<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/NCT01732198</url>
  </required_header>
  <id_info>
    <org_study_id>CP-NU300-02</org_study_id>
    <nct_id>NCT01732198</nct_id>
  </id_info>
  <brief_title>A Phase 2, Multicenter, Open-label Study to Assess the Immunogenicity of an Investigational Hib Vaccine (NU300)in Toddlers</brief_title>
  <official_title>A Phase 2, Multicenter, Randomized, Double-Blind, Immunogenicity, Reactogenicity, and Safety Study of NU300 Booster Dose Compared to ActHIB®, Both Co-administered With Prevnar 13® at 12-15 Months of Age, in Healthy Toddlers Who Have Received a Primary Series of a Licensed Hib Vaccine and Prevnar 13®</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nuron Biotech Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nuron Biotech Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluate the safety and tolerability of a single booster dose of NU300, co-administered with&#xD;
      Prevnar 13® over a 28 day period following the injection compared to a single booster of&#xD;
      ACTHIB co-administered with Prevnar 13® over a 28 day period following the injection.&#xD;
&#xD;
      Evaluate the immunogenicity, as determined by anti-PRP polysaccharide response, of a single&#xD;
      booster dose of NU300 co-administered with Prevnar 13® compared to a single booster dose of&#xD;
      ActHIB® co-administered with Prevnar 13®.&#xD;
&#xD;
      Evaluate the individual IgG antibody quantitative response to the 13 antigens in Prevnar 13®&#xD;
      following NU300 co-administration with Prevnar 13® compared to the IgG antibody response to&#xD;
      the pneumococcal polysaccharides following ActHIB® co-administration with Prevnar 13® 28 days&#xD;
      following injection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>March 2013</start_date>
  <completion_date type="Anticipated">April 2014</completion_date>
  <primary_completion_date type="Anticipated">January 2014</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>safety and efficacy</measure>
    <time_frame>one month</time_frame>
    <description>Evaluate the safety and tolerability of a single booster dose of NU300, co-administered with Prevnar 13® compared to a single booster dose of ActHIB® co-administered with Prevnar 13®, over a 28 day period following injection&#xD;
Evaluate the immunogenicity, as determined by anti-PRP polysaccharide response, of a single booster dose of NU300 co-administered with Prevnar 13® compared to a single booster dose of ActHIB® co-administered with Prevnar 13®.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the individual IgG antibody quantitative response to the 13 antigens in Prevnar 13®</measure>
    <time_frame>one month</time_frame>
    <description>Evaluate the individual IgG antibody quantitative response to the 13 antigens in Prevnar 13® following NU300 co-administration with Prevnar 13® compared to the IgG antibody response to the pneumococcal polysaccharides following ActHIB® co-administration with Prevnar 13® 28 days following injection</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">220</enrollment>
  <condition>Infectious Disease</condition>
  <arm_group>
    <arm_group_label>NU300 and Prevnar 13</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NU300 at a single dose of 0.5 mL IM</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ActHIB and Prevnar 13</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ActHIB at a dose of 0.5 ml IM</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>NU300</intervention_name>
    <arm_group_label>NU300 and Prevnar 13</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ActHIB</intervention_name>
    <arm_group_label>ActHIB and Prevnar 13</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Prevnar 13</intervention_name>
    <arm_group_label>ActHIB and Prevnar 13</arm_group_label>
    <arm_group_label>NU300 and Prevnar 13</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Written informed consent obtained from the parent or guardian of the subject&#xD;
&#xD;
          2. Male or female subjects 12-15 months of age at the time of booster vaccination, who&#xD;
             had previously received complete primary vaccination series with a licensed Hib&#xD;
             product and Prevnar 13® in accordance with the FDA approved labels.&#xD;
&#xD;
          3. Subjects for whom the investigator believes that the parent/guardian can and will&#xD;
             comply with the requirements of the protocol&#xD;
&#xD;
          4. Subjects free of obvious health problems as established by medical history and&#xD;
             clinical examination before entering the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous booster vaccination against Hib and/or Prevnar 13®&#xD;
&#xD;
          2. Any confirmed or suspected Haemophilus influenzae or pneumococcal illness.&#xD;
&#xD;
          3. Administration of a vaccine not foreseen by the study protocol during the period&#xD;
