<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/NCT04420221</url>
  </required_header>
  <id_info>
    <org_study_id>208833</org_study_id>
    <secondary_id>2021-006215-29</secondary_id>
    <nct_id>NCT04420221</nct_id>
  </id_info>
  <brief_title>Safety, Immunogenicity and Efficacy of GSK S. Aureus Candidate Vaccine (GSK3878858A) When Administered to Healthy Adults (Dose-escalation) and to Adults 18 to 64 Years of Age With a Recent S. Aureus Skin and Soft Tissue Infection (SSTI)</brief_title>
  <official_title>A Phase I/II, Observer-blind, Randomised, Placebo-controlled Study to Assess Safety, Immunogenicity and Efficacy of GSK S. Aureus Candidate Vaccine When Administered to Healthy Adults (Dose-escalation) and to Adults 18 to 64 Years of Age With a Recent S. Aureus Skin and Soft Tissue Infection (SSTI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Safety, immunogenicity and efficacy of GSK S. aureus candidate vaccine (GSK3878858A) when&#xD;
      administered to healthy adults (dose-escalation) and to adults 18 to 64 years of age with a&#xD;
      recent S. aureus skin and soft tissue infection (SSTI). In the dose-escalation safety lead-in&#xD;
      phase in healthy adults safety and immunogenicity of 4 different compositions is assessed.&#xD;
      After safety has been shown in this phase, in the second phase, proof of principle (PoP)&#xD;
      phase of the study in adults with a recent SSTI safety, immunogenicity and efficacy of the&#xD;
      final composition of the vaccine is assessed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 29, 2020</start_date>
  <completion_date type="Anticipated">March 14, 2024</completion_date>
  <primary_completion_date type="Anticipated">March 14, 2024</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>Sequential Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with solicited local adverse events (AEs) (any, grade 3)</measure>
    <time_frame>During 7 days after the first dose (Days 1 to 8)</time_frame>
    <description>The solicited local AE(s) assessed are pain, redness and swelling. Any = any solicited local AE, regardless of intensity; Grade 3 pain = Significant pain at rest, that prevents normal every day activities; Grade 3 redness/swelling = greater than or equal to (≥)100 mm diameter (greatest surface diameter in millimetres [mm]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with solicited local adverse events (AEs) (any, grade 3)</measure>
    <time_frame>During 7 days after the second dose (Days 61 to 68)</time_frame>
    <description>The solicited local AE(s) assessed are pain, redness and swelling. Any = any solicited local AE, regardless of intensity; Grade 3 pain = Significant pain at rest, that prevents normal every day activities; Grade 3 redness/swelling = greater than or equal to (≥)100 mm diameter (greatest surface diameter in millimeters [mm]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with solicited general AEs (any, grade 3)</measure>
    <time_frame>During 7 days after the first dose (Days 1 to 8)</time_frame>
    <description>The solicited general AE(s) assessed are headache, fatigue, nausea, vomiting, diarrhea, abdominal pain, myalgia, shivering and fever (temperature ≥ 38.0 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F). Any = any solicited general AE regardless of intensity; Grade 3 headache/fatigue/nausea/abdominal pain/myalgia/shivering = Severe: Prevents daily activity. Grade 3 vomiting = Severe: 6 or more times in 24 hours or requires intravenous hydration. Grade 3 diarrhea = Severe: 6 or more loose stools in 24 hours or requires intravenous hydration. Grade 3 fever = body temperature greater than (&gt;) 40.0°C/104°F.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with solicited general AEs (any, grade 3)</measure>
    <time_frame>During 7 days after the second dose (Days 61 to 68)</time_frame>
    <description>The solicited general AE(s) assessed are headache, fatigue, nausea, vomiting, diarrhea, abdominal pain, myalgia, shivering and fever (temperature ≥ 38.0 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F). Any = any solicited general AE regardless of intensity; Grade 3 headache/fatigue/nausea/abdominal pain/myalgia/shivering = Severe: Prevents daily activity. Grade 3 vomiting = Severe: 6 or more times in 24 hours or requires intravenous hydration. Grade 3 diarrhea = Severe: 6 or more loose stools in 24 hours or requires intravenous hydration. Grade 3 fever = body temperature greater than (&gt;) 40.0°C/104°F.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with unsolicited AEs (any, grade 3, related, related grade 3)</measure>
    <time_frame>During 30 days after the first dose (Days 1 to 31)</time_frame>
    <description>Any (independent from causality) unsolicited AEs regardless of intensity; Grade 3 unsolicited AEs = An AE which prevents normal, everyday activities. Such an AE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related unsolicited AEs = AEs assessed by the investigator to be causally related to vaccination. Grade 3 related unsolicited AEs = An AE which prevents normal, everyday activities. Such an AE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with unsolicited AEs (any, grade 3, related, related grade 3)</measure>
