xml: <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/NCT05969626</url>
    </required_header>
    <id_info>
      <org_study_id>AIM1813-III</org_study_id>
      <nct_id>NCT05969626</nct_id>
    </id_info>
    <brief_title>Clinical Trial of Freeze-dried Human Rabies Vaccine (Without Serum Vero Cells)</brief_title>
    <official_title>A Randomized, Blinded, Parallel Controlled Phase 3 Clinical Trial to Evaluate the Immunogenicity and Safety of Freeze-dried Human Rabies Vaccine (Without Serum Vero Cells) Administered to People Aged 10-60 Years With Different Immunization Procedures</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ningbo Rongan Biological Pharmaceutical Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ningbo Rongan Biological Pharmaceutical Co., Ltd.</source>
    <oversight_info>
      <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 was intended to explore the safety and immunogenicity of the test vaccine compared&#xD;
        to the control vaccine. The trial consisted of two phases.&#xD;
  &#xD;
        Phase I used an open-ended design. Phase II used a randomized, blinded, parallel-controlled&#xD;
        non-inferiority design with the same type of active vaccine, in which the control vaccine&#xD;
        5-dose group and the test vaccine 5 group were kept blinded throughout, the test vaccine&#xD;
        4-dose B group was kept blinded from the other three groups until visit 4 （D14）, and the test&#xD;
        vaccine 4-dose A group was kept blinded from the control vaccine 5-dose group and the test&#xD;
        vaccine 5-dose group until visit 5 （D28）.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">April 2024</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Antibody SCR in 5-dose groups of test vaccine and 5-dose groups of control vaccine</measure>
      <time_frame>Day 14</time_frame>
      <description>Antibody Seroconversion rate in 5-dose groups of test vaccine and 5-dose groups of control vaccine</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Antibody GMC in 5-dose groups of test vaccine and 5-dose groups of control vaccine</measure>
      <time_frame>Day 14</time_frame>
      <description>Antibody Geometric Mean Concentration in 5-dose groups of test vaccine and 5-dose groups of control vaccine</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Antibody SCR in 4-dose groups of test vaccine and 5-dose groups of control vaccine</measure>
      <time_frame>Day 14</time_frame>
      <description>Antibody Seroconversion rate in 4-dose groups of test vaccine and 5-dose groups of control vaccine</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Antibody GMC in 4-dose groups of test vaccine and 5-dose groups of control vaccine</measure>
      <time_frame>Day 14</time_frame>
      <description>Antibody Geometric Mean Concentration in 4-dose groups of test vaccine and 5-dose groups of control vaccine</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Antibody SCR in 5-dose groups of test vaccine and 5-dose groups of control vaccine</measure>
      <time_frame>Day 42</time_frame>
      <description>Antibody Seroconversion rate in 5-dose groups of test vaccine and 5-dose groups of control vaccine</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Antibody SCR in 4-dose groups of test vaccine and 5-dose groups of control vaccine</measure>
      <time_frame>Day 42</time_frame>
      <description>Antibody Seroconversion rate in 4-dose groups of test vaccine and 5-dose groups of control vaccine</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">2460</enrollment>
    <condition>Rabies</condition>
    <arm_group>
      <arm_group_label>5-dose group of test vaccine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>5-dose group of control vaccine</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>4-dose A group of test vaccine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>4-dose B group of test vaccine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>5-dose group of test vaccine</intervention_name>
      <description>Subjects will be vaccinated on days 0, 3, 7, 14, and 28</description>
      <arm_group_label>5-dose group of test vaccine</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>5-dose group of control vaccine</intervention_name>
      <description>Subjects will be vaccinated on days 0, 3, 7, 14, and 28</description>
      <arm_group_label>5-dose group of control vaccine</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>4-dose A group of test vaccine</intervention_name>
      <description>Subjects will be vaccinated on days 0, 3, 7, 14</description>
      <arm_group_label>4-dose A group of test vaccine</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>4-dose B group of test vaccine</intervention_name>
      <description>Subjects will be vaccinated on days 0, 3, 7, 28</description>
      <arm_group_label>4-dose B group of test vaccine</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. The age of the subject is 10-60 years old (≥10 years old, &lt;61 years old);&#xD;
  &#xD;
            2. Subjects aged 10-17 and their guardians can provide valid identification; subjects&#xD;
               aged 18-60 can provide valid identification;&#xD;
  &#xD;
            3. Subjects aged 10-17 and at least one of their guardians voluntarily participate with&#xD;
               informed consent, and sign the Informed Consent for minors and adults respectively;&#xD;
               Subjects aged 18-60 voluntarily participate with informed consent and sign the adult&#xD;
