<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04422366</url>
  </required_header>
  <id_info>
    <org_study_id>9-HPV-3001</org_study_id>
    <nct_id>NCT04422366</nct_id>
  </id_info>
  <brief_title>Evaluate the Efficacy, Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females</brief_title>
  <official_title>A Multicenter,Randomized,Blind and Positive-Controlled Phase Ⅲ Study to Evaluate the Efficacy, Immunogenicity and Safety of the 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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Bovax Biotechnology Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Bovax Biotechnology Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to evaluate the vaccine efficacy, immunogenicity and safety of the&#xD;
      9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine&#xD;
      (Hansenula Polymorpha) in Chinese Female Subjects Aged 20-45 Years .&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 28, 2020</start_date>
  <completion_date type="Anticipated">September 15, 2029</completion_date>
  <primary_completion_date type="Anticipated">September 15, 2027</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related high-grade cervical abnormalities (CIN 2/3) at least 1 month post Dose 3</measure>
    <time_frame>1 month post vaccination 3 (Month 7) up to Month 84</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related 6-month and 12-month Persistent Infection at least 1 month post Dose 3</measure>
    <time_frame>1 month post vaccination 3 (Month 7) up to Month 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related VIN 1/2/3, VaIN1/2/3, AIN1/2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 3</measure>
    <time_frame>1 month post vaccination 3 (Month 7) up to Month 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related VIN 2/3, VaIN2/3, AIN2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 3</measure>
    <time_frame>1 month post vaccination 3 (Month 7) up to Month 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The person-year incidence of other HPV types related CIN 2/3 at least 1 month post Dose 3</measure>
    <time_frame>1 month post vaccination 3 (Month 7) up to Month 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The person-year incidence of other HPV types related VIN 1/2/3, VaIN1/2/3, AIN1/2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 3</measure>
    <time_frame>1 month post vaccination 3 (Month 7) up to Month 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related high-grade cervical abnormalities (CIN 2/3) at least 1 month post Dose 1</measure>
    <time_frame>1 month post vaccination 1 up to Month 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related 6-month and 12-month Persistent Infection at least 1 month post Dose 1</measure>
    <time_frame>1 month post vaccination 1 up to Month 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related VIN 2/3, VaIN2/3, AIN2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 1</measure>
    <time_frame>1 month post vaccination 1 up to Month 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related VIN 1/2/3, VaIN1/2/3, AIN1/2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 1</measure>
    <time_frame>1 month post vaccination 1 up to Month 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The person-year incidence of other HPV types related VIN 2/3, VaIN2/3, AIN2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 3</measure>
    <time_frame>1 month post vaccination 3 (Month 7) up to Month 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The person-year incidence of other HPV types related CIN 2/3 at least 1 month post Dose 1</measure>
    <time_frame>1 month post vaccination 1 up to Month 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The person-year incidence of other HPV types related VIN 1/2/3, VaIN1/2/3, AIN1/2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 1</measure>
    <time_frame>1 month post vaccination 1 up to Month 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The person-year incidence of other HPV types related VIN 2/3, VaIN2/3, AIN2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 1</measure>
    <time_frame>1 month post vaccination 1 up to Month 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Report at Least 1 Solicited Injection-site and Systemic Adverse Event 30 minutes post any vaccination</measure>
    <time_frame>30 minutes post any vaccination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Report at Least 1 Solicited Adverse Event 7 days post any vaccination</measure>
    <time_frame>7 days post any vaccination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Report at Least 1 Solicited and Unsolicited Adverse Event 30 days post any vaccination</measure>