    <time_frame>During 30 days after the second dose (Days 61 to 91)</time_frame>
    <description>Any (independent from causality) unsolicited AEs regardless of intensity; Grade 3 unsolicited AEs = An AE which prevents normal, everyday activities. Such an AE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related unsolicited AEs = AEs assessed by the investigator to be causally related to vaccination. Grade 3 related unsolicited AEs = An AE which prevents normal, everyday activities. Such an AE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with serious AEs (SAEs) (any, grade 3, related, related grade 3)</measure>
    <time_frame>Throughout the study period [from Day 1 (day of vaccination) until Day 366</time_frame>
    <description>Any (independent from causality) SAEs regardless of intensity; Grade 3 SAEs = SAE which prevents normal, everyday activities. Such an SAE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related SAEs = SAEs assessed by the investigator to be causally related to vaccination. Grade 3 related SAEs = SAE which prevents normal, everyday activities. Such an SAE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with serious AEs (SAEs) (any, grade 3, related, related grade 3)</measure>
    <time_frame>Throughout the study period [from Day 1 (day of vaccination) until Day 426</time_frame>
    <description>Any (independent from causality) SAEs regardless of intensity; Grade 3 SAEs = SAE which prevents normal, everyday activities. Such an SAE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related SAEs = SAEs assessed by the investigator to be causally related to vaccination. Grade 3 related SAEs = SAE which prevents normal, everyday activities. Such an SAE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with potential immune-mediated diseases (PIMDs) (any, grade 3, related, related grade 3)</measure>
    <time_frame>Throughout the study period [from Day 1 (day of vaccination) until Day 366</time_frame>
    <description>Any (independent from causality) PIMDs regardless of intensity; Grade 3 PIMDs = PIMD which prevents normal, everyday activities. Such an PIMD would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related PIMDs = PIMDs assessed by the investigator to be causally related to vaccination. Grade 3 related PIMDs = PIMD which prevents normal, everyday activities. Such an PIMD would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with potential immune-mediated diseases (PIMDs) (any, grade 3, related, related grade 3)</measure>
    <time_frame>Throughout the study period [from Day 1 (day of vaccination) until Day 426</time_frame>
    <description>Any (independent from causality) PIMDs regardless of intensity; Grade 3 PIMDs = PIMD which prevents normal, everyday activities. Such an PIMD would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related PIMDs = PIMDs assessed by the investigator to be causally related to vaccination. Grade 3 related PIMDs = PIMD which prevents normal, everyday activities. Such an PIMD would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with haematological and biochemical laboratory abnormalities and changes from the baseline values</measure>
    <time_frame>At Day 8 (7 days after the first dose)</time_frame>
    <description>The number of participants having hematology and biochemistry results below, within or above the normal laboratory ranges, compared to baseline range indicator.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with haematological and biochemical laboratory abnormalities and changes from the baseline values</measure>
    <time_frame>At Day 68 (7 days after the second dose)</time_frame>
    <description>The number of participants having hematology and biochemistry results below, within or above the normal laboratory ranges, compared to baseline range indicator.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with at least one culture confirmed case of recurrent S. aureus SSTI</measure>
    <time_frame>Starting from Day 75 (i.e.14 days after the second dose) up to Day 426 (12 months after the second dose).</time_frame>
    <description>This key secondary outcome measure is to evaluate efficacy in terms of number of participants with at least one culture confirmed case of recurrent S. aureus SSTI starting 14 days after the second dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with at least one culture confirmed case of recurrent S. aureus SSTI</measure>
    <time_frame>Starting from Day 15 (i.e. 14 days after the first dose) up to Day 426 (12 months after the second dose).</time_frame>
    <description>This co-secondary outcome measure is to evaluate efficacy in terms of number of participants with at least one culture confirmed case of recurrent S. aureus SSTI starting 14 days after the first dose.</description>
  </secondary_outcome>
  <number_of_arms>10</number_of_arms>
  <enrollment type="Anticipated">632</enrollment>
  <condition>Infections, Soft Tissue</condition>
  <arm_group>
    <arm_group_label>Half dose non-adj Group 1a</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, non-adjuvanted at Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Group 1b</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of placebo (saline) at Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Full dose non-adj Group 2a</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of Sa-5Ag (5 antigens of S. aureus) full dose, non-adjuvanted at Day 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Group 2b</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of placebo (saline) at Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Half dose adj Group 3a</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, adjuvanted at Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Group 3b</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of placebo (saline) at Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Full dose adj Group 4a</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects aged 18 to 50 at the time of first vaccination who receive a series of 2 doses of S. aureus candidate vaccine (Sa-5Ag full dose adjuvanted) given approximately 2 months apart (Days 1 and 61)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Group 4b</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects aged 18 to 50 at the time of first vaccination who receive a series of 2 doses of placebo (saline) given approximately 2 months apart (Days 1 and 61).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vaccine Group 5a</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects aged 18 to 64 at the time of first vaccination who receive a series of 2 doses of S. aureus candidate vaccine (Sa-5Ag full dose adjuvanted) given approximately 2 months apart (Days 1 and 61).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Group 5b</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects aged 18 to 64 at the time of first vaccination who receive a series of 2 doses of placebo (saline) given approximately 2 months apart (Days 1 and 61).</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Sa-5Ag half dose non-adjuvanted</intervention_name>
    <description>1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, non-adjuvanted at Day 1, administered intramuscularly.</description>
    <arm_group_label>Half dose non-adj Group 1a</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Sa-5Ag full dose non-adjuvanted</intervention_name>
    <description>1 dose of Sa-5Ag (5 antigens of S. aureus) full dose, non-adjuvanted at Day 1, administered intramuscularly.</description>
    <arm_group_label>Full dose non-adj Group 2a</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Sa-5Ag half dose adjuvanted</intervention_name>
    <description>1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, adjuvanted at Day 1, administered intramuscularly.</description>
    <arm_group_label>Half dose adj Group 3a</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Sa-5Ag full dose adjuvanted</intervention_name>
    <description>A series of 2 doses of S. aureus candidate vaccine (Sa-5Ag full dose adjuvanted) given approximately 2 months apart (Days 1 and 61), administered intramuscularly.</description>
    <arm_group_label>Full dose adj Group 4a</arm_group_label>
    <arm_group_label>Vaccine Group 5a</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>One dose of placebo (saline solution for injection/ vial or prefilled syringe) at Day 1 for placebo groups 1 to 3 and a series of 2 doses of placebo given approximately 2 months apart (Days 1 and 61) for placebo groups 4 and 5, administered intramuscularly.</description>
    <arm_group_label>Placebo Group 1b</arm_group_label>
    <arm_group_label>Placebo Group 2b</arm_group_label>
    <arm_group_label>Placebo Group 3b</arm_group_label>
    <arm_group_label>Placebo Group 4b</arm_group_label>
    <arm_group_label>Placebo Group 5b</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All subjects must satisfy all the following criteria at study entry:&#xD;
&#xD;
          -  Subjects who, in the opinion of the investigator, can and will comply with the&#xD;
             requirements of the protocol (e.g. completion of the diary cards, return for follow-up&#xD;
             visits).&#xD;
&#xD;
          -  Written or witnessed informed consent obtained from the subject prior to performance&#xD;
             of any study specific procedure.&#xD;
&#xD;
          -  Subject satisfying screening requirements.&#xD;
&#xD;
          -  Subjects who, after the nature of the study has been explained to them, have shown&#xD;
             adequate comprehension of the study procedures and knowledge of study.&#xD;
&#xD;
          -  A male or female&#xD;
&#xD;
          -  Dose escalation and safety lead-in phase: Aged between 18 and 50 years of age,&#xD;
             inclusive, at the time of first vaccination.&#xD;
&#xD;
          -  PoP phase: Aged between 18 and 64 years of age, inclusive, at the time of first&#xD;
             vaccination.&#xD;
&#xD;
          -  Female subjects of non-childbearing potential may be enrolled in the study.&#xD;
             Non-childbearing potential is defined as pre-menarche, current bilateral tubal&#xD;
             ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.&#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,&#xD;
&#xD;
          -  has a negative pregnancy test on the day of enrolment, and&#xD;
&#xD;
          -  has agreed to continue adequate contraception during the entire treatment period and&#xD;
             for 2 months after completion of the vaccination series.&#xD;
&#xD;
        Additional inclusion criteria only for subjects to be enrolled in the dose-escalation&#xD;
        safety lead-in screening epoch:&#xD;
&#xD;
        - Healthy subjects as established by medical history, clinical examination and laboratory&#xD;
        assessment.&#xD;
&#xD;
        Additional inclusion criteria only for subjects to be enrolled in the PoP screening epoch:&#xD;
&#xD;
        - Healthy subjects as established by medical history and clinical examination before&#xD;
        entering into the study with an ongoing SSTI suspected to be caused by S. aureus, as&#xD;
        diagnosed by investigator (before randomization subjects have to be treated until clinical&#xD;
        resolution of culture confirmed SSTI caused by S. aureus). SSTI must be amenable to&#xD;
        microbiological culturing per standard clinical practice (i.e. recovery of drainage sample&#xD;
        from abscess or suppurative cellulitis).&#xD;
&#xD;
        OR&#xD;
&#xD;
        - Healthy subjects as established by medical history and clinical examination before&#xD;
        entering into the study with an ongoing S. aureus SSTI (i.e. S. aureus is the most likely&#xD;
        cause), as confirmed by a S. aureus positive culture performed outside the study procedures&#xD;
        and not earlier than 30 days prior to Informed Consent Form signature. Before randomisation&#xD;
        subjects have to be treated until clinical resolution of the culture confirmed SSTI caused&#xD;
        by S. aureus. These subjects will be enrolled whether they have or have not already started&#xD;
        specific treatment of the infection. In case they have not started the treatment, this will&#xD;
        be then given in compliance with the standard medical practice for the management of S.&#xD;
        aureus SSTIs and the choice and judgment of the most appropriate treatment will be applied&#xD;
        by the investigator, outside the study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        All subjects at study entry&#xD;
&#xD;
          -  BMI &gt;40 kg/m2&#xD;
&#xD;
          -  History of any reaction or hypersensitivity likely to be exacerbated by any component&#xD;
             of the vaccine&#xD;
&#xD;
          -  Hypersensitivity to latex&#xD;
&#xD;
          -  Recurrent history of uncontrolled neurological disorders or seizures&#xD;
&#xD;
          -  History of potential immune-mediated disease (pIMD)&#xD;
&#xD;
          -  Clinical conditions that in the investigator's opinion represent a contraindication to&#xD;
             intramuscular vaccination and blood draws&#xD;
&#xD;
          -  Known bleeding diathesis or any condition that may be associated with a prolonged&#xD;
             bleeding time&#xD;
&#xD;
          -  Use of any investigational or non-registered product (drug, vaccine or medical device)&#xD;
             other than the study vaccine(s) within 30 days before the first dose of study&#xD;
             vaccine(s)/placebo (Day -29 to Day 1), or during the study period&#xD;
&#xD;
          -  Chronic administration (defined as more than 14 days in total) of immunosuppressants&#xD;
             or other immune-modifying drugs during the period starting 3 months prior to the first&#xD;
             vaccine/placebo dose&#xD;
&#xD;
          -  Cytotoxic therapy (e.g., medications used during cancer chemotherapy)&#xD;
&#xD;
          -  Administration of long-acting immune-modifying drugs at any time during the study&#xD;
             period (e.g. infliximab)&#xD;
&#xD;
          -  Administration of immunoglobulins and/or any blood products or plasma derivatives&#xD;
             within 3 months before the first dose of study vaccine or during the study period&#xD;
&#xD;
          -  Planned administration/administration of a vaccine not foreseen by the study protocol&#xD;
             in the period starting 15 days before the first dose and ending 15 days after the last&#xD;
             dose of vaccine(s) administration with the exception of any non-adjuvanted influenza&#xD;
             vaccine which may be administered ≥7 days before or after each study vaccination&#xD;
&#xD;
             *In case an emergency mass vaccination for an unforeseen public health threat (e.g.: a&#xD;
             pandemic) is organised by the public health authorities, outside the routine&#xD;
             immunisation program, the time period described above can be reduced if necessary for&#xD;
             that vaccine provided it is licensed and used according to its Product Information.&#xD;
&#xD;
          -  Concurrently participating in another clinical study, in which the subject has been or&#xD;
             will be exposed to an investigational or a non-investigational vaccine/product (drug&#xD;
