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/NCT05975060</url>
    </required_header>
    <id_info>
      <org_study_id>2019nCoV-313</org_study_id>
      <nct_id>NCT05975060</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.</brief_title>
    <acronym>COVID-19</acronym>
    <official_title>A Phase 2/3 Open-Label Study to Evaluate the Safety and Immunogenicity of an XBB.1.5 (Omicron Subvariant) SARS CoV-2 rS Vaccine Booster Dose in Previously mRNA COVID 19 Vaccinated and Baseline SARS CoV 2 Seropositive COVID-19 Vaccine Naïve Participants</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Novavax</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Novavax</source>
    <oversight_info>
      <has_dmc>Yes</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 2/3 open-label study to evaluate the safety and immunogenicity of a booster&#xD;
        dose of the XBB.1.5 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant&#xD;
        (r) spike (S) protein nanoparticle vaccine (SARS-CoV-2 rS) adjuvanted with Matrix-M™ in&#xD;
        previously mRNA COVID-19 vaccinated adult participants ≥18 years of age and baseline SARS&#xD;
        CoV-2 seropositive COVID-19 vaccine naïve participants ≥18 years of age.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Novavax, Inc. developed a recombinant prototype COVID-19 vaccine constructed from the&#xD;
        full-length ancestral (Wuhan) SARS CoV-2 S glycoprotein (GP) adjuvanted with the&#xD;
        saponin-based Matrix-M adjuvant (NVX-CoV2373). Subsequently, the SARS CoV 2 Omicron variant&#xD;
        and subvariants emerged with enhanced transmissibility and the most significant number of&#xD;
        mutations in any strain to date. Current evidence demonstrates that variant strain mutations&#xD;
        such as those in the Omicron XBB.1.5 sublineage confer the ability to evade both natural and&#xD;
        vaccine-induced neutralizing antibodies.&#xD;
  &#xD;
        Part 1 of the study aims to investigate the safety and immunogenicity of the Novavax XBB.1.5&#xD;
        SARS-CoV-2 rS vaccine (NVX-CoV2601) adjuvanted with Matrix-M in previously COVID-19 mRNA&#xD;
        vaccinated participants to determine if it induces superior antibody responses compared to a&#xD;
        historical control of the prototype vaccine (original Wuhan strain), NVX-CoV2373.&#xD;
  &#xD;
        Part 2 of the study aims to investigate the safety and immunogenicity of 1 dose of NVX&#xD;
        CoV2601 in baseline SARS-CoV-2 seropositive COVID-19 vaccine naïve participants to determine&#xD;
        if it induces non-inferior antibody responses compared to 1 booster dose of NVX-CoV2601 in&#xD;
        previously COVID-19 mRNA vaccinated individuals participating in Part 1.&#xD;
  &#xD;
        Part 1:&#xD;
  &#xD;
        Approximately 330 previously mRNA COVID-19 vaccinated participants will receive a booster&#xD;
        dose of XBB.1.5 Omicron subvariant vaccine (NVX-CoV2601) on Day 0. Immunogenicity and 28-day&#xD;
        safety data will be used for an interim analysis, while participants remain on the study for&#xD;
        immunogenicity and safety data collection up to Day 180 post-vaccination.&#xD;
  &#xD;
        Part 2:&#xD;
  &#xD;
        After completion of Part 1, approximately 330 unvaccinated participants with a clinical&#xD;
        history of COVID-19-like disease during the previous year will receive a booster dose of&#xD;
        NVX-CoV2601 on Day 0. Immunogenicity and 28-day safety data will be used for an interim&#xD;
        analysis, while participants remain on the study for immunogenicity and safety data&#xD;
        collection up to Day 180 post vaccination.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 7, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2024</primary_completion_date>
    <phase>Phase 2/Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Part 1: Pseudovirus neutralization (inhibitory dilution at a concentration of 50%; ID 50 ) to the NVX-CoV2601 vaccine</measure>
      <time_frame>Day 28</time_frame>
      <description>Pseudovirus neutralization (inhibitory dilution at a concentration of 50%; ID 50 ) to the NVX-CoV2601 vaccine assessed at Day 28 following study vaccination.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Part 1: Seroresponse Rates (SRRs) in ID 50 titers to the NVXCoV2601 vaccine</measure>
      <time_frame>Day 28</time_frame>
      <description>SRRs (proportion of seroconverted participants) in ID 50 titers to the NVXCoV2601 vaccine assessed at Day 28 following the study vaccination.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Part 2: SRRs in ID 50 titers to the XBB.1.5 Omicron subvariant</measure>
      <time_frame>Day 28</time_frame>
      <description>SRRs (proportion of seroconverted participants) in ID 50 titers to the XBB.1.5 Omicron subvariant assessed at Day 28 following study vaccination.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Part 2: ID 50 (Geometric Mean Titers) GMTs to the XBB.1.5 Omicron subvariant</measure>
      <time_frame>Day 28</time_frame>
      <description>ID 50 GMTs to the XBB.1.5 Omicron subvariant assessed at Day 28 following study vaccination.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Part 1: Pseudovirus neutralization (inhibitory dilution at a concentration of 50%; ID50) to the NVX-CoV2601 vaccine</measure>
