Immunogenicity and Safety of One Dose of HPV Vaccine

Immunogenicity and Safety of One Dose of Cecolin and One Dose of Gardasil

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

Study Overview

• Status: Completed
• Conditions: Human Papillomavirus Vaccines
• Intervention / Treatment: Biological: HPV vaccine

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350012
      • Fujian Provincial Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Bivalent HPV Vaccine (Cecolin)	Biological: 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
Active Comparator: Group B; Quadrivalent HPV vaccine (Gardasil)	Biological: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-HPV seropositivity	Seropositivity to HPV16 and HPV18 types of the neutralizing antibody in subjects will be assessed.	At 1 month after first dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-HPV Seropositivity	Seropositivity to HPV16 and HPV18 types of the neutralizing antibody in subjects will be assessed.	At 2 months after first dose
HPV Antibody Titers	Geometric mean titers (GMT) of HPV16 and HPV18 types at 1 and 2 months after the first dose of vaccine administration in the subjects will be assessed.	At 1 and 2 months after first dose
Local and Systemic Reactions/Event	Soliciting local reactions/events; Soliciting systemic reactions/events; Non solicited adverse events; Serious adverse events	7 and 30 days after each dose of vaccination; 0-7 months

Collaborators and Investigators

• Sponsor: Xiamen Innovax Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2023
• Primary Completion (Actual): January 17, 2024
• Study Completion (Actual): January 17, 2024

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: PROPMHP002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No