<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/NCT03296410</url>
  </required_header>
  <id_info>
    <org_study_id>20170710</org_study_id>
    <nct_id>NCT03296410</nct_id>
  </id_info>
  <brief_title>The Phase IVd of Inactivated Enterovirus 71 Vaccine</brief_title>
  <official_title>The Safety and Immunogenicity of Enterovirus Type 71 Inactivated Vaccine (Human Diploid Cell) With Two Measles Attenuated Live Vaccine and Live Attenuated Japanese Encephalitis Vaccine at the Same Time Point in Infants (8-month-old)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Guangdong Center for Disease Prevention and Control</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</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>
      Enterovirus 71 (EV71), a major pathogen causing hand-foot-and-mouth disease (HFMD) worldwide,&#xD;
      is a member of the Human Enterovirus species A, family Picornaviridae. Its infection&#xD;
      occasionally leads to severe diseases and death, with central nervous system (CNS) damage.&#xD;
&#xD;
      Recently, except of inactivated vaccine, several EV71 vaccine candidates have been evaluated&#xD;
      in animals but no final results of clinical trials, such as attenuated vaccine, subunit&#xD;
      vaccine. A formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been&#xD;
      finished phase I, II and III clinical trials and licensed by SFDA in China at Dec. 3, 2015.&#xD;
      Based on the results of clinical trials, the protective efficacy of inactivated EV71 vaccine&#xD;
      is 97% against HFMD caused by EV71. The phase IV clinical trial has been carried out from&#xD;
      July 2016. The purpose of phase IVd is to evaluated the immunogenicity and safety of the&#xD;
      inactive EV71 vaccine within two measles attenuated live vaccine and live attenuated Japanese&#xD;
      encephalitis vaccine at the same time point in large scale population of Chinese children (8&#xD;
      months old) in Guangdong Province, China.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are two parts of phase IVd clinical trials have been performed. First, to evaluate the&#xD;
      immunogenicity of the inactive EV71 vaccine within two measles attenuated live vaccine and&#xD;
      live attenuated Japanese encephalitis vaccine at the same time point in large scale&#xD;
      population of Chinese children (8 months old), within 56-day-post-immunized.&#xD;
&#xD;
      Second, to safety of the inactive EV71 vaccine within two measles attenuated live vaccine and&#xD;
      live attenuated Japanese encephalitis vaccine at the same time point in large scale&#xD;
      population of Chinese children (8 months old), within 56-day-post-immunized.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">September 14, 2017</start_date>
  <completion_date type="Anticipated">September 2, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 2, 2019</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the seropositive rate of anti-EV71 antibodies in serum of children before first vaccination</measure>
    <time_frame>at 0 day before finishing 1st doses immunization</time_frame>
    <description>Bloods were obtained before first vaccination. The antibody titers were tested in serum of children.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate the seropositive rate of anti-EBV antibodies in serum of children before first vaccination</measure>
    <time_frame>at 0 day before finishing 1st doses immunization</time_frame>
    <description>Bloods were obtained before first vaccination. The antibody titers were tested in serum of children.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate the seropositive rate of anti-measles virus antibodies in serum of children before first vaccination</measure>
    <time_frame>at 0 day before finishing 1st doses immunization</time_frame>
    <description>Bloods were obtained before first vaccination. The antibody titers were tested in serum of children.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate the seropositive rate of anti-Rubella virus antibodies in serum of children before first vaccination</measure>
    <time_frame>at 0 day before finishing 1st doses immunization</time_frame>
    <description>Bloods were obtained before first vaccination. The antibody titers were tested in serum of children.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate the seroconversion rate of anti-EV71 antibodies in serum of children at 56 days after first vaccination</measure>
    <time_frame>at 56 days after finishing 1st doses immunization</time_frame>
    <description>Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate the seroconversion rate of anti-EBV antibodies in serum of children at 56 days after first vaccination</measure>
    <time_frame>at 56 days after finishing 1st doses immunization</time_frame>
    <description>Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate the seroconversion rate of anti-measles virus antibodies in serum of children at 56 days after first vaccination</measure>