      <time_frame>Day 28</time_frame>
      <description>Pseudovirus neutralization (inhibitory dilution at a concentration of 50%; ID50) to the NVX-CoV2601 vaccine assessed at baseline and 28 days following study vaccination.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Part 1: ID 50 GMTs to the XBB.1.5 Omicron subvariant</measure>
      <time_frame>Day 0 to Day 180</time_frame>
      <description>ID 50 GMTs to the XBB.1.5 Omicron subvariant at relevant time points</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Part 1: ID 50 geometric mean fold rise (GMFR) to the XBB.1.5 Omicron subvariant at relevant time points (Days 28 and 180) from baseline (Day 0).</measure>
      <time_frame>Day 0 to Day 180</time_frame>
      <description>ID 50 GMFR to the XBB.1.5 Omicron subvariant at relevant time points (Days 28 and 180) from baseline (Day 0).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Part 1: SRRs in ID 50 titer concentrations to the XBB.1.5 Omicron subvariant at relevant time points.</measure>
      <time_frame>Day 28 to Day 180</time_frame>
      <description>SRRs in ID 50 titer concentrations to the XBB.1.5 Omicron subvariant at relevant time points.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Part 1: Anti-S immunoglobulin G (IgG) geometric mean concentrations (GMCs, EU/mL) to the NVX-CoV2601 vaccine at relevant time points</measure>
      <time_frame>Day 0 to Day 180</time_frame>
      <description>Anti-S IgG geometric mean concentrations (GMCs, EU/mL) to the NVX-CoV2601 vaccine at relevant time points (Days 0, 28, and 180).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Part 1: Incidence and severity of solicited local and systemic adverse events (AEs)</measure>
      <time_frame>Day 0 to Day 7</time_frame>
      <description>Incidence, duration, and severity of solicited local and systemic adverse events (AEs) for 7 days following vaccination.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Part 1: Incidence and severity of unsolicited AEs</measure>
      <time_frame>Day 28</time_frame>
      <description>Incidence, severity, and relationship of unsolicited AEs through 28 days after vaccination.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Part 1: Incidence and severity of MAAEs attributed to study vaccine, adverse events of special interest (AESIs), and serious adverse events (SAEs)</measure>
      <time_frame>Day 0 to Day 180</time_frame>
      <description>Incidence and severity of Medically attended adverse event (MAAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) through day 180 or EOS.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Part 2: Pseudovirus neutralization (ID 50 ) to the XBB.1.5 Omicron subvariant</measure>
      <time_frame>Day 0 to Day 28</time_frame>
      <description>Pseudovirus neutralization (ID 50 ) to the XBB.1.5 Omicron subvariant assessed at baseline and at Day 28 following study vaccination.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Part 2: Incidence and severity of solicited local and systemic adverse events (AEs)</measure>
      <time_frame>Day 0 to Day 7</time_frame>
      <description>Incidence, duration, and severity of solicited local and systemic adverse events (AEs) for 7 days following vaccination.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Part 2: Incidence, and severity of unsolicited AEs</measure>
      <time_frame>Day 28</time_frame>
      <description>Incidence, severity, and relationship of unsolicited AEs through 28 days after vaccination.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Part 2: Incidence and severity of MAAEs, AESIs, and SAEs</measure>
      <time_frame>Day 0 to Day 180</time_frame>
      <description>Incidence and severity of MAAEs attributed to study vaccine, adverse events of special interest (AESIs) (predefined list including PIMMCs, myocarditis and/or pericarditis, and complications specific to COVID-19), and serious adverse events (SAEs) through day 180 or EOS.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">660</enrollment>
    <condition>COVID-19</condition>
    <arm_group>
      <arm_group_label>Group-A XBB.1.5 Vaccine (Booster)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The Monovalent [5 μg/50 μg] NVX-CoV2601 XBB.1.5 Vaccine (Booster)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group-B The monovalent XBB.1.5 Vaccine (Single Dose).</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group-B The monovalent [5 μg/50 μg] NVX-CoV2601 XBB.1.5 Vaccine (Single Dose).</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>XBB.1.5 Vaccine (Booster)</intervention_name>
      <description>Omicron sub variant XBB.1.5 SARS-CoV-2 rS /Matrix-M Adjuvant the monovalent [5 μg/50 μg] NVX-CoV2601) XBB.1.5 Vaccine (Booster)</description>
      <arm_group_label>Group-A XBB.1.5 Vaccine (Booster)</arm_group_label>
      <other_name>Omicron sub variant XBB.1.5 vaccine( booster) SARS-CoV-2 rS /Matrix-M Adjuvant</other_name>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>XBB.1.5 Vaccine (single dose)</intervention_name>
