Immunogenicity and Safety of One Dose of HPV Vaccine

Xiamen Innovax Biotech

Status and phase

Completed

Phase 4

Conditions

Human Papillomavirus Vaccines

Treatments

Biological: HPV vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT06345885

PROPMHP002

Details and patient eligibility

About

This study will assess the immunogenicity and safety of one dose of Cecolin and one dose of Gardasil

Enrollment

200 patients

Sex

Female

Ages

9 to 14 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Female, aged between 9 and 14 years (including 9 and 14 years) on the day of enrollment
Judged as healthy and eligible for vaccination by the investigators through a self- reported medical history and some physical examinations
Subjects and legal guardians are informed and agree, and sign the Informed Consent Form
Female urine pregnancy test is negative

Exclusion criteria

Axillary temperature>37.2 ℃
Other investigational or unregistered products (drugs or vaccines) that have been used or planned to be used during the study period within 30 days prior to receiving the research vaccine
Systemic use of immunosuppressants or other immunomodulatory drugs or corticosteroids for a long period of time (lasting for more than 14 days) within 6 months prior to receiving the research vaccine, but local use is allowed (such as ointments, eye drops, inhalers, or nasal sprays)
Within 3 months prior to vaccination, immunoglobulin and/or blood preparations were used or planned to be used during the study period, but emergency use of tetanus immunoglobulin and rabies immunoglobulin is allowed after exposure
Received inactivated vaccines within 14 days prior to enrollment in the study, or received live vaccines within 21 days prior to enrollment in the study
Fever (axillary temperature ≥ 38.0 ℃) within 3 days prior to vaccination, or any acute illness requiring systemic antibiotics or antiviral treatment within the past 5 days
Previously received HPV vaccine
Immunodeficiency diseases, chronic medical histories that require treatment for important organs such as primary diseases, cancer (or precancerous lesions), immune diseases (including systemic lupus erythematosus, rheumatoid arthritis, any condition leading to splenectomy or splenectomy, and other immune diseases that researchers believe may have an impact on immune response)
Have a history of allergies, including serious adverse reactions from previous vaccination, such as allergies, urticaria, breathing difficulties, angiogenic edema, or abdominal pain
Asthma, with unstable conditions in the past two years requiring emergency treatment, hospitalization, oral or intravenous corticosteroids
Complicated with serious medical diseases, such as hypertension, heart disease, diabetes, hyperthyroidism, etc
Abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities) or coagulation disorders diagnosed by doctors
Epilepsy, excluding febrile epilepsy under 2 years old and simple epilepsy that did not require treatment in the past 3 years
Due to the inability to comply with research requirements due to psychological conditions, having a past or present mental illness that has not been well controlled within the past two years, requiring medication for mental illness, and having suicidal tendencies in the past five years
According to the researcher's judgment, due to various medical, psychological, social, occupational factors or other conditions, it is contrary to the research plan or affects the recipient and guardian to sign informed consent