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Immunogenicity and Safety of Quadrivalent HPV Vaccine in Healthy Chinese Female Subjects Aged 9 to 19 Years | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

NCT05027776•Shanghai Bovax Biotechnology Co., Ltd.

View on ClinicalTrials.gov

Summary

This phase 3 study will evaluate the immunogenicity and safety of Quadrivalent HPV recombinant vaccine in Chinese females aged 9 to 26 years

Detailed Description

This is a singel-center study (protocol 4-HPV-3002) in which women are planned to receive q-HPV vaccine. Study participation will last approximately 60 months and involves a total of nine or eleven scheduled visits. This study will also assess whether the immunogenicity of the q-HPV vaccine given 2-dose schedule in 9-14 year old girls is noninferior to that in young women, aged 20-26, receiving 3 doses, and 3 doses in 9-19 year old girls is noninferior to that in young women receiving 3 doses, while assessing the safety of this vaccine.

Eligibility

Age

9 - 26 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. Healthy Chinese females aged 9 to 26 years; Provide legal identification;
•2. 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;
•3. 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;
•4. 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 );
•5. Be able to understand the study procedures and promise to participate in regular follow-ups under the requirements;

Exclusion Criteria

•1. Received marketed HPV vaccine or plan to receive marketed HPV vaccine during this study period or have enrolled in HPV vaccine clinical trials;
•2. Enrolling or plan to enroll in other clinical trials (drug or vaccine);
•3. 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;
•4. 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.;
•5. 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.;
•6. Had primary or acquired immunodeficiency such as HIV, SLE, JRA, etc;
•7. History of epilepsy and convulsions (except fever convulsions in children under 5 years of age);
•8. Subjects with existing infectious diseases such as TB, viral hepatitis, and/or HIV infection; or existing liver or kidney conditions, CVDs, and malignancy;
•9. 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);
•10. With prohibitive contraindications such as Thrombocytopenia or coagulopathy;
+7 more criteria

Locations (1)

Center for Disease Control and Prevention

Mianyang, Sichuan, China

Key Dates

Start Date

September 15, 2021

Primary Completion Date

November 22, 2023

Completion Date

September 29, 2026

Last Updated

April 17, 2024

Enrollment

1,348

ESTIMATED participants

Conditions

HPV InfectionsCervical Cancer Stage IIaVaginal CancerGenital WartCIN1CIN2CIN3

Interventions

2-doses Group among 9-14 years

BIOLOGICAL

3-doses Group among 9-19 years

BIOLOGICAL

3-doses Group among 20-26 years

BIOLOGICAL

Contacts

Ting Huang

CONTACT

86-13330993324 cocoht@163.com

Ji Zhang

CONTACT

86-(028)85586087 20079460@qq.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 17, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Immunogenicity and Safety of Quadrivalent HPV Vaccine in Healthy Chinese Female Subjects Aged 9 to 19 Years

Inclusion Criteria

Exclusion Criteria

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