<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/NCT01709019</url>
  </required_header>
  <id_info>
    <org_study_id>NVX757.102</org_study_id>
    <nct_id>NCT01709019</nct_id>
  </id_info>
  <brief_title>RSV-F Vaccine and Influenza Vaccine Co-Administration Study in the Elderly</brief_title>
  <official_title>A Phase I Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of an RSV-F Protein Nanoparticle Vaccine, With or Without Aluminum Adjuvant, and Co-administered With a Licensed Inactivated Influenza Vaccine, in Healthy Subjects ≥ 60 Years of Age.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novavax</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novavax</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Up to 220 eligible subjects will be enrolled into one of five treatment groups. It is&#xD;
      anticipated that some of the randomized study subjects may not complete the study; subjects&#xD;
      who withdraw or are discontinued, will not be replaced. Randomization will be stratified by&#xD;
      age (60 to &lt;75 years and ≥ 75 years) in order to distribute the proportion of such persons in&#xD;
      each age group equally across treatment groups.&#xD;
&#xD;
      Treatments will comprise a single IM dose of a placebo or RSV-F protein nanoparticle vaccine&#xD;
      on Day 0, with concurrent IM immunization with a licensed inactivated influenza vaccine. A&#xD;
      rescue dose of the licensed TIV will be provided to subjects in all groups except the placebo&#xD;
      group on Day 28, the placebo group will receive saline. For each subject, study follow-up&#xD;
      will span approximately one year from the first immunization (on Day 0) for all subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">July 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, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of Safety</measure>
    <time_frame>Day 0 to Day 364</time_frame>
    <description>Number (and percentage) of subjects with solicited local and systemic Adverse Events over the seven days post injection; all adverse events, solicited and unsolicited over 56 days post-first injection.&#xD;
Significant New Medical Conditions, Medically Attended Events and Serious Adverse Events will be collected for one year.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Immunogenicity as assessed by serum IgG antibody titers for the F-Protein antigen</measure>
    <time_frame>Day 0 to Day 364</time_frame>
    <description>Immunogenicity will be measured using derived / calculated endpoints based on:&#xD;
Geometric mean titer (GMT)&#xD;
Geometric mean ratio (GMR)&#xD;
Seroconversion rate (SCR)&#xD;
Seroresponse rate (SRR)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity as assessed by serum HAI titers specific for the influenza antigens contained in the seasonal vaccine.</measure>
    <time_frame>Day 0 to Day 56</time_frame>
    <description>Immunogenicity will be measured using derived / calculated endpoints based on:&#xD;
Geometric mean titer (GMT)&#xD;
Geometric mean ratio (GMR)&#xD;
Seroconversion rate (SCR)&#xD;
Seroprotection rate (SPR)</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">220</enrollment>
  <condition>Respiratory Syncytial Virus (RSV)</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low dose RSV-F Vaccine with Adjuvant (Day 0); Seasonal TIV (Day 0 &amp; Day 28)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low dose RSV-F Vaccine without Adjuvant (Day 0); Seasonal TIV (Day 0 &amp; Day 28)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High dose RSV-F Vaccine with Adjuvant (Day 0); Seasonal TIV (Day 0 &amp; Day 28)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High dose RSV-F Vaccine without Adjuvant (Day 0); Seasonal TIV (Day 0 &amp; Day 28)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group E</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo (Day 0 &amp; Day 28); Seasonal TIV (Day 28)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Low dose RSV-F Vaccine with Adjuvant (Day 0); Seasonal TIV (Day 0 &amp; Day 28)</intervention_name>
    <description>0.5mL IM injections</description>
    <arm_group_label>Group A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Low dose RSV-F Vaccine without Adjuvant (Day 0); Seasonal TIV (Day 0 &amp; day 28)</intervention_name>
    <description>0.5mL IM injections</description>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>High dose RSV-F Vaccine with Adjuvant (Day 0); Seasonal TIV (Day 0 &amp; Day 28)</intervention_name>
    <description>0.5mL IM injections</description>
    <arm_group_label>Group C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>High dose RSV-F Vaccine without Adjuvant (Day 0); Seasonal TIV (Day 0 &amp; Day 28)</intervention_name>
    <description>0.5mL IM injections</description>
    <arm_group_label>Group D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo (Day 0 &amp; Day 28); Seasonal TIV (Day 0)</intervention_name>
    <description>0.5mL IM Injections</description>
    <arm_group_label>Group E</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult males and females, ≥ 60 years of age, without symptomatic cardiopulmonary&#xD;
             disease. Note that subjects who have any functional limitation or symptoms related to&#xD;
             cardiac and/or pulmonary disease (including asthma or other episodic symptoms), or who&#xD;
             receive ongoing therapy to control symptoms or functional limitation, are not&#xD;
             eligible. The following are examples of subjects who may bear cardio-pulmonary&#xD;
             diagnoses but who would remain eligible:&#xD;
&#xD;