      <description>Omicron sub variant XBB.1.5 SARS-CoV-2 rS /Matrix-M Adjuvant the monovalent [5 μg/50 μg] NVX-CoV2601) XBB.1.5 Vaccine ( single dose)</description>
      <arm_group_label>Group-B The monovalent XBB.1.5 Vaccine (Single Dose).</arm_group_label>
      <other_name>Omicron sub variant XBB.1.5 vaccine(single dose) SARS-CoV-2 rS /Matrix-M Adjuvant</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Adults ≥ 18 years of age at time of study vaccination.&#xD;
  &#xD;
            2. Part 1: Previously vaccinated with ≥ 3 doses of the Moderna and/or Pfizer /BioNTech&#xD;
               prototype monovalent and/or BA.4/5 containing bivalent COVID-19 vaccines with the last&#xD;
               dose administered ≥ 90 days prior to study vaccination.&#xD;
  &#xD;
               Part 2: Clinical history of COVID-19-like disease during the previous year.&#xD;
  &#xD;
            3. Willing and able to give informed consent prior to study enrollment and to comply with&#xD;
               study procedures.&#xD;
  &#xD;
            4. Female participants of childbearing potential (defined as any participant who has&#xD;
               experienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral&#xD;
               tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea ≥&#xD;
               12 consecutive months]) must agree to be heterosexually in-active from at least 28&#xD;
               days prior to enrollment and through the end of the study OR agree to consistently use&#xD;
               a medically acceptable method of contraception listed below from ≥ 28 days prior to&#xD;
               enrollment and through the end of the study.&#xD;
  &#xD;
                 1. Condoms (male or female) with spermicide (if acceptable in country)&#xD;
  &#xD;
                 2. Diaphragm with spermicide&#xD;
  &#xD;
                 3. Cervical cap with spermicide&#xD;
  &#xD;
                 4. Intrauterine device&#xD;
  &#xD;
                 5. Oral or patch contraceptives&#xD;
  &#xD;
                 6. Norplant®, Depo-Provera®, or other in country regulatory approved contraceptive&#xD;
                    method that is designed to protect against pregnancy.&#xD;
  &#xD;
                 7. Abstinence, as a form of contraception, is acceptable if in line with the&#xD;
                    participant's lifestyle NOTE: Periodic abstinence (eg, calendar, ovulation,&#xD;
                    sympto-thermal, post-ovulation methods) and withdrawal are not acceptable methods&#xD;
                    of contraception.&#xD;
  &#xD;
            5. Is medically stable, as determined by the investigator (based on review of health&#xD;
               status, vital signs [to include body temperature], medical history, and physical&#xD;
               examination [to include body weight]). Vital signs must be within medically acceptable&#xD;
               ranges prior to study vaccination.&#xD;
  &#xD;
            6. Agrees to not participate in any research involving receipt of investigational&#xD;
               products (drug/biologic/device) including other SARS-CoV-2 prevention or treatment&#xD;
               trials for the duration of the study.&#xD;
  &#xD;
          NOTE: For participants who become hospitalized with COVID-19, participation in&#xD;
          investigational treatment studies is permitted.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Received COVID-19 vaccines other than Moderna and/or Pfizer-BioNTech in the past,&#xD;
               inclusive of clinical trial COVID-19 vaccines.&#xD;
  &#xD;
            2. Participation in research involving receipt of investigational products&#xD;
               (drug/biologic/device) within 90 days prior to study vaccination (Day 0).&#xD;
  &#xD;
            3. Received influenza vaccination within 14 days prior to study vaccination, or any other&#xD;
               vaccine within 30 days prior to study vaccination.&#xD;
  &#xD;
            4. Any known allergies to products contained in the investigational product.&#xD;
  &#xD;
            5. Any history of anaphylaxis to any prior vaccine.&#xD;
  &#xD;
            6. Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring&#xD;
               ongoing immunomodulatory therapy.&#xD;
  &#xD;
               NOTE: Stable endocrine disorders (eg, thyroiditis, pancreatitis), including stable&#xD;
               diabetes mellitus with no history of diabetic ketoacidosis are NOT excluded.&#xD;
  &#xD;
            7. Chronic administration (defined as &gt; 14 continuous days) of immunosuppressant,&#xD;
               systemic glucocorti-coids, or other immune-modifying drugs within 90 days prior to&#xD;
               study vaccination (Day 0).&#xD;
  &#xD;
               NOTE: An immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 10&#xD;
               mg of prednisone per day or equivalent. The use of topical or intranasal&#xD;
               glucocorticoids is permitted. Topical tacrolimus and ocular cyclosporin are permitted.&#xD;
               Use of inhaled glucocorticoids is prohibited.&#xD;
  &#xD;
            8. Received any prohibited medication (see Section 7.4.1), immunoglobulin, blood-derived&#xD;
               products, or immunosuppressant drugs within 90 days prior to study vaccination (Day&#xD;
