xml: <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/NCT05975840</url>
    </required_header>
    <id_info>
      <org_study_id>219833</org_study_id>
      <nct_id>NCT05975840</nct_id>
    </id_info>
    <brief_title>Safety and Immunogenicity of Different Formulations of Monovalent Influenza A/Astrakhan/3212/2020 Like (H5N8) Virus Vaccine With AS03 Adjuvant System in Medically Stable Adults</brief_title>
    <official_title>A Phase I/II Observer-blind, Randomized, Multi-center Trial to Evaluate the Safety and Immunogenicity of Different Formulations of Monovalent Influenza A/Astrakhan/3212/2020 Like (H5N8) Virus Vaccine With AS03 Adjuvant System (Referred to as Q-Pan H5N8), Given as a Two-dose Series to Adults 18 to 64 Years of Age and 65 Years of Age and Older</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to assess the safety and immunogenicity of different&#xD;
        formulations of monovalent Influenza A/Astrakhan/3212/2020-like virus vaccine with AS03&#xD;
        adjuvant system in adults greater than or equal to (&gt;=)18 years of age.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 28, 2023</start_date>
    <completion_date type="Anticipated">May 8, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 19, 2023</primary_completion_date>
    <phase>Phase 1/Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>This study will be observer blind.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Hemagglutination-inhibiting (HI) antibody titers against vaccine-homologous H5N8</measure>
      <time_frame>At Day 43</time_frame>
      <description>HI antibody titers are expressed as GMTs.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Geometric mean fold rise (GMFR) of serum HI antibody titers against vaccine-homologous H5N8</measure>
      <time_frame>At Day 43</time_frame>
      <description>GMFR is defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of seroprotected (SP) participants for HI antibody titers</measure>
      <time_frame>At Day 43</time_frame>
      <description>SP is defined as the percentage of participants with HI antibody titer &gt;=1:40.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of participants reporting each solicited administration site event</measure>
      <time_frame>Within the 7-day follow-up period after first study intervention dose (administered at Day 1)</time_frame>
      <description>Solicited administration site events are pain, redness and swelling.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of participants reporting each solicited administration site event</measure>
      <time_frame>Within the 7-day follow-up period after second study intervention dose (administered at Day 22)</time_frame>
      <description>Solicited administration site events are pain, redness and swelling.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of participants reporting each solicited systemic event</measure>
      <time_frame>Within the 7-day follow-up period after first study intervention dose (administered at Day 1)</time_frame>
      <description>Solicited systemic events are fatigue, fever, headache, joint pain, shivering (chills) Gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain). Fever is defined as temperature &gt;=38 degrees Celsius (°C) for oral route (preferred location for measuring temperature).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of participants reporting each solicited systemic event</measure>
      <time_frame>Within the 7-day follow-up period after second study intervention dose (administered at Day 22)</time_frame>
      <description>Solicited systemic events are fatigue, fever, headache, joint pain, shivering (chills) Gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain). Fever is defined as temperature &gt;=38 degrees Celsius (°C) for oral route (preferred location for measuring temperature).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of participants with increased toxicity grading in either Hematological or Biochemical Laboratory Parameters</measure>
      <time_frame>7 days after the first study intervention dose (administered at Day 1)</time_frame>
      <description>The following laboratory assessments includes Hematology; complete blood count with differential and platelet count; Chemistry/metabolic panel: Sodium, Potassium, Creatinine, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline Phosphatase, total bilirubin, and blood urea nitrogen (BUN) which are graded by FDA toxicity grading scale. Assessed grades are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, and Grade 4 = potentially life threatening.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of participants with increased toxicity grading in either Hematological or Biochemical Laboratory Parameters</measure>
      <time_frame>7 days after the second study intervention dose (administered at Day 22)</time_frame>
      <description>The following laboratory assessments includes Hematology; complete blood count with differential and platelet count; Chemistry/metabolic panel: Sodium, Potassium, Creatinine, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline Phosphatase, total bilirubin, and blood urea nitrogen (BUN) which are graded by FDA toxicity grading scale. Assessed grades are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, and Grade 4 = potentially life threatening.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of participants reporting unsolicited adverse events (AEs)</measure>
