<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/NCT01678677</url>
  </required_header>
  <id_info>
    <org_study_id>116647</org_study_id>
    <nct_id>NCT01678677</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Non-typeable Haemophilus Influenzae (NTHi) Investigational Vaccine (GSK2838497A) in Current and Former Smokers</brief_title>
  <official_title>An Observer-blind Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Non-typeable Haemophilus Influenzae (NTHi) Investigational Vaccine (GSK2838497A) in Current and Former Smokers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the safety, reactogenicity and immunogenicity of 8&#xD;
      different formulations of investigational NTHI vaccine in current and former smokers, 50-70&#xD;
      years of age.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This Protocol Posting has been updated following Protocol Amendment 1, dated 10 October 2012,&#xD;
      leading to a change in an inclusion criterion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 31, 2012</start_date>
  <completion_date type="Actual">January 30, 2014</completion_date>
  <primary_completion_date type="Actual">January 30, 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>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of each solicited local and general adverse event (AE), in all subjects, in all groups.</measure>
    <time_frame>During a 7-day follow-up period (from day 0 to day 6) after each vaccination.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of any unsolicited AE, in all subjects, in all groups.</measure>
    <time_frame>During a 30-day follow-up period (from day 0 to day 29) after each vaccination.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of haematological and biochemical laboratory abnormalities, in all subjects, in all groups.</measure>
    <time_frame>Prior to each vaccination.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of haematological and biochemical laboratory abnormalities, in all subjects, in all groups.</measure>
    <time_frame>7 days after each vaccination.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of haematological and biochemical laboratory abnormalities, in all subjects, in all groups.</measure>
    <time_frame>At study conclusion (Day 420).</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of any serious adverse event (SAE), in all subjects, in all groups.</measure>
    <time_frame>From first vaccination (Day 0) to study conclusion (Day 420).</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of any potential immune-mediated disease (pIMD) in all subjects, in all groups.</measure>
    <time_frame>From first vaccination (Day 0) to study conclusion (Day 420).</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Humoral immune response to the components of the NTHi vaccine formulations, in all subjects, in all groups, in terms of antibody concentrations.</measure>
    <time_frame>Prior to each vaccination, 30 days after each vaccination, and at study conclusion (Day 420).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cell-mediated immune (CMI) responses to components of the NTHi vaccine formulations, in a sub-cohort of subjects, in all groups.</measure>
    <time_frame>Prior to each vaccination, 30 days after each vaccination, and at study conclusion (Day 420).</time_frame>
  </secondary_outcome>
  <number_of_arms>10</number_of_arms>
  <enrollment type="Actual">272</enrollment>
  <condition>Respiratory Disorders</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this group will receive formulation 1 of NTHi vaccine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this group will receive formulation 2 of NTHi vaccine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this group will receive formulation 3 of NTHi vaccine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this group will receive formulation 4 of NTHi vaccine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group E</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this group will receive formulation 5 of NTHi vaccine and a placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group F</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this group will receive formulation 6 of NTHi vaccine and a placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group G</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this group will receive formulation 7 of NTHi vaccine and a placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group H</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this group will receive formulation 8 of NTHi vaccine and a placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Placebo 1</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects in this group will receive placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Placebo 2</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects in this group will receive placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>NTHI vaccine GSK2838500A (formulation 1)</intervention_name>
    <description>Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.</description>
    <arm_group_label>Group A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>NTHI vaccine GSK2838501A (formulation 2)</intervention_name>
    <description>Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.</description>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>NTHI vaccine GSK2838502A (formulation 3)</intervention_name>
    <description>Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.</description>
    <arm_group_label>Group C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>NTHI vaccine GSK2838503A (formulation 4)</intervention_name>
    <description>Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.</description>
    <arm_group_label>Group D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>NTHI vaccine GSK2838504A (formulation 5)</intervention_name>
    <description>Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.</description>
    <arm_group_label>Group E</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>NTHI vaccine GSK2838505A (formulation 6)</intervention_name>