               0).&#xD;
  &#xD;
            9. Active cancer (malignancy) on chemotherapy within 3 years prior to first study&#xD;
               vaccination (with the exception of adequately treated non-melanomatous skin carcinoma&#xD;
               or lentigo malign and uterine cervical carcinoma in situ without evidence of disease,&#xD;
               at the discretion of the investigator).&#xD;
  &#xD;
           10. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to&#xD;
               the end of study.&#xD;
  &#xD;
           11. Suspected or known history of alcohol abuse or drug addiction within 2 years prior to&#xD;
               study vaccination that, in the opinion of the investigator, might interfere with&#xD;
               protocol compliance.&#xD;
  &#xD;
           12. Any other condition that, in the opinion of the investigator, would pose a health risk&#xD;
               to the participant if enrolled or could interfere with evaluation of the study vaccine&#xD;
               or interpretation of study results (includ-ing neurologic or psychiatric conditions&#xD;
               likely to impair the quality of safety reporting).&#xD;
  &#xD;
           13. Study team member or immediate family member of any study team member (inclusive of&#xD;
               Sponsor, clinical research organization [CRO], and study site personnel involved in&#xD;
               the conduct or planning of the study).&#xD;
  &#xD;
           14. Known history of myocarditis or pericarditis.&#xD;
  &#xD;
           15. Respiratory symptoms in the past 3 days (ie, cough, sore throat, difficulty&#xD;
               breathing).&#xD;
  &#xD;
           16. Temperature of &gt; 38°C within 24 hours of planned study vaccination (site measured or&#xD;
               participant meas-ured).&#xD;
  &#xD;
           17. Blood pressure of ≥ 160/100 mmHg.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>54 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Clinical Development</last_name>
      <role>Study Director</role>
      <affiliation>Novavax, Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Novavax Customer Service Center</last_name>
      <phone>1-844-Novavax (668-2829)</phone>
    </overall_contact>
    <location>
      <facility>
        <name>AMR</name>
        <address>
          <city>Mobile</city>
          <state>Alabama</state>
          <zip>36608</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Natalie Powe</last_name>
        <phone>251-414-1984</phone>
        <email>natalie.powe@amrllc.com</email>
      </contact>
      <investigator>
        <last_name>Harry Studdard</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Benchmark Research</name>
        <address>
          <city>Sacramento</city>
          <state>California</state>
          <zip>95864</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Cheryl Smith</last_name>
        <phone>916-476-2805</phone>
        <email>cherylsmith@benchmarkresearch.net</email>
      </contact>
      <investigator>
        <last_name>R. David Ferrera</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Lynn Institute of the Rockies</name>
        <address>
          <city>Colorado Springs</city>
          <state>Colorado</state>
          <zip>80918</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Bobbi Shofner</last_name>
        <phone>719-636-3784</phone>
        <email>bshofner@lhsi.net</email>
      </contact>
      <investigator>
        <last_name>Ripley Hollister</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>AMR LLC-Miami</name>
        <address>
          <city>Coral Gables</city>
          <state>Florida</state>
          <zip>33134</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Olga Acosta</last_name>
        <phone>305-445-5637</phone>
        <email>Olga.Acosta@amrllc.com</email>
      </contact>
      <investigator>
        <last_name>Monica Mauri</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>AMR</name>
        <address>
          <city>Fort Myers</city>
          <state>Florida</state>
          <zip>33912</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Marjorie Barron</last_name>
        <phone>239-908-0812</phone>
        <email>marjorie.barron@amrllc.com</email>
      </contact>
      <investigator>
        <last_name>Pedro Ylisastigui</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Health Awareness,LLC</name>
        <address>
          <city>Jupiter</city>
          <state>Florida</state>
          <zip>33458</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Erika Gordon</last_name>
        <phone>561-741-2033</phone>
        <email>erika@healthawareness.com</email>
      </contact>
      <investigator>
        <last_name>Ronald Surowitz</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Tekton Research</name>
        <address>
          <city>Lawrenceville</city>
          <state>Georgia</state>
          <zip>30046</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Bridgette Hall-Maynor</last_name>
        <phone>470-632-5353</phone>
        <email>bridgette.hall-maynor@tektonresearch.com</email>
      </contact>
      <investigator>
        <last_name>Adebayo Akinsola</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Alliance for Multispecialty RSCH</name>
