<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/NCT03755427</url>
  </required_header>
  <id_info>
    <org_study_id>2016L09902/3-2</org_study_id>
    <nct_id>NCT03755427</nct_id>
  </id_info>
  <brief_title>A Study of An Adjuvanted Inactivated H7N9 Influenza Vaccine</brief_title>
  <official_title>Immunogenicity and Safety of an Alum-adjuvanted Inactivated H7N9 Influenza Vaccine: a Randomized, Blind, Placebo-controlled, a Phase II Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Institute Of Biological Products</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Institute Of Biological Products</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The aim of this study is to investigate the immunogenicity and safety of the inactivated&#xD;
      whole-virion vaccine for teenagers and adults.&#xD;
&#xD;
      The investigators will test the vaccine in participants aged above 12 years, for a&#xD;
      randomized, blind, placebo-controlled, clinical study. The investigators designed one dosage&#xD;
      groups: 15 μg of hemagglutinin antigen. Control group is designed to inoculate seasonal&#xD;
      influence vaccine and aluminum hydroxide adjuvant. Participants will receive 2 doses of&#xD;
      vaccine at 21-day intervals. Safety up to 6 months and changes in hemagglutinin inhibition&#xD;
      (HI) titers at 21 days after each vaccination will be determined.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 2018</start_date>
  <completion_date type="Anticipated">January 2020</completion_date>
  <primary_completion_date type="Anticipated">May 2019</primary_completion_date>
  <phase>Phase 2</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>Number of Subjects Reporting Solicited and Unsolicited Adverse Events (AEs)</measure>
    <time_frame>Continuous observation for 30 days after two inoculations</time_frame>
    <description>For each group the incidence rate of subjects with solicited AE(s) with 95% confidence interval&#xD;
For each group the incidence rate of subjects with unsolicited AE(s) with 95% confidence interval</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants that presented seroconversion post injection</measure>
    <time_frame>21 days after two inoculations</time_frame>
    <description>Seroconvertion is defined as: prevaccination Hemagglutination-inhibition test (HI) antibody titer ≤1:10 and postvaccination HI antibody titer ≥1:40, or prevaccination HI antibody titer ≥1:10 and a postvaccination increase by a factor of four or more.&#xD;
Participants will be collected blood post first study injection, when blood samples will be taken for HI testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants that presented seroprotection post injection</measure>
    <time_frame>21 days after two inoculations</time_frame>
    <description>Seroprotection is defined as postvaccination Hemagglutination-inhibition test (HI) antibody titer ≥ 1:40.&#xD;
Participants will be collected blood post first study injection, when blood samples will be taken for HI testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric mean of Hemagglutination-inhibition titre post first study injection</measure>
    <time_frame>21 days after two inoculations</time_frame>
    <description>Geometric mean of Hemagglutination-inhibition test titre will be calculated for the different groups of participants post first study injection.&#xD;
Participants will be collected blood post first study injection, when blood samples will be taken for HI testing.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">560</enrollment>
  <condition>H7N9 Influenza</condition>
  <arm_group>
    <arm_group_label>15μg H7N9 Vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be inoculated with 2 doses of 15μg hemagglutinin antigen of H7N9 vaccine at 21-day intervals.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aluminum hydroxide adjuvant</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will be first inoculated with one dose of seasonal influenza vaccine and followed with one dose of aluminum hydroxide adjuvant at 21-day intervals.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>15μg H7N9 Vaccine</intervention_name>
    <description>The vaccine was a inactivated, whole virion preparation of the influenza A/Shanghai/2/2013(H7N9) virus, propagated in embryonated chicken eggs，mixed with aluminum hydroxide adjuvant.</description>
    <arm_group_label>15μg H7N9 Vaccine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Aluminum Hydroxide Adjuvant</intervention_name>
    <description>The seasonal influenza vaccine was a inactivated, split virion preparation of the influenza virus, propagated in embryonated chicken eggs. The aluminum hydroxide adjuvant was 0.5ml aluminum hydroxide adjuvant.</description>
    <arm_group_label>Aluminum hydroxide adjuvant</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over the age of 12 years, healthy population&#xD;
&#xD;
          -  Subjects/ (and the guardian) informed consent, voluntarily participated and signed the&#xD;
             informed consent form, with the ability to use thermometers, scales and to fill in&#xD;
             diary cards as required&#xD;
&#xD;
          -  To comply with the requirements of clinical trial program, receive blood test before&#xD;
             and after immunization and cooperate with follow-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A history of influenza A (H7N9) virus infection or suspected infection Abnormal blood&#xD;
             routine, blood biochemistry and urine routine examination indexes&#xD;
&#xD;
          -  Allergy to any component in the vaccine (allergy history of any previous vaccination),&#xD;
             especially for egg allergy&#xD;
&#xD;
          -  History of asthma, history of thyroid resection, vascular nerve edema, diabetes&#xD;
             mellitus, hypertension can not be controlled by medicine, liver and kidney diseases or&#xD;
             malignant tumor history&#xD;
&#xD;
          -  Suffered from any serious illness, such as cancer, autoimmune disease, progressive&#xD;
             atherosclerotic disease or complications of diabetes, chronic obstructive pulmonary&#xD;
             disease, need oxygen therapy for acute or progressive liver or kidney disease,&#xD;
             congestive heart-failure etc.&#xD;
&#xD;
          -  History of signs disease or symptoms of neurological symptoms&#xD;
&#xD;
          -  Suffering from severe chronic diseases (such as Down's syndrome, diabetes, sicklemia&#xD;
             or neurological disorders, Green's Barre syndrome)&#xD;
&#xD;
          -  Acute attacks of various acute or chronic diseases in the past 7 days&#xD;