    <description>Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.</description>
    <arm_group_label>Group F</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>NTHI vaccine GSK2838508A (formulation 7)</intervention_name>
    <description>Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.</description>
    <arm_group_label>Group G</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>NTHI vaccine GSK2838509A (formulation 8)</intervention_name>
    <description>Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.</description>
    <arm_group_label>Group H</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo comparator</intervention_name>
    <description>Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.</description>
    <arm_group_label>Group Placebo 1</arm_group_label>
    <arm_group_label>Group Placebo 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who, in the opinion of the investigator, can and will comply with the&#xD;
             requirements of the protocol.&#xD;
&#xD;
          -  A male or female between, and including, 50 and 70 years of age at the time of the&#xD;
             first vaccination.&#xD;
&#xD;
          -  Written informed consent obtained from the subject.&#xD;
&#xD;
          -  Subjects without medical history, clinical finding or laboratory finding which in the&#xD;
             opinion of the investigator could pose a safety concern or interfere with the&#xD;
             protocol.&#xD;
&#xD;
          -  Current or former smokers.&#xD;
&#xD;
          -  A smoking history of at least 10 pack-years.&#xD;
&#xD;
          -  Female subjects of non-childbearing potential may be enrolled in the study.&#xD;
&#xD;
          -  Female subjects of childbearing potential may be enrolled in the study, if the&#xD;
             subject:&#xD;
&#xD;
               -  has practiced adequate contraception for 30 days prior to vaccination, and&#xD;
&#xD;
               -  has a negative pregnancy test on the day of vaccination, and&#xD;
&#xD;
               -  has agreed to continue adequate contraception during the entire treatment period&#xD;
                  and for 2 months after completion of the vaccination series.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of any investigational or non-registered product other than the study vaccines&#xD;
             within 30 days preceding the first dose of study vaccine, or planned use during the&#xD;
             study period.&#xD;
&#xD;
          -  Concurrently participating in another clinical study, at any time during the study&#xD;
             period, in which the subject has been or will be exposed to an investigational or a&#xD;
             non-investigational vaccine/product.&#xD;
&#xD;
          -  Planned administration/ administration of a vaccine not foreseen by the study protocol&#xD;
             in the period starting 30 days before the first dose and ending 30 days after the last&#xD;
             dose of vaccine, with the exception of any influenza vaccine which may be administered&#xD;
             ≥ 15 days preceding or following any study vaccine dose.&#xD;
&#xD;
          -  Previous vaccination with any vaccine containing NTHi-antigens.&#xD;
&#xD;
          -  Chronic administration of immunosuppressants or other immune-modifying drugs within&#xD;
             six months prior to the first vaccine dose. Topical steroids are allowed.&#xD;
&#xD;
          -  Administration of immunoglobulins and/or any blood products within the 3 months&#xD;
             preceding the first dose of study vaccine or planned administration during the study&#xD;
             period.&#xD;
&#xD;
          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on&#xD;
             medical history and physical examination.&#xD;
&#xD;
          -  History of or current autoimmune disease.&#xD;
&#xD;
          -  Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) &lt; 80% of predicted&#xD;
             normal value.&#xD;
&#xD;
          -  Diagnosed with a respiratory disorder. Please note that subjects with mild pulmonary&#xD;
             obstruction can be enrolled.&#xD;
&#xD;
          -  Laboratory evidence of clinically significant haematological abnormalities at&#xD;
             Screening.&#xD;
&#xD;
          -  Acute disease and/or fever at the time of enrolment.&#xD;
&#xD;
          -  Current alcoholism and/or drug abuse.&#xD;
&#xD;
          -  Has significant disease, in the opinion of the investigator, likely to interfere with&#xD;
             the study and/or likely to cause death within the study duration.&#xD;
&#xD;
          -  History of or current condition preventing intramuscular injection as bleeding or&#xD;
             coagulation disorder.&#xD;
&#xD;
          -  Has contraindication for spirometry testing.&#xD;
&#xD;
          -  Malignancies within previous 5 years and lymphoproliferative disorders.&#xD;
&#xD;
          -  Pregnant or lactating female.&#xD;
&#xD;
          -  Female planning to become pregnant or planning to discontinue contraceptive&#xD;
             precautions.&#xD;
&#xD;
          -  Any other condition that the investigator judges may interfere with study findings.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Antwerpen</city>
        <zip>2060</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Wilrijk</city>
        <zip>2610</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>May 12, 2017</last_update_submitted>
  <last_update_submitted_qc>May 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>non-typeable Haemophilus influenzae</keyword>
  <keyword>immunogenicity</keyword>
  <keyword>reactogenicity</keyword>
  <keyword>safety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
    <mesh_term>Respiration Disorders</mesh_term>
    <mesh_term>Respiratory Tract Diseases</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/NCT01678677
org study id: 116647
nct id: NCT01678677
lead sponsor: 
The purpose of this study is to assess the safety, reactogenicity and immunogenicity of 8
      different formulations of investigational NTHI vaccine in current and former smokers, 50-70
      years of age.