      <time_frame>21 days after the first study intervention dose (administered at Day 1)</time_frame>
      <description>An unsolicited AE is defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of participants reporting unsolicited AEs</measure>
      <time_frame>21 days after the second study intervention dose (administered at Day 22)</time_frame>
      <description>An unsolicited AE is defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of participants reporting medically attended adverse events (MAEs)</measure>
      <time_frame>21 days after the first study intervention dose (administered at Day 1)</time_frame>
      <description>MAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., symptoms or illnesses requiring a hospitalization, emergency room visit, or visit to/by a healthcare provider).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of participants reporting MAEs</measure>
      <time_frame>21 days after the second study intervention dose (administered at Day 22)</time_frame>
      <description>MAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., symptoms or illnesses requiring a hospitalization, emergency room visit, or visit to/by a healthcare provider).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of participants reporting serious adverse events (SAEs)</measure>
      <time_frame>From Day 1 to Day 43</time_frame>
      <description>An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an abnormal pregnancy outcome (e.g., spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy), or is a suspected transmission of any infectious agent via an authorized medicinal product.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of participants reporting SAEs</measure>
      <time_frame>From Day 1 to 6 months after the second study intervention dose (administered at Day 22)</time_frame>
      <description>An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an abnormal pregnancy outcome (e.g., spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy), or is a suspected transmission of any infectious agent via an authorized medicinal product.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of participants reporting potential immune-mediated diseases (pIMDs)</measure>
      <time_frame>From Day 1 to Day 43</time_frame>
      <description>pIMDs are a subset of AEs of special interest that includes autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of participants reporting potential immune-mediated diseases (pIMDs)</measure>
      <time_frame>From Day 1 to 6 months after the second study intervention dose (administered at Day 22)</time_frame>
      <description>pIMDs are a subset of AEs of special interest that includes autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>HI antibody titers against vaccine-homologous H5N8</measure>
      <time_frame>Day 1, Day 22, and 6 months after the second intervention dose (administered at Day 22)</time_frame>
      <description>HI antibody titers are expressed as GMTs. It is measured in terms of milliliter (mL).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>GMFR of serum HI antibody titers against vaccine-homologous H5N8</measure>
      <time_frame>At Day 22 and 6 months after the second intervention dose (administered at Day 22)</time_frame>
      <description>GMFR is defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of seroprotected (SP) participants for HI antibody titers</measure>
      <time_frame>Day 1, Day 22, and 6 months after the second intervention dose (administered at Day 22)</time_frame>
      <description>SP is defined as the percentage of participants with HI antibody titer &gt;=1:40.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of seroconverted participants for HI antibody titers</measure>
      <time_frame>Day 22, Day 43, and 6 months after the second study intervention dose (administered at Day 22)</time_frame>
      <description>HI seroconversion is defined as a post vaccination titer &gt;=1:40 in the serum of participants with pre-vaccination titer below 1:10 or as a &gt;=4-fold rise in post vaccination HI titer with pre-vaccination titer &gt;=1:10.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Microneutralization (MN) antibody titers for a subset of participants</measure>
      <time_frame>Day 1, Day 22, 43, and 6 months after the second study intervention dose (administered at Day 22)</time_frame>
      <description>MN antibody titers are expressed as Geometric Mean Titers (GMTs). MN analyses are performed on the MN subset that includes approximately 260 participants (50% of the planned enrolled participants).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Seropositive participants for MN antibody titers for a subset of participants</measure>
      <time_frame>Day 1, Day 22, Day 43, and 6 months after the second intervention dose (administered at Day 22)</time_frame>
      <description>A seropositive participant is a participant whose antibody titer is greater than or equal to the assay cut-off value. Note: The cut-off value for antibody titer is defined by the laboratory before the analysis. MN analyses is performed on the MN subset that includes approximately 260 participants (50% of the planned enrolled participants).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants meeting vaccine response (VR) criteria of MN antibody titers for a subset of participants</measure>