             or medical device)&#xD;
&#xD;
          -  Received a vaccine against S. aureus&#xD;
&#xD;
          -  Pregnant or lactating female&#xD;
&#xD;
          -  Female planning to become pregnant or planning to discontinue contraceptive&#xD;
             precautions before 2 months after completion of the vaccination series&#xD;
&#xD;
          -  History of chronic alcohol consumption and/or drug abuse&#xD;
&#xD;
          -  Any study personnel or immediate dependents, family, or household member&#xD;
&#xD;
        All subjects at the time of vaccination&#xD;
&#xD;
          -  Any clinically significant hematological (hemoglobin level, white blood cell,&#xD;
             lymphocyte, neutrophil, eosinophil, platelet count and red blood cell count) and/or&#xD;
             biochemical (alanine aminotransferase [ALT], aspartate aminotransferase [AST],&#xD;
             creatinine) laboratory abnormality&#xD;
&#xD;
        Additional exclusion criteria applied only for dose-escalation safety lead-in&#xD;
&#xD;
          -  Any active or ongoing illness at screening or time of injection&#xD;
&#xD;
          -  History of any serious chronic or progressive disease according to the judgment of the&#xD;
             investigator&#xD;
&#xD;
        Additional exclusion criteria applied only for PoP at study entry&#xD;
&#xD;
          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on&#xD;
             medical history and physical examination&#xD;
&#xD;
          -  Major congenital defects, as assessed by the investigator&#xD;
&#xD;
          -  Acute or chronic, clinically significant pulmonary, cardiovascular*, hepatic or renal&#xD;
             functional abnormality, neoplasm, diabetes type 1 and uncontrolled diabetes type 2*,&#xD;
             as determined by physical examination or laboratory screening tests * Note:&#xD;
             Well-controlled type 2 diabetes mellitus (HbA1c &lt;7%) and well-controlled arterial&#xD;
             hypertension (blood pressure &lt;140/90 mmHg) can be considered for inclusion in the&#xD;
             study.&#xD;
&#xD;
          -  Any behavioral or cognitive impairment or psychiatric disease that, in the opinion of&#xD;
             the investigator, may interfere with the subject's ability to participate in the study&#xD;
&#xD;
          -  Individuals at risk for severe or life-threatening SSTIs (e.g., lymphatic or venous&#xD;
             insufficiency, liver and kidney disease, IV drug use, etc.)&#xD;
&#xD;
          -  Any other clinical condition that, in the opinion of the investigator, might pose&#xD;
             additional risk to the subject due to participation in the study&#xD;
&#xD;
        Additional exclusion criteria applied only for PoP at vaccination&#xD;
&#xD;
        - Microbiological test results of drainage suggest that the SSTI etiology could be other&#xD;
        than infection with S. aureus&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 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>GlaxoSmithKlline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Slidell</city>
        <state>Louisiana</state>
        <zip>70458</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Coffs Harbour</city>
        <state>New South Wales</state>
        <zip>2450</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Darlinghurst, Sydney</city>
        <state>New South Wales</state>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fortitude Valley</city>
        <state>Queensland</state>
        <zip>4006</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Southport</city>
        <state>Queensland</state>
        <zip>4215</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Geelong</city>
        <state>Victoria</state>
        <zip>3220</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ahmedabad</city>
        <state>Gujarat</state>
        <zip>380006</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ahmedabad</city>
        <state>Gujarat</state>
        <zip>380015</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ahmedabad</city>
        <state>Gujarat</state>
        <zip>380054</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ahmedabad</city>
        <state>Gujarat</state>
        <zip>380061</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Shivajinagar,Pune</city>
        <state>Maharashtra</state>
        <zip>411005</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Thane</city>
        <state>Maharashtra</state>
        <zip>400606</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kanpur</city>
        <state>Uttar Pradesh</state>
        <zip>208002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Varanasi</city>
        <state>Uttar Pradesh</state>
        <zip>221007</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kolkata</city>
        <state>West Bengal</state>
        <zip>700016</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lucknow</city>
        <zip>226000</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nagpur</city>
        <zip>440003</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nagpur</city>
        <zip>441108</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pune</city>