        <address>
          <city>Newton</city>
          <state>Kansas</state>
          <zip>67114</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Caressa Presley</last_name>
        <phone>316-804-7301</phone>
        <email>caressa.presley@amrllc.com</email>
      </contact>
      <investigator>
        <last_name>Stacy Slechta</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Tekton Research</name>
        <address>
          <city>Wichita</city>
          <state>Kansas</state>
          <zip>67218</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Loren Moore</last_name>
        <phone>316-402-1004</phone>
        <email>lmoore@tektonresearch.com</email>
      </contact>
      <investigator>
        <last_name>Brandon Alleman</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>AMR New Orleans</name>
        <address>
          <city>New Orleans</city>
          <state>Louisiana</state>
          <zip>70119</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Elaine Broussard</last_name>
        <phone>504-821-8158</phone>
        <email>elaine.broussard@amrllc.com</email>
      </contact>
      <investigator>
        <last_name>Robert Noveck</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of Maryland</name>
        <address>
          <city>Baltimore</city>
          <state>Maryland</state>
          <zip>21201</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Cheryl Young</last_name>
        <phone>443-306-7102</phone>
        <email>cheryl.young@SOM.umaryland.edu</email>
      </contact>
      <investigator>
        <last_name>Karen Kotloff</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>AMR</name>
        <address>
          <city>Kansas City</city>
          <state>Missouri</state>
          <zip>64114</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mia Rubisoff</last_name>
        <phone>816-943-0770</phone>
        <email>novavax2093@amrllc.com</email>
      </contact>
      <investigator>
        <last_name>Sue Fanning</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Sundance Clinical Research</name>
        <address>
          <city>Saint Louis</city>
          <state>Missouri</state>
          <zip>63141</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Anya Penly</last_name>
        <phone>314-567-3377</phone>
        <email>apenly@sundanceclinicalresearch.com</email>
      </contact>
      <investigator>
        <last_name>Larkin Wadsworth</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Velocity Clinical Research</name>
        <address>
          <city>Norfolk</city>
          <state>Nebraska</state>
          <zip>68701</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jill C Smith</last_name>
        <phone>402-371-0797</phone>
        <email>jillsmith@velocityclinical.com</email>
      </contact>
      <investigator>
        <last_name>Keith Vrbicky</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>AMR</name>
        <address>
          <city>Las Vegas</city>
          <state>Nevada</state>
          <zip>89119</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yazil Ramirez</last_name>
        <phone>702-597-9825</phone>
        <email>yazil.ramirez@amrll.com</email>
      </contact>
      <investigator>
        <last_name>Michael Jacobs</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>AXCES Research</name>
        <address>
          <city>Albuquerque</city>
          <state>New Mexico</state>
          <zip>87109</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Andrea Rodriguez</last_name>
        <phone>505-207-8078</phone>
        <email>andrear@axcesresearch.com</email>
      </contact>
      <investigator>
        <last_name>Linda Gorgos</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Rochester Clinical Research</name>
        <address>
          <city>Rochester</city>
          <state>New York</state>
          <zip>14609</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jennifer Foley</last_name>
        <phone>585-288-0890</phone>
        <email>jfoley@rcrclinical.com</email>
      </contact>
      <investigator>
        <last_name>Matthew Davis</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Tekton Research</name>
        <address>
          <city>Yukon</city>
          <state>Oklahoma</state>
          <zip>73099</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Elivia Layton</last_name>
        <phone>405-594-7712</phone>
        <email>elayton@tektonresearch.com</email>
      </contact>
      <investigator>
        <last_name>Robert Lockwood</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>DM Clinical Research</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19147</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kristopher Baylor</last_name>
        <phone>281-517-0550</phone>
        <email>Kristopher.Baylor@dmclinical.com</email>
      </contact>
      <investigator>
        <last_name>kem Yenal</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>AMR</name>
        <address>
          <city>Knoxville</city>
          <state>Tennessee</state>
          <zip>37909</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Raegan Holloway</last_name>
        <phone>865-321-9047</phone>