      <time_frame>Day 22, Day 43, and 6 months after the second study intervention dose (administered at Day 22)</time_frame>
      <description>MN VR is defined as titer &gt;=4*Lower limit of quantitation (LLOQ) for participants with pre vaccination titer below LLOQ or as a &gt;=4-fold increase in MN titer for participants with pre vaccination titer &gt;=LLOQ. MN analyses are being performed on the MN subset that includes approximately 260 participants (50% of the planned enrolled participants).</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">520</enrollment>
    <condition>Influenza, Human</condition>
    <arm_group>
      <arm_group_label>FLU Q-PAN H5N8 Formulation 1_B Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Medically stable participants receive two doses of FLU Q-PAN H5N8 Formulation 1 vaccine and AS03B adjuvant. Participants receive the first dose at Day 1 and the second dose at Day 22.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>FLU Q-PAN H5N8 Formulation 1_A Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Medically stable participants receive two doses of FLU Q-PAN H5N8 Formulation 1 vaccine and AS03A adjuvant. Participants receive the first dose at Day 1 and the second dose at Day 22.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>FLU Q-PAN H5N8 Formulation 2_B Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Medically stable participants receive two doses of FLU Q-PAN H5N8 Formulation 2 vaccine and AS03B adjuvant. Participants receive the first dose at Day 1 and the second dose at Day 22.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>FLU Q-PAN H5N8 Formulation 2_A Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Medically stable participants receive two doses of FLU Q-PAN H5N8 Formulation 2 vaccine and AS03A adjuvant. Participants receive the first dose at Day 1 and the second dose at Day 22.</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>FLU Q-PAN H5N8 Formulation 1</intervention_name>
      <description>Participants receive two doses of the FLU Q-PAN H5N8 Formulation 1 vaccine by intramuscular injection in the non-dominant arm.</description>
      <arm_group_label>FLU Q-PAN H5N8 Formulation 1_A Group</arm_group_label>
      <arm_group_label>FLU Q-PAN H5N8 Formulation 1_B Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>AS03B</intervention_name>
      <description>Participants receive two doses of the AS03B adjuvant by intramuscular injection in the non-dominant arm.</description>
      <arm_group_label>FLU Q-PAN H5N8 Formulation 1_B Group</arm_group_label>
      <arm_group_label>FLU Q-PAN H5N8 Formulation 2_B Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>AS03A</intervention_name>
      <description>Participants receive two doses of the AS03A adjuvant by intramuscular injection in the non-dominant arm.</description>
      <arm_group_label>FLU Q-PAN H5N8 Formulation 1_A Group</arm_group_label>
      <arm_group_label>FLU Q-PAN H5N8 Formulation 2_A Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>FLU Q-PAN H5N8 Formulation 2</intervention_name>
      <description>Participants receive two doses of the FLU Q-PAN H5N8 Formulation 2 vaccine by intramuscular injection in the non dominant arm.</description>
      <arm_group_label>FLU Q-PAN H5N8 Formulation 2_A Group</arm_group_label>
      <arm_group_label>FLU Q-PAN H5N8 Formulation 2_B Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Medically stable participants as established by medical history and clinical&#xD;
               examination before entering into the study.&#xD;
  &#xD;
            -  A male or female &gt;=18 years of age at the time of signing consent form.&#xD;
  &#xD;
            -  Participants, who, in the opinion of the investigator, can and will comply with the&#xD;
               requirements of the protocol.&#xD;
  &#xD;
            -  Written or witnessed/thumb printed informed consent obtained from the participant&#xD;
               prior to performance of any study specific procedure.&#xD;
  &#xD;
            -  Female participants of childbearing potential or non-childbearing potential may be&#xD;
               enrolled in the study if specific criteria are met.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Current diagnosis or history of autoimmune disorder(s) except hypothyroidism due to&#xD;
               Hashimoto's thyroiditis.&#xD;
  &#xD;
            -  History of any reaction or hypersensitivity likely to be exacerbated by any component&#xD;
               of the vaccine.&#xD;
  &#xD;
            -  Clinically significant acute or chronic pulmonary, cardiovascular, hepatic, or renal&#xD;
               disease that appears uncontrolled or untreated, as determined by history or physical&#xD;
               examination.&#xD;
  &#xD;
            -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on&#xD;
               medical history, physical examination, or abnormalities in screening blood tests.&#xD;
  &#xD;
            -  Recurrent history of or uncontrolled neurological disorders or seizures.&#xD;
  &#xD;
            -  History of Guillain-Barré syndrome.&#xD;
  &#xD;
            -  Diagnosed with cancer, or treatment for cancer within 3 years.&#xD;
  &#xD;
                 -  Persons with a history of cancer who are disease-free without treatment for 3&#xD;
                    years or more are eligible.&#xD;
  &#xD;
                 -  Persons with a history of histologically confirmed basal cell carcinoma of the&#xD;