        <zip>411001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Auckland</city>
        <zip>1010</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Christchurch</city>
        <zip>8013</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nawton</city>
        <zip>3200</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nelson</city>
        <zip>7011</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>New Lynn</city>
        <zip>0600</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Otahuhu</city>
        <zip>1640</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bialystok</city>
        <zip>15-453</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Katowice</city>
        <zip>40-851</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lodz</city>
        <zip>91-363</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lublin</city>
        <zip>20-078</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Szczecin</city>
        <zip>70-332</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Warszawa</city>
        <zip>00-215</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Warszawa</city>
        <zip>01-142</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <zip>2013</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Durban</city>
        <state>KwaZulu- Natal</state>
        <zip>4052</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cape Town</city>
        <zip>7708</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nottingham</city>
        <zip>NG7 2QW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>West Midlands</city>
        <zip>B9 5SS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>India</country>
    <country>New Zealand</country>
    <country>Poland</country>
    <country>South Africa</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>August 4, 2023</last_update_submitted>
  <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>S. aureus</keyword>
  <keyword>skin and soft tissue infection</keyword>
  <keyword>first time in human</keyword>
  <keyword>S. aureus vaccine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Soft Tissue Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD for this study will be made available via the Clinical Study Data Request site.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study</ipd_time_frame>
    <ipd_access_criteria>Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.</ipd_access_criteria>
    <ipd_url>https://clinicalstudydatarequest.com</ipd_url>
  </patient_data>
  <!-- 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/NCT04420221
org study id: 208833
secondary id: 2021-006215-29
nct id: NCT04420221
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Safety, immunogenicity and efficacy of GSK S. aureus candidate vaccine (GSK3878858A) when
      administered to healthy adults (dose-escalation) and to adults 18 to 64 years of age with a
      recent S. aureus skin and soft tissue infection (SSTI). In the dose-escalation safety lead-in
      phase in healthy adults safety and immunogenicity of 4 different compositions is assessed.
      After safety has been shown in this phase, in the second phase, proof of principle (PoP)
      phase of the study in adults with a recent SSTI safety, immunogenicity and efficacy of the
      final composition of the vaccine is assessed.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of participants with solicited local adverse events (AEs) (any, grade 3)
time frame: During 7 days after the first dose (Days 1 to 8)
description: The solicited local AE(s) assessed are pain, redness and swelling. Any = any solicited local AE, regardless of intensity; Grade 3 pain = Significant pain at rest, that prevents normal every day activities; Grade 3 redness/swelling = greater than or equal to (≥)100 mm diameter (greatest surface diameter in millimetres [mm]).
measure: Number of participants with solicited local adverse events (AEs) (any, grade 3)
time frame: During 7 days after the second dose (Days 61 to 68)
description: The solicited local AE(s) assessed are pain, redness and swelling. Any = any solicited local AE, regardless of intensity; Grade 3 pain = Significant pain at rest, that prevents normal every day activities; Grade 3 redness/swelling = greater than or equal to (≥)100 mm diameter (greatest surface diameter in millimeters [mm]).
measure: Number of participants with solicited general AEs (any, grade 3)
time frame: During 7 days after the first dose (Days 1 to 8)
description: The solicited general AE(s) assessed are headache, fatigue, nausea, vomiting, diarrhea, abdominal pain, myalgia, shivering and fever (temperature ≥ 38.0 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F). Any = any solicited general AE regardless of intensity; Grade 3 headache/fatigue/nausea/abdominal pain/myalgia/shivering = Severe: Prevents daily activity. Grade 3 vomiting = Severe: 6 or more times in 24 hours or requires intravenous hydration. Grade 3 diarrhea = Severe: 6 or more loose stools in 24 hours or requires intravenous hydration. Grade 3 fever = body temperature greater than (>) 40.0°C/104°F.
