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/NCT05966090</url>
    </required_header>
    <id_info>
      <org_study_id>219331</org_study_id>
      <nct_id>NCT05966090</nct_id>
    </id_info>
    <brief_title>A Study on Safety and Immune Response of Investigational RSV OA Vaccine in Combination With Herpes Zoster Vaccine in Healthy Adults</brief_title>
    <acronym>RSV-OA=ADJ-020</acronym>
    <official_title>A Phase III, Open-label, Randomized, Controlled, Multi-country Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With Herpes Zoster Recombinant Subunit (HZ/su) Vaccine in Adults Aged 50 Years 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>Yes</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>
        To assess the ability of RSVPreF3 OA investigational vaccine to generate an immune response&#xD;
        when given in combination with HZ/su vaccine and its safety in older adults, aged &gt;=50 years&#xD;
        of age.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 28, 2023</start_date>
    <completion_date type="Anticipated">September 13, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 12, 2024</primary_completion_date>
    <phase>Phase 3</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>None (Open Label)</masking>
      <masking_description>The laboratory in charge of sample testing will be blinded to the study intervention assignment.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Anti-gE antibody concentrations expressed as group geometric mean concentration (GMC) ratio</measure>
      <time_frame>1-month after the second dose of HZ/su vaccine (at day 91)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Concentration of RSV-A neutralizing titers expressed as group geometric mean titer (GMT) ratio</measure>
      <time_frame>1-month after the RSVPreF3 OA investigational vaccine dose (at Day 31 for the Co-administration group and at Day 61 for the Control group)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Concentration of RSV-B neutralizing titers expressed as group GMT ratio</measure>
      <time_frame>1-month after the RSVPreF3 OA investigational vaccine dose (at Day 31 for the Co-administration group and at Day 61 for the Control group)</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Anti-gE antibody concentrations expressed as seropositivity rate</measure>
      <time_frame>At pre-vaccination (Day 1) and 1-month after the second dose of HZ/su vaccine (at Day 91)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anti-gE antibody concentrations expressed as GMC</measure>
      <time_frame>At pre-vaccination (Day 1) and 1-month after the second dose of HZ/su vaccine (at Day 91)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anti-gE antibody concentrations expressed as mean geometric increase (MGI)</measure>
      <time_frame>At 1-month after the second dose of HZ/su vaccine (at Day 91) versus pre-vaccination (Day 1)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vaccine response rate at 1-month postsecond dose of HZ/su vaccine</measure>
      <time_frame>At 1-month after the second dose of HZ/su vaccine (at Day 91)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of RSV-A neutralizing titers expressed as GMT</measure>
      <time_frame>At pre-vaccination and at 1-month after the RSVPreF3 OA investigational vaccine dose (at Day 1 and Day 31 for the Co-administration group and at Day 31 and Day 61 for the Control group)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of RSV-A neutralizing titers expressed as MGI</measure>
      <time_frame>At 1-month after the RSVPreF3 OA investigational vaccine administration versus pre-vaccination (at Day 31 versus Day 1 for the Co-administration group and at Day 61 versus Day 31 for the Control group)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of RSV-B neutralizing titers expressed as GMT</measure>
      <time_frame>At pre-vaccination and at 1-month after the RSVPreF3 OA investigational vaccine dose (at Day 1 and Day 31 for the Co-administration group and at Day 31 and Day 61 for the Control group)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of RSV-B neutralizing titers expressed as MGI</measure>
      <time_frame>At 1-month after the RSVPreF3 OA investigational vaccine administration versus pre-vaccination (at Day 31 versus Day 1 for the Co-administration group and at Day 61 versus Day 31 for the Control group)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants reporting solicited administration site events (AE)</measure>
      <time_frame>During the 7 days after each vaccine administration (i.e., the day of vaccination and 6 subsequent days, vaccines administered at Day 1, Day 31 and Day 61)</time_frame>
      <description>The solicited administration site AEs are erythema, pain and swelling.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants reporting solicited systemic events</measure>
      <time_frame>During the 7 days after each vaccine administration (i.e., the day of vaccination and 6 subsequent days, vaccines administered at Day 1, Day 31 and Day 61)</time_frame>
