<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/NCT01712906</url>
  </required_header>
  <id_info>
    <org_study_id>FMumps-KMB17-I-IMB-CAMS</org_study_id>
    <nct_id>NCT01712906</nct_id>
  </id_info>
  <brief_title>A Phase I, Safety Study of Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Chinese Children</brief_title>
  <official_title>A Phase II Clinical Trial for Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Chinese Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Mumps is an acute infectious respiratory disease caused by the mumps virus (MuV), which&#xD;
      occurs mainly in children and adolescents. Its main clinical symptoms were parotid gland&#xD;
      suppurative swelling and pain with fever. The pathological changes and harm caused by mumps&#xD;
      was not only confined to the parotid gland, on the contrary, the social harm caused by&#xD;
      serious complications cannot be ignored. As mumps is a vaccine-preventable infectious&#xD;
      disease, vaccination is a fundamental strategy for controlling mumps. So far, there are 13&#xD;
      genotypes of MuV. Based on the analysis of molecular epidemiology, the main epidemic strain&#xD;
      of MuV in China was the F genotype. The commonly used vaccine strains represented only a&#xD;
      small number of known genotypes, e.g. Jeryl-Lynn (JL) and Rubini strains, which belong to&#xD;
      type A, Urabe strain belongs to type B, and L-Zagreb strains belongs to type D. Virus seed of&#xD;
      Live Attenuated Mumps Vaccine (Human diploid cell) developed by the institute was SP-A&#xD;
      strain, which was the first separation and preparation of the attenuated mumps viruses in&#xD;
      China. SP-A belongs to F genotype, which was the domestic epidemic genotype. In addition, the&#xD;
      cell substrate prepared for vaccine was human diploid cell (KMB-17 strain), which is much&#xD;
      safer to use. The preliminary test results showed that the vaccine possessed good&#xD;
      immunogenicity and good antigenic cross-reactivity. The application of this vaccine will&#xD;
      provide more effective means to prevent and control of mumps epidemic.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</primary_completion_date>
  <phase>Phase 1</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the Safety of Attenuated Mumps Vaccine (Human Diploid Cell, KMB-17) in Chinese Adults.</measure>
    <time_frame>within the first 28 days after the vaccination</time_frame>
    <description>Adverse reactions associated with vaccine were observed in Chinese Adults (from 16 to 59 years old) after the vaccination</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate the Safety of Attenuated Mumps Vaccine (Human Diploid Cell, KMB-17) in Chinese Children.</measure>
    <time_frame>within the first 28 days after the vaccination</time_frame>
    <description>Adverse reactions associated with vaccine were observed in Chinese Children (from 5 to 15 years old) after the vaccination.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate the safety of Attenuated Mumps Vaccine (Human Diploid Cell, KMB-17) in Chinese Children.</measure>
    <time_frame>within the first 28 days after the vaccination</time_frame>
    <description>Adverse reactions associated with vaccine were observed in Chinese Children (from 2 to 4 years old) after the vaccination.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate the safety of Attenuated Mumps Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants.</measure>
    <time_frame>within the first 28 days after the vaccination</time_frame>
    <description>Adverse reactions associated with vaccine were observed in Chinese Infants (from 8 to 23 months old) after the vaccination.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the seroconversion rate of anti-Mumps antibodies in serum of adults, children and infants, after vaccination.</measure>
    <time_frame>within the first 28 days after the vaccination</time_frame>
    <description>The seroconversion rate of anti-MuV antibodies was evaluated in serum of adults at the 0 and 28 days after vaccination.&#xD;
The seroconversion rate of anti-MuV antibodies was evaluated in serum of children at the 0 and 28 days after vaccination.&#xD;
The seroconversion rate of anti-MuV antibodies was evaluated in serum of infants at the 0 and 28 days after vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the abnormity change of live and kidney function indexes in serum of adults, children and infants, after vaccination</measure>
    <time_frame>within the first 4 days after the vaccination</time_frame>
    <description>The abnormity change of live and kidney function indexes were evaluated in serum of adults at 0, 4 days after vaccination.&#xD;
The abnormity change of live and kidney function indexes were evaluated in serum of children at 0, 4 days after vaccination.&#xD;
The abnormity change of live and kidney function indexes were evaluated in serum of infants at 0, 4 days after vaccination.</description>
  </secondary_outcome>
  <number_of_arms>18</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>The Study Focused on the Safety of Attenuated Mumps Vaccine (Human Diploid Cell) Against Mumps in Chinese Adults, Children and Infants.</condition>