measure: Number of participants with solicited general AEs (any, grade 3)
time frame: During 7 days after the second dose (Days 61 to 68)
description: The solicited general AE(s) assessed are headache, fatigue, nausea, vomiting, diarrhea, abdominal pain, myalgia, shivering and fever (temperature ≥ 38.0 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F). Any = any solicited general AE regardless of intensity; Grade 3 headache/fatigue/nausea/abdominal pain/myalgia/shivering = Severe: Prevents daily activity. Grade 3 vomiting = Severe: 6 or more times in 24 hours or requires intravenous hydration. Grade 3 diarrhea = Severe: 6 or more loose stools in 24 hours or requires intravenous hydration. Grade 3 fever = body temperature greater than (>) 40.0°C/104°F.
measure: Number of participants with unsolicited AEs (any, grade 3, related, related grade 3)
time frame: During 30 days after the first dose (Days 1 to 31)
description: Any (independent from causality) unsolicited AEs regardless of intensity; Grade 3 unsolicited AEs = An AE which prevents normal, everyday activities. Such an AE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related unsolicited AEs = AEs assessed by the investigator to be causally related to vaccination. Grade 3 related unsolicited AEs = An AE which prevents normal, everyday activities. Such an AE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.
measure: Number of participants with unsolicited AEs (any, grade 3, related, related grade 3)
time frame: During 30 days after the second dose (Days 61 to 91)
description: Any (independent from causality) unsolicited AEs regardless of intensity; Grade 3 unsolicited AEs = An AE which prevents normal, everyday activities. Such an AE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related unsolicited AEs = AEs assessed by the investigator to be causally related to vaccination. Grade 3 related unsolicited AEs = An AE which prevents normal, everyday activities. Such an AE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.
measure: Number of participants with serious AEs (SAEs) (any, grade 3, related, related grade 3)
time frame: Throughout the study period [from Day 1 (day of vaccination) until Day 366
description: Any (independent from causality) SAEs regardless of intensity; Grade 3 SAEs = SAE which prevents normal, everyday activities. Such an SAE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related SAEs = SAEs assessed by the investigator to be causally related to vaccination. Grade 3 related SAEs = SAE which prevents normal, everyday activities. Such an SAE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.
measure: Number of participants with serious AEs (SAEs) (any, grade 3, related, related grade 3)
time frame: Throughout the study period [from Day 1 (day of vaccination) until Day 426
description: Any (independent from causality) SAEs regardless of intensity; Grade 3 SAEs = SAE which prevents normal, everyday activities. Such an SAE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related SAEs = SAEs assessed by the investigator to be causally related to vaccination. Grade 3 related SAEs = SAE which prevents normal, everyday activities. Such an SAE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.
measure: Number of participants with potential immune-mediated diseases (PIMDs) (any, grade 3, related, related grade 3)
time frame: Throughout the study period [from Day 1 (day of vaccination) until Day 366
description: Any (independent from causality) PIMDs regardless of intensity; Grade 3 PIMDs = PIMD which prevents normal, everyday activities. Such an PIMD would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related PIMDs = PIMDs assessed by the investigator to be causally related to vaccination. Grade 3 related PIMDs = PIMD which prevents normal, everyday activities. Such an PIMD would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.
measure: Number of participants with potential immune-mediated diseases (PIMDs) (any, grade 3, related, related grade 3)
time frame: Throughout the study period [from Day 1 (day of vaccination) until Day 426
description: Any (independent from causality) PIMDs regardless of intensity; Grade 3 PIMDs = PIMD which prevents normal, everyday activities. Such an PIMD would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related PIMDs = PIMDs assessed by the investigator to be causally related to vaccination. Grade 3 related PIMDs = PIMD which prevents normal, everyday activities. Such an PIMD would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.
measure: Number of participants with haematological and biochemical laboratory abnormalities and changes from the baseline values
time frame: At Day 8 (7 days after the first dose)
description: The number of participants having hematology and biochemistry results below, within or above the normal laboratory ranges, compared to baseline range indicator.
measure: Number of participants with haematological and biochemical laboratory abnormalities and changes from the baseline values
time frame: At Day 68 (7 days after the second dose)
description: The number of participants having hematology and biochemistry results below, within or above the normal laboratory ranges, compared to baseline range indicator.
measure: Number of participants with at least one culture confirmed case of recurrent S. aureus SSTI
time frame: Starting from Day 75 (i.e.14 days after the second dose) up to Day 426 (12 months after the second dose).
