Evaluate the Immunogenicity and Safety of 4-valent and 9-valent HPV Recombinant Vaccine in Chinese Healthy Females

Learn more about:
Related Clinical Trial
Gynaecology Exercise and Mindfulness Study Prolonged Grief and Perception of Femininity in Gynecological Cancer Patients Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer Evaluate the Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females Survey on Lymphedema After Sentinel Lymph Node Biopsy in People With Cervical or Vulvar Cancer Retrospective Study of Brachytherapy Groningen International Study on Sentinel Nodes in Vulvar Cancer-III Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types Early Detection of Vulval CAncer Through Self-Examination (EDuCATE): Intervention Study Education, Immigration and HPV Vaccination: an Informational Randomized Trial Immunobridging Study of 9-valent Human Papillomavirus Recombinant Vaccine in Chinese Females Aged 9 to 19 Years Serial MRI Scans During Radiation Therapy A Safety and Efficacy Study of Intra-tumoural Diffusing Alpha Radiation Emitters for the Treatment of Vulva Cancer Indocyanine Green Fluorescence Imaging, Sentinel Lymph Node Mapping in Patients With Vulvar Cancer Evaluate the Immunogenicity and Safety of 4-valent and 9-valent HPV Recombinant Vaccine in Chinese Healthy Females Evaluate the Efficacy, Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females Cisplatin+Pembrolizumab+RT in Vulvar Cancer Efficacy of Immunotherapy Plus a Drug in Patients With Progressive Advanced Mucosal Cancer of Different Locations Developing a Stepped Approach to Improving Sexual Function aFteR Treatment fOr gyNaecological Cancer Integrating a Health Information Technology System for Primary and Secondary Cervical Cancer Prevention Videoscopic Versus Open Inguinal Lymphadenectomy for Cancer Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery MR-HIFU for Recurrent Gynaecological Cancer Pelvic Floor Disorders in Survivors of Gynecologic Malignancies Outcomes From Home in Patients Recovering From Major Gynecologic Cancer Surgery: Measuring Symptoms and Health-related Quality of Life Paclitaxel Therapeutic Drug Monitoring in Cancer Patients Validation of a Nutrition Screening Tool A Survivorship Care Plan for Gynaecological Cancer Patients Self-Advocacy Serious Game in Advanced Cancer Octreotide in Preventing Diarrhea in Patients Who Are Undergoing Radiation Therapy to the Pelvis Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004) A Study to Evaluate Tolerability and Immunogenicity of V504 Administered Concomitantly With GARDASIL (V504-001)(COMPLETED) Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001) Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002) Chemoradiation-Induced Nausea and Emesis: Quality of Life A Multilevel Intervention to Improve Timely Cancer Detection and Treatment Initiation Long-term Follow-up of Broad Spectrum Human Papillomavirus (HPV) Vaccine Study in Women (V503-021) A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002) Longitudinal Evaluation of Women Undergoing Pelvic Exenteration for Treatment of Gynecologic Malignancy Phase I Study of Intravenous Triapine (IND # 68338) in Combination With Pelvic Radiation Therapy With or Without Weekly Intravenous Cisplatin Chemotherapy for Locally Advanced Cervical, Vaginal, or Pelvic Gynecologic Malignancies ChemoFx® PRO – A Post-Market Data Collection Study Evaluate the Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females Colposcopy and High Resolution Anoscopy in Screening For Anal Dysplasia in Patients With Cervical, Vaginal, or Vulvar Dysplasia or Cancer Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001) HORIZONS: Understanding the Impact of Cancer Diagnosis and Treatment on Everyday Life The Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology Study Vaccine Therapy in Treating Patients With Advanced or Recurrent Cancer Durvalumab, Tremelimumab + Radiotherapy in Gynecologic Cancer Image-Guided Gynecologic Brachytherapy Flexitouch® Home Maintenance Therapy or Standard Home Maintenance Therapy in Treating Patients With Lower-Extremity Lymphedema Caused by Treatment for Cervical Cancer, Vulvar Cancer, or Endometrial Cancer Topical Imiquimod in Treating Patients With Recurrent Paget’s Disease of the Vulva Antineoplaston Therapy in Treating Patients With Stage IV Cancer of the Cervix and/or Vulva Chemoprevention of Cancer in the Lower Female Genital Tract: The Antineoplastic Activity of the Fungicide Ciclopirox. The Impact of the “WOMAN-PRO II Program” on Patients With Vulvar Neoplasia to Minimize Post-surgical Symptom Prevalence CaptHPV : Validation of the Method “CaptHPV” for the Diagnosis of Human Papillomavirus Associated Infiltrating Carcinomas Intratreatment FDG-PET During Radiation Therapy for Gynecologic and Gastrointestinal Cancers Effectiveness of an Individualized Symptom Education Program (ISEP) A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006) Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva A Non-Randomized Study to Evaluate Leg Lymphatic Drainage Associated With Surgical Intervention for Vulvar Cancer Radiation Therapy or Surgery in Treating Patients With Previously Untreated Vulva Cancer With Positive Groin Lymph Nodes Observation in Patients With Early-Stage Vulvar Cancer Undergoing Sentinel Lymph Node Dissection Study to Evaluate the Role of PlasmaJet in Patients Undergoing Groin Node Dissection for Vulval Cancer Bioimpedance Spectroscopy in Detecting Lower-Extremity Lymphedema in Patients With Stage I, Stage II, Stage III, or Stage IV Vulvar Cancer Undergoing Surgery and Lymphadenectomy Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Cancer of the Vulva Added-value of SPECT/CT in Patients Undergoing LM/SL for Gynecological Cancers Lymphedema After Surgery in Patients With Endometrial Cancer, Cervical Cancer, or Vulvar Cancer OCT-AF Imaging of Pre-cancers of Vulva and Cervix Fibrin Sealant in Decreasing Lymphedema Following Surgery to Remove Lymph Nodes in Patients With Cancer of the Vulva Groin Sentinel Node Biopsy and 18FDG-PET/CT in cN0 Vulvar Cancer Patients Candidate to Standard Lymphadenectomy Ultrasound Morphometric and Cyto/Histological Combined Pre-operative Assessment of Inguinal Lymph Node Status in Women With Invasive Vulvar Carcinoma Lymphatic Mapping in Treating Patients With Stage I or Stage II Cancer of the Vulva Conservative Management With Isolated Sentinel Lymph Node Biopsy in Vulvar Cancer Patients. Quality of Life, Unmet Needs and Satisfaction With Care After Vulvar Cancer Sentinel Node Extended in Squamous Cell Vulvar Cancer Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer. Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva

Brief Title

Evaluate the Immunogenicity and Safety of 4-valent and 9-valent HPV Recombinant Vaccine in Chinese Healthy Females

Official Title

A Randomized, Double-Blind and Positive-Controlled Phase 3 Study to Evaluate the Immunogenicity and Safety of the 4-valent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (Hansenula Polymorpha) and 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 20-45 Years

Brief Summary

      The study will evaluate the immunogenicity and safety of 4-valent and 9-valent HPV
      recombinant vaccine in Chinese healthy females 20 to 45 years of age.

Study Phase

Phase 3

Study Type


Primary Outcome

Percentage of participants 20 to 45 Years of Age that achieve the neutralizing antibody serostatus cutoffs for seroconversion to HPV Types 6, 11, 16 and 18 at least 1 month post Dose 3.

Secondary Outcome

 The neutralizing antibody GMTs for HPV Types 6, 11, 16 and 18 in participants 20 to 45 Years of Age at least 1 month post Dose 3.


Cervical Cancer


4-valent HPV Vaccine

Study Arms / Comparison Groups

 4-valent HPV Vaccine
Description:  Participants in this arm would receive 4-valent Human Papillomavirus (Types 6, 11, 16 and18) Recombinant Vaccine (Hansenula Polymorpha)


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

May 28, 2020

Completion Date

September 6, 2021

Primary Completion Date

September 6, 2021

Eligibility Criteria

        Inclusion Criteria:

          1. Chinese women aged 20-45 who can provide legal identification;

          2. The subject agreed to participate in the study, and voluntarily signs the informed

          3. Subjects are able to understand the study procedures and participate in follow-up
             according to the study requirements;

          4. When the subjects were enrolled, the urine pregnancy test was negative, they were not
             in the lactation period and had no family planning within 7 months after enrollment.2
             weeks before included in the study, effective contraceptive measures has been adopted
             and agreed to in the first seven months after the study (vaccinations after 1 months
             ago) continue to adopt effective contraceptive measures (effective contraceptive
             measures including the pill or condoms, etc );

        Exclusion Criteria:

          1. Have been vaccinated with commercially available HPV vaccine in the past or planned to
             be vaccinated with commercially available HPV vaccine during the study period;Or have
             participated in a clinical trial of the HPV vaccine;

          2. Has a history of cervical diseases, such as cervical screening showing abnormal
             results including CIN or a history of hysterectomy (vaginal or total abdominal
             hysterectomy) or pelvic radiation therapy. Has a history of genital diseases (such as
             vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, genital warts,
             vulvar cancer, vaginal cancer and anal cancer, etc.) or has a previous sexual history
             (including syphilis, gonorrhea, chancre, venereal lymphatic granuloma, granuloma

          3. A history of severe allergies requiring medical intervention, such as anaphylactic
             shock, anaphylactic laryngeal edema, allergic purpura, thrombocytopenic purpura, local
             allergic necrosis reaction (Arthus reaction), etc;

          4. Have an acute illness or an acute episode of a chronic illness within 3 days prior to
             vaccination or the use of antipyretic, analgesic and antiallergic drugs (e.g.,
             acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.);

          5. Subjects received inactivated or recombinant vaccines within 14 days prior to study
             enrollment, or attenuated live vaccines within 28 days prior to study enrollment;

          6. Subjects present with immune impairment or have been diagnosed with congenital or
             acquired immune deficiency, HIV infection, lymphoma, leukemia, systemic lupus
             erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA),
             inflammatory bowel disease or other autoimmune diseases. Long-term immunosuppressive
             therapy, e.g., long-term (more than 2 weeks) treatment with glucocorticoids (e.g.,
             prednisone or similar drugs);

          7. Has been diagnosed with a severe congenital malformation or chronic disease such as
             Down syndrome, heart disease, liver disease, kidney disease, diabetes, etc., which may
             interfere with the conduct or completion of the study;

          8. Subject receives any immunoglobulin or blood product within 3 months prior to the
             first dose of vaccination;

          9. Participating in other (drug or vaccine) clinical trials prior to enrollment or
             planning to participate during the study;

         10. Has been diagnosed with an infectious disease, such as tuberculosis, viral hepatitis
             and/or HIV infection;

         11. A history or family history of convulsions, epilepsy, encephalopathy and mental

         12. Have contraindications to intramuscular injection, such as having been diagnosed with
             thrombocytopenia, any coagulation disorder or receiving anticoagulant therapy;

         13. Absence of a spleen, functional absence of a spleen, and absence or removal of a
             spleen in any case;

         14. Body temperature ≥37.3℃ (underarm body temperature);

         15. Subjects may be unable to comply with the study procedure, comply with the agreement,
             or plan to permanently relocate from the region prior to completion of the study, or
             may be permanently absent from the region during the scheduled visit;

         16. In the opinion of the investigators, the subjects had any other factors that made them
             unsuitable to participate in the clinical trial.




20 Years - 45 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers


, , 

Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party


Study Sponsor

Shanghai Bovax Biotechnology Co., Ltd.


 Chongqing Bovax Biopharmaceutical Co., Ltd.

Study Sponsor

, , 

Verification Date

February 2022