               1. Subjects on stable (no change in ≥ 2 months) therapy for findings (e.g.,&#xD;
                  hypertension or hyperlipidemia) that are not associated with current symptoms or&#xD;
                  disability.&#xD;
&#xD;
               2. Subjects who receive intermittent prophylaxis for risks associated with&#xD;
                  asymptomatic findings (e.g., antibiotic prophylaxis prior to dental procedures in&#xD;
                  a subject with asymptomatic mitral valve prolapse).&#xD;
&#xD;
               3. Other clinically insignificant findings, not deemed to be associated with&#xD;
                  increased risk due to respiratory viral infections as determined by the&#xD;
                  Investigator.&#xD;
&#xD;
          -  Free of other illnesses which are believed to increase the risk of influenza or&#xD;
             influenza related complications including: diabetes mellitus, congenital or acquired&#xD;
             blood dyscrasias, renal or hepatic dysfunction, and morbid obesity.&#xD;
&#xD;
          -  Willing and able to give informed consent prior to study enrollment.&#xD;
&#xD;
          -  Able to comply with study requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in research involving investigational product (drug / biologic / device)&#xD;
             within 45 days before planned date of first vaccination and/or planned participation&#xD;
             at any time during the study.&#xD;
&#xD;
          -  History of a serious reaction to any prior vaccination or known allergy to&#xD;
             constituents of licensed TIV (e.g., egg proteins).&#xD;
&#xD;
          -  History of Guillain-Barré Syndrome within 6 weeks following a previous influenza&#xD;
             vaccine.&#xD;
&#xD;
          -  Receipt of any influenza vaccine within the preceding 3 months.&#xD;
&#xD;
          -  Receipt of any vaccine in the 4 weeks preceding the study vaccination and planned&#xD;
             receipt of a licensed vaccine any time prior to Day 56.&#xD;
&#xD;
          -  Receipt of an RSV vaccine at any time.&#xD;
&#xD;
          -  Any known or suspected immunosuppressive condition, acquired or congenital, as&#xD;
             determined by medical history and/or physical examination.&#xD;
&#xD;
          -  Chronic administration (defined as more than 14 continuous days) of immunosuppressants&#xD;
             or other immune-modifying drugs within 6 months prior to the administration of the&#xD;
             study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a&#xD;
             systemic dose ≥10 mg of prednisone per day or equivalent. The use of topical, inhaled,&#xD;
             and nasal glucocorticoids will be permitted provided these are not administered for&#xD;
             diagnoses inconsistent with the inclusion criteria. The use of inhaled&#xD;
             glucocorticoids, although typically not associated with system absorption, will&#xD;
             generally indicate the presence of a diagnosis inconsistent with inclusion criteria 1&#xD;
             or 2.&#xD;
&#xD;
          -  Administration of immunoglobulins and/or any blood products within the 3 months&#xD;
             preceding the administration of the study vaccine or during the study.&#xD;
&#xD;
          -  Acute disease at the time of enrollment (defined as the presence of a moderate or&#xD;
             severe illness with or without fever, or an oral temperature &gt;38.0°C on the planned&#xD;
             day of vaccine administration).&#xD;
&#xD;
          -  Known disturbance of coagulation.&#xD;
&#xD;
          -  Suspicion or recent history (within one year of planned vaccination) of alcohol or&#xD;
             other substance abuse.&#xD;
&#xD;
          -  Any condition that in the opinion of the Investigator would pose a health risk to the&#xD;
             subject if enrolled or could interfere with evaluation of the vaccine or&#xD;
             interpretation of study results (including neurologic or psychiatric conditions deemed&#xD;
             likely to impair the quality of safety reporting).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>D. Nigel Thomas, Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Novavax, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Genova Clinical Research</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accelovance</name>
      <address>
        <city>Melbourne</city>
        <state>Florida</state>
        <zip>32935</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Across America</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jean Brown Research</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.novavax.com</url>
    <description>Novavax Homepage</description>
  </link>
  <verification_date>March 2014</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <last_update_submitted>March 4, 2014</last_update_submitted>
  <last_update_submitted_qc>March 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 5, 2014</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>Influenza, Human</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/NCT01709019
org study id: NVX757.102
nct id: NCT01709019
lead sponsor: 
has dmc: No
Up to 220 eligible subjects will be enrolled into one of five treatment groups. It is
      anticipated that some of the randomized study subjects may not complete the study; subjects
      who withdraw or are discontinued, will not be replaced. Randomization will be stratified by
      age (60 to <75 years and ≥ 75 years) in order to distribute the proportion of such persons in
      each age group equally across treatment groups.

