<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/NCT01672645</url>
  </required_header>
  <id_info>
    <org_study_id>B3771001</org_study_id>
    <nct_id>NCT01672645</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Safety and Tolerability of Different Doses of PF-05402536 and PF-06413367 in Healthy Adult Smokers.</brief_title>
  <official_title>A Phase 1, Randomized, Double Blind, Placebo Controlled Study To Evaluate The Safety, Tolerability, Immunogenicity, And Exploratory Efficacy Of Multiple Ascending Dose Levels Of Pf-05402536 And Pf-06413367 In Healthy Adult Smokers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the safety and tolerability of multiple doses of&#xD;
      PF-05402536 and PF-06413367 in healthy adult smokers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of solicited local reactions (erythema, induration, and pain) and severity of the local reactions as self-reported on electronic diaries (e-diaries) for 7 days following vaccination.</measure>
    <time_frame>Within 7 days after dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of solicited systemic events (fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, and new or worsening joint pain) and severity of solicited systemic events as self-reported on e-diaries for 7 days following vaccination.</measure>
    <time_frame>Within 7 days after dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Unsolicited Treatment-Emergent Adverse Events (AEs) by Seriousness and Relationship to Treatment</measure>
    <time_frame>Baseline up to Day 364</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Abnormal Safety Laboratory Findings by Seriousness and Relationship to Treatment</measure>
    <time_frame>Baseline up to Day 364</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Antibody titers against nicotine.</measure>
    <time_frame>Up to Day 364</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Avidity of antibodies against nicotine.</measure>
    <time_frame>Up to Day 364</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>7-day point prevalence of smoking abstinence</measure>
    <time_frame>Up to Day 364</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>4-week continuous abstinence rate from smoking</measure>
    <time_frame>Up to Day 364</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>smoking behavioral measurements (including Minnesota Nicotine Withdrawal Scale, Modified Cigarette Evaluation Questionnaire, and Brief Questionnaire of Smoking Urges)</measure>
    <time_frame>Up to Day 364</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">277</enrollment>
  <condition>Smoking</condition>
  <condition>Vaccines</condition>
  <arm_group>
    <arm_group_label>PF-05402536</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>PF-06413367</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intramuscular, multiple dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intramuscular</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>NIC7-001</intervention_name>
    <description>Intramuscular, multiple dose</description>
    <arm_group_label>PF-05402536</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>NIC7-003</intervention_name>
    <description>Intramuscular, multiple dose</description>
    <arm_group_label>PF-06413367</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>Saline (0.9% sodium chloride)</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Current cigarette smokers&#xD;
&#xD;
          -  Males or females of non-child bearing potential, who are between the minimum legal age&#xD;
             for smoking (approximately 18 or 19 years, depending on local jurisdiction) and 55&#xD;
             years, inclusive, and who are motivated to stop smoking.&#xD;
&#xD;
          -  Subjects must have smoked an average of at least 10 cigarettes per day during the past&#xD;
             year and during the month prior to the prescreening assessment for entry, with no&#xD;
             period of abstinence greater than 3 months in the past year.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence or history of clinically significant hematological, renal, endocrine,&#xD;
             pulmonary, gastrointestinal, cardiovascular, hepatic, or neurologic disease that may&#xD;
             compromise their ability to safely participate in the study.&#xD;
&#xD;
          -  Active suicidal ideation or history of suicidal behaviors within the past 5 years&#xD;
             prior to the screening visit.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 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>INC Research Toronto Inc.</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5V 2T3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diex Research Montreal, Inc.</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2Y 1S1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diex Research Sherbrooke Inc.</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H 1Z1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3771001&amp;StudyName=A%20study%20to%20assess%20the%20safety%20and%20tolerability%20of%20different%20doses%20of%20PF-05402536%20and%20PF-06413367%20in%20healthy%20adult%20smokers.</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>July 5, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <last_update_submitted>January 25, 2016</last_update_submitted>
  <last_update_submitted_qc>January 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Smoking cessation</keyword>
  <keyword>vaccine</keyword>
  <keyword>Phase 1</keyword>
  <!-- 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/NCT01672645
org study id: B3771001
nct id: NCT01672645
lead sponsor: 
has dmc: No
The purpose of this study is to determine the safety and tolerability of multiple doses of
      PF-05402536 and PF-06413367 in healthy adult smokers.
allocation: Randomized
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Frequency of solicited local reactions (erythema, induration, and pain) and severity of the local reactions as self-reported on electronic diaries (e-diaries) for 7 days following vaccination.
time frame: Within 7 days after dose
measure: Frequency of solicited systemic events (fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, and new or worsening joint pain) and severity of solicited systemic events as self-reported on e-diaries for 7 days following vaccination.
time frame: Within 7 days after dose
measure: Number of Participants With Unsolicited Treatment-Emergent Adverse Events (AEs) by Seriousness and Relationship to Treatment
time frame: Baseline up to Day 364
measure: Number of Participants With Abnormal Safety Laboratory Findings by Seriousness and Relationship to Treatment
time frame: Baseline up to Day 364
measure: Antibody titers against nicotine.
time frame: Up to Day 364
measure: Avidity of antibodies against nicotine.
time frame: Up to Day 364
measure: 7-day point prevalence of smoking abstinence
time frame: Up to Day 364
measure: 4-week continuous abstinence rate from smoking
time frame: Up to Day 364
measure: smoking behavioral measurements (including Minnesota Nicotine Withdrawal Scale, Modified Cigarette Evaluation Questionnaire, and Brief Questionnaire of Smoking Urges)
time frame: Up to Day 364
arm group label: PF-05402536
arm group type: Experimental
arm group label: PF-06413367
arm group type: Experimental
description: Intramuscular, multiple dose
arm group label: Placebo
arm group type: Placebo Comparator
description: Intramuscular
intervention type: Biological
intervention name: NIC7-001
description: Intramuscular, multiple dose
arm group label: PF-05402536
intervention type: Biological
intervention name: NIC7-003
description: Intramuscular, multiple dose
arm group label: PF-06413367
intervention type: Biological
intervention name: Saline
description: Saline (0.9% sodium chloride)
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
facility: 
facility: 
country: Canada
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3771001&StudyName=A%20study%20to%20assess%20the%20safety%20and%20tolerability%20of%20different%20doses%20of%20PF-05402536%20and%20PF-06413367%20in%20healthy%20adult%20smokers.
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor