<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/NCT01704365</url>
  </required_header>
  <id_info>
    <org_study_id>NVX757.201</org_study_id>
    <nct_id>NCT01704365</nct_id>
  </id_info>
  <brief_title>RSV-F Vaccine Dose Ranging Study in Young Women</brief_title>
  <official_title>A Phase II Randomized, Observer-Blinded, Placebo-Controlled, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of an RSV-F Protein Nanoparticle Vaccine, With or Without Aluminum, in Healthy Women of Child-Bearing Age</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novavax</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>PATH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Novavax</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the immunogenicty and safety of an RSV-F protein&#xD;
      nanoparticle vaccine, with out without aluminum, in healthy women of child-bearing potential.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Immunogenicity as assessed by serum IgG antibody titers specific for the F-Protein antigen across treatment groups</measure>
    <time_frame>Day 0 to Day 112</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>
  <primary_outcome>
    <measure>Assessment of the safety</measure>
    <time_frame>Day 0 to Day 182</time_frame>
    <description>Number (and percentage) of subjects with solicited local and systemic Adverse Events over the seven days post-injections; 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 six months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity based on neturalizing antibody titer</measure>
    <time_frame>Day 0 to Day 112</time_frame>
  </secondary_outcome>
  <number_of_arms>10</number_of_arms>
  <enrollment type="Actual">330</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 and 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 with Adjuvant (Day 0); Placebo (Day 28)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low dose RSV-F Vaccine without Adjuvant (Day 0 and Day 28)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low dose RSV-F Vaccine without Adjuvant (Day 0); Placebo (Day 28)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group E</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High dose RSV-F Vaccine with Adjuvant (Day 0 and Day 28)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group F</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High dose RSV-F Vaccine with Adjuvant (Day 0); Placebo (Day 28)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group G</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High dose RSV-F Vaccine without Adjuvant (Day 0 and Day 28)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group H</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High dose RSV-F Vaccine without Adjuvant (Day 0); Placebo (Day 28)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group J</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low dose RSV-F Vaccine with Adjuvant [Bedside Mixing] (Day 0 &amp; Day 28)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group K</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo (Day 0 and Day 28)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Low dose RSV-F Vaccine with Adjuvant</intervention_name>
    <description>0.5mL IM Injection</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Low dose RSV-F Vaccine without Adjuvant</intervention_name>
    <description>0.5ml IM Injection</description>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_label>Group D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>High dose RSV-F Vaccine with Adjuvant</intervention_name>
    <description>0.5mL IM Injection</description>
    <arm_group_label>Group E</arm_group_label>
    <arm_group_label>Group F</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>High dose RSV-F Vaccine without Adjuvant</intervention_name>
    <description>0.5mL IM Injection</description>
    <arm_group_label>Group G</arm_group_label>
    <arm_group_label>Group H</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Low dose RSV-F Vaccine with Adjuvant [Bedside Mixing]</intervention_name>
    <description>0.5mL IM Injection</description>
    <arm_group_label>Group J</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>0.5mL IM Injection</description>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group D</arm_group_label>
    <arm_group_label>Group F</arm_group_label>
    <arm_group_label>Group H</arm_group_label>
    <arm_group_label>Group K</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adult females, ≥ 18 and ≤ 35 years of age. &quot;Healthy&quot; shall be defined by the&#xD;
             absence of any illness, acute or chronic, that requires ongoing systemic therapy for&#xD;
             the control of symptoms or prevention of disability.&#xD;
&#xD;
          -  Subjects on stable (no change in ≥ 3 months) therapy for findings (e.g., hypertension&#xD;
             or hyperlipidemia) that are not associated with symptoms or disability are eligible,&#xD;
             as are users of hormonal contraceptives.&#xD;
&#xD;
          -  Subjects who receive intermittent prophylaxis for risks associated with asymptomatic&#xD;
             findings (e.g., antibiotic prophylaxis prior to dental procedures in a subject with&#xD;
             mitral valve prolapse) are eligible.&#xD;
&#xD;
          -  Ongoing therapy will be defined as continuous or, if intermittent, more frequent than&#xD;
             once every 3 months (e.g., use of an inhaled bronchodilator for exercise-induced&#xD;
             bronchospasm more than once every 3 months). Immunosuppressives are subject to&#xD;
             exclusion criterion #5 below.&#xD;
&#xD;
          -  Persons being treated for illnesses or conditions that would become acutely&#xD;
             symptomatic or disabling in the absence of treatment are not eligible.&#xD;
&#xD;
          -  Willing and able to give informed consent prior to study enrollment.&#xD;
&#xD;
          -  Able to comply with study requirements.&#xD;
&#xD;