             starting from 30 days before and ending 28 days after administration of study vaccines&#xD;
             (before the blood draw at Visit 2).&#xD;
&#xD;
          4. Chronic administration of immunosuppressants or other immune-modifying drugs within 30&#xD;
             days prior to dosing in the study.&#xD;
&#xD;
          5. Any confirmed or suspected immunosuppressive or immunodeficient condition based on&#xD;
             medical history and/or clinical examination.&#xD;
&#xD;
          6. Early pre-term birth (delivery before 32 weeks).&#xD;
&#xD;
          7. Major congenital defects or serious chronic diseases, or serious conditions including&#xD;
             history of seizures, apnea, etc.&#xD;
&#xD;
          8. Concurrent participation in another clinical study at any time during the study period&#xD;
             or within the previous 6 months in which the subject has been or will be exposed to an&#xD;
             investigational or non-investigational product (pharmaceutical product, formula, or&#xD;
             device)&#xD;
&#xD;
          9. Presence of a moderate or severe illness with or without fever at the time of&#xD;
             vaccination (fever is defined as a temperature of ≥ 38.0C [100.4F]).&#xD;
&#xD;
         10. Known history of thrombocytopenia or any coagulation disorder.&#xD;
&#xD;
         11. Known hypersensitivity to any of the components of the vaccines.&#xD;
&#xD;
         12. Known hypersensitivity to latex.&#xD;
&#xD;
         13. The subject is unable to provide an adequate blood draw for immunogenicity assays, and&#xD;
             safety panels at Visit 1&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>15 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bardstown</city>
        <state>Kentucky</state>
        <zip>40004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2013</verification_date>
  <study_first_submitted>November 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>September 20, 2013</last_update_submitted>
  <last_update_submitted_qc>September 20, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 23, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heptavalent Pneumococcal Conjugate Vaccine</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/NCT01732198
org study id: CP-NU300-02
nct id: NCT01732198
lead sponsor: 
has dmc: Yes
Evaluate the safety and tolerability of a single booster dose of NU300, co-administered with
      Prevnar 13® over a 28 day period following the injection compared to a single booster of
      ACTHIB co-administered with Prevnar 13® over a 28 day period following the injection.

      Evaluate the immunogenicity, as determined by anti-PRP polysaccharide response, of a single
      booster dose of NU300 co-administered with Prevnar 13® compared to a single booster dose of
      ActHIB® co-administered with Prevnar 13®.

      Evaluate the individual IgG antibody quantitative response to the 13 antigens in Prevnar 13®
      following NU300 co-administration with Prevnar 13® compared to the IgG antibody response to
      the pneumococcal polysaccharides following ActHIB® co-administration with Prevnar 13® 28 days
      following injection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: safety and efficacy
time frame: one month
description: Evaluate the safety and tolerability of a single booster dose of NU300, co-administered with Prevnar 13® compared to a single booster dose of ActHIB® co-administered with Prevnar 13®, over a 28 day period following injection
Evaluate the immunogenicity, as determined by anti-PRP polysaccharide response, of a single booster dose of NU300 co-administered with Prevnar 13® compared to a single booster dose of ActHIB® co-administered with Prevnar 13®.
measure: Evaluate the individual IgG antibody quantitative response to the 13 antigens in Prevnar 13®
time frame: one month
description: Evaluate the individual IgG antibody quantitative response to the 13 antigens in Prevnar 13® following NU300 co-administration with Prevnar 13® compared to the IgG antibody response to the pneumococcal polysaccharides following ActHIB® co-administration with Prevnar 13® 28 days following injection
arm group label: NU300 and Prevnar 13
arm group type: Experimental
description: NU300 at a single dose of 0.5 mL IM
arm group label: ActHIB and Prevnar 13
arm group type: Active Comparator
description: ActHIB at a dose of 0.5 ml IM
intervention type: Biological
intervention name: NU300
arm group label: NU300 and Prevnar 13
intervention type: Biological
intervention name: ActHIB
arm group label: ActHIB and Prevnar 13
intervention type: Biological
intervention name: Prevnar 13
arm group label: ActHIB and Prevnar 13
arm group label: NU300 and Prevnar 13
criteria: 
gender: All
minimum age: 12 Months
maximum age: 15 Months
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Communicable Diseases
mesh term: Infections
mesh term: Heptavalent Pneumococcal Conjugate Vaccine