      Treatments will comprise a single IM dose of a placebo or RSV-F protein nanoparticle vaccine
      on Day 0, with concurrent IM immunization with a licensed inactivated influenza vaccine. A
      rescue dose of the licensed TIV will be provided to subjects in all groups except the placebo
      group on Day 28, the placebo group will receive saline. For each subject, study follow-up
      will span approximately one year from the first immunization (on Day 0) for all subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Assessment of Safety
time frame: Day 0 to Day 364
description: Number (and percentage) of subjects with solicited local and systemic Adverse Events over the seven days post injection; all adverse events, solicited and unsolicited over 56 days post-first injection.
Significant New Medical Conditions, Medically Attended Events and Serious Adverse Events will be collected for one year.
measure: Immunogenicity as assessed by serum IgG antibody titers for the F-Protein antigen
time frame: Day 0 to Day 364
description: Immunogenicity will be measured using derived / calculated endpoints based on:
Geometric mean titer (GMT)
Geometric mean ratio (GMR)
Seroconversion rate (SCR)
Seroresponse rate (SRR)
measure: Immunogenicity as assessed by serum HAI titers specific for the influenza antigens contained in the seasonal vaccine.
time frame: Day 0 to Day 56
description: Immunogenicity will be measured using derived / calculated endpoints based on:
Geometric mean titer (GMT)
Geometric mean ratio (GMR)
Seroconversion rate (SCR)
Seroprotection rate (SPR)
arm group label: Group A
arm group type: Experimental
description: Low dose RSV-F Vaccine with Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28)
arm group label: Group B
arm group type: Experimental
description: Low dose RSV-F Vaccine without Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28)
arm group label: Group C
arm group type: Experimental
description: High dose RSV-F Vaccine with Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28)
arm group label: Group D
arm group type: Experimental
description: High dose RSV-F Vaccine without Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28)
arm group label: Group E
arm group type: Placebo Comparator
description: Placebo (Day 0 & Day 28); Seasonal TIV (Day 28)
intervention type: Biological
intervention name: Low dose RSV-F Vaccine with Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28)
description: 0.5mL IM injections
arm group label: Group A
intervention type: Biological
intervention name: Low dose RSV-F Vaccine without Adjuvant (Day 0); Seasonal TIV (Day 0 & day 28)
description: 0.5mL IM injections
arm group label: Group B
intervention type: Biological
intervention name: High dose RSV-F Vaccine with Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28)
description: 0.5mL IM injections
arm group label: Group C
intervention type: Biological
intervention name: High dose RSV-F Vaccine without Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28)
description: 0.5mL IM injections
arm group label: Group D
intervention type: Biological
intervention name: Placebo (Day 0 & Day 28); Seasonal TIV (Day 0)
description: 0.5mL IM Injections
arm group label: Group E
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: D. Nigel Thomas, Ph.D.
role: Study Director
affiliation: Novavax, Inc.
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://www.novavax.com
description: Novavax Homepage
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Vaccines