This Protocol Posting has been updated following Protocol Amendment 1, dated 10 October 2012,
      leading to a change in an inclusion criterion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Occurrence of each solicited local and general adverse event (AE), in all subjects, in all groups.
time frame: During a 7-day follow-up period (from day 0 to day 6) after each vaccination.
measure: Occurrence of any unsolicited AE, in all subjects, in all groups.
time frame: During a 30-day follow-up period (from day 0 to day 29) after each vaccination.
measure: Occurrence of haematological and biochemical laboratory abnormalities, in all subjects, in all groups.
time frame: Prior to each vaccination.
measure: Occurrence of haematological and biochemical laboratory abnormalities, in all subjects, in all groups.
time frame: 7 days after each vaccination.
measure: Occurrence of haematological and biochemical laboratory abnormalities, in all subjects, in all groups.
time frame: At study conclusion (Day 420).
measure: Occurrence of any serious adverse event (SAE), in all subjects, in all groups.
time frame: From first vaccination (Day 0) to study conclusion (Day 420).
measure: Occurrence of any potential immune-mediated disease (pIMD) in all subjects, in all groups.
time frame: From first vaccination (Day 0) to study conclusion (Day 420).
measure: Humoral immune response to the components of the NTHi vaccine formulations, in all subjects, in all groups, in terms of antibody concentrations.
time frame: Prior to each vaccination, 30 days after each vaccination, and at study conclusion (Day 420).
measure: Cell-mediated immune (CMI) responses to components of the NTHi vaccine formulations, in a sub-cohort of subjects, in all groups.
time frame: Prior to each vaccination, 30 days after each vaccination, and at study conclusion (Day 420).
arm group label: Group A
arm group type: Experimental
description: Subjects in this group will receive formulation 1 of NTHi vaccine.
arm group label: Group B
arm group type: Experimental
description: Subjects in this group will receive formulation 2 of NTHi vaccine.
arm group label: Group C
arm group type: Experimental
description: Subjects in this group will receive formulation 3 of NTHi vaccine.
arm group label: Group D
arm group type: Experimental
description: Subjects in this group will receive formulation 4 of NTHi vaccine.
arm group label: Group E
arm group type: Experimental
description: Subjects in this group will receive formulation 5 of NTHi vaccine and a placebo.
arm group label: Group F
arm group type: Experimental
description: Subjects in this group will receive formulation 6 of NTHi vaccine and a placebo.
arm group label: Group G
arm group type: Experimental
description: Subjects in this group will receive formulation 7 of NTHi vaccine and a placebo.
arm group label: Group H
arm group type: Experimental
description: Subjects in this group will receive formulation 8 of NTHi vaccine and a placebo.
arm group label: Group Placebo 1
arm group type: Placebo Comparator
description: Subjects in this group will receive placebo.
arm group label: Group Placebo 2
arm group type: Placebo Comparator
description: Subjects in this group will receive placebo.
intervention type: Biological
intervention name: NTHI vaccine GSK2838500A (formulation 1)
description: Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
arm group label: Group A
intervention type: Biological
intervention name: NTHI vaccine GSK2838501A (formulation 2)
description: Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
arm group label: Group B
intervention type: Biological
intervention name: NTHI vaccine GSK2838502A (formulation 3)
description: Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
arm group label: Group C
intervention type: Biological
intervention name: NTHI vaccine GSK2838503A (formulation 4)
description: Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
arm group label: Group D
intervention type: Biological
intervention name: NTHI vaccine GSK2838504A (formulation 5)
description: Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
arm group label: Group E
intervention type: Biological
intervention name: NTHI vaccine GSK2838505A (formulation 6)
description: Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
arm group label: Group F
intervention type: Biological
intervention name: NTHI vaccine GSK2838508A (formulation 7)
description: Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
arm group label: Group G
intervention type: Biological
intervention name: NTHI vaccine GSK2838509A (formulation 8)
description: Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
arm group label: Group H
intervention type: Drug
intervention name: Placebo comparator
description: Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
arm group label: Group Placebo 1
arm group label: Group Placebo 2
criteria: 
gender: All
minimum age: 50 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
facility: 
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Respiration Disorders
mesh term: Respiratory Tract Diseases
mesh term: Vaccines