  <arm_group>
    <arm_group_label>3.50±0.25logCCID50/ml in adults</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in 16 adults aged 16-59 years old on day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4.25±0.25 logCCID50/ml in adults</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 adults aged 16-59 years old on day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5.00±0.25 logCCID50/ml in adults</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 adults aged 16-59 years old on day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0 logCCID50/ml in adults</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>0 logCCID50/ml in 18 adults aged 16-59 years old on day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3.50±0.25logCCID50/ml in children (5-15 years old)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in 16 children aged 5-15 years old on day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4.25±0.25 logCCID50/ml in children (5-15 years old)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 children aged 5-15 years old on day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5.00±0.25 logCCID50/ml in children (5-15 years old)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Attenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in 16 children aged 5-15 years old on day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0 logCCID50/ml in children (5-15 years old)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>0 logCCID50/ml in 18 children aged 5-15 years old on day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3.50±0.25logCCID50/ml in children (2-4 years old)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in 16 children aged 2-4 years old on day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4.25±0.25 logCCID50/ml in children (2-4 years old)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 children aged 2-4 years old on day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5.00±0.25 logCCID50/ml in children (2-4 years old)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Attenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in 16 children aged 2-4 years old on day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0 logCCID50/ml in children (2-4 years old)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>0 logCCID50/ml in 18 children aged 2-4 years old on day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Attenuated Mumps vaccine in children (2-4 years old)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1) in 18 children aged 2-4 years old on day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3.50±0.25logCCID50/ml in infants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in 16 infants aged 8-23 months old on day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4.25±0.25 logCCID50/ml in infants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 infants aged 8-23 months old on day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5.00±0.25 logCCID50/ml in infants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Attenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in 16 infants aged 8-23 months old on day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0 logCCID50/ml in infants</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>0 logCCID50/ml in 18 infants aged 8-23 months old on day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Attenuated Mumps vaccine in infants</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1) in 18 infants aged 8-23 months old on day 0.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>3.50±0.25logCCID50/ml</intervention_name>
    <description>Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in adults (16-59 years old)，children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.</description>
    <arm_group_label>3.50±0.25logCCID50/ml in adults</arm_group_label>
    <arm_group_label>3.50±0.25logCCID50/ml in children (2-4 years old)</arm_group_label>
    <arm_group_label>3.50±0.25logCCID50/ml in children (5-15 years old)</arm_group_label>
    <arm_group_label>3.50±0.25logCCID50/ml in infants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>4.25±0.25 logCCID50/ml</intervention_name>
    <description>Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in adults (16-59 years old)，children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.</description>
    <arm_group_label>4.25±0.25 logCCID50/ml in adults</arm_group_label>
    <arm_group_label>4.25±0.25 logCCID50/ml in children (2-4 years old)</arm_group_label>
    <arm_group_label>4.25±0.25 logCCID50/ml in children (5-15 years old)</arm_group_label>
    <arm_group_label>4.25±0.25 logCCID50/ml in infants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>5.00±0.25 logCCID50/ml</intervention_name>
    <description>Attenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in adults (16-59 years old)，children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.</description>
    <arm_group_label>5.00±0.25 logCCID50/ml in adults</arm_group_label>
    <arm_group_label>5.00±0.25 logCCID50/ml in children (2-4 years old)</arm_group_label>
    <arm_group_label>5.00±0.25 logCCID50/ml in children (5-15 years old)</arm_group_label>