               version of Informed Consent; Basic reading and writing skills are required;&#xD;
  &#xD;
            4. If the subjects are WOCBP (women of childbearing potential), they should not be&#xD;
               pregnant or breastfeeding, have a negative urine pregnancy test before vaccination,&#xD;
               and have taken effective contraceptive measures within 2 weeks before being enrolled&#xD;
               in this study; From enrollment in the study until 6 months after full exemption, no&#xD;
               family planning and consent to use effective contraception during the study period.&#xD;
               Effective forms of birth control include: oral contraceptives (excluding emergency&#xD;
               contraceptives)Injectable or embedded contraception, sustained release topical&#xD;
               contraceptives, hormonal patches, intrauterine devices, sterilization, abstinence,&#xD;
               condoms (male), isolationMembrane, cervical cap, etc.;&#xD;
  &#xD;
            5. * On the day of enrollment, armpit body temperature of subjects &gt;14 years old was&#xD;
               &lt;37.3℃, and armpit body temperature of subjects &lt;14 years old was &lt;37.5℃;&#xD;
  &#xD;
            6. Adult subjects or minor subjects and their guardians shall comply with the&#xD;
               requirements of the clinical study protocol.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Exclusion Criteria at 1-dose:&#xD;
  &#xD;
                 1. A history of rabies vaccine immunization or rabies virus passive immunization was&#xD;
                    asked;&#xD;
  &#xD;
                 2. A history of grade 2 or 3 injury in animals susceptible to rabies virus (cats,&#xD;
                    dogs, etc.) within 12 months prior to the first dose of vaccination (the&#xD;
                    assessment criteria was the Technical Guidelines for Rabies Prevention and&#xD;
                    Control (2016));&#xD;
  &#xD;
                 3. Plan to participate in other clinical trials during the clinical study;&#xD;
  &#xD;
                 4. Allergic to any component of the test vaccine; History of severe allergies that&#xD;
                    require medical intervention, such as anaphylactic shock, allergic laryngeal&#xD;
                    edema, anaphylactoid purpura, thrombocytopenic purpura, allergic necrosis&#xD;
                    reaction (Arthus reaction), severe urticaria, dyspnea, angioneurotic edema, etc.;&#xD;
  &#xD;
                 5. Have been diagnosed with a congenital or acquired immunodeficiency disease, such&#xD;
                    as HIV infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid&#xD;
                    arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other&#xD;
                    immune disease that the investigator has determined may affect the evaluation of&#xD;
                    the trial;&#xD;
  &#xD;
                 6. Known or suspected serious medical conditions upon inquiry include: severe&#xD;
                    respiratory diseases, poorly controlled chronic diseases, severe liver and kidney&#xD;
                    diseases, severe cardiovascular diseases, malignant tumors, etc.;&#xD;
  &#xD;
                 7. * Medically unmanageable hypertension, such as systolic blood pressure &gt;120mmHg&#xD;
                    and/or diastolic blood pressure &gt;80mmHg in subjects 10 to 17 years of age prior&#xD;
                    to enrollment, systolic blood pressure of 140mmHg and/or diastolic blood pressure&#xD;
                    of 90mmHg in subjects 18 years of age and older;&#xD;
  &#xD;
                 8. Coagulation dysfunction (e.g. coagulation factor deficiency, coagulation&#xD;
                    disorders, platelet abnormalities) or coagulation disorders diagnosed by a&#xD;
                    physician;&#xD;
  &#xD;
                 9. Asplenia, functional asplenia, and any condition resulting in asplenia or&#xD;
                    splenectomy;&#xD;
  &#xD;
                10. Have received immunosuppressive therapy within 3 months prior to vaccination or&#xD;
                    plan to receive immunosuppressive therapy throughout the study period;&#xD;
  &#xD;
                11. Plan to receive such treatment within 30 days after the first dose to the full&#xD;
                    dose, such as long-term systemic glucocorticoid therapy (2 weeks or more at a&#xD;
                    dose of &gt;2mg/kg/ day or &gt;20mg/ day of prednisone or equivalent); Allow topical&#xD;
                    use (such as ointment, eye drops, inhalants or nasal sprays);&#xD;
  &#xD;
                12. * Received immunoglobulins or blood-related products within 3 months prior to&#xD;
                    vaccination or plan to receive them throughout the study period;&#xD;
  &#xD;
                13. * Acute illness or acute onset of chronic disease within 3 days prior to&#xD;
                    vaccination;&#xD;
  &#xD;
                14. * Antipyretic, analgesic and anti-allergic drugs were used within 3 days prior to&#xD;
                    vaccination;&#xD;
  &#xD;
                15. * Have received COVID-19 vaccine or live attenuated vaccine within 28 days prior&#xD;
                    to vaccination, and have received inactivated vaccines other than COVID-19&#xD;
                    inactivated vaccines within 14 days prior to vaccination;&#xD;
  &#xD;
                16. Previous or current diagnosis of neurological or psychiatric disorders (including&#xD;
                    but not limited to dementia, schizophrenia, bipolar disorder, etc.) or confirmed&#xD;