      <description>The solicited systemic events are arthralgia, fatigue, fever, headache, myalgia, shivering/chills and gastrointestinal symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants reporting unsolicited Adverse Events (AEs)</measure>
      <time_frame>During the 30 days after each vaccine administration (i.e., the day of vaccination and 29 subsequent days, vaccines administered at Day 1, Day 31 and Day 61)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants reporting serious adverse events (SAEs)</measure>
      <time_frame>From Day 1 up to study end (6 months after last vaccination administered at Day 61)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants reporting potential immune mediated disorders (pIMDs)</measure>
      <time_frame>From Day 1 up to study end (6 months after last vaccination administered at Day 61)</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">530</enrollment>
    <condition>Respiratory Syncytial Viruses</condition>
    <condition>Respiratory Syncytial Virus Infections</condition>
    <arm_group>
      <arm_group_label>RSV+ HZ/su Co-administration Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be administered first dose of HZ/su vaccine and the RSVPreF3 OA investigational vaccine together on Day 1. A second dose of the HZ/su vaccine will be administered at Day 61.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>RSV+HZ/su Control Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will be administered first dose HZ/su vaccine on Day 1, followed by the RSVPreF3 OA investigational vaccine on Day 31, and then second dose of HZ/su vaccine on Day 61.</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>RSVPreF3 OA investigational vaccine</intervention_name>
      <description>One dose of RSVPreF3 OA investigational vaccine given intramuscularly on Day 1 (Coadministration group) or Day 31 (Control group).</description>
      <arm_group_label>RSV+ HZ/su Co-administration Group</arm_group_label>
      <arm_group_label>RSV+HZ/su Control Group</arm_group_label>
      <other_name>Respiratory Syncytial Virus PreFusion protein 3 Older Adults vaccine</other_name>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>HZ/su vaccine</intervention_name>
      <description>Two doses of HZ/su vaccine given intramuscularly on Day 1 and Day 61.</description>
      <arm_group_label>RSV+ HZ/su Co-administration Group</arm_group_label>
      <arm_group_label>RSV+HZ/su Control Group</arm_group_label>
      <other_name>Herpes Zoster recombinant subunit vaccine, Shingrix</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  A male or female participant ≥50 YOA at the time of the first study intervention&#xD;
               administration.&#xD;
  &#xD;
            -  Female participants of non-childbearing potential may be enrolled in the study.&#xD;
  &#xD;
            -  Female participants of childbearing potential may be enrolled in the study, if the&#xD;
               participant:&#xD;
  &#xD;
                 -  has practiced adequate contraception from 1 month prior to study intervention&#xD;
                    administration.&#xD;
  &#xD;
                 -  has a negative pregnancy test on the day of and prior to study intervention&#xD;
                    administration.&#xD;
  &#xD;
                 -  has agreed to continue effective contraception until the end of the study.&#xD;
  &#xD;
            -  Participants who, in the opinion of the investigator, can and will comply with the&#xD;
               requirements of the protocol. Written or witnessed informed consent obtained from the&#xD;
               participant prior to any study specific procedure being performed.&#xD;
  &#xD;
            -  Participants living in the general community or in an assisted-living facility that&#xD;
               provides minimal assistance, such that the participant is primarily responsible for&#xD;
               self-care and activities of daily living.&#xD;
  &#xD;
            -  Participants who are medically stable in the opinion of the investigator at the time&#xD;
               of first study intervention administration. Participants with chronic stable medical&#xD;
               conditions with or without specific treatment, such as diabetes mellitus,&#xD;
               hypertension, or cardiac disease, are allowed to participate in this study if&#xD;
               considered by the investigator as medically stable.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Pregnant or lactating female.&#xD;
  &#xD;
            -  Female planning to become pregnant or planning to discontinue contraceptive&#xD;
               precautions.&#xD;
  &#xD;
            -  Any confirmed or suspected autoimmune disorders, immunosuppressive or immunodeficient&#xD;
               condition resulting from disease or immunosuppressive/cytotoxic therapy, based on&#xD;
               medical history and physical examination.&#xD;
  &#xD;