    <time_frame>30 days post any vaccination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE) from 1st vaccination to the completion of study</measure>
    <time_frame>1 month post vaccination 3 (Month 7) up to Month 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Experience Pregnancy from 1st vaccination to the completion of study</measure>
    <time_frame>1 month post vaccination 3 (Month 7) up to Month 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>neutralizing antibody level</measure>
    <time_frame>30 days post third dose of vaccination</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">8000</enrollment>
  <condition>Cervical Cancer</condition>
  <condition>Vulvar Cancer</condition>
  <condition>Vaginal Cancer</condition>
  <condition>CIN1</condition>
  <condition>CIN2</condition>
  <condition>CIN3</condition>
  <condition>VaIN1</condition>
  <condition>VaIN2</condition>
  <condition>VaIN3</condition>
  <condition>Genital Wart</condition>
  <condition>VIN 1</condition>
  <condition>VIN 2</condition>
  <condition>VIN 3</condition>
  <condition>AIS</condition>
  <arm_group>
    <arm_group_label>9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm would receive 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GARDASIL®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this arm would receive GARDASIL®</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha)</intervention_name>
    <description>Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule.</description>
    <arm_group_label>9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>GARDASIL®</intervention_name>
    <description>Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule</description>
    <arm_group_label>GARDASIL®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        (If the &quot;*&quot; option is not met during screening, the visit can be rescheduled)&#xD;
&#xD;
          -  Chinese women aged 20-45 who can provide legal identification and have a sexual life&#xD;
             history;&#xD;
&#xD;
          -  The subject fully understands the study procedures, understands the risks and benefits&#xD;
             associated with participating in the study, and voluntarily signs the informed&#xD;
             consent;&#xD;
&#xD;
          -  Subjects are able to read, understand and fill in application forms such as diary&#xD;
             CARDS and contact CARDS, and participate in follow-up according to the study&#xD;
             requirements;&#xD;
&#xD;
          -  Subjects have not been screened for cervical cancer, or have been screened for&#xD;
             cervical cancer but the results are normal;&#xD;
&#xD;
          -  *0 days before the gynecological visit, no sex within 48 hours, no flushing or vaginal&#xD;
             cleaning within 72 hours, no use of vaginal drugs or preparations;Subject agrees to&#xD;
             refrain from sexual intercourse (including anal, vaginal, or genital/genital contact&#xD;
             of the same or opposite sex) for 48 hours prior to any visit that includes&#xD;
             gynecological sample collection, and to refrain from vaginal flushing, vaginal&#xD;
             cleansing, or use of vaginal medications or preparations for 72 hours;&#xD;
&#xD;
          -  When the subjects were enrolled, the urine pregnancy test was negative (sensitivity&#xD;
             was 25mIU/ml cox-hcg), they were not in the lactation period and had no family&#xD;
             planning within 7 months after enrollment (1 month before whole-course inoculation).2&#xD;
             weeks before included in the study, effective contraceptive measures has been adopted&#xD;
             and agreed to in the first seven months after the study (vaccinations after 1 months&#xD;
             ago) continue to adopt effective contraceptive measures (effective contraceptive&#xD;
             measures include: the pill, injection or embedded contraception, slow-release local&#xD;
             birth control pills, hormone patch, the intrauterine device (IUD), sterilization,&#xD;
             abstinence, condom (men), diaphragm, cervical cap, etc.), rhythm, withdrawal and&#xD;
             emergency contraception is unacceptable contraception;&#xD;
&#xD;
          -  *body temperature &lt;37.3℃ (underarm body temperature)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        First dose exclusion criteria(If the &quot;*&quot; option is met during screening, the visit can be&#xD;
        rescheduled)&#xD;
&#xD;
          -  Have been vaccinated with commercially available HPV vaccine in the past or planned to&#xD;