                    Seizures, convulsions (excluding febrile convulsions in children 5 years of age&#xD;
                    and younger)), and other neuropsychiatric disorders deemed unsuitable for&#xD;
                    participation in this study by the investigator;&#xD;
  &#xD;
                17. Due to various medical, psychological, social, or other conditions that, in the&#xD;
                    judgment of the investigator, are inconsistent with the study protocol or cannot&#xD;
                    be complied with.&#xD;
  &#xD;
                    For the criteria marked with an (*), if the subject has the conditions specified&#xD;
                    in that criteria, the visit may be rescheduled when those conditions are no&#xD;
                    longer present.&#xD;
  &#xD;
                    In addition to the examination items set by the protocol, other medical history,&#xD;
                    surgical history, and medication history were obtained in the form of&#xD;
                    consultation.&#xD;
  &#xD;
                    Criteria for subsequent dose delays:If any of the following conditions occur&#xD;
                    before any subsequent dose of the subject, the vaccination should be postponed&#xD;
                    until the vaccination requirements are met.&#xD;
  &#xD;
                 1. On the day of vaccination, the axillary temperature is measured at 37.3℃ for&#xD;
                    subjects &gt;14 years old and 37.5℃ for subjects &lt;14 years old.&#xD;
  &#xD;
                 2. Acute illness or acute onset of chronic disease within 3 days prior to&#xD;
                    vaccination;&#xD;
  &#xD;
                 3. Other conditions for which investigators decide vaccination should be delayed.&#xD;
                    Exclusion criteria for subsequent dose vaccination:If any of the following occurs&#xD;
                    during the study safety observation period, subjects may not continue with&#xD;
                    vaccination, but may continue with other study steps at the discretion of the&#xD;
                    investigator.&#xD;
  &#xD;
                 1. Newly discovered or newly occurred before vaccination that did not meet the&#xD;
                    inclusion criteria (except items with *);&#xD;
  &#xD;
                 2. Meet the exclusion criteria for the first dose (except for items with *);&#xD;
  &#xD;
                 3. Vaccination-related adverse events occur after vaccination and subsequent doses&#xD;
                    are not considered appropriate by investigators;&#xD;
  &#xD;
                 4. The investigator determines any circumstances that require discontinuation of&#xD;
                    vaccination from a subject risk and benefit perspective.&#xD;
  &#xD;
          Exclusion criteria for immunopersistent blood collection:&#xD;
  &#xD;
            1. Incomplete full immunization;&#xD;
  &#xD;
            2. Vaccination with rabies immunoglobulin or other rabies vaccines within 12 months after&#xD;
               full immunization;&#xD;
  &#xD;
            3. Long-term use (&gt;15 days) of immunosuppressants or other immunomodulatory drugs (such&#xD;
               as glucocorticoids) within 12 months after full vaccination;&#xD;
  &#xD;
            4. Any other circumstances that the investigator believes may affect the evaluation of&#xD;
               the trial.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>10 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ting Huang</last_name>
      <phone>13330993324</phone>
      <email>cocoht@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Sichuan Center for Disease Control and Prevention</name>
        <address>
          <city>Chengdu</city>
          <state>Sichuan</state>
          <zip>610041</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Ting Huang</last_name>
        <phone>13330993324</phone>
        <email>cocoht@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Center for Disease Control and Prevention, Mianyang City</name>
        <address>
          <city>Mianyang</city>
          <state>Sichuan</state>
          <zip>621000</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Youquan Liu</last_name>
        <phone>13608120046</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shizhong District, Neijiang City Center for Disease Control and Prevention</name>
        <address>
          <city>Neijiang</city>
          <state>Sichuan</state>
          <zip>511002</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Ling Zhong</last_name>
        <phone>18981435233</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Rongxian Center for Disease Control and Prevention</name>
        <address>
          <city>Zigong</city>
          <state>Sichuan</state>
          <zip>643199</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Zaixing Li</last_name>
        <phone>18990015566</phone>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 6, 2023</last_update_submitted>
    <last_update_submitted_qc>August 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</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>Rabies</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vaccines</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05969626
  org study id: AIM1813-III
  nct id: NCT05969626
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study was intended to explore the safety and immunogenicity of the test vaccine compared
        to the control vaccine. The trial consisted of two phases.
