<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/NCT02253407</url>
  </required_header>
  <id_info>
    <org_study_id>MMR-01/12</org_study_id>
    <secondary_id>CTRI/2013/05/003702</secondary_id>
    <nct_id>NCT02253407</nct_id>
  </id_info>
  <brief_title>Safety &amp; Immunogenicity of MMR Vaccine by DSJI to That by Needle-Syringe in 15-18 Months Old Children</brief_title>
  <official_title>A Phase IV, Non-Inferiority, Observer Blind Randomized Clinical Study Comparing Safety And Immunogenicity Of MMR Subcutaneous Vaccination By Disposable-Syringe Jet Injector To Vaccination By Needle And Syringe For The Administration In Healthy Children In India Aged 15 To 18 Months</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Serum Institute of India Pvt. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>PATH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Serum Institute of India Pvt. Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a study planned to determine and compare immunogenicity and reactogenicity of MMR&#xD;
      vaccine of SIIL delivered either with disposable-Syringe Jet Injector (DSJI) or&#xD;
      disposable-syringe needle in total 340 Indian infants aged 15 to 18 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, observer blind, non-inferior, parallel group, multi-centre clinical&#xD;
      study to determine and compare immunogenicity and reactogenicity of MMR vaccine of SIIL&#xD;
      delivered either with disposable-Syringe Jet Injector (DSJI) or disposable-syringe needle in&#xD;
      total 340 Indian infants aged 15 to 18 months. Sera samples will be analyzed by ELISA for&#xD;
      seroconversion / seropositivity for each individual component of vaccine i.e. measles, mumps&#xD;
      and rubella at 35 days after administration of a single dose of MMR vaccine of Serum&#xD;
      Institute of India.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Seropositivity of individual child for measles, mumps and rubella</measure>
    <time_frame>35 days after administration of the study vaccines</time_frame>
    <description>Seropositivity of the individual child for particular vaccine component will be defined according to the levels given in the kit literature.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of Geometric Mean titers (GMTs) for anti-measles, anti-mumps and anti-rubella antibodies</measure>
    <time_frame>Day 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Solicited adverse reactions</measure>
    <time_frame>Day 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unsolicited adverse events</measure>
    <time_frame>Day 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious adverse events (SAEs)</measure>
    <time_frame>Day 35</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">341</enrollment>
  <condition>Immune Response to MMR Vaccine</condition>
  <arm_group>
    <arm_group_label>Disposable syringe jet injector</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this arm will be given a single subcutaneous 0.5 mL dose of Serum Institute of India Ltd.'s MMR vaccine (Brand name: Tresivac) via Disposable Syringe Jet Injector (Brand Name:Stratis) of Pharmajet Inc.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Needle-Syringe</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in this arm will be given a single subcutaneous 0.5 mL dose of Serum Institute of India Ltd.'s MMR vaccine (Brand name: Tresivac) via conventional needle and Syringe</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>MMR vaccine</intervention_name>
    <arm_group_label>Disposable syringe jet injector</arm_group_label>
    <arm_group_label>Needle-Syringe</arm_group_label>
    <other_name>Tresivac</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Normal healthy infants of age 15-18 months at the time of the screening and have not&#xD;
             received their first dose of MMR vaccine.&#xD;
&#xD;
          2. Previously received a measles monovalent vaccine at 9 months, as confirmed by the&#xD;
             childhood vaccination record.&#xD;
&#xD;
          3. Parents or legal guardians of subject willing to give written informed consent and&#xD;
             willing to comply with study protocol.&#xD;
&#xD;
          4. Free of obvious health problems as established by medical history and screening&#xD;
             evaluation including clinical examination.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Infant subject participating in other clinical trial or planned participation in&#xD;
             another clinical trial during the present trial period&#xD;
&#xD;
          2. Infant with congenital or acquired immunodeficiency, malignancy or receiving&#xD;
             immunosuppressive therapy.&#xD;
&#xD;
          3. Infant with history of allergy or systemic hypersensitivity to any of the vaccine&#xD;
             component or to a vaccine containing the same substances.&#xD;
&#xD;
          4. Infant with history of epilepsy or a seizure disorder or neurodevelopmental disorders.&#xD;
&#xD;
          5. Clinical history of measles, mumps, or rubella infection.&#xD;
&#xD;
          6. Infants with leukemia, lymphoma, or any other cancer or neoplasm.&#xD;
&#xD;
          7. Acute or chronic, clinically significant pulmonary, endocrine, autoimmune,&#xD;
             neurological, cardiovascular, metabolic, hepatic or renal functional abnormality, as&#xD;
             determined by medical history, and physical examination tests, which in the opinion of&#xD;
             the investigator, might interfere with the study objectives&#xD;
&#xD;
          8. Infant with any other condition, which, in the opinion of the investigator would&#xD;
             jeopardize the safety or rights of the infant participating in the study or making it&#xD;
             unlikely the subject could complete the protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Months</minimum_age>