    <time_frame>at 56 days after finishing 1st doses immunization</time_frame>
    <description>Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate the seroconversion rate of anti-Rubella virus antibodies in serum of children at 56 days after first vaccination</measure>
    <time_frame>at 56 days after finishing 1st doses immunization</time_frame>
    <description>Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the antibody titers of anti-EV71 antibodies in serum of children</measure>
    <time_frame>at 56 days after finishing 1st doses immunization</time_frame>
    <description>Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children at 56 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the antibody titers of anti-EBV antibodies in serum of children</measure>
    <time_frame>at 56 days after finishing 1st doses immunization</time_frame>
    <description>Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children at 56 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the antibody titers of anti-measles virus antibodies in serum of children</measure>
    <time_frame>at 56 days after finishing 1st doses immunization</time_frame>
    <description>Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children at 56 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the antibody titers of anti-Rubella virus antibodies in serum of children</measure>
    <time_frame>at 56 days after finishing 1st doses immunization</time_frame>
    <description>Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children at 56 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of treatment adverse events finishing 1st doses immunization</measure>
    <time_frame>within 28 days after finishing 1st doses immunization</time_frame>
    <description>The adverse events were observed and recorded within 30 minutes post immunization (p.i.), within 0-1 days post immunization (d.p.i.), within 1-3 d.p.i. and within 28 d.p.i. after the 1st injection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of treatment adverse events finishing 2nd doses immunization</measure>
    <time_frame>within 28 days after finishing 2nd doses immunization</time_frame>
    <description>The adverse events were observed and recorded within 30 minutes post immunization (p.i.), within 0-1 days post immunization (d.p.i.), within 1-3 d.p.i. and within 28 d.p.i. after injection.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">1220</enrollment>
  <condition>Hand, Foot and Mouth Disease (HFMD)</condition>
  <arm_group>
    <arm_group_label>EV71 and two measles attenuated live vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>infants vaccinated with enterovirus type 71 inactivated vaccine (human diploid cell) and two measles attenuated live vaccine at 8 months old, and vaccinated with the second dose of enterovirus type 71 inactivated vaccine (human diploid cell) at 9 months old.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EV71 and attenuated Japanese encephalitis vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>infants vaccinated with enterovirus type 71 inactivated vaccine (human diploid cell) and live attenuated Japanese encephalitis vaccine at 8 months old, and vaccinated with the second dose of enterovirus type 71 inactivated vaccine (human diploid cell) at 9 months old.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>two measles attenuated live vaccine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>infants vaccinated with two measles attenuated live vaccine at 8 months old</description>
  </arm_group>
  <arm_group>
    <arm_group_label>live attenuated Japanese encephalitis vaccine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>infants vaccinated with live attenuated Japanese encephalitis vaccine at 8 months old</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EV71 vaccine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>infants vaccinated with enterovirus type 71 inactivated vaccine (human diploid cell) at 8 months old, and vaccinated with the second dose of enterovirus type 71 inactivated vaccine (human diploid cell) at 9 months old.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>EV71 and two measles attenuated live vaccine</intervention_name>
    <description>infants vaccined with two dose (3.0 EU/dose) of inactivated enterovirus 71 vaccine (KMB-17) at 8 months old and 9 months old (namely interval one month). And meanwhile, they routine vaccined with two measles attenuated live vaccine at 8 months old.</description>
    <arm_group_label>EV71 and two measles attenuated live vaccine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>EV71 and attenuated Japanese encephalitis vaccine</intervention_name>
    <description>infants vaccined with two dose (3.0 EU/dose) of inactivated enterovirus 71 vaccine (KMB-17) at 8 months old and 9 months old (namely interval one month). And meanwhile, they routine vaccined with attenuated Japanese encephalitis vaccine at 8 months old.</description>
    <arm_group_label>EV71 and attenuated Japanese encephalitis vaccine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>two measles attenuated live vaccine</intervention_name>