          -  Women who are not surgically sterile must have a negative urine pregnancy test prior&#xD;
             to each vaccination; will be advised through the Informed Consent process to avoid&#xD;
             becoming pregnant over the duration of the study, and must assert that they will&#xD;
             employ an effective form of birth control for the duration of the study. Acceptable&#xD;
             forms of birth control are: credible history of continuous abstinence from&#xD;
             heterosexual activity, hormonal contraceptives (oral, injectable, implant, patch,&#xD;
             ring), double-barrier contraceptives (condom or diaphragm, with spermicide), and IUD.&#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.&#xD;
&#xD;
          -  History of a serious reaction to any prior vaccination.&#xD;
&#xD;
          -  Received any vaccine in the 4 weeks preceding the study vaccination; or any RSV&#xD;
             vaccine at any time.&#xD;
&#xD;
          -  Any known or suspected immunosuppressive condition, acquired or congenital, as&#xD;
             determined by 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 ≥10mg of prednisone per day or equivalent. The use of topical, inhaled,&#xD;
             and nasal glucocorticoids will be permitted.&#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;
          -  Women who are pregnant or breastfeeding, or plan to become pregnant during the study.&#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>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</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>Anaheim Clinical Trials</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accelovance Rockville</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Carolina Research</name>
      <address>
        <city>Mount Pleasant</city>
        <state>South Carolina</state>
        <zip>29464</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of Texas</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</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>February 2014</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <disposition_first_submitted>February 5, 2014</disposition_first_submitted>
  <disposition_first_submitted_qc>February 5, 2014</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">March 7, 2014</disposition_first_posted>
  <last_update_submitted>February 5, 2014</last_update_submitted>
  <last_update_submitted_qc>February 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 7, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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, but a results disposition has been submitted           -->
</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/NCT01704365
org study id: NVX757.201
nct id: NCT01704365
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate the immunogenicty and safety of an RSV-F protein
      nanoparticle vaccine, with out without aluminum, in healthy women of child-bearing potential.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Immunogenicity as assessed by serum IgG antibody titers specific for the F-Protein antigen across treatment groups
time frame: Day 0 to Day 112
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: Assessment of the safety
time frame: Day 0 to Day 182
description: Number (and percentage) of subjects with solicited local and systemic Adverse Events over the seven days post-injections; 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 six months
measure: Immunogenicity based on neturalizing antibody titer
time frame: Day 0 to Day 112
arm group label: Group A
arm group type: Experimental
description: Low dose RSV-F Vaccine with Adjuvant (Day 0 and Day 28)
arm group label: Group B
arm group type: Experimental
description: Low dose RSV-F Vaccine with Adjuvant (Day 0); Placebo (Day 28)
arm group label: Group C
arm group type: Experimental
description: Low dose RSV-F Vaccine without Adjuvant (Day 0 and Day 28)
arm group label: Group D
arm group type: Experimental
description: Low dose RSV-F Vaccine without Adjuvant (Day 0); Placebo (Day 28)
arm group label: Group E
arm group type: Experimental
description: High dose RSV-F Vaccine with Adjuvant (Day 0 and Day 28)
arm group label: Group F
arm group type: Experimental
description: High dose RSV-F Vaccine with Adjuvant (Day 0); Placebo (Day 28)
arm group label: Group G
arm group type: Experimental
description: High dose RSV-F Vaccine without Adjuvant (Day 0 and Day 28)
arm group label: Group H
arm group type: Experimental
description: High dose RSV-F Vaccine without Adjuvant (Day 0); Placebo (Day 28)
arm group label: Group J
arm group type: Experimental
description: Low dose RSV-F Vaccine with Adjuvant [Bedside Mixing] (Day 0 & Day 28)
arm group label: Group K
arm group type: Placebo Comparator
description: Placebo (Day 0 and Day 28)
intervention type: Biological
intervention name: Low dose RSV-F Vaccine with Adjuvant
description: 0.5mL IM Injection
arm group label: Group A
arm group label: Group B
intervention type: Biological
intervention name: Low dose RSV-F Vaccine without Adjuvant
description: 0.5ml IM Injection
arm group label: Group C
arm group label: Group D
intervention type: Biological
intervention name: High dose RSV-F Vaccine with Adjuvant
description: 0.5mL IM Injection
arm group label: Group E
arm group label: Group F
intervention type: Biological
intervention name: High dose RSV-F Vaccine without Adjuvant
description: 0.5mL IM Injection
arm group label: Group G
arm group label: Group H
intervention type: Biological
intervention name: Low dose RSV-F Vaccine with Adjuvant [Bedside Mixing]
description: 0.5mL IM Injection
arm group label: Group J
intervention type: Biological
intervention name: Placebo
description: 0.5mL IM Injection
arm group label: Group B
arm group label: Group D
arm group label: Group F
arm group label: Group H
arm group label: Group K
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
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: Vaccines