<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/NCT01706367</url>
  </required_header>
  <id_info>
    <org_study_id>B5091001</org_study_id>
    <nct_id>NCT01706367</nct_id>
  </id_info>
  <brief_title>Evaluation of a 3-dose Vaccination Regimen With One of Three Ascending Dose Levels of Clostridium Difficile Vaccine With or Without Adjuvant in Healthy Adults Aged 50 to 85 Years</brief_title>
  <official_title>A Phase 1, Placebo-Controlled, Randomized, Observer-Blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Clostridium Difficile Vaccine Administered With Or Without Adjuvant, In A 3-Dose Regimen In Healthy Adults Aged 50 To 85 Years</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a first-in-human study (phase 1) of a 3-dose vaccination regimen with one of three&#xD;
      dose levels of C difficile vaccine with or without adjuvant in healthy adults aged 50 to 85&#xD;
      years. The main goal of the study is to determine how safe and well-tolerated the vaccine is.&#xD;
      In addition, the study aims to assess the immune response to the C difficile vaccine.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</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>Basic Science</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number subjects reporting local reactions (pain, erythema, and induration) and their severity, as self reported on eDiaries for 7 days following each vaccination.</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects reporting systemic reactions (fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, and new or worsening joint pain) and their severity, as self reported on eDiaries for 7 days following each vaccination.</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects reporting AEs from day 1 (at the time of vaccination) up to 28 days post Dose 3 (visit 9, month 7) and SAEs throughout the study period.</measure>
    <time_frame>7 months (AEs) 12 months (SAEs)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with abnormal hematology and blood chemistry laboratory assessments after each vaccination dose.</measure>
    <time_frame>Day 3, Day 14, Month 1, Day 37, Month 6, Day 187</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neutralizing antibody levels at Month 2.</measure>
    <time_frame>Month 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neutralizing antibody levels after each vaccination dose.</measure>
    <time_frame>Baseline, Day 14, Month 1, Day 37, Month 6, Day 187, Month 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects in each treatment group with 4 and higher fold-rises in neutralizing antibody levels after each vaccination dose.</measure>
    <time_frame>Baseline, Day 14, Month 1, Day 37, Month 2, Month 6, Day 187, Month 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects in each treatment group with neutralizing antibody levels ≥ a specified threshold after each vaccination dose.</measure>
    <time_frame>Baseline, Day 14, Month 1, Day 37, Month 2, Month 6, Day 187, Month 7</time_frame>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">192</enrollment>
  <condition>Clostridium Difficile Associated Disease</condition>
  <arm_group>
    <arm_group_label>Low dose C diff vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Low dose C diff vaccine + adjuvant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Mid dose C diff vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Mid dose C diff vaccine + adjuvant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose C diff vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose C diff vaccine + adjuvant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>C. difficile vaccine</intervention_name>
    <description>0.5 mL IM injection</description>
    <arm_group_label>Low dose C diff vaccine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>C. difficile vaccine +adjuvant</intervention_name>
    <description>0.5 mL IM injection</description>
    <arm_group_label>Low dose C diff vaccine + adjuvant</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>C. difficile vaccine</intervention_name>
    <description>0.5 mL IM injection</description>
    <arm_group_label>Mid dose C diff vaccine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>C. difficile vaccine +adjuvant</intervention_name>
    <description>0.5 mL IM injection</description>
    <arm_group_label>Mid dose C diff vaccine + adjuvant</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>C. difficile vaccine</intervention_name>
    <description>0.5 mL IM injection</description>
    <arm_group_label>High dose C diff vaccine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>C. difficile vaccine +adjuvant</intervention_name>
    <description>0.5 mL IM injection</description>
    <arm_group_label>High dose C diff vaccine + adjuvant</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Evidence of a personally signed and dated informed consent document.&#xD;
&#xD;
          2. Healthy male and female adults aged 50 to 85 years at enrollment as determined by&#xD;
             medical history, physical examination, and the clinical judgment of the investigator&#xD;
             to be eligible for the study. Subjects with preexisting chronic medical conditions&#xD;
             determined to be stable may be included.&#xD;
&#xD;
          3. Male subjects who, in the opinion of the investigator, are biologically capable of&#xD;
             fathering children, and who are sexually active with women of childbearing potential&#xD;
             must agree to use a highly effective method of contraception from the time of informed&#xD;
             consent through at least 28 days after the last dose of investigational product&#xD;
             (through Visit 9 at Month 7).&#xD;
&#xD;
          4. Female subjects who are not of childbearing potential (ie, meet at least one of the&#xD;
             following criteria):&#xD;
&#xD;
               -  Have undergone hysterectomy or bilateral oophorectomy;&#xD;
&#xD;
               -  Have medically confirmed ovarian failure or&#xD;
&#xD;
               -  Are medically confirmed to be postmenopausal&#xD;
&#xD;
          5. Availability for the entire duration of the study, and able to comply with scheduled&#xD;
             visits, treatment plan, laboratory tests, and other study procedures including&#xD;
             completion of the electronic diary (eDiary) from Day 1 to Day 7 following each&#xD;