    <description>infants vaccined with one dose two measles attenuated live vaccine at 8 months old.</description>
    <arm_group_label>two measles attenuated live vaccine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>live attenuated Japanese encephalitis vaccine</intervention_name>
    <description>infants vaccined with one dose attenuated Japanese encephalitis vaccine at 8 months old.</description>
    <arm_group_label>live attenuated Japanese encephalitis vaccine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>EV71 vaccine</intervention_name>
    <description>infants vaccined with two dose (3.0 EU/dose) of inactivated enterovirus 71 vaccine (KMB-17) at 8 months old and 9 months old (namely interval one month).</description>
    <arm_group_label>EV71 vaccine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects (6-71 months old children) as established by medical history and&#xD;
             clinical examination&#xD;
&#xD;
          -  The subjects' legal guardian must be aware of this vaccines&#xD;
&#xD;
          -  The subjects' legal guardian voluntarily participate in the study and signed Informed&#xD;
             Consent Form&#xD;
&#xD;
          -  Subjects with temperature ≤ 37.0 ℃&#xD;
&#xD;
          -  The subjects' legal guardian with the ability and objective to comply with the&#xD;
             requirements of the protocol&#xD;
&#xD;
          -  Persist for a 14-month visit (and receive blood, stool (or specimens by means of a&#xD;
             swab) tests according to program requirements in immunogenicity observation group)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy or serious side-effects to a vaccine or any ingredient of vaccine&#xD;
&#xD;
          -  Epilepsy, seizures, convulsions, neurological illness&#xD;
&#xD;
          -  Congenital or hereditary immunodeficiency&#xD;
&#xD;
          -  Autoimmune disease&#xD;
&#xD;
          -  Asthma, thyroidectomy, angioneurotic edema, diabetes or cancer&#xD;
&#xD;
          -  Asplenia, functional asplenia, and any circumstances leading to the asplenia or&#xD;
             splenectomy&#xD;
&#xD;
          -  Clinical diagnosis of coagulopathy (such as clotting factor deficiency, coagulation&#xD;
             disorders, platelet abnormalities), significant bruising or blood clotting disorder&#xD;
&#xD;
          -  Acute illness or acute exacerbation of chronic disease in last 7 days&#xD;
&#xD;
          -  Any prior administration of immunodepressant or corticosteroids in last 6 months&#xD;
&#xD;
          -  Any prior administration of blood products in last 3 months&#xD;
&#xD;
          -  Any prior administration of live-attenuated vaccine in last 15 days&#xD;
&#xD;
          -  Any prior administration of subunit or inactivated vaccines in last 7 days&#xD;
&#xD;
          -  Fever before vaccination, axillary temperature ﹥37.0 ℃&#xD;
&#xD;
          -  The laboratory test abnormalities before vaccination, including blood tests&#xD;
             (hemoglobin, total white blood cells, WBC, platelets), blood biochemistry tests (ALT,&#xD;
             total bilirubin, direct bilirubin, Cr, BUN) and urine tests (urine protein, urine&#xD;
             sugar, blood cells), etc.&#xD;
&#xD;
          -  Hypertension or hypotension. Systolic blood pressure ﹥140 mmHg and/ or diastolic blood&#xD;
             pressure ﹥90 mmHg; systolic blood pressure ﹤90 mmHg and/or diastolic blood pressure&#xD;
             ﹤60 mmHg&#xD;
&#xD;
          -  Any condition that in the opinion of the investigator, may interfere with the&#xD;
             evaluation of study objectives&#xD;
&#xD;
          -  take part into other vaccine or drug clinical trials in last half year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Months</minimum_age>
    <maximum_age>9 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Guangdong Province Center for Diseases Control and Prevention</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>511430</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>September 27, 2017</last_update_submitted>
  <last_update_submitted_qc>September 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Qihan Li</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Hand, Foot and Mouth Disease (HFMD)</keyword>
  <keyword>immunogenicity</keyword>
  <keyword>safety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Foot-and-Mouth Disease</mesh_term>
    <mesh_term>Hand, Foot and Mouth Disease</mesh_term>
    <mesh_term>Mouth Diseases</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>


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/NCT03296410
org study id: 20170710
nct id: NCT03296410
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Enterovirus 71 (EV71), a major pathogen causing hand-foot-and-mouth disease (HFMD) worldwide,
      is a member of the Human Enterovirus species A, family Picornaviridae. Its infection
      occasionally leads to severe diseases and death, with central nervous system (CNS) damage.