        <email>raegan.holloway@amrllc.com</email>
      </contact>
      <investigator>
        <last_name>William Smith</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Benchmark Research</name>
        <address>
          <city>Austin</city>
          <state>Texas</state>
          <zip>78705</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ronesha Davis</last_name>
        <phone>512-478-5416</phone>
        <email>roneshadavis@benchmarkresearch.net</email>
      </contact>
      <investigator>
        <last_name>Laurence chu</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Tekton Research</name>
        <address>
          <city>Austin</city>
          <state>Texas</state>
          <zip>78745</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lyric Pullman</last_name>
        <phone>512-388-5717</phone>
        <email>lpullman@tektonresearch.com</email>
      </contact>
      <investigator>
        <last_name>Paul Pickrell</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Tekton Research</name>
        <address>
          <city>Beaumont</city>
          <state>Texas</state>
          <zip>77706</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Michael Helms</last_name>
        <phone>409-234-1678</phone>
        <email>mhelms@tektonresearch.com</email>
      </contact>
      <investigator>
        <last_name>Robert Bell</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Pan American clinical Research,LLC</name>
        <address>
          <city>Brownsville</city>
          <state>Texas</state>
          <zip>78520</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rafael Badillo</last_name>
        <phone>956-443-0016</phone>
        <email>rbadillo@panamclinicalresearch.com</email>
      </contact>
      <investigator>
        <last_name>Eduardo Uribe</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Benchmark Research</name>
        <address>
          <city>Fort Worth</city>
          <state>Texas</state>
          <zip>76135</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>John Villegas</last_name>
        <phone>817-238-7254</phone>
        <email>johnvillegas@benchmarkresearch.net</email>
      </contact>
      <investigator>
        <last_name>William seger</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Research For Your Health</name>
        <address>
          <city>Plano</city>
          <state>Texas</state>
          <zip>75093</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lorine Cook</last_name>
        <phone>972-999-1155</phone>
        <email>lorine@researchforyourhealth.com</email>
      </contact>
      <investigator>
        <last_name>Jeffrey Adelglass</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Tekton Research</name>
        <address>
          <city>San Antonio</city>
          <state>Texas</state>
          <zip>78229</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Gerardo Diaz</last_name>
        <phone>210-996-2600</phone>
        <email>tdiaz@tektonresearch.com</email>
      </contact>
      <investigator>
        <last_name>Jara McDonald, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>AMR Layton Research Centre</name>
        <address>
          <city>Layton</city>
          <state>Utah</state>
          <zip>84041</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Elisabeth Folkman</last_name>
        <phone>801-679-4153</phone>
        <email>lisa.folkman@amrllc.com</email>
      </contact>
      <investigator>
        <last_name>Craig Julien</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Health Research of Hampton Roads</name>
        <address>
          <city>Newport News</city>
          <state>Virginia</state>
          <zip>23606</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Tim O'Malley</last_name>
        <phone>757-591-8100</phone>
        <email>tomalley@hrhr-inc.com</email>
      </contact>
      <investigator>
        <last_name>George Freeman</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of Washington</name>
        <address>
          <city>Seattle</city>
          <state>Washington</state>
          <zip>98104</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Virology Research Clinic</last_name>
        <phone>206-520-4340</phone>
        <email>vrc@uw.edu</email>
      </contact>
      <investigator>
        <last_name>R. Scott McClelland</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>COVID-19, XBB.1.5</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>COVID-19</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vaccines</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
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/NCT05975060
  org study id: 2019nCoV-313
  nct id: NCT05975060
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This is a Phase 2/3 open-label study to evaluate the safety and immunogenicity of a booster
        dose of the XBB.1.5 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant
        (r) spike (S) protein nanoparticle vaccine (SARS-CoV-2 rS) adjuvanted with Matrix-M™ in
        previously mRNA COVID-19 vaccinated adult participants ≥18 years of age and baseline SARS
        CoV-2 seropositive COVID-19 vaccine naïve participants ≥18 years of age.