             vaccination.&#xD;
&#xD;
          6. Ability to be contacted by telephone during study participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous administration of an investigational C. difficile vaccine or C. difficile&#xD;
             monoclonal antibody therapy.&#xD;
&#xD;
          2. Proven or suspected prior episode of CDAD.&#xD;
&#xD;
          3. Unstable chronic medical condition or disease requiring significant change in therapy&#xD;
             or hospitalization for worsening disease within 12 weeks before receipt of study&#xD;
             vaccine.&#xD;
&#xD;
          4. Serious chronic medical disorders including metastatic malignancy, severe chronic&#xD;
             obstructive pulmonary disease (COPD) , end stage renal disease with or without&#xD;
             dialysis, clinically unstable cardiac disease, or any other disorder that in the&#xD;
             investigator's opinion precludes the subject from participating in the study.&#xD;
&#xD;
          5. Donation of blood volume of 250 mL or greater, or donation of plasma within 3 months&#xD;
             prior to enrollment or during the conduct of the study.&#xD;
&#xD;
          6. Bleeding diathesis or condition associated with prolonged bleeding time that may&#xD;
             contraindicate intramuscular injection or blood draw including subjects taking&#xD;
             anticoagulant, antiplatelet and/or antithrombotic agents except for low dose daily&#xD;
             aspirin (≤325mg per day) within 30 days before enrollment through completion of Visit&#xD;
             9 (Month 7).&#xD;
&#xD;
          7. Any contraindication to vaccination or vaccine components.&#xD;
&#xD;
          8. &quot;Immunocompromised persons or subjects currently on immunosuppressive therapy or with&#xD;
             a history of immunosuppressive therapy, including chemotherapy agents for treatment of&#xD;
             diseases including, but not limited to cancer, inflammatory bowel disease or&#xD;
             autoimmune disease. Recent history (within the past 6 months) of long term (7 days or&#xD;
             longer) systemic corticosteroid use.&quot;&#xD;
&#xD;
          9. Subjects who received oral or parenteral antibiotics within 1 month before enrollment.&#xD;
             Topical antibiotics are allowed.&#xD;
&#xD;
         10. Receipt of blood products or immunoglobulins (including monoclonal antibodies) within&#xD;
             6 months before enrollment through conclusion of the study.&#xD;
&#xD;
         11. Participation in other investigational or interventional studies within 30 days before&#xD;
             the current study begins and/or during study participation. Participation in purely&#xD;
             observational studies is acceptable.&#xD;
&#xD;
         12. Subjects who are investigational site staff members or relatives of those site staff&#xD;
             members, or subjects who are Pfizer employees directly involved in the conduct of the&#xD;
             trial.&#xD;
&#xD;
         13. Females of childbearing potential; males of childbearing potential not using highly&#xD;
             effective contraception or not agreeing to continue highly effective contraception for&#xD;
             at least 28 days after last dose of investigational product (through Visit 9 at Month&#xD;
             7).&#xD;
&#xD;
         14. Females receiving exogenous estrogen therapy.&#xD;
&#xD;
         15. Residence in a nursing home, long-term care facility, requirement for semiskilled&#xD;
             nursing care or assisted living. An ambulatory subject who lives in an autonomous&#xD;
             manner in a retirement home or village is eligible for the trial.&#xD;
&#xD;
         16. Any abnormality in screening hematology and/or blood chemistry laboratory values&#xD;
             according to the toxicity grading scale. Subjects with stable Grade 1 abnormalities&#xD;
             for hemoglobin, leukocyte count, and platelets may be considered eligible at the&#xD;
             discretion of the investigator.&#xD;
&#xD;
         17. A positive screening test or known infection with human immunodeficiency virus (HIV),&#xD;
             hepatitis B virus (HBV) and/or hepatitis C virus (HCV).&#xD;
&#xD;
         18. Other severe acute or chronic medical or psychiatric condition or laboratory&#xD;
             abnormality that may increase the risk associated with study participation or&#xD;
             investigational product administration or may interfere with the interpretation of&#xD;
             study results and, in the judgment of the investigator, would make the subject&#xD;
             inappropriate for entry into this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pfizer Investigational Site</name>
      <address>
        <city>Pembroke Pines</city>
        <state>Florida</state>
        <zip>33026</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pfizer Investigational Site</name>
      <address>
        <city>South Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pfizer Investigational Site</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pfizer Investigational Site</name>
      <address>
        <city>Cary</city>
        <state>North Carolina</state>
        <zip>27518</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B5091001&amp;StudyName=Evaluation%20of%20a%203-dose%20vaccination%20regimen%20with%20one%20of%20three%20ascending%20dose%20levels%20of%20Clostridium%20difficile%20vaccine%20with%20or%20without%20ad</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>March 2014</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>March 5, 2014</last_update_submitted>
  <last_update_submitted_qc>March 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 6, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Clostridium difficile</keyword>
  <keyword>vaccine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clostridium Infections</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/NCT01706367
org study id: B5091001
nct id: NCT01706367
lead sponsor: 
has dmc: Yes
This is a first-in-human study (phase 1) of a 3-dose vaccination regimen with one of three
      dose levels of C difficile vaccine with or without adjuvant in healthy adults aged 50 to 85
      years. The main goal of the study is to determine how safe and well-tolerated the vaccine is.
