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/NCT05981846</url>
    </required_header>
    <id_info>
      <org_study_id>HIPRA-HH-11</org_study_id>
      <nct_id>NCT05981846</nct_id>
    </id_info>
    <brief_title>A Phase II Trial to Evaluate the Safety and Immunogenicity of BIMERVAX® When Coadministered With Seasonal Influenza Vaccine (SIIV) in Adults Older Than 65 Years of Age Fully Vaccinated Against COVID-19</brief_title>
    <official_title>A Phase II, Randomized, Double-blind, Multi-centre Trial to Evaluate the Safety and Immunogenicity of BIMERVAX® When Coadministered With Seasonal Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine (SIIV) in Adults Older Than 65 Years of Age Fully Vaccinated Against COVID-19</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hipra Scientific, S.L.U</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hipra Scientific, S.L.U</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a Phase II, randomized, double-blind, multi-centre trial to evaluate the safety and&#xD;
        immunogenicity of BIMERVAX® when coadministered with seasonal surface antigen inactivated&#xD;
        adjuvanted influenza vaccine (SIIV) in adults older than 65 years of age fully vaccinated&#xD;
        against COVID-19.&#xD;
  &#xD;
        In this study approximately 300 adults aged 65 or older will be enrolled and followed for 1&#xD;
        month after study treatment. Safety and immunogenicity of all participants will be assessed.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 4, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2023</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>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number, percentage, and characteristics of solicited local and systemic reactions through Day 7 after vaccination.</measure>
      <time_frame>Day 0, Day 7</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number, percentage, and characteristics of unsolicited local and systemic adverse events (AEs) through the end of the study.</measure>
      <time_frame>Day 0, Day 7, Day 28</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number and percentage of serious adverse events (SAEs) through the end of the study.</measure>
      <time_frame>Day 0, Day 7, Day 28</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number and percentage of adverse events of special interest (AESI) through the end of the study</measure>
      <time_frame>Day 0, Day 7, Day 28</time_frame>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">300</enrollment>
    <condition>SARS CoV 2 Infection</condition>
    <condition>Influenza, Human</condition>
    <arm_group>
      <arm_group_label>BIMERVAX + SIIV</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>BIMERVAX + PLACEBO</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>SIIV + PLACEBO</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>BIMERVAX</intervention_name>
      <description>One dose of booster vaccine</description>
      <arm_group_label>BIMERVAX + PLACEBO</arm_group_label>
      <arm_group_label>BIMERVAX + SIIV</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>SIIV</intervention_name>
      <description>One dose</description>
      <arm_group_label>BIMERVAX + SIIV</arm_group_label>
      <arm_group_label>SIIV + PLACEBO</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Adults aged 65 or older at Day 0.&#xD;
  &#xD;
            2. Are willing and able to sign the informed consent and can comply with all study visits&#xD;
               and procedures.&#xD;
  &#xD;
            3. Participant must have received at least a primary scheme of an mRNA vaccine (2 doses).&#xD;
               Booster doses or previous COVID-19 infections are allowed. Last dose must have been&#xD;
               administered at least 6 months before Day 0. History of COVID-19 infection is allowed&#xD;
               if occurred at least &gt;30 days before Day 0.&#xD;
  &#xD;
            4. Have a negative Rapid Antigen Test (RAT) at Day 0 before vaccinations.&#xD;
  &#xD;
            5. Adults determined by clinical assessment, including medical history and clinical&#xD;
               judgement, to be eligible for the study, including adults with pre-existing chronic&#xD;
               and stable diseases (non-immunocompromised), if these are stable and well-controlled&#xD;
               according to the investigator's judgment.&#xD;
  &#xD;
               Exclusion Criteria:&#xD;
  &#xD;
            6. Acute illness with fever ≥ 38.0°C at Day 0 or within 24 hours prior to vaccination.&#xD;
               Afebrile participants with minor illnesses can be enrolled at the discretion of the&#xD;
               investigator.&#xD;
  &#xD;
            7. Allergy to egg proteins (egg or egg products) or chicken proteins.&#xD;
  &#xD;
            8. History of Guillain-Barré syndrome (GBS)&#xD;
  &#xD;
            9. History of COVID-19 infection (described as a positive RAT or PCR), in the previous 30&#xD;
               days before Day 0.&#xD;
  &#xD;
           10. Other medical or psychiatric condition including recent (within the past year) or&#xD;
               active suicidal ideation/behaviour that may increase the risk of study participation&#xD;
               or, in the investigator's judgment, make the participant inappropriate for the study.&#xD;
  &#xD;
           11. History of severe adverse reaction associated with a vaccine and/or severe allergic&#xD;
               reaction (e.g. anaphylaxis) to any component of the study intervention(s).&#xD;
  &#xD;
           12. Immunocompromised individuals defined as those with primary and secondary immune&#xD;
               deficiencies and those receiving chemotherapy or immunosuppressant drugs other than&#xD;
               steroids and glucocorticoids (maximum 30mg/day of prednisone, or equivalent, by any&#xD;