  Novavax, Inc. developed a recombinant prototype COVID-19 vaccine constructed from the
        full-length ancestral (Wuhan) SARS CoV-2 S glycoprotein (GP) adjuvanted with the
        saponin-based Matrix-M adjuvant (NVX-CoV2373). Subsequently, the SARS CoV 2 Omicron variant
        and subvariants emerged with enhanced transmissibility and the most significant number of
        mutations in any strain to date. Current evidence demonstrates that variant strain mutations
        such as those in the Omicron XBB.1.5 sublineage confer the ability to evade both natural and
        vaccine-induced neutralizing antibodies.
  
        Part 1 of the study aims to investigate the safety and immunogenicity of the Novavax XBB.1.5
        SARS-CoV-2 rS vaccine (NVX-CoV2601) adjuvanted with Matrix-M in previously COVID-19 mRNA
        vaccinated participants to determine if it induces superior antibody responses compared to a
        historical control of the prototype vaccine (original Wuhan strain), NVX-CoV2373.
  
        Part 2 of the study aims to investigate the safety and immunogenicity of 1 dose of NVX
        CoV2601 in baseline SARS-CoV-2 seropositive COVID-19 vaccine naïve participants to determine
        if it induces non-inferior antibody responses compared to 1 booster dose of NVX-CoV2601 in
        previously COVID-19 mRNA vaccinated individuals participating in Part 1.
  
        Part 1:
  
        Approximately 330 previously mRNA COVID-19 vaccinated participants will receive a booster
        dose of XBB.1.5 Omicron subvariant vaccine (NVX-CoV2601) on Day 0. Immunogenicity and 28-day
        safety data will be used for an interim analysis, while participants remain on the study for
        immunogenicity and safety data collection up to Day 180 post-vaccination.
  
        Part 2:
  
        After completion of Part 1, approximately 330 unvaccinated participants with a clinical
        history of COVID-19-like disease during the previous year will receive a booster dose of
        NVX-CoV2601 on Day 0. Immunogenicity and 28-day safety data will be used for an interim
        analysis, while participants remain on the study for immunogenicity and safety data
        collection up to Day 180 post vaccination.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Part 1: Pseudovirus neutralization (inhibitory dilution at a concentration of 50%; ID 50 ) to the NVX-CoV2601 vaccine
  time frame: Day 28
  description: Pseudovirus neutralization (inhibitory dilution at a concentration of 50%; ID 50 ) to the NVX-CoV2601 vaccine assessed at Day 28 following study vaccination.
  measure: Part 1: Seroresponse Rates (SRRs) in ID 50 titers to the NVXCoV2601 vaccine
  time frame: Day 28
  description: SRRs (proportion of seroconverted participants) in ID 50 titers to the NVXCoV2601 vaccine assessed at Day 28 following the study vaccination.
  measure: Part 2: SRRs in ID 50 titers to the XBB.1.5 Omicron subvariant
  time frame: Day 28
  description: SRRs (proportion of seroconverted participants) in ID 50 titers to the XBB.1.5 Omicron subvariant assessed at Day 28 following study vaccination.
  measure: Part 2: ID 50 (Geometric Mean Titers) GMTs to the XBB.1.5 Omicron subvariant
  time frame: Day 28
  description: ID 50 GMTs to the XBB.1.5 Omicron subvariant assessed at Day 28 following study vaccination.
  measure: Part 1: Pseudovirus neutralization (inhibitory dilution at a concentration of 50%; ID50) to the NVX-CoV2601 vaccine
  time frame: Day 28
  description: Pseudovirus neutralization (inhibitory dilution at a concentration of 50%; ID50) to the NVX-CoV2601 vaccine assessed at baseline and 28 days following study vaccination.
  measure: Part 1: ID 50 GMTs to the XBB.1.5 Omicron subvariant
  time frame: Day 0 to Day 180
  description: ID 50 GMTs to the XBB.1.5 Omicron subvariant at relevant time points
  measure: Part 1: ID 50 geometric mean fold rise (GMFR) to the XBB.1.5 Omicron subvariant at relevant time points (Days 28 and 180) from baseline (Day 0).
