of vaccination. Safe-period contraception, in vitro ejaculation, and emergency contraception are unacceptable methods of contraception.
Exclusion criteria
✕. Blood pressure (BP) before the first dose of vaccination was higher than normal or increased (systolic BP ≥140mmHg and/or diastolic BP ≥90mmHg);
What they're measuring
1
The person-year incidence of HPV 16 and 18-related CIN 2+ observed in Chinese women aged 18-45 years after receiving 3 doses of quadrivalent HPV vaccine at least 30 days ago.
✕. \* Subjects had fever symptoms (axillary's temperature ≥37.3℃) before the first day of vaccination (within 24 hours before vaccination);
✕. History of severe side effect to previous vaccinations or History of severe allergies (e.g. Swelling of the mouth and throat, Dyspnea, Hypotension or Shock, Severe urticaria) to components of study vaccine (e.g. Histidine, Polysorbate, and Aluminium phosphate). History of severe allergies requiring medical intervention, such as anaphylactic shock, anaphylactic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), etc;
✕. Subjects with compromised immune systemsor have been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease or Autoimmune thyroid disease （e.g. Hyperthyroidism，Thyroiditis/Subacute thyroiditis，or Hypothyroidism), and other Autoimmune diseases ;
✕. Previous or current have epilepsy, seizures (except febrile seizures in children) or convulsions, or mental diseases, with a family history of psychosis;
✕. Absence of spleen or functional absence of spleen, and absence of spleen or splenectomy in any case;
✕. Previous or current have severe liver, kidney and cardiovascular diseases, diabetic complications or malignant tumor;
✕. Patients with thrombocytopenia or any coagulation disorders that may be contraindications to intramuscular injection;