            -  History of any reaction or hypersensitivity likely to be exacerbated by any component&#xD;
               of the study interventions, in particular any history of severe allergic reaction to&#xD;
               any vaccine component.&#xD;
  &#xD;
            -  History of Guillain-Barré syndrome.&#xD;
  &#xD;
            -  Any history of dementia or any medical condition that moderately or severely impairs&#xD;
               cognition.&#xD;
  &#xD;
            -  Recurrent or uncontrolled neurological disorders or seizures. Participants with&#xD;
               medically controlled chronic neurological diseases can be enrolled in the study as per&#xD;
               investigator assessment, provided that their condition will allow them to comply with&#xD;
               the requirements of the protocol.&#xD;
  &#xD;
            -  Significant underlying illness that in the opinion of the investigator would be&#xD;
               expected to prevent completion of the study.&#xD;
  &#xD;
            -  Any medical condition that in the judgment of the investigator would make&#xD;
               intramuscular injection unsafe.&#xD;
  &#xD;
            -  Clinically suspected or polymerase chain reaction (PCR)-confirmed ongoing episode of&#xD;
               herpes zoster.&#xD;
  &#xD;
            -  History of previous vaccination with any licensed or investigational recombinant&#xD;
               adjuvanted zoster vaccine (HZ/su vaccine; Shingrix) before the study start or planned&#xD;
               receipt through study participation.&#xD;
  &#xD;
            -  History of previous vaccination with any licensed or investigational live herpes&#xD;
               zoster vaccine (Zostavax) in the last 2 years from enrollment, or planned receipt&#xD;
               through study participation.&#xD;
  &#xD;
            -  Previous vaccination with licensed or investigational RSV vaccine.&#xD;
  &#xD;
            -  Use of any investigational or non-registered product (drug, vaccine or medical device)&#xD;
               other than the study interventions during the period beginning 30 days before the&#xD;
               first dose of study interventions, or their planned use during the study period.&#xD;
  &#xD;
            -  Planned or actual administration of a vaccine not foreseen by the study protocol in&#xD;
               the period starting 30 days before the first study intervention administration and&#xD;
               ending 30 days after the last study intervention administration.&#xD;
  &#xD;
               o In the case of COVID-19 and inactivated/subunit/split influenza vaccines, this time&#xD;
               window can be decreased to 14 days before and after each study intervention&#xD;
               administration provided COVID-19 vaccine use is in line with local governmental&#xD;
               recommendations.&#xD;
  &#xD;
            -  Planned or actual administration of adjuvanted quadrivalent influenza vaccine not&#xD;
               foreseen by the study protocol in the period starting 30 days before the first study&#xD;
               intervention administration and ending 30 days after the last study intervention&#xD;
               administration.&#xD;
  &#xD;
            -  Administration of long-acting immune-modifying drugs during the period starting 180&#xD;
               days before the administration of first dose of study interventions or planned&#xD;
               administration at any time during the study period (e.g., infliximab).&#xD;
  &#xD;
            -  Administration of immunoglobulins and/or any blood products or plasma derivatives&#xD;
               during the period starting 90 days before the administration of first dose of study&#xD;
               interventions or planned administration during the study period.&#xD;
  &#xD;
            -  Chronic administration (defined as more than 14 consecutive days in total) of&#xD;
               immunosuppressants or other immune modifying drugs during the period starting 90 days&#xD;
               prior to the first study intervention dose or planned administration during the study&#xD;
               period. For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent.&#xD;
               Inhaled, topical or intra-articular steroids are allowed.&#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 (IMP) (drug or invasive medical device).&#xD;
  &#xD;
            -  History of chronic alcohol consumption and/or drug abuse as deemed by the investigator&#xD;
               to render the potential participant unable/unlikely to provide accurate safety reports&#xD;
               or comply with study procedures.&#xD;
  &#xD;
            -  Bedridden participants.&#xD;
  &#xD;
            -  Planned move during the study conduct that prohibits participation until study end.&#xD;
  &#xD;
            -  Participation of any study personnel or their immediate dependents, family, or&#xD;
               household members.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>EU GSK Clinical Trials Call Center</last_name>