description: This key secondary outcome measure is to evaluate efficacy in terms of number of participants with at least one culture confirmed case of recurrent S. aureus SSTI starting 14 days after the second dose.
measure: Number of participants with at least one culture confirmed case of recurrent S. aureus SSTI
time frame: Starting from Day 15 (i.e. 14 days after the first dose) up to Day 426 (12 months after the second dose).
description: This co-secondary outcome measure is to evaluate efficacy in terms of number of participants with at least one culture confirmed case of recurrent S. aureus SSTI starting 14 days after the first dose.
arm group label: Half dose non-adj Group 1a
arm group type: Experimental
description: Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, non-adjuvanted at Day 1.
arm group label: Placebo Group 1b
arm group type: Placebo Comparator
description: Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of placebo (saline) at Day 1.
arm group label: Full dose non-adj Group 2a
arm group type: Experimental
description: Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of Sa-5Ag (5 antigens of S. aureus) full dose, non-adjuvanted at Day 1
arm group label: Placebo Group 2b
arm group type: Placebo Comparator
description: Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of placebo (saline) at Day 1.
arm group label: Half dose adj Group 3a
arm group type: Experimental
description: Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, adjuvanted at Day 1.
arm group label: Placebo Group 3b
arm group type: Placebo Comparator
description: Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of placebo (saline) at Day 1.
arm group label: Full dose adj Group 4a
arm group type: Experimental
description: Subjects aged 18 to 50 at the time of first vaccination who receive a series of 2 doses of S. aureus candidate vaccine (Sa-5Ag full dose adjuvanted) given approximately 2 months apart (Days 1 and 61)
arm group label: Placebo Group 4b
arm group type: Placebo Comparator
description: Subjects aged 18 to 50 at the time of first vaccination who receive a series of 2 doses of placebo (saline) given approximately 2 months apart (Days 1 and 61).
arm group label: Vaccine Group 5a
arm group type: Experimental
description: Subjects aged 18 to 64 at the time of first vaccination who receive a series of 2 doses of S. aureus candidate vaccine (Sa-5Ag full dose adjuvanted) given approximately 2 months apart (Days 1 and 61).
arm group label: Placebo Group 5b
arm group type: Placebo Comparator
description: Subjects aged 18 to 64 at the time of first vaccination who receive a series of 2 doses of placebo (saline) given approximately 2 months apart (Days 1 and 61).
intervention type: Biological
intervention name: Sa-5Ag half dose non-adjuvanted
description: 1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, non-adjuvanted at Day 1, administered intramuscularly.
arm group label: Half dose non-adj Group 1a
intervention type: Biological
intervention name: Sa-5Ag full dose non-adjuvanted
description: 1 dose of Sa-5Ag (5 antigens of S. aureus) full dose, non-adjuvanted at Day 1, administered intramuscularly.
arm group label: Full dose non-adj Group 2a
intervention type: Biological
intervention name: Sa-5Ag half dose adjuvanted
description: 1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, adjuvanted at Day 1, administered intramuscularly.
arm group label: Half dose adj Group 3a
intervention type: Biological
intervention name: Sa-5Ag full dose adjuvanted
description: A series of 2 doses of S. aureus candidate vaccine (Sa-5Ag full dose adjuvanted) given approximately 2 months apart (Days 1 and 61), administered intramuscularly.
arm group label: Full dose adj Group 4a
arm group label: Vaccine Group 5a
intervention type: Biological
intervention name: Placebo
description: One dose of placebo (saline solution for injection/ vial or prefilled syringe) at Day 1 for placebo groups 1 to 3 and a series of 2 doses of placebo given approximately 2 months apart (Days 1 and 61) for placebo groups 4 and 5, administered intramuscularly.
arm group label: Placebo Group 1b
arm group label: Placebo Group 2b
arm group label: Placebo Group 3b
arm group label: Placebo Group 4b
arm group label: Placebo Group 5b
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKlline
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country: Australia
country: India
country: New Zealand
country: Poland
country: South Africa
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Soft Tissue Infections
sharing ipd: Yes
ipd description: IPD for this study will be made available via the Clinical Study Data Request site.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
ipd access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
ipd url: https://clinicalstudydatarequest.com