    <maximum_age>18 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ashish Bavdekar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Pediatrics, KEM Hospital Research Centre, Pune, India</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jitendra Oswal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Pediatrics, Bharati Vidyapeeth Deemed University Medical College and Hospital, Pune, India</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Paediatrics, Andhra Medical College, King George Hospital, Maharanipet,</name>
      <address>
        <city>Visakhapatnam</city>
        <state>Andhra Pradesh</state>
        <zip>530002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krishna Institute of Medical Sciences Deemed University,</name>
      <address>
        <city>Karad</city>
        <state>Maharashtra</state>
        <zip>415110</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shirdi Sai Baba Rural Hospital, KEM Hospital Research Centre, Vadu Rural Health Program, Vadu Budruk, Tal: Shirur</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <zip>412216</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Pediatrics, KEM Hospital Research Centre, Sardar Moodliar Road, Rasta Peth,</name>
      <address>
        <city>Pune</city>
        <state>Maharashtr</state>
        <zip>411011</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Pediatrics, Bharati Vidyapeeth Deemed University Medical College and Hospital, Satara Road, Katraj, Dhankawadi</name>
      <address>
        <city>Pune</city>
        <state>Maharasthra</state>
        <zip>411043</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dept of Pediatrics, Sri Ramachandra Medical Centre, No. 1, Ramachandra nagar, Porur,</name>
      <address>
        <city>Chennai</city>
        <state>Tamil Nadu</state>
        <zip>600116</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <results_reference>
    <citation>Bavdekar A, Oswal J, Ramanan PV, Aundhkar C, Venugopal P, Kapse D, Miller T, McGray S, Zehrung D, Kulkarni PS; SII MMR author group. Immunogenicity and safety of measles-mumps-rubella vaccine delivered by disposable-syringe jet injector in India: A randomized, parallel group, non-inferiority trial. Vaccine. 2018 Feb 21;36(9):1220-1226. doi: 10.1016/j.vaccine.2018.01.006. Epub 2018 Feb 1.</citation>
    <PMID>29395526</PMID>
  </results_reference>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>September 27, 2014</study_first_submitted>
  <study_first_submitted_qc>September 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>March 13, 2018</last_update_submitted>
  <last_update_submitted_qc>March 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02253407
org study id: MMR-01/12
secondary id: CTRI/2013/05/003702
nct id: NCT02253407
lead sponsor: 
collaborator: 
has dmc: No
This is a study planned to determine and compare immunogenicity and reactogenicity of MMR
      vaccine of SIIL delivered either with disposable-Syringe Jet Injector (DSJI) or
      disposable-syringe needle in total 340 Indian infants aged 15 to 18 months.
This is a randomized, observer blind, non-inferior, parallel group, multi-centre clinical
      study to determine and compare immunogenicity and reactogenicity of MMR vaccine of SIIL
      delivered either with disposable-Syringe Jet Injector (DSJI) or disposable-syringe needle in
      total 340 Indian infants aged 15 to 18 months. Sera samples will be analyzed by ELISA for
      seroconversion / seropositivity for each individual component of vaccine i.e. measles, mumps
      and rubella at 35 days after administration of a single dose of MMR vaccine of Serum
      Institute of India.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Seropositivity of individual child for measles, mumps and rubella
time frame: 35 days after administration of the study vaccines
description: Seropositivity of the individual child for particular vaccine component will be defined according to the levels given in the kit literature.
measure: Comparison of Geometric Mean titers (GMTs) for anti-measles, anti-mumps and anti-rubella antibodies
time frame: Day 35
measure: Solicited adverse reactions
time frame: Day 14
measure: Unsolicited adverse events
time frame: Day 35
measure: Serious adverse events (SAEs)
time frame: Day 35
arm group label: Disposable syringe jet injector
arm group type: Experimental
description: Subjects in this arm will be given a single subcutaneous 0.5 mL dose of Serum Institute of India Ltd.'s MMR vaccine (Brand name: Tresivac) via Disposable Syringe Jet Injector (Brand Name:Stratis) of Pharmajet Inc.
arm group label: Needle-Syringe
arm group type: Active Comparator
description: Subjects in this arm will be given a single subcutaneous 0.5 mL dose of Serum Institute of India Ltd.'s MMR vaccine (Brand name: Tresivac) via conventional needle and Syringe
intervention type: Biological
intervention name: MMR vaccine
arm group label: Disposable syringe jet injector
arm group label: Needle-Syringe
other name: Tresivac
criteria: 
gender: All
minimum age: 15 Months
maximum age: 18 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Ashish Bavdekar, MD
role: Principal Investigator
affiliation: Department of Pediatrics, KEM Hospital Research Centre, Pune, India
last name: Jitendra Oswal, MD
role: Principal Investigator
affiliation: Department of Pediatrics, Bharati Vidyapeeth Deemed University Medical College and Hospital, Pune, India
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: India
citation: Bavdekar A, Oswal J, Ramanan PV, Aundhkar C, Venugopal P, Kapse D, Miller T, McGray S, Zehrung D, Kulkarni PS; SII MMR author group. Immunogenicity and safety of measles-mumps-rubella vaccine delivered by disposable-syringe jet injector in India: A randomized, parallel group, non-inferiority trial. Vaccine. 2018 Feb 21;36(9):1220-1226. doi: 10.1016/j.vaccine.2018.01.006. Epub 2018 Feb 1.
PMID: 29395526
responsible party type: Sponsor