      <phone>+44 (0) 20 89904466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Daphne</city>
          <state>Alabama</state>
          <zip>36526</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Tempe</city>
          <state>Arizona</state>
          <zip>85281</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Corte Madera</city>
          <state>California</state>
          <zip>94925</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Aurora</city>
          <state>Colorado</state>
          <zip>80918</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>North Miami Beach</city>
          <state>Florida</state>
          <zip>33162</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Columbus</city>
          <state>Georgia</state>
          <zip>31904</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Versailles</city>
          <state>Kentucky</state>
          <zip>40383</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>New Orleans</city>
          <state>Louisiana</state>
          <zip>70115</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Fort Worth</city>
          <state>Texas</state>
          <zip>76104</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>San Antonio</city>
          <state>Texas</state>
          <zip>78244</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Brampton</city>
          <state>Ontario</state>
          <zip>L6T 0G1</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Guelph</city>
          <state>Ontario</state>
          <zip>N1H 1B1</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Sarnia</city>
          <state>Ontario</state>
          <zip>N7T 4X3</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Toronto</city>
          <state>Ontario</state>
          <zip>M4G 3E8</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Toronto</city>
          <state>Ontario</state>
          <zip>M9V 4B4</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Levis</city>
          <state>Quebec</state>
          <zip>G6W 0M5</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Mirabel</city>
          <state>Quebec</state>
          <zip>J7J 2K8</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>GSK investigational Site</name>
        <address>
          <city>Pointe-Claire</city>
          <state>Quebec</state>
          <zip>H9R 4S3</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Sherbrooke</city>
          <state>Quebec</state>
          <zip>J1L 0H8</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Quebec</city>
          <zip>G1V 4T3</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Exeter</city>
          <state>Devon</state>
          <zip>EX2 5DW</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Southampton</city>
          <state>Hampshire</state>
          <zip>SO16 6YD</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Nottingham</city>
          <state>Nottinghamshire</state>
          <zip>NG7 2QW</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Newcastle upon Tyne</city>
          <state>Tyne &amp; Wear</state>
          <zip>NE1 4LP</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location_countries>
      <country>Canada</country>
      <country>United Kingdom</country>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Respiratory syncytial virus</keyword>
    <keyword>Infection</keyword>
    <keyword>Vaccine</keyword>
    <keyword>Older adult</keyword>
    <keyword>Immunogenicity</keyword>
    <keyword>Safety</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Herpes Zoster</mesh_term>
      <mesh_term>Respiratory Syncytial Virus Infections</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vaccines</mesh_term>
    </intervention_browse>
    <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>https://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/NCT05966090
  org study id: 219331
  nct id: NCT05966090
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  To assess the ability of RSVPreF3 OA investigational vaccine to generate an immune response
        when given in combination with HZ/su vaccine and its safety in older adults, aged >=50 years
        of age.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  masking description: The laboratory in charge of sample testing will be blinded to the study intervention assignment.
  measure: Anti-gE antibody concentrations expressed as group geometric mean concentration (GMC) ratio
  time frame: 1-month after the second dose of HZ/su vaccine (at day 91)
  measure: Concentration of RSV-A neutralizing titers expressed as group geometric mean titer (GMT) ratio
  time frame: 1-month after the RSVPreF3 OA investigational vaccine dose (at Day 31 for the Co-administration group and at Day 61 for the Control group)
  measure: Concentration of RSV-B neutralizing titers expressed as group GMT ratio
  time frame: 1-month after the RSVPreF3 OA investigational vaccine dose (at Day 31 for the Co-administration group and at Day 61 for the Control group)