    <arm_group_label>5.00±0.25 logCCID50/ml in infants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>0 logCCID50/ml</intervention_name>
    <description>0 logCCID50/ml in adults (16-59 years old)，children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.</description>
    <arm_group_label>0 logCCID50/ml in adults</arm_group_label>
    <arm_group_label>0 logCCID50/ml in children (2-4 years old)</arm_group_label>
    <arm_group_label>0 logCCID50/ml in children (5-15 years old)</arm_group_label>
    <arm_group_label>0 logCCID50/ml in infants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1)</intervention_name>
    <description>Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1) in children (2-4 years old) and infants (8-23 months old) on day 0.</description>
    <arm_group_label>Attenuated Mumps vaccine in children (2-4 years old)</arm_group_label>
    <arm_group_label>Attenuated Mumps vaccine in infants</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects (8 months-59 years old) as established by medical history and&#xD;
             clinical examination&#xD;
&#xD;
          -  The subjects oneself or their legal guardian must be aware of this vaccines&#xD;
&#xD;
          -  Voluntarily participate in the study and signed Informed Consent Form&#xD;
&#xD;
          -  Subjects with temperature ≤ 37.0℃&#xD;
&#xD;
          -  With the ability and objective to comply with the requirements of the protocol&#xD;
&#xD;
          -  Persist for a 1-month visit and receive blood tests according to program requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject who has a clinical diagnosis Mumps&#xD;
&#xD;
          -  Subject who vaccinated Mumps vaccine in last 6 months&#xD;
&#xD;
          -  ≤37 weeks gestation&#xD;
&#xD;
          -  weight ≤ 2500 g when it was born&#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;
          -  Severe malnutrition or dysgenopathy&#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 28 days or 1 months&#xD;
&#xD;
          -  Any prior administration of subunit or inactivated vaccines in last 14 days&#xD;
&#xD;
          -  Under the anti-TB prevention or therapy&#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 ﹥140mmHg and/or diastolic blood&#xD;
             pressure ﹥90mmHg; systolic blood pressure ﹤90mmHg and/or diastolic blood pressure&#xD;
             ﹤60mmHg&#xD;
&#xD;
          -  Breast-feeding, pregnant, planning a pregnancy within 60 days or positive pregnancy&#xD;
             test women&#xD;
&#xD;
          -  Any condition that in the opinion of the investigator, may interfere with the&#xD;
             evaluation of study objectives&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Months</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuliang Zhao, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hebei Provincial Center for Diseases Control and Prevention</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hebei Provincial Center for Diseases Control and Prevention</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>April 26, 2013</last_update_submitted>
  <last_update_submitted_qc>April 26, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 30, 2013</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>Longding Liu</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mumps</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/NCT01712906
org study id: FMumps-KMB17-I-IMB-CAMS
nct id: NCT01712906
lead sponsor: 
has dmc: Yes
Mumps is an acute infectious respiratory disease caused by the mumps virus (MuV), which
      occurs mainly in children and adolescents. Its main clinical symptoms were parotid gland
      suppurative swelling and pain with fever. The pathological changes and harm caused by mumps
      was not only confined to the parotid gland, on the contrary, the social harm caused by
      serious complications cannot be ignored. As mumps is a vaccine-preventable infectious
      disease, vaccination is a fundamental strategy for controlling mumps. So far, there are 13
      genotypes of MuV. Based on the analysis of molecular epidemiology, the main epidemic strain
      of MuV in China was the F genotype. The commonly used vaccine strains represented only a
      small number of known genotypes, e.g. Jeryl-Lynn (JL) and Rubini strains, which belong to
      type A, Urabe strain belongs to type B, and L-Zagreb strains belongs to type D. Virus seed of
      Live Attenuated Mumps Vaccine (Human diploid cell) developed by the institute was SP-A
      strain, which was the first separation and preparation of the attenuated mumps viruses in
      China. SP-A belongs to F genotype, which was the domestic epidemic genotype. In addition, the
      cell substrate prepared for vaccine was human diploid cell (KMB-17 strain), which is much
      safer to use. The preliminary test results showed that the vaccine possessed good
      immunogenicity and good antigenic cross-reactivity. The application of this vaccine will
      provide more effective means to prevent and control of mumps epidemic.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Evaluate the Safety of Attenuated Mumps Vaccine (Human Diploid Cell, KMB-17) in Chinese Adults.