  time frame: Day 0 to Day 180
  description: ID 50 GMFR to the XBB.1.5 Omicron subvariant at relevant time points (Days 28 and 180) from baseline (Day 0).
  measure: Part 1: SRRs in ID 50 titer concentrations to the XBB.1.5 Omicron subvariant at relevant time points.
  time frame: Day 28 to Day 180
  description: SRRs in ID 50 titer concentrations to the XBB.1.5 Omicron subvariant at relevant time points.
  measure: Part 1: Anti-S immunoglobulin G (IgG) geometric mean concentrations (GMCs, EU/mL) to the NVX-CoV2601 vaccine at relevant time points
  time frame: Day 0 to Day 180
  description: Anti-S IgG geometric mean concentrations (GMCs, EU/mL) to the NVX-CoV2601 vaccine at relevant time points (Days 0, 28, and 180).
  measure: Part 1: Incidence and severity of solicited local and systemic adverse events (AEs)
  time frame: Day 0 to Day 7
  description: Incidence, duration, and severity of solicited local and systemic adverse events (AEs) for 7 days following vaccination.
  measure: Part 1: Incidence and severity of unsolicited AEs
  time frame: Day 28
  description: Incidence, severity, and relationship of unsolicited AEs through 28 days after vaccination.
  measure: Part 1: Incidence and severity of MAAEs attributed to study vaccine, adverse events of special interest (AESIs), and serious adverse events (SAEs)
  time frame: Day 0 to Day 180
  description: Incidence and severity of Medically attended adverse event (MAAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) through day 180 or EOS.
  measure: Part 2: Pseudovirus neutralization (ID 50 ) to the XBB.1.5 Omicron subvariant
  time frame: Day 0 to Day 28
  description: Pseudovirus neutralization (ID 50 ) to the XBB.1.5 Omicron subvariant assessed at baseline and at Day 28 following study vaccination.
  measure: Part 2: Incidence and severity of solicited local and systemic adverse events (AEs)
  time frame: Day 0 to Day 7
  description: Incidence, duration, and severity of solicited local and systemic adverse events (AEs) for 7 days following vaccination.
  measure: Part 2: Incidence, and severity of unsolicited AEs
  time frame: Day 28
  description: Incidence, severity, and relationship of unsolicited AEs through 28 days after vaccination.
  measure: Part 2: Incidence and severity of MAAEs, AESIs, and SAEs
  time frame: Day 0 to Day 180
  description: Incidence and severity of MAAEs attributed to study vaccine, adverse events of special interest (AESIs) (predefined list including PIMMCs, myocarditis and/or pericarditis, and complications specific to COVID-19), and serious adverse events (SAEs) through day 180 or EOS.
  arm group label: Group-A XBB.1.5 Vaccine (Booster)
  arm group type: Experimental
  description: The Monovalent [5 μg/50 μg] NVX-CoV2601 XBB.1.5 Vaccine (Booster)
  arm group label: Group-B The monovalent XBB.1.5 Vaccine (Single Dose).
  arm group type: Active Comparator
  description: Group-B The monovalent [5 μg/50 μg] NVX-CoV2601 XBB.1.5 Vaccine (Single Dose).
  intervention type: Biological
  intervention name: XBB.1.5 Vaccine (Booster)
  description: Omicron sub variant XBB.1.5 SARS-CoV-2 rS /Matrix-M Adjuvant the monovalent [5 μg/50 μg] NVX-CoV2601) XBB.1.5 Vaccine (Booster)
  arm group label: Group-A XBB.1.5 Vaccine (Booster)
  other name: Omicron sub variant XBB.1.5 vaccine( booster) SARS-CoV-2 rS /Matrix-M Adjuvant
  intervention type: Biological
  intervention name: XBB.1.5 Vaccine (single dose)
  description: Omicron sub variant XBB.1.5 SARS-CoV-2 rS /Matrix-M Adjuvant the monovalent [5 μg/50 μg] NVX-CoV2601) XBB.1.5 Vaccine ( single dose)
  arm group label: Group-B The monovalent XBB.1.5 Vaccine (Single Dose).
  other name: Omicron sub variant XBB.1.5 vaccine(single dose) SARS-CoV-2 rS /Matrix-M Adjuvant
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 54 Years
  healthy volunteers: No
  last name: Clinical Development
  role: Study Director
  affiliation: Novavax, Inc.
  last name: Novavax Customer Service Center
  phone: 1-844-Novavax (668-2829)
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: COVID-19
  mesh term: Vaccines