      In addition, the study aims to assess the immune response to the C difficile vaccine.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Investigator)
measure: Number subjects reporting local reactions (pain, erythema, and induration) and their severity, as self reported on eDiaries for 7 days following each vaccination.
time frame: 7 days
measure: Number of subjects reporting systemic reactions (fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, and new or worsening joint pain) and their severity, as self reported on eDiaries for 7 days following each vaccination.
time frame: 7 days
measure: Number of subjects reporting AEs from day 1 (at the time of vaccination) up to 28 days post Dose 3 (visit 9, month 7) and SAEs throughout the study period.
time frame: 7 months (AEs) 12 months (SAEs)
measure: Number of subjects with abnormal hematology and blood chemistry laboratory assessments after each vaccination dose.
time frame: Day 3, Day 14, Month 1, Day 37, Month 6, Day 187
measure: Neutralizing antibody levels at Month 2.
time frame: Month 2
measure: Neutralizing antibody levels after each vaccination dose.
time frame: Baseline, Day 14, Month 1, Day 37, Month 6, Day 187, Month 7
measure: Number of subjects in each treatment group with 4 and higher fold-rises in neutralizing antibody levels after each vaccination dose.
time frame: Baseline, Day 14, Month 1, Day 37, Month 2, Month 6, Day 187, Month 7
measure: Number of subjects in each treatment group with neutralizing antibody levels ≥ a specified threshold after each vaccination dose.
time frame: Baseline, Day 14, Month 1, Day 37, Month 2, Month 6, Day 187, Month 7
arm group label: Low dose C diff vaccine
arm group type: Experimental
arm group label: Low dose C diff vaccine + adjuvant
arm group type: Experimental
arm group label: Mid dose C diff vaccine
arm group type: Experimental
arm group label: Mid dose C diff vaccine + adjuvant
arm group type: Experimental
arm group label: High dose C diff vaccine
arm group type: Experimental
arm group label: High dose C diff vaccine + adjuvant
arm group type: Experimental
intervention type: Biological
intervention name: C. difficile vaccine
description: 0.5 mL IM injection
arm group label: Low dose C diff vaccine
intervention type: Biological
intervention name: C. difficile vaccine +adjuvant
description: 0.5 mL IM injection
arm group label: Low dose C diff vaccine + adjuvant
intervention type: Biological
intervention name: C. difficile vaccine
description: 0.5 mL IM injection
arm group label: Mid dose C diff vaccine
intervention type: Biological
intervention name: C. difficile vaccine +adjuvant
description: 0.5 mL IM injection
arm group label: Mid dose C diff vaccine + adjuvant
intervention type: Biological
intervention name: C. difficile vaccine
description: 0.5 mL IM injection
arm group label: High dose C diff vaccine
intervention type: Biological
intervention name: C. difficile vaccine +adjuvant
description: 0.5 mL IM injection
arm group label: High dose C diff vaccine + adjuvant
criteria: 
gender: All
minimum age: 50 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
facility: 
facility: 
facility: 
country: United States
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B5091001&StudyName=Evaluation%20of%20a%203-dose%20vaccination%20regimen%20with%20one%20of%20three%20ascending%20dose%20levels%20of%20Clostridium%20difficile%20vaccine%20with%20or%20without%20ad
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Clostridium Infections
mesh term: Vaccines