Immunogenicity and Safety of Quadrivalent HPV Vaccine in Healthy Chinese Female Subjects Aged 9 to 19 Years
Evaluating the Immunogenicity and Safety of Quadrivalent Human Papillomavirus Recombinant Vaccine (Type 6, 11, 16, 18) in Healthy Chinese Female Subjects Aged 9 to 26 Years: A Phase 3, Open-label, Non-randomized Clinical Trial
1 other identifier
interventional
1,348
1 country
1
Brief Summary
This phase 3 study will evaluate the immunogenicity and safety of Quadrivalent HPV recombinant vaccine in Chinese females aged 9 to 26 years
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2021
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2021
CompletedFirst Posted
Study publicly available on registry
August 30, 2021
CompletedStudy Start
First participant enrolled
September 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 22, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 29, 2026
ExpectedApril 17, 2024
April 1, 2024
2.2 years
August 20, 2021
April 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary immunogenicity outcome
Number of subjects receiving the whole schedule vaccination with antibody responses as assessed by GMT and SCR, change from baseline among the seronegative vaccine recipients at Month 8
At month 8
Secondary Outcomes (6)
Secondary immunogenicity outcome
At month 12, 24, 36, 48 and 60
Number of subjecs with AEs
Within 30 minutes (Days 0) after vaccination
Numbers of subjects with solication of AEs
Within 8 days (Days 0-8) after vaccination
Numbers of subjects with unsolicited AEs
Within days 0-30 after vaccination
Number of subjects receiving the whole schedule vaccination with SAEs
Subjects receiving a 2-doses shceduled vaccination from Day o to Month 60; Subjects receiving a 3-doses shceduled vaccination from Day o to Month 12
- +1 more secondary outcomes
Study Arms (3)
Experimental: 2-doses Group
EXPERIMENTALSubjects aged 9-14 years, received 2 doses of q-HPV vaccine, which was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 6-month schedule.
Experimental: 3-doses Group
EXPERIMENTALSubjects aged 9-19 years, received 3 doses of q-HPV vaccine, which was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 2，6-month schedule.
Acitve Group
ACTIVE COMPARATORSubjects aged 20-26 years, received 3 doses of q-HPV vaccine, which was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 2，6-month schedule.
Interventions
Subjects were planned to receive two doses of the study vaccine administered intramuscularly according to a 0, 6 month vaccination schedule.
Subjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 2, 6 month vaccination schedule.
Subjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 2, 6 month vaccination schedule.
Eligibility Criteria
You may qualify if:
- Healthy Chinese females aged 9 to 26 years; Provide legal identification;
- The subject voluntarily agrees to enroll in this study. If the subject is a minor, both the subject and subject's legal guardian should voluntarily agree to enroll in this study and sign an informed consent form;
- Had a negative urine pregnancy test on the day of enrollment, among the subjects of childbearing age; Not in the duration of breast-feeding and no birth plan within 7 months; According to the investigator's judgment that there is no possibility of pregnancy at that time: subjects have taken effective contraception, or asexual life after the last menstrual period, or use IUD, or had undergone ligation; subjects agree to continue take effective contraception such as taking OCS and condom use;
- No fever symptoms on the day of enrollment (aged\> 14 years old, axillary temperature\<37.3°C; aged ≤ 14 years old, axillary temperature\<37.5°C );
- Be able to understand the study procedures and promise to participate in regular follow-ups under the requirements;
You may not qualify if:
- Received marketed HPV vaccine or plan to receive marketed HPV vaccine during this study period or have enrolled in HPV vaccine clinical trials;
- Enrolling or plan to enroll in other clinical trials (drug or vaccine);
- History of positive test to HPV, history of cervical cancer (e.g. abnormal screening test results, abnormal cervical biopsy results, including CIN, LSIL, and cervical cancer) or history of pelvic radiotherapyherpes;
- History of diseases related to HPV infection (e.g. genital warts, VIN, VaIN, and related cancers) or history of STDs, including syphilis, gonorrhea, genital herpes, Mycoplasma genitalium, Lymphgranuloma Venereum, granuloma inguinale, etc.;
- Known allergy to any vaccine components or history of severe allergic diseases requiring treatment, including shock, laryngeal edema, urticarial, Henoch-Schonlein purpura, Arthus reaction, etc.;
- Had primary or acquired immunodeficiency such as HIV, SLE, JRA, etc;
- History of epilepsy and convulsions (except fever convulsions in children under 5 years of age);
- Subjects with existing infectious diseases such as TB, viral hepatitis, and/or HIV infection; or existing liver or kidney conditions, CVDs, and malignancy;
- Untreated/uncontrolled hypertension before vaccination (aged 9 to 17 years: systolic BP≥120mmHg and/or diastolic BP≥80mmHg; aged more than 18 years: Systolic BP≥140mmHg and/or diastolic BP ≥90mmHg);
- With prohibitive contraindications such as Thrombocytopenia or coagulopathy;
- Asplenic, functionally asplenic, or splenectomy caused by any condition;
- Received immunosuppressive treatment within one month before study such as long-term glucocorticoid use(≥2mg per kg per day, lasted more than two wks), or plan to receive such treatment from month 0 to month 7；
- Receipt of immune globulin or blood-related products within 3 months; or plan to receive such products during this study period（month 0 to month 7）;
- Within 3 days prior to vaccination, have an acute disease or are in the acute attack of a chronic disease or have used antipyretic, analgesic and anti-allergic drugs (such as: acetaminophen, ibuprofen, aspirin, loratadine, ceti Rizine, etc.);
- Receipt of inactivated, RNA, and recombinant vaccines within 14 days, live vaccines within 28 days;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Disease Control and Prevention
Mianyang, Sichuan, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ting Huang
Sichuan Provincial Center for Disease Control and Prevention
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2021
First Posted
August 30, 2021
Study Start
September 15, 2021
Primary Completion
November 22, 2023
Study Completion (Estimated)
September 29, 2026
Last Updated
April 17, 2024
Record last verified: 2024-04