             be vaccinated with commercially available HPV vaccine during the study period;Or have&#xD;
             participated in a clinical trial of the HPV vaccine and have received a&#xD;
             vaccine/placebo vaccination;&#xD;
&#xD;
          -  Previous positive history of HPV;&#xD;
&#xD;
          -  Has a history of abnormal cervical cytology, including squamous intraepithelial&#xD;
             lesions (SIL) or not clear meaning of the atypical squamous cells (ASC - US), except&#xD;
             the atypical squamous cells - not highly squamous intraepithelial lesion (ASC - H),&#xD;
             atypical glandular epithelial cells, or those with cervical intraepithelial neoplasia&#xD;
             (CIN) and carcinoma in situ or abnormal cervical biopsy results such as the history;&#xD;
&#xD;
          -  Past history of anal and genital diseases (such as vulvar intraepithelial neoplasia,&#xD;
             vaginal intraepithelial neoplasia, genital warts, vulvar cancer, vaginal cancer and&#xD;
             anal cancer, etc.);&#xD;
&#xD;
          -  Received total hysterectomy or pelvic radiotherapy;&#xD;
&#xD;
          -  Cervical insufficiency or abnormal cervical structure (judged by the results of&#xD;
             routine gynecological examination);&#xD;
&#xD;
          -  Previous sexual history (including syphilis, gonorrhea, chancre, venereal lymphatic&#xD;
             granuloma, granuloma inguinal) or have obvious condyloma;&#xD;
&#xD;
          -  A history of seizures, convulsions or convulsions, or a family history of mental&#xD;
             illness;&#xD;
&#xD;
          -  Have participated in other gynecology-related clinical trials within 6 months, and&#xD;
             have used or plan to use other investigational or unregistered products (drugs or&#xD;
             vaccines) other than the vaccine in this study within 3 months;&#xD;
&#xD;
          -  A history of severe allergies requiring medical intervention, such as anaphylactic&#xD;
             shock, anaphylactic laryngeal edema, allergic purpura, thrombocytopenic purpura, local&#xD;
             allergic necrosis reaction (Arthus reaction), etc.A history of severe adverse&#xD;
             reactions to previous vaccinations or a history of severe allergies to any of the&#xD;
             components of the vaccine under study (histidine, polysorbate, aluminum phosphate,&#xD;
             sodium borate, amorphous aluminum phosphate sulfate adjuvant and water for injection)&#xD;
             (such as swelling of the mouth and throat, dyspnea, hypotension or shock, severe&#xD;
             urticaria, etc.);&#xD;
&#xD;
          -  Subject receives any immunoglobulin or blood product within 3 months prior to the&#xD;
             first dose of vaccination, or plans to receive such product within the next 7 months&#xD;
             (1 month prior to the full course of vaccination);&#xD;
&#xD;
          -  Subjects present/present with immune impairment or have been diagnosed with congenital&#xD;
             or acquired immune deficiency, HIV infection, lymphoma, leukemia, systemic lupus&#xD;
             erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA),&#xD;
             inflammatory bowel disease or other autoimmune diseases;&#xD;
&#xD;
          -  Immunosuppressant therapy within 1 month before the first dose of vaccination, such as&#xD;
             long-term use of systemic glucocorticoid therapy (≥2mg/kg/ day, for more than 2 weeks,&#xD;
             such as prednisone or similar drugs;Topical administration (such as ointment, eye&#xD;
             drops, inhalant or nasal spray) not exceeding the recommended dosage in the directions&#xD;
             or showing any signs of systemic exposure) or planning to receive such treatment&#xD;
             within the next 7 months (1 month before the full course of inoculation);&#xD;
&#xD;
          -  Absence of spleen or functional absence of spleen, and absence of spleen or&#xD;
             splenectomy in any case;&#xD;
&#xD;
          -  Patients with severe liver, kidney and cardiovascular diseases, diabetes or malignant&#xD;
             tumor with complications;&#xD;
&#xD;
          -  Patients with thrombocytopenia or any coagulation disorders that may be&#xD;
             contraindications to intramuscular injection;&#xD;
&#xD;
          -  * subjects received inactivated or recombinant vaccines within 14 days prior to study&#xD;
             enrollment, or attenuated live vaccines within 28 days prior to study enrollment;&#xD;
&#xD;
          -  * an acute illness or an acute episode of a chronic illness within 3 days prior to&#xD;