      Recently, except of inactivated vaccine, several EV71 vaccine candidates have been evaluated
      in animals but no final results of clinical trials, such as attenuated vaccine, subunit
      vaccine. A formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been
      finished phase I, II and III clinical trials and licensed by SFDA in China at Dec. 3, 2015.
      Based on the results of clinical trials, the protective efficacy of inactivated EV71 vaccine
      is 97% against HFMD caused by EV71. The phase IV clinical trial has been carried out from
      July 2016. The purpose of phase IVd is to evaluated the immunogenicity and safety of the
      inactive EV71 vaccine within two measles attenuated live vaccine and live attenuated Japanese
      encephalitis vaccine at the same time point in large scale population of Chinese children (8
      months old) in Guangdong Province, China.
There are two parts of phase IVd clinical trials have been performed. First, to evaluate the
      immunogenicity of the inactive EV71 vaccine within two measles attenuated live vaccine and
      live attenuated Japanese encephalitis vaccine at the same time point in large scale
      population of Chinese children (8 months old), within 56-day-post-immunized.

      Second, to safety of the inactive EV71 vaccine within two measles attenuated live vaccine and
      live attenuated Japanese encephalitis vaccine at the same time point in large scale
      population of Chinese children (8 months old), within 56-day-post-immunized.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Evaluate the seropositive rate of anti-EV71 antibodies in serum of children before first vaccination
time frame: at 0 day before finishing 1st doses immunization
description: Bloods were obtained before first vaccination. The antibody titers were tested in serum of children.
measure: Evaluate the seropositive rate of anti-EBV antibodies in serum of children before first vaccination
time frame: at 0 day before finishing 1st doses immunization
description: Bloods were obtained before first vaccination. The antibody titers were tested in serum of children.
measure: Evaluate the seropositive rate of anti-measles virus antibodies in serum of children before first vaccination
time frame: at 0 day before finishing 1st doses immunization
description: Bloods were obtained before first vaccination. The antibody titers were tested in serum of children.
measure: Evaluate the seropositive rate of anti-Rubella virus antibodies in serum of children before first vaccination
time frame: at 0 day before finishing 1st doses immunization
description: Bloods were obtained before first vaccination. The antibody titers were tested in serum of children.
measure: Evaluate the seroconversion rate of anti-EV71 antibodies in serum of children at 56 days after first vaccination
time frame: at 56 days after finishing 1st doses immunization
description: Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children.
measure: Evaluate the seroconversion rate of anti-EBV antibodies in serum of children at 56 days after first vaccination
time frame: at 56 days after finishing 1st doses immunization
description: Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children.
measure: Evaluate the seroconversion rate of anti-measles virus antibodies in serum of children at 56 days after first vaccination
time frame: at 56 days after finishing 1st doses immunization
description: Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children.
measure: Evaluate the seroconversion rate of anti-Rubella virus antibodies in serum of children at 56 days after first vaccination
time frame: at 56 days after finishing 1st doses immunization
description: Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children.
measure: Evaluate the antibody titers of anti-EV71 antibodies in serum of children
time frame: at 56 days after finishing 1st doses immunization
description: Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children at 56 days.
measure: Evaluate the antibody titers of anti-EBV antibodies in serum of children
time frame: at 56 days after finishing 1st doses immunization
description: Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children at 56 days.
measure: Evaluate the antibody titers of anti-measles virus antibodies in serum of children
time frame: at 56 days after finishing 1st doses immunization
description: Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children at 56 days.
