cervical carcinoma
Conditions
Interventions
Group A:Inoculate 1 dose of cecoline
Group B:Inoculate with 1 dose of Gardasil
Sponsors
Fujian Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
Female
Age
9 Years to 14 Years
Inclusion criteria
Inclusion criteria: 1. Subjects are female, aged between 9 and 14 years at the time of vaccination (including 9 and 14 years); 2. After medical history and physical examination, the subject was clinically determined to be healthy and meet the requirements for immunization with this product; 3. The subject and legal guardian have been informed and agreed, and signed the informed consent; 4. Female urine pregnancy test was negative.
Exclusion criteria
Exclusion criteria: 1. Armpit temperature > 37.2?; 2. Other investigational or unregistered products (drug products or vaccines) have been used or planned to be used during the study period within 30 days prior to receiving the study vaccine; 3. Long-term (lasting more than 14 days) use of immunosuppressants or other immunomodulatory drugs, systemic use of corticosteroids, but topical use (such as ointments, eye drops, inhalants or nasal sprays) is permitted within 6 months prior to the study vaccine; 4. Immunoglobulin and/or blood preparations were used in the 3 months prior to vaccination or planned to be used during the study, but emergency use of tetanus immunoglobulin and rabies immunoglobulin after exposure is permitted; 5. Received inactivated vaccine within 14 days prior to study inclusion or live vaccine within 21 days prior to study inclusion; 6. Had a fever (armpit temperature >=38.0?) in the 3 days prior to vaccination or had any acute illness in the past 5 days that required systemic antibiotic or antiviral treatment; 7. Previous HPV vaccination; 8. Immunodeficiency diseases, chronic medical history requiring treatment of primary diseases of vital organs, cancer (or precancerous lesions), immune diseases (including systemic lupus erythematosus, rheumatoid arthritis, any condition resulting from asthenia or splenectomy, and other immune diseases that investigators believe may affect immune response); 9. A history of allergy, including severe adverse reactions to previous vaccination, such as anaphylaxis, urticaria, dyspnea, angioedema, or abdominal pain; 10. Asthma, unstable condition in the past two years requiring emergency treatment, hospitalization, oral or intravenous corticosteroids; 11. Complicated with serious medical conditions such as hypertension, heart disease, diabetes, hyperthyroidism, etc.; 12. Abnormal coagulation function (such as deficiency of coagulation factor, coagulation disease, platelet abnormality) or coagulation disorder diagnosed by a physician; 13. Epilepsy, excluding febrile epilepsy under 2 years of age and simple epilepsy that did not require treatment in the past 3 years; 14. A past or present mental illness due to inability to comply with the study requirements, a lack of control in the past two years, a mental illness requiring medication, or suicidal tendencies in the past five years; 15. Medical, psychological, social, occupational or other conditions which, in the judgment of the researcher, are contrary to the study protocol or affect the informed consent signed by the subject and guardian.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sero-conversion rate of neutralizing antibodies to HPV16 and HPV18; | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean concentrations of HPV16 and HPV18 antibodies at 1 and 2 months after the first dose of vaccine; | — |
Countries
China
Contacts
Public ContactZhang Dongjuan
Fujian Provincial Center for Disease Control and Prevention
Outcome results
None listed