                    skin successfully treated with local excision only, are accepted and are&#xD;
                    eligible, but other histologic types of skin cancer are exclusionary.&#xD;
  &#xD;
                 -  Women who are disease-free 3 years or more after treatment for breast cancer and&#xD;
                    receiving long-term prophylaxis are eligible.&#xD;
  &#xD;
            -  Documented human immunodeficiency virus-positive participants.&#xD;
  &#xD;
            -  Bedridden participants.&#xD;
  &#xD;
            -  Personal or family history of narcolepsy.&#xD;
  &#xD;
            -  Food and Drug Administration (FDA) toxicity Grade 2, or greater, laboratory tests at&#xD;
               Screening.&#xD;
  &#xD;
            -  Any other clinical condition that, in the opinion of the investigator, might pose&#xD;
               additional risk to the participant due to participation in the study.&#xD;
  &#xD;
            -  Use of any investigational or non-registered product other than the study vaccine&#xD;
               during the period beginning 30 days before the first dose of study vaccine (Day -29 to&#xD;
               Day 1), or planned use during the entire study period.&#xD;
  &#xD;
            -  Use of public health emergency vaccines like coronavirus disease 2019 (COVID-19),&#xD;
               Monkey pox (mpox) etc. These can be given at any time, but there should a gap of 2 -&#xD;
               weeks before a dose of study vaccine can be given.&#xD;
  &#xD;
            -  Use of any licensed vaccines: prior to receipt of the study vaccine and continuing up&#xD;
               to 3 weeks after receiving the dose 2 of study vaccine.&#xD;
  &#xD;
            -  Administration of long-acting immune-modifying drugs at any time during the study&#xD;
               period.&#xD;
  &#xD;
            -  Administration of immunoglobulins and/or any blood products or plasma derivatives&#xD;
               during the period starting 3 months before the first dose of study vaccine or planned&#xD;
               administration during the study period.&#xD;
  &#xD;
            -  Chronic administration of immunosuppressants or other immune-modifying drugs during&#xD;
               the period starting 3 months prior to the first vaccine dose and through the entire&#xD;
               study period. For corticosteroids, this will mean prednisone equivalent &gt;=20&#xD;
               milligrams/day for 14 days or a total of &gt;=280 mg of prednisone equivalent dose in any&#xD;
               14-day period. Inhaled and topical steroids are allowed.&#xD;
  &#xD;
            -  Pregnant or lactating female.&#xD;
  &#xD;
            -  Female planning to become pregnant or planning to discontinue contraceptive&#xD;
               precautions within 2 months after completion of the vaccination series.&#xD;
  &#xD;
            -  History of/or current drug/alcohol abuse.&#xD;
  &#xD;
            -  Any study personnel or their immediate dependents, family, or household member.&#xD;
  &#xD;
            -  Concurrently participating in another clinical study, at any time during the study&#xD;
               period, in which the participant has been or will be exposed to an investigational or&#xD;
               a non investigational vaccine/product.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Influenza</keyword>
    <keyword>Safety</keyword>
    <keyword>Immunogenicity</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Influenza, Human</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/</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>Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.</ipd_time_frame>
      <ipd_access_criteria>Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.</ipd_access_criteria>
      <ipd_url>http://www.gsk.com/en-gb/innovation/trials/data-transparency</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05975840
  org study id: 219833
  nct id: NCT05975840
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to assess the safety and immunogenicity of different
        formulations of monovalent Influenza A/Astrakhan/3212/2020-like virus vaccine with AS03
        adjuvant system in adults greater than or equal to (>=)18 years of age.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: This study will be observer blind.
  measure: Hemagglutination-inhibiting (HI) antibody titers against vaccine-homologous H5N8
  time frame: At Day 43
  description: HI antibody titers are expressed as GMTs.
  measure: Geometric mean fold rise (GMFR) of serum HI antibody titers against vaccine-homologous H5N8
  time frame: At Day 43
  description: GMFR is defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.
  measure: Percentage of seroprotected (SP) participants for HI antibody titers
  time frame: At Day 43
  description: SP is defined as the percentage of participants with HI antibody titer >=1:40.
  measure: Percentage of participants reporting each solicited administration site event
  time frame: Within the 7-day follow-up period after first study intervention dose (administered at Day 1)
  description: Solicited administration site events are pain, redness and swelling.
  measure: Percentage of participants reporting each solicited administration site event
  time frame: Within the 7-day follow-up period after second study intervention dose (administered at Day 22)
  description: Solicited administration site events are pain, redness and swelling.