measure: Evaluate the antibody titers of anti-Rubella virus antibodies in serum of children
time frame: at 56 days after finishing 1st doses immunization
description: Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children at 56 days.
measure: Incidence of treatment adverse events finishing 1st doses immunization
time frame: within 28 days after finishing 1st doses immunization
description: The adverse events were observed and recorded within 30 minutes post immunization (p.i.), within 0-1 days post immunization (d.p.i.), within 1-3 d.p.i. and within 28 d.p.i. after the 1st injection.
measure: Incidence of treatment adverse events finishing 2nd doses immunization
time frame: within 28 days after finishing 2nd doses immunization
description: The adverse events were observed and recorded within 30 minutes post immunization (p.i.), within 0-1 days post immunization (d.p.i.), within 1-3 d.p.i. and within 28 d.p.i. after injection.
arm group label: EV71 and two measles attenuated live vaccine
arm group type: Experimental
description: infants vaccinated with enterovirus type 71 inactivated vaccine (human diploid cell) and two measles attenuated live vaccine at 8 months old, and vaccinated with the second dose of enterovirus type 71 inactivated vaccine (human diploid cell) at 9 months old.
arm group label: EV71 and attenuated Japanese encephalitis vaccine
arm group type: Experimental
description: infants vaccinated with enterovirus type 71 inactivated vaccine (human diploid cell) and live attenuated Japanese encephalitis vaccine at 8 months old, and vaccinated with the second dose of enterovirus type 71 inactivated vaccine (human diploid cell) at 9 months old.
arm group label: two measles attenuated live vaccine
arm group type: Active Comparator
description: infants vaccinated with two measles attenuated live vaccine at 8 months old
arm group label: live attenuated Japanese encephalitis vaccine
arm group type: Active Comparator
description: infants vaccinated with live attenuated Japanese encephalitis vaccine at 8 months old
arm group label: EV71 vaccine
arm group type: Active Comparator
description: infants vaccinated with enterovirus type 71 inactivated vaccine (human diploid cell) at 8 months old, and vaccinated with the second dose of enterovirus type 71 inactivated vaccine (human diploid cell) at 9 months old.
intervention type: Biological
intervention name: EV71 and two measles attenuated live vaccine
description: infants vaccined with two dose (3.0 EU/dose) of inactivated enterovirus 71 vaccine (KMB-17) at 8 months old and 9 months old (namely interval one month). And meanwhile, they routine vaccined with two measles attenuated live vaccine at 8 months old.
arm group label: EV71 and two measles attenuated live vaccine
intervention type: Biological
intervention name: EV71 and attenuated Japanese encephalitis vaccine
description: infants vaccined with two dose (3.0 EU/dose) of inactivated enterovirus 71 vaccine (KMB-17) at 8 months old and 9 months old (namely interval one month). And meanwhile, they routine vaccined with attenuated Japanese encephalitis vaccine at 8 months old.
arm group label: EV71 and attenuated Japanese encephalitis vaccine
intervention type: Biological
intervention name: two measles attenuated live vaccine
description: infants vaccined with one dose two measles attenuated live vaccine at 8 months old.
arm group label: two measles attenuated live vaccine
intervention type: Biological
intervention name: live attenuated Japanese encephalitis vaccine
description: infants vaccined with one dose attenuated Japanese encephalitis vaccine at 8 months old.
arm group label: live attenuated Japanese encephalitis vaccine
intervention type: Biological
intervention name: EV71 vaccine
description: infants vaccined with two dose (3.0 EU/dose) of inactivated enterovirus 71 vaccine (KMB-17) at 8 months old and 9 months old (namely interval one month).
arm group label: EV71 vaccine
criteria: 
gender: All
minimum age: 8 Months
maximum age: 9 Months
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
investigator full name: Qihan Li
investigator title: Professor
mesh term: Foot-and-Mouth Disease
mesh term: Hand, Foot and Mouth Disease
mesh term: Mouth Diseases
mesh term: Vaccines