&#xD;
          -  Known or suspected of respiratory disease, acute infection or chronic disease active&#xD;
             period, HIV infection, cardiovascular disease, severe hypertension, malignant tumor&#xD;
             during treatment, skin diseases&#xD;
&#xD;
          -  Congenital malformations or developmental disorders, genetic defects, severe&#xD;
             malnutrition etc&#xD;
&#xD;
          -  No spleen, functional absence of spleen, and splenectomy or splenectomy without any&#xD;
             condition&#xD;
&#xD;
          -  Autoimmune diseases or immunodeficiency have been treated with immunosuppressive&#xD;
             agents in the past 6 months&#xD;
&#xD;
          -  History of epilepsy, convulsions, or a family history of psychosis&#xD;
&#xD;
          -  Abnormal coagulation function (such as coagulation factor deficiency, coagulation&#xD;
             disorders, platelet abnormalities), or obvious bruising or coagulopathy&#xD;
&#xD;
          -  The blood products were received within 3 months prior to the acceptance of the&#xD;
             vaccine&#xD;
&#xD;
          -  Received a live vaccine within 14 days prior to receiving the vaccine, or received a&#xD;
             subunit or inactivated vaccine within 7 days&#xD;
&#xD;
          -  Fever within 3 days prior to vaccination, axillary temperature ≥38 ℃&#xD;
&#xD;
          -  Being febrile When inoculating vaccine, axillary temperature &gt;37.0 ℃&#xD;
&#xD;
          -  Women are pregnant or in the near future planned pregnancy or pregnancy test positive&#xD;
&#xD;
          -  Participants in another clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xia Shengli, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Henan Center for Disease Control and Prevention</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chen Ze, PhD</last_name>
    <phone>+86-021-62826658</phone>
    <email>chenze2005@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Suiping Center for Disease Control and Prevention</name>
      <address>
        <city>Zhumadian</city>
        <state>Henan</state>
        <zip>463100</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 14, 2018</study_first_submitted>
  <study_first_submitted_qc>November 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>November 27, 2018</last_update_submitted>
  <last_update_submitted_qc>November 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>H7N9</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
    <mesh_term>Influenza in Birds</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aluminum Hydroxide</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 18, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT03755427/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03755427
org study id: 2016L09902/3-2
nct id: NCT03755427
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to investigate the immunogenicity and safety of the inactivated
      whole-virion vaccine for teenagers and adults.

      The investigators will test the vaccine in participants aged above 12 years, for a
      randomized, blind, placebo-controlled, clinical study. The investigators designed one dosage
      groups: 15 μg of hemagglutinin antigen. Control group is designed to inoculate seasonal
      influence vaccine and aluminum hydroxide adjuvant. Participants will receive 2 doses of
      vaccine at 21-day intervals. Safety up to 6 months and changes in hemagglutinin inhibition
      (HI) titers at 21 days after each vaccination will be determined.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Subjects Reporting Solicited and Unsolicited Adverse Events (AEs)
time frame: Continuous observation for 30 days after two inoculations
description: For each group the incidence rate of subjects with solicited AE(s) with 95% confidence interval
For each group the incidence rate of subjects with unsolicited AE(s) with 95% confidence interval
measure: Number of participants that presented seroconversion post injection
time frame: 21 days after two inoculations
description: Seroconvertion is defined as: prevaccination Hemagglutination-inhibition test (HI) antibody titer ≤1:10 and postvaccination HI antibody titer ≥1:40, or prevaccination HI antibody titer ≥1:10 and a postvaccination increase by a factor of four or more.
Participants will be collected blood post first study injection, when blood samples will be taken for HI testing
measure: Number of participants that presented seroprotection post injection
time frame: 21 days after two inoculations
description: Seroprotection is defined as postvaccination Hemagglutination-inhibition test (HI) antibody titer ≥ 1:40.
Participants will be collected blood post first study injection, when blood samples will be taken for HI testing
measure: Geometric mean of Hemagglutination-inhibition titre post first study injection
time frame: 21 days after two inoculations
description: Geometric mean of Hemagglutination-inhibition test titre will be calculated for the different groups of participants post first study injection.
Participants will be collected blood post first study injection, when blood samples will be taken for HI testing.
arm group label: 15μg H7N9 Vaccine
arm group type: Experimental
description: Participants will be inoculated with 2 doses of 15μg hemagglutinin antigen of H7N9 vaccine at 21-day intervals.
arm group label: Aluminum hydroxide adjuvant
arm group type: Placebo Comparator
description: Participants will be first inoculated with one dose of seasonal influenza vaccine and followed with one dose of aluminum hydroxide adjuvant at 21-day intervals.
intervention type: Biological
intervention name: 15μg H7N9 Vaccine
description: The vaccine was a inactivated, whole virion preparation of the influenza A/Shanghai/2/2013(H7N9) virus, propagated in embryonated chicken eggs，mixed with aluminum hydroxide adjuvant.
arm group label: 15μg H7N9 Vaccine
intervention type: Biological
intervention name: Aluminum Hydroxide Adjuvant
description: The seasonal influenza vaccine was a inactivated, split virion preparation of the influenza virus, propagated in embryonated chicken eggs. The aluminum hydroxide adjuvant was 0.5ml aluminum hydroxide adjuvant.
arm group label: Aluminum hydroxide adjuvant
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Xia Shengli, PhD
role: Principal Investigator
affiliation: Henan Center for Disease Control and Prevention
last name: Chen Ze, PhD
phone: +86-021-62826658
email: chenze2005@hotmail.com
facility: 
country: China
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Influenza in Birds
mesh term: Aluminum Hydroxide
provided document: 