time frame: within the first 28 days after the vaccination
description: Adverse reactions associated with vaccine were observed in Chinese Adults (from 16 to 59 years old) after the vaccination
measure: Evaluate the Safety of Attenuated Mumps Vaccine (Human Diploid Cell, KMB-17) in Chinese Children.
time frame: within the first 28 days after the vaccination
description: Adverse reactions associated with vaccine were observed in Chinese Children (from 5 to 15 years old) after the vaccination.
measure: Evaluate the safety of Attenuated Mumps Vaccine (Human Diploid Cell, KMB-17) in Chinese Children.
time frame: within the first 28 days after the vaccination
description: Adverse reactions associated with vaccine were observed in Chinese Children (from 2 to 4 years old) after the vaccination.
measure: Evaluate the safety of Attenuated Mumps Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants.
time frame: within the first 28 days after the vaccination
description: Adverse reactions associated with vaccine were observed in Chinese Infants (from 8 to 23 months old) after the vaccination.
measure: Evaluate the seroconversion rate of anti-Mumps antibodies in serum of adults, children and infants, after vaccination.
time frame: within the first 28 days after the vaccination
description: The seroconversion rate of anti-MuV antibodies was evaluated in serum of adults at the 0 and 28 days after vaccination.
The seroconversion rate of anti-MuV antibodies was evaluated in serum of children at the 0 and 28 days after vaccination.
The seroconversion rate of anti-MuV antibodies was evaluated in serum of infants at the 0 and 28 days after vaccination.
measure: Evaluate the abnormity change of live and kidney function indexes in serum of adults, children and infants, after vaccination
time frame: within the first 4 days after the vaccination
description: The abnormity change of live and kidney function indexes were evaluated in serum of adults at 0, 4 days after vaccination.
The abnormity change of live and kidney function indexes were evaluated in serum of children at 0, 4 days after vaccination.
The abnormity change of live and kidney function indexes were evaluated in serum of infants at 0, 4 days after vaccination.
arm group label: 3.50±0.25logCCID50/ml in adults
arm group type: Experimental
description: Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in 16 adults aged 16-59 years old on day 0.
arm group label: 4.25±0.25 logCCID50/ml in adults
arm group type: Experimental
description: Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 adults aged 16-59 years old on day 0.
arm group label: 5.00±0.25 logCCID50/ml in adults
arm group type: Experimental
description: Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 adults aged 16-59 years old on day 0.
arm group label: 0 logCCID50/ml in adults
arm group type: Placebo Comparator
description: 0 logCCID50/ml in 18 adults aged 16-59 years old on day 0.
arm group label: 3.50±0.25logCCID50/ml in children (5-15 years old)
arm group type: Experimental
description: Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in 16 children aged 5-15 years old on day 0.
arm group label: 4.25±0.25 logCCID50/ml in children (5-15 years old)
arm group type: Experimental
description: Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 children aged 5-15 years old on day 0.
arm group label: 5.00±0.25 logCCID50/ml in children (5-15 years old)
arm group type: Experimental
description: Attenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in 16 children aged 5-15 years old on day 0.
arm group label: 0 logCCID50/ml in children (5-15 years old)
arm group type: Placebo Comparator
description: 0 logCCID50/ml in 18 children aged 5-15 years old on day 0.