  
        Phase I used an open-ended design. Phase II used a randomized, blinded, parallel-controlled
        non-inferiority design with the same type of active vaccine, in which the control vaccine
        5-dose group and the test vaccine 5 group were kept blinded throughout, the test vaccine
        4-dose B group was kept blinded from the other three groups until visit 4 （D14）, and the test
        vaccine 4-dose A group was kept blinded from the control vaccine 5-dose group and the test
        vaccine 5-dose group until visit 5 （D28）.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Antibody SCR in 5-dose groups of test vaccine and 5-dose groups of control vaccine
  time frame: Day 14
  description: Antibody Seroconversion rate in 5-dose groups of test vaccine and 5-dose groups of control vaccine
  measure: Antibody GMC in 5-dose groups of test vaccine and 5-dose groups of control vaccine
  time frame: Day 14
  description: Antibody Geometric Mean Concentration in 5-dose groups of test vaccine and 5-dose groups of control vaccine
  measure: Antibody SCR in 4-dose groups of test vaccine and 5-dose groups of control vaccine
  time frame: Day 14
  description: Antibody Seroconversion rate in 4-dose groups of test vaccine and 5-dose groups of control vaccine
  measure: Antibody GMC in 4-dose groups of test vaccine and 5-dose groups of control vaccine
  time frame: Day 14
  description: Antibody Geometric Mean Concentration in 4-dose groups of test vaccine and 5-dose groups of control vaccine
  measure: Antibody SCR in 5-dose groups of test vaccine and 5-dose groups of control vaccine
  time frame: Day 42
  description: Antibody Seroconversion rate in 5-dose groups of test vaccine and 5-dose groups of control vaccine
  measure: Antibody SCR in 4-dose groups of test vaccine and 5-dose groups of control vaccine
  time frame: Day 42
  description: Antibody Seroconversion rate in 4-dose groups of test vaccine and 5-dose groups of control vaccine
  arm group label: 5-dose group of test vaccine
  arm group type: Experimental
  arm group label: 5-dose group of control vaccine
  arm group type: Active Comparator
  arm group label: 4-dose A group of test vaccine
  arm group type: Experimental
  arm group label: 4-dose B group of test vaccine
  arm group type: Experimental
  intervention type: Biological
  intervention name: 5-dose group of test vaccine
  description: Subjects will be vaccinated on days 0, 3, 7, 14, and 28
  arm group label: 5-dose group of test vaccine
  intervention type: Biological
  intervention name: 5-dose group of control vaccine
  description: Subjects will be vaccinated on days 0, 3, 7, 14, and 28
  arm group label: 5-dose group of control vaccine
  intervention type: Biological
  intervention name: 4-dose A group of test vaccine
  description: Subjects will be vaccinated on days 0, 3, 7, 14
  arm group label: 4-dose A group of test vaccine
  intervention type: Biological
  intervention name: 4-dose B group of test vaccine
  description: Subjects will be vaccinated on days 0, 3, 7, 28
  arm group label: 4-dose B group of test vaccine
  criteria: 
  gender: All
  minimum age: 10 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ting Huang
  phone: 13330993324
  email: cocoht@163.com
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Rabies
  mesh term: Vaccines