Lot Consistency Clinical Trial of of Recombinant HPV Bivalent Vaccine in 9 to14 Years Old Healthy Female

NCT05426148 | Completed Phase 4

• 1 other identifier: HPV-PRO-010
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate lot-lot consistency of Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) .

Conditions

Cervical Intraepithelial Neoplasia; Cervical Cancer; Vaginal Intraepithelial Neoplasia; Vulvar Intraepithelial Neoplasia; Persistent Infection

Keywords

Human Papillomavirus Infection; Bivalent HPV Vaccine; Immunogenicity

Outcome Measures

Primary Outcomes (1)

• The Geometric Mean concentration (GMC) of anti-HPV16/18 IgG at at one month after the 2nd dose.

  Measure anti-HPV16/18 IgG in serum samples at 7 month to evaluate the immunogenicity of the HPV vaccine.

  7 months

Secondary Outcomes (6)

• Seroconversion rate of anti-HPV16/18 IgG at one month after the 2nd dose.

  7 months

• Measure solicited local adverse reactions within 7 days after each vaccination.

  7 days

• Measure solicited systematic adverse reactions within 7 days after each vaccination.

  7 days

• Measure unsolicited adverse reactions within 30 days after vaccination.

  30 days

• Measure serious adverse events occurred throughout the study.

  up to 7 months

Study Arms (3)

Bivalent HPV Vaccine Consistency Lot 1

EXPERIMENTAL

Biological/Vaccine: Participants would receive 2 doses of Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) intramuscularly at 0, 6 month.

Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) / Cecolin®

Bivalent HPV Vaccine Consistency Lot 2

EXPERIMENTAL

Biological/Vaccine: Participants would receive 2 doses of Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) intramuscularly at 0, 6 month.

Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) / Cecolin®

Bivalent HPV Vaccine Consistency Lot 3

EXPERIMENTAL

Biological/Vaccine: Participants would receive 2 doses of Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) intramuscularly at 0, 6 month.

Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) / Cecolin®

Interventions

Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) / Cecolin® BIOLOGICAL

The bivalent HPV 16/18 vaccine was a mixture of two aluminum hydroxide adjuvant-absorbed recombinant L1 VLPs of HPV-16 and HPV-18 expressed in E. coli. A 0.5 ml dose of the bivalent HPV test vaccine comprised 40 μg of HPV-16 and 20 μg of HPV-18 L1 VLPs absorbed with aluminum adjuvant.

Also known as: There is no other Intervention in this study

Bivalent HPV Vaccine Consistency Lot 1; Bivalent HPV Vaccine Consistency Lot 2; Bivalent HPV Vaccine Consistency Lot 3

Eligibility Criteria

• Age: 9 Years - 14 Years
• Gender Eligibility Details: Cecolin® is indicated for women to prevent the diseases caused by human papillomavirus (HPV) types 16 and/or 18, such as cervical cancer, cervical intraepithelial neoplasia Grade 2 or 3 (CIN2/3) and adenocarcinoma in-situ (AIS).
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \. Aged over 9 years old to 14 years old Female at the time of the first vaccine injection;
• \. Statutory guardian of the subjects able to provide legal identification or the trustee able to provide the authorization certificate;
• \. Judged as healthy and eligible for vaccination by the investigators through a selfreported medical history and some physical examinations;
• Axillary temperature is below than 37.0 ℃;
• Negative for urine pregnancy test.
• The statutory guardian and trustee able to understand this study information and willing to comply with all study requirements(the statutory guardian or subject able to fill in the diary card and attend the follow-up on schedule).
• Willing to participate in this study and sign informed consent form.

You may not qualify if:

• Administration of HPV Vaccine before the study;
• Use of any investigational product or non-registered product (drug or vaccine)within 30 days preceding the first dose of the study vaccine or plan to use during the study period;
• Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, except local treatment(such as ointment, eyedrops, inhalants or nasal sprays);
• Administration of any immunoglobulin or blood products within 3 months preceding the first dose of the study vaccine,or plan to use during the study period;
• Administration of any inactivated vaccines within 14 days preceding the first dose of the study or attenuated live vaccines within 21 days preceding the first dose of the study;
• Had a fever (axillary temperature over 38°C) within 3 days or acute illness, or use systemic antibiotics or antiviral treatment within 5 days before vaccination;
• Participate in any other clinical trial during the study period;
• Immunodeficiency (such as HIV carriers), primary disease of important organs, malignant tumor, or any immune disease (such as systemic lupus erythematosus, rheumatoid arthritis, splenectomy or functional asplenia or other disease which might affect immune response), or other chronic diseases requiring treatment;
• History of allergic disease or history of serious adverse events occurring after vaccination, such as allergy,urticaria, dyspnea, angioneurotic edema or abdominal pain;
• Asthma that needed emergency treatment, hospitalization, oral or intravenous corticosteroid to keep stable in the past two years;
• Combining another severe internal medicine disease(such as hypertension, cardiopathy,diabetes and hyperthyroidism);
• Anormal coagulation function or coagulopathy diagnosed by doctor;
• Epilepsy(not including febrile seizures under 2 years old, alcohol epilepsy within 3 years prior to abstinence and simple epilepsy that have not required treatment within 3 years prior to the study) ;
• Anormal psychology or mind affecting the individual ability to obey the study requirements. Psychiatric disorders, not controlled in the past two years, required medication, or suicidal tendency in the past five years;
• Other medical, psychological, social or occupational factors that, according to the investigators' judgment, might affect the individual ability to obey the protocol or sign the informed consent.

Sponsors & Collaborators

• Xiamen Innovax Biotech Co., Ltd: lead
• Jiangsu Province Centers for Disease Control and Prevention: collaborator
• Dongtai City Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Dongtai City Center for Disease Control and Prevention Dongtai, Jiangsu

Dongtai, Jiangsu, 224200, China

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Uterine Cervical Neoplasms; Persistent Infection; Papillomavirus Infections

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; DNA Virus Infections; Virus Diseases; Tumor Virus Infections

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• Yuemei Hu

  Jiangsu Provincial Center for Disease Prevention and Control

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 21, 2022
• Study Start: May 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: April 30, 2021
• Last Updated: June 29, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)