arm group label: 3.50±0.25logCCID50/ml in children (2-4 years old)
arm group type: Experimental
description: Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in 16 children aged 2-4 years old on day 0.
arm group label: 4.25±0.25 logCCID50/ml in children (2-4 years old)
arm group type: Experimental
description: Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 children aged 2-4 years old on day 0.
arm group label: 5.00±0.25 logCCID50/ml in children (2-4 years old)
arm group type: Experimental
description: Attenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in 16 children aged 2-4 years old on day 0.
arm group label: 0 logCCID50/ml in children (2-4 years old)
arm group type: Placebo Comparator
description: 0 logCCID50/ml in 18 children aged 2-4 years old on day 0.
arm group label: Attenuated Mumps vaccine in children (2-4 years old)
arm group type: Active Comparator
description: Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1) in 18 children aged 2-4 years old on day 0.
arm group label: 3.50±0.25logCCID50/ml in infants
arm group type: Experimental
description: Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in 16 infants aged 8-23 months old on day 0.
arm group label: 4.25±0.25 logCCID50/ml in infants
arm group type: Experimental
description: Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 infants aged 8-23 months old on day 0.
arm group label: 5.00±0.25 logCCID50/ml in infants
arm group type: Experimental
description: Attenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in 16 infants aged 8-23 months old on day 0.
arm group label: 0 logCCID50/ml in infants
arm group type: Placebo Comparator
description: 0 logCCID50/ml in 18 infants aged 8-23 months old on day 0.
arm group label: Attenuated Mumps vaccine in infants
arm group type: Active Comparator
description: Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1) in 18 infants aged 8-23 months old on day 0.
intervention type: Biological
intervention name: 3.50±0.25logCCID50/ml
description: Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in adults (16-59 years old)，children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.
arm group label: 3.50±0.25logCCID50/ml in adults
arm group label: 3.50±0.25logCCID50/ml in children (2-4 years old)
arm group label: 3.50±0.25logCCID50/ml in children (5-15 years old)
arm group label: 3.50±0.25logCCID50/ml in infants
intervention type: Biological
intervention name: 4.25±0.25 logCCID50/ml
description: Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in adults (16-59 years old)，children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.
arm group label: 4.25±0.25 logCCID50/ml in adults
arm group label: 4.25±0.25 logCCID50/ml in children (2-4 years old)
arm group label: 4.25±0.25 logCCID50/ml in children (5-15 years old)
arm group label: 4.25±0.25 logCCID50/ml in infants
intervention type: Biological
intervention name: 5.00±0.25 logCCID50/ml
description: Attenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in adults (16-59 years old)，children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.
arm group label: 5.00±0.25 logCCID50/ml in adults
arm group label: 5.00±0.25 logCCID50/ml in children (2-4 years old)
arm group label: 5.00±0.25 logCCID50/ml in children (5-15 years old)
arm group label: 5.00±0.25 logCCID50/ml in infants
intervention type: Biological
intervention name: 0 logCCID50/ml
description: 0 logCCID50/ml in adults (16-59 years old)，children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.
arm group label: 0 logCCID50/ml in adults
arm group label: 0 logCCID50/ml in children (2-4 years old)
arm group label: 0 logCCID50/ml in children (5-15 years old)
arm group label: 0 logCCID50/ml in infants
intervention type: Biological
intervention name: Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1)
description: Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1) in children (2-4 years old) and infants (8-23 months old) on day 0.
arm group label: Attenuated Mumps vaccine in children (2-4 years old)
arm group label: Attenuated Mumps vaccine in infants
criteria: 
gender: All
minimum age: 8 Months
maximum age: 59 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yuliang Zhao, Master
role: Principal Investigator
affiliation: Hebei Provincial Center for Diseases Control and Prevention
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
investigator full name: Longding Liu
investigator title: Professor
mesh term: Mumps