Immunogenicity and Safety of One Dose of HPV Vaccine

Human Papillomavirus Vaccines Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06345885
• Other study ID #: PROPMHP002
• Status: Completed
• Phase: Phase 4
• Start date: February 23, 2023
• Est. completion date: January 17, 2024

Study information

• Verified date: March 2024
• Source: Xiamen Innovax Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 17, 2024
• Est. primary completion date: January 17, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 9 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Human Papillomavirus Vaccines

Intervention

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

Locations

Country	Name	City	State
China	Fujian Provincial Center for Disease Control and Prevention	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Xiamen Innovax Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Anti-HPV Seropositivity	Seropositivity to HPV16 and HPV18 types of the neutralizing antibody in subjects will be assessed.	At 2 months after first dose
Secondary	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
Secondary	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