             vaccination or the use of antipyretic, analgesic and antiallergic drugs (e.g.,&#xD;
             acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.);&#xD;
&#xD;
          -  * the first dose of vaccine was in pregnancy at the time of vaccination, or the end of&#xD;
             pregnancy had not exceeded 6 weeks;&#xD;
&#xD;
          -  * after questioning, subjects had fever symptoms (subaxillary body temperature ≥37.3℃)&#xD;
             before the first day of vaccination (within 24 hours before vaccination);&#xD;
&#xD;
          -  * the subject is in the menstrual period;&#xD;
&#xD;
          -  * severe acute vaginitis and suppurative cervicitis found by naked eye during&#xD;
             gynecological examination (purulent secretion visible by naked eye);&#xD;
&#xD;
          -  Blood pressure on physical examination before the first dose of vaccination was higher&#xD;
             than normal or increased (systolic blood pressure ≥140mmHg and/or diastolic blood&#xD;
             pressure ≥90mmHg);&#xD;
&#xD;
          -  Gynecological examination before the first dose of vaccination suspected genital&#xD;
             warts, or on the basis of clinical symptoms and signs suspected vulva, vagina or&#xD;
             cervical precancerous lesions and the possibility of cancer;&#xD;
&#xD;
          -  Subjects may be unable to comply with the study procedure, comply with the agreement,&#xD;
             or plan to permanently relocate from the region prior to completion of the study, or&#xD;
             may be permanently absent from the region during the scheduled visit;&#xD;
&#xD;
          -  In the opinion of the investigators, the subjects had any other factors that made them&#xD;
             unsuitable to participate in the clinical trial, so that continued participation in&#xD;
             the study could not guarantee the maximum benefit of the subjects.&#xD;
&#xD;
        Second and third doses of vaccine were excluded criteria&#xD;
&#xD;
          -  new discoveries or new occurrences that meet the first dose exclusion criteria (except&#xD;
             for articles 2, 3, 4, 21);&#xD;
&#xD;
          -  other serious adverse events: the investigator decides whether to terminate the&#xD;
             experimental vaccination according to its treatment needs;&#xD;
&#xD;
          -  the investigator assays for any other reasons that may be considered necessary to&#xD;
             terminate the trial vaccination.&#xD;
&#xD;
        Second and third doses of vaccine were delayed criteria&#xD;
&#xD;
        Vaccination may be postponed if:&#xD;
&#xD;
          -  fever (underarm body temperature ≥37.3℃);&#xD;
&#xD;
          -  before inoculation (on the day of inoculation), the urine pregnancy test was positive&#xD;
             (sensitivity was 25mIU/ml n-hcg);&#xD;
&#xD;
          -  acute illness or acute attack of a chronic disease or use of antipyretic, analgesic&#xD;
             and antiallergic drugs (e.g., acetaminophen, ibuprofen, aspirin, loratadine,&#xD;
             cetirizine, etc.) within 3 days before vaccination;&#xD;
&#xD;
          -  insufficient interval between other vaccines (inactivated or recombinant vaccines&#xD;
             received within 14 days prior to vaccination, or any live attenuated vaccine received&#xD;
             within 28 days);&#xD;
&#xD;
          -  any immunoglobulin or blood products received during vaccination should be&#xD;
             administered at least 3 months after the vaccination;&#xD;
&#xD;
          -  other circumstances that can be postponed as judged by the researcher.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Zhaojun Mo, Master</last_name>
    <phone>+8615177771508</phone>
    <email>mozhj@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Rongan County Center for Disease Control and Prevention</name>
      <address>
        <city>Rongan County</city>
        <state>Guangxi Zhuang Autonomous Region</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dingkai Wei, Master</last_name>
      <phone>+0860772-8135640</phone>
      <email>racdc@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>May 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>February 20, 2022</last_update_submitted>
  <last_update_submitted_qc>February 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Condylomata Acuminata</mesh_term>
    <mesh_term>Vulvar Neoplasms</mesh_term>
    <mesh_term>Vaginal Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04422366
org study id: 9-HPV-3001
nct id: NCT04422366
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is designed to evaluate the vaccine efficacy, immunogenicity and safety of the
