Immunogenicity and Safety of One Dose of HPV Vaccine

NCT ID: NCT06345885

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-23
• Study Completion Date: 2024-01-17

Brief Summary

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

Conditions

Human Papillomavirus Vaccines

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group A

Bivalent HPV Vaccine (Cecolin)

Group Type: EXPERIMENTAL

HPV vaccine

Intervention Type: BIOLOGICAL

Participants in the group A will be administrated with bivalent HPV vaccine Cecolin. The immunization schedule is 0, 6 months; Participants in the group B will be administrated with quadrivalent HPV vaccine Gardssil. The immunization schedule is 0, 2, 6 months

Group B

Quadrivalent HPV vaccine (Gardasil)

Group Type: ACTIVE_COMPARATOR

HPV vaccine

Intervention Type: BIOLOGICAL

Participants in the group A will be administrated with bivalent HPV vaccine Cecolin. The immunization schedule is 0, 6 months; Participants in the group B will be administrated with quadrivalent HPV vaccine Gardssil. The immunization schedule is 0, 2, 6 months

Interventions

HPV vaccine

Participants in the group A will be administrated with bivalent HPV vaccine Cecolin. The immunization schedule is 0, 6 months; Participants in the group B will be administrated with quadrivalent HPV vaccine Gardssil. The immunization schedule is 0, 2, 6 months

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Xiamen Innovax Biotech Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fujian Provincial Center for Disease Control and Prevention

Fuzhou, Fujian, China

Countries

China

Other Identifiers

PROPMHP002

Identifier Type: -

Identifier Source: org_study_id