  measure: Anti-gE antibody concentrations expressed as seropositivity rate
  time frame: At pre-vaccination (Day 1) and 1-month after the second dose of HZ/su vaccine (at Day 91)
  measure: Anti-gE antibody concentrations expressed as GMC
  time frame: At pre-vaccination (Day 1) and 1-month after the second dose of HZ/su vaccine (at Day 91)
  measure: Anti-gE antibody concentrations expressed as mean geometric increase (MGI)
  time frame: At 1-month after the second dose of HZ/su vaccine (at Day 91) versus pre-vaccination (Day 1)
  measure: Vaccine response rate at 1-month postsecond dose of HZ/su vaccine
  time frame: At 1-month after the second dose of HZ/su vaccine (at Day 91)
  measure: Concentration of RSV-A neutralizing titers expressed as GMT
  time frame: At pre-vaccination and at 1-month after the RSVPreF3 OA investigational vaccine dose (at Day 1 and Day 31 for the Co-administration group and at Day 31 and Day 61 for the Control group)
  measure: Concentration of RSV-A neutralizing titers expressed as MGI
  time frame: At 1-month after the RSVPreF3 OA investigational vaccine administration versus pre-vaccination (at Day 31 versus Day 1 for the Co-administration group and at Day 61 versus Day 31 for the Control group)
  measure: Concentration of RSV-B neutralizing titers expressed as GMT
  time frame: At pre-vaccination and at 1-month after the RSVPreF3 OA investigational vaccine dose (at Day 1 and Day 31 for the Co-administration group and at Day 31 and Day 61 for the Control group)
  measure: Concentration of RSV-B neutralizing titers expressed as MGI
  time frame: At 1-month after the RSVPreF3 OA investigational vaccine administration versus pre-vaccination (at Day 31 versus Day 1 for the Co-administration group and at Day 61 versus Day 31 for the Control group)
  measure: Percentage of participants reporting solicited administration site events (AE)
  time frame: During the 7 days after each vaccine administration (i.e., the day of vaccination and 6 subsequent days, vaccines administered at Day 1, Day 31 and Day 61)
  description: The solicited administration site AEs are erythema, pain and swelling.
  measure: Percentage of participants reporting solicited systemic events
  time frame: During the 7 days after each vaccine administration (i.e., the day of vaccination and 6 subsequent days, vaccines administered at Day 1, Day 31 and Day 61)
  description: The solicited systemic events are arthralgia, fatigue, fever, headache, myalgia, shivering/chills and gastrointestinal symptoms.
  measure: Percentage of participants reporting unsolicited Adverse Events (AEs)
  time frame: During the 30 days after each vaccine administration (i.e., the day of vaccination and 29 subsequent days, vaccines administered at Day 1, Day 31 and Day 61)
  measure: Percentage of participants reporting serious adverse events (SAEs)
  time frame: From Day 1 up to study end (6 months after last vaccination administered at Day 61)
  measure: Percentage of participants reporting potential immune mediated disorders (pIMDs)
  time frame: From Day 1 up to study end (6 months after last vaccination administered at Day 61)
  arm group label: RSV+ HZ/su Co-administration Group
  arm group type: Experimental
  description: Participants will be administered first dose of HZ/su vaccine and the RSVPreF3 OA investigational vaccine together on Day 1. A second dose of the HZ/su vaccine will be administered at Day 61.
  arm group label: RSV+HZ/su Control Group
  arm group type: Active Comparator
  description: Participants will be administered first dose HZ/su vaccine on Day 1, followed by the RSVPreF3 OA investigational vaccine on Day 31, and then second dose of HZ/su vaccine on Day 61.
  intervention type: Biological
  intervention name: RSVPreF3 OA investigational vaccine
  description: One dose of RSVPreF3 OA investigational vaccine given intramuscularly on Day 1 (Coadministration group) or Day 31 (Control group).
  arm group label: RSV+ HZ/su Co-administration Group
  arm group label: RSV+HZ/su Control Group
  other name: Respiratory Syncytial Virus PreFusion protein 3 Older Adults vaccine
  intervention type: Biological
  intervention name: HZ/su vaccine
  description: Two doses of HZ/su vaccine given intramuscularly on Day 1 and Day 61.
  arm group label: RSV+ HZ/su Co-administration Group
  arm group label: RSV+HZ/su Control Group
  other name: Herpes Zoster recombinant subunit vaccine, Shingrix
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: US GSK Clinical Trials Call Center
  phone: 877-379-3718
  email: GSKClinicalSupportHD@gsk.com
  last name: EU GSK Clinical Trials Call Center
  phone: +44 (0) 20 89904466
  email: GSKClinicalSupportHD@gsk.com
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  country: Canada
  country: United Kingdom
  country: United States
  responsible party type: Sponsor
  mesh term: Herpes Zoster
  mesh term: Respiratory Syncytial Virus Infections
  mesh term: Vaccines
  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: https://www.gsk.com/en-gb/innovation/trials/data-transparency/