               administration route for a maximum of 30 consecutive days), within 90 days prior to&#xD;
               vaccination or during the study.&#xD;
  &#xD;
           13. Bleeding diathesis or condition associated with prolonged bleeding that would, in the&#xD;
               opinion of the investigator, contraindicate intramuscular injection.&#xD;
  &#xD;
           14. Receipt of blood-derived immune globulins, blood, or blood-derived products in the&#xD;
               past 3 months.&#xD;
  &#xD;
           15. Participation in other studies involving study intervention within 28 days prior to&#xD;
               screening and/or during study participation.&#xD;
  &#xD;
           16. Received any non-study vaccine within 14 days before or after screening. For live or&#xD;
               attenuated vaccines, 4 weeks before or after screening.&#xD;
  &#xD;
           17. History of a diagnosis or other conditions that, in the judgment of the investigator,&#xD;
               may affect study endpoint assessment or compromise participant safety.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Teresa Prat</last_name>
      <phone>972430660</phone>
      <email>teresa.prat@hipra.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hospital Clínico Universitario de Santiago</name>
        <address>
          <city>Santiago De Compostela</city>
          <state>A Coruña</state>
          <zip>15706</zip>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>Federico Martinón, MD</last_name>
        <email>federico.martinon.torres@sergas.es</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital Germans Trias i Pujol</name>
        <address>
          <city>Badalona</city>
          <state>Barcelona</state>
          <zip>08916</zip>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>José Moltó, MD</last_name>
        <email>jmolto@lluita.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>CAP Centelles</name>
        <address>
          <city>Centelles</city>
          <state>Barcelona</state>
          <zip>08540</zip>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>Sílvia Narejos, MD</last_name>
        <email>snarejos@ebacentelles.cat</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital HM Modelo</name>
        <address>
          <city>A Coruña</city>
          <zip>15011</zip>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>Ignacio Ramil, MD</last_name>
        <email>iramilfrean@hmhospitales.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital Clínic de Barcelona</name>
        <address>
          <city>Barcelona</city>
          <zip>08036</zip>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>Anna Vilella, MD</last_name>
        <email>avilella@recerca.clinic.cat</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital Josep Trueta</name>
        <address>
          <city>Girona</city>
          <zip>17001</zip>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>Antoni Castro, MD</last_name>
        <email>acastro.girona.ics@gencat.cat</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital Regional de Málaga</name>
        <address>
          <city>Málaga</city>
          <zip>29010</zip>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>Maria Jesús López, MD</last_name>
        <email>mj.lopez.fernandez.sspa@juntadeandalucía.es</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital Clínico de Valladolid</name>
        <address>
          <city>Valladolid</city>
          <zip>47003</zip>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>Javier Castrodeza, MD</last_name>
        <email>jjcastrodeza@saludcastillayleon.es</email>
      </contact>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Influenza, Human</mesh_term>
      <mesh_term>COVID-19</mesh_term>
    </condition_browse>
    <!-- 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/NCT05981846
  org study id: HIPRA-HH-11
  nct id: NCT05981846
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a Phase II, randomized, double-blind, multi-centre trial to evaluate the safety and
        immunogenicity of BIMERVAX® when coadministered with seasonal surface antigen inactivated
        adjuvanted influenza vaccine (SIIV) in adults older than 65 years of age fully vaccinated
        against COVID-19.
  
        In this study approximately 300 adults aged 65 or older will be enrolled and followed for 1
        month after study treatment. Safety and immunogenicity of all participants will be assessed.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Number, percentage, and characteristics of solicited local and systemic reactions through Day 7 after vaccination.
  time frame: Day 0, Day 7
  measure: Number, percentage, and characteristics of unsolicited local and systemic adverse events (AEs) through the end of the study.
  time frame: Day 0, Day 7, Day 28
  measure: Number and percentage of serious adverse events (SAEs) through the end of the study.
  time frame: Day 0, Day 7, Day 28
  measure: Number and percentage of adverse events of special interest (AESI) through the end of the study
  time frame: Day 0, Day 7, Day 28
  arm group label: BIMERVAX + SIIV
  arm group type: Experimental
  arm group label: BIMERVAX + PLACEBO
  arm group type: Active Comparator
  arm group label: SIIV + PLACEBO
  arm group type: Active Comparator
  intervention type: Biological
  intervention name: BIMERVAX
  description: One dose of booster vaccine
  arm group label: BIMERVAX + PLACEBO
  arm group label: BIMERVAX + SIIV
  intervention type: Biological
  intervention name: SIIV
  description: One dose
  arm group label: BIMERVAX + SIIV
  arm group label: SIIV + PLACEBO
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Teresa Prat
  phone: 972430660
  email: teresa.prat@hipra.com
  facility: 
  contact: 
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  country: Spain
  responsible party type: Sponsor
  mesh term: Influenza, Human
  mesh term: COVID-19