  measure: Percentage of participants reporting each solicited systemic event
  time frame: Within the 7-day follow-up period after first study intervention dose (administered at Day 1)
  description: Solicited systemic events are fatigue, fever, headache, joint pain, shivering (chills) Gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain). Fever is defined as temperature >=38 degrees Celsius (°C) for oral route (preferred location for measuring temperature).
  measure: Percentage of participants reporting each solicited systemic event
  time frame: Within the 7-day follow-up period after second study intervention dose (administered at Day 22)
  description: Solicited systemic events are fatigue, fever, headache, joint pain, shivering (chills) Gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain). Fever is defined as temperature >=38 degrees Celsius (°C) for oral route (preferred location for measuring temperature).
  measure: Percentage of participants with increased toxicity grading in either Hematological or Biochemical Laboratory Parameters
  time frame: 7 days after the first study intervention dose (administered at Day 1)
  description: The following laboratory assessments includes Hematology; complete blood count with differential and platelet count; Chemistry/metabolic panel: Sodium, Potassium, Creatinine, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline Phosphatase, total bilirubin, and blood urea nitrogen (BUN) which are graded by FDA toxicity grading scale. Assessed grades are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, and Grade 4 = potentially life threatening.
  measure: Percentage of participants with increased toxicity grading in either Hematological or Biochemical Laboratory Parameters
  time frame: 7 days after the second study intervention dose (administered at Day 22)
  description: The following laboratory assessments includes Hematology; complete blood count with differential and platelet count; Chemistry/metabolic panel: Sodium, Potassium, Creatinine, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline Phosphatase, total bilirubin, and blood urea nitrogen (BUN) which are graded by FDA toxicity grading scale. Assessed grades are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, and Grade 4 = potentially life threatening.
  measure: Percentage of participants reporting unsolicited adverse events (AEs)
  time frame: 21 days after the first study intervention dose (administered at Day 1)
  description: An unsolicited AE is defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event.
  measure: Percentage of participants reporting unsolicited AEs
  time frame: 21 days after the second study intervention dose (administered at Day 22)
  description: An unsolicited AE is defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event.
  measure: Percentage of participants reporting medically attended adverse events (MAEs)
  time frame: 21 days after the first study intervention dose (administered at Day 1)
  description: MAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., symptoms or illnesses requiring a hospitalization, emergency room visit, or visit to/by a healthcare provider).
  measure: Percentage of participants reporting MAEs
  time frame: 21 days after the second study intervention dose (administered at Day 22)
  description: MAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., symptoms or illnesses requiring a hospitalization, emergency room visit, or visit to/by a healthcare provider).
  measure: Percentage of participants reporting serious adverse events (SAEs)
  time frame: From Day 1 to Day 43
  description: An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an abnormal pregnancy outcome (e.g., spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy), or is a suspected transmission of any infectious agent via an authorized medicinal product.
  measure: Percentage of participants reporting SAEs
  time frame: From Day 1 to 6 months after the second study intervention dose (administered at Day 22)
  description: An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an abnormal pregnancy outcome (e.g., spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy), or is a suspected transmission of any infectious agent via an authorized medicinal product.
  measure: Percentage of participants reporting potential immune-mediated diseases (pIMDs)
  time frame: From Day 1 to Day 43
  description: pIMDs are a subset of AEs of special interest that includes autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
  measure: Percentage of participants reporting potential immune-mediated diseases (pIMDs)
  time frame: From Day 1 to 6 months after the second study intervention dose (administered at Day 22)
  description: pIMDs are a subset of AEs of special interest that includes autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
  measure: HI antibody titers against vaccine-homologous H5N8
  time frame: Day 1, Day 22, and 6 months after the second intervention dose (administered at Day 22)
  description: HI antibody titers are expressed as GMTs. It is measured in terms of milliliter (mL).
  measure: GMFR of serum HI antibody titers against vaccine-homologous H5N8
  time frame: At Day 22 and 6 months after the second intervention dose (administered at Day 22)
  description: GMFR is defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.
  measure: Percentage of seroprotected (SP) participants for HI antibody titers
  time frame: Day 1, Day 22, and 6 months after the second intervention dose (administered at Day 22)
  description: SP is defined as the percentage of participants with HI antibody titer >=1:40.