      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 .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related high-grade cervical abnormalities (CIN 2/3) at least 1 month post Dose 3
time frame: 1 month post vaccination 3 (Month 7) up to Month 84
measure: The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related 6-month and 12-month Persistent Infection at least 1 month post Dose 3
time frame: 1 month post vaccination 3 (Month 7) up to Month 84
measure: The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related VIN 1/2/3, VaIN1/2/3, AIN1/2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 3
time frame: 1 month post vaccination 3 (Month 7) up to Month 84
measure: The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related VIN 2/3, VaIN2/3, AIN2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 3
time frame: 1 month post vaccination 3 (Month 7) up to Month 84
measure: The person-year incidence of other HPV types related CIN 2/3 at least 1 month post Dose 3
time frame: 1 month post vaccination 3 (Month 7) up to Month 84
measure: The person-year incidence of other HPV types related VIN 1/2/3, VaIN1/2/3, AIN1/2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 3
time frame: 1 month post vaccination 3 (Month 7) up to Month 84
measure: The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related high-grade cervical abnormalities (CIN 2/3) at least 1 month post Dose 1
time frame: 1 month post vaccination 1 up to Month 84
measure: The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related 6-month and 12-month Persistent Infection at least 1 month post Dose 1
time frame: 1 month post vaccination 1 up to Month 84
measure: The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related VIN 2/3, VaIN2/3, AIN2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 1
time frame: 1 month post vaccination 1 up to Month 84
measure: The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related VIN 1/2/3, VaIN1/2/3, AIN1/2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 1
time frame: 1 month post vaccination 1 up to Month 84
measure: The person-year incidence of other HPV types related VIN 2/3, VaIN2/3, AIN2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 3
time frame: 1 month post vaccination 3 (Month 7) up to Month 84
measure: The person-year incidence of other HPV types related CIN 2/3 at least 1 month post Dose 1
time frame: 1 month post vaccination 1 up to Month 84
measure: The person-year incidence of other HPV types related VIN 1/2/3, VaIN1/2/3, AIN1/2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 1
time frame: 1 month post vaccination 1 up to Month 84
measure: The person-year incidence of other HPV types related VIN 2/3, VaIN2/3, AIN2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 1
time frame: 1 month post vaccination 1 up to Month 84
measure: Percentage of Participants Who Report at Least 1 Solicited Injection-site and Systemic Adverse Event 30 minutes post any vaccination
time frame: 30 minutes post any vaccination
measure: Percentage of Participants Who Report at Least 1 Solicited Adverse Event 7 days post any vaccination
time frame: 7 days post any vaccination
measure: Percentage of Participants Who Report at Least 1 Solicited and Unsolicited Adverse Event 30 days post any vaccination
time frame: 30 days post any vaccination
measure: Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE) from 1st vaccination to the completion of study
time frame: 1 month post vaccination 3 (Month 7) up to Month 84
measure: Percentage of Participants Who Experience Pregnancy from 1st vaccination to the completion of study
time frame: 1 month post vaccination 3 (Month 7) up to Month 84
measure: neutralizing antibody level
time frame: 30 days post third dose of vaccination
arm group label: 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52
arm group type: Experimental
description: Participants in this arm would receive 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha)
arm group label: GARDASIL®
arm group type: Active Comparator
description: Participants in this arm would receive GARDASIL®
intervention type: Biological
intervention name: 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha)
description: Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule.
arm group label: 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52
intervention type: Biological
intervention name: GARDASIL®
description: Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule
arm group label: GARDASIL®
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Zhaojun Mo, Master
phone: +8615177771508
email: mozhj@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Condylomata Acuminata
mesh term: Vulvar Neoplasms
mesh term: Vaginal Neoplasms