  measure: Percentage of seroconverted participants for HI antibody titers
  time frame: Day 22, Day 43, and 6 months after the second study intervention dose (administered at Day 22)
  description: HI seroconversion is defined as a post vaccination titer >=1:40 in the serum of participants with pre-vaccination titer below 1:10 or as a >=4-fold rise in post vaccination HI titer with pre-vaccination titer >=1:10.
  measure: Microneutralization (MN) antibody titers for a subset of participants
  time frame: Day 1, Day 22, 43, and 6 months after the second study intervention dose (administered at Day 22)
  description: MN antibody titers are expressed as Geometric Mean Titers (GMTs). MN analyses are performed on the MN subset that includes approximately 260 participants (50% of the planned enrolled participants).
  measure: Percentage of Seropositive participants for MN antibody titers for a subset of participants
  time frame: Day 1, Day 22, Day 43, and 6 months after the second intervention dose (administered at Day 22)
  description: A seropositive participant is a participant whose antibody titer is greater than or equal to the assay cut-off value. Note: The cut-off value for antibody titer is defined by the laboratory before the analysis. MN analyses is performed on the MN subset that includes approximately 260 participants (50% of the planned enrolled participants).
  measure: Percentage of participants meeting vaccine response (VR) criteria of MN antibody titers for a subset of participants
  time frame: Day 22, Day 43, and 6 months after the second study intervention dose (administered at Day 22)
  description: MN VR is defined as titer >=4*Lower limit of quantitation (LLOQ) for participants with pre vaccination titer below LLOQ or as a >=4-fold increase in MN titer for participants with pre vaccination titer >=LLOQ. MN analyses are being performed on the MN subset that includes approximately 260 participants (50% of the planned enrolled participants).
  arm group label: FLU Q-PAN H5N8 Formulation 1_B Group
  arm group type: Active Comparator
  description: Medically stable participants receive two doses of FLU Q-PAN H5N8 Formulation 1 vaccine and AS03B adjuvant. Participants receive the first dose at Day 1 and the second dose at Day 22.
  arm group label: FLU Q-PAN H5N8 Formulation 1_A Group
  arm group type: Active Comparator
  description: Medically stable participants receive two doses of FLU Q-PAN H5N8 Formulation 1 vaccine and AS03A adjuvant. Participants receive the first dose at Day 1 and the second dose at Day 22.
  arm group label: FLU Q-PAN H5N8 Formulation 2_B Group
  arm group type: Active Comparator
  description: Medically stable participants receive two doses of FLU Q-PAN H5N8 Formulation 2 vaccine and AS03B adjuvant. Participants receive the first dose at Day 1 and the second dose at Day 22.
  arm group label: FLU Q-PAN H5N8 Formulation 2_A Group
  arm group type: Active Comparator
  description: Medically stable participants receive two doses of FLU Q-PAN H5N8 Formulation 2 vaccine and AS03A adjuvant. Participants receive the first dose at Day 1 and the second dose at Day 22.
  intervention type: Biological
  intervention name: FLU Q-PAN H5N8 Formulation 1
  description: Participants receive two doses of the FLU Q-PAN H5N8 Formulation 1 vaccine by intramuscular injection in the non-dominant arm.
  arm group label: FLU Q-PAN H5N8 Formulation 1_A Group
  arm group label: FLU Q-PAN H5N8 Formulation 1_B Group
  intervention type: Biological
  intervention name: AS03B
  description: Participants receive two doses of the AS03B adjuvant by intramuscular injection in the non-dominant arm.
  arm group label: FLU Q-PAN H5N8 Formulation 1_B Group
  arm group label: FLU Q-PAN H5N8 Formulation 2_B Group
  intervention type: Biological
  intervention name: AS03A
  description: Participants receive two doses of the AS03A adjuvant by intramuscular injection in the non-dominant arm.
  arm group label: FLU Q-PAN H5N8 Formulation 1_A Group
  arm group label: FLU Q-PAN H5N8 Formulation 2_A Group
  intervention type: Biological
  intervention name: FLU Q-PAN H5N8 Formulation 2
  description: Participants receive two doses of the FLU Q-PAN H5N8 Formulation 2 vaccine by intramuscular injection in the non dominant arm.
  arm group label: FLU Q-PAN H5N8 Formulation 2_A Group
  arm group label: FLU Q-PAN H5N8 Formulation 2_B Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Sponsor
  mesh term: Influenza, Human
  sharing ipd: Yes
  ipd description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
  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: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
  ipd access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.
  ipd url: http://www.gsk.com/en-gb/innovation/trials/data-transparency