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/NCT05973006</url>
    </required_header>
    <id_info>
      <org_study_id>2019nCoV-314</org_study_id>
      <nct_id>NCT05973006</nct_id>
    </id_info>
    <brief_title>Phase 3 Adolescent Study for SARS-CoV-2 rS Variant Vaccines</brief_title>
    <acronym>COVID-19</acronym>
    <official_title>A Phase 3, Randomized, Double-Blinded Study to Evaluate the Safety and Immunogenicity of Omicron Subvariant and Bivalent SARS-CoV-2 rS Vaccines in Adolescents Previously Vaccinated With mRNA COVID-19 Vaccines</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 3, Randomized, Double-Blinded Study to Evaluate the Safety and Immunogenicity&#xD;
        of Omicron Subvariant and Bivalent SARS-CoV-2 rS Vaccines in Adolescents Previously&#xD;
        Vaccinated with mRNA COVID-19 Vaccines.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a Phase 3, randomized, double-blinded study to evaluate the safety and immunogenicity&#xD;
        of booster doses of Omicron subvariant severe acute respiratory syndrome coronavirus 2&#xD;
        (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle vaccines (SARS-CoV-2 rS)&#xD;
        adjuvanted with Matrix-M™ adjuvant (NVX-CoV2601 [Omicron XBB.1.5]) and bivalent (NVX-CoV2373&#xD;
        [prototype] + NVX CoV2601) in previously vaccinated adolescent participants ≥ 12 to &lt; 18&#xD;
        years of age.&#xD;
  &#xD;
        Approximately 400 adolescents who have received a regimen of ≥ 2 doses of the Moderna and/or&#xD;
        Pfizer-BioNTech monovalent and/or bivalent COVID-19 vaccines ≥ 90 days previously will be&#xD;
        randomized 1:1 to Group A or Group B:&#xD;
  &#xD;
          -  Group A: 1 dose of NVX-CoV2601 (1 on Day 0)&#xD;
  &#xD;
          -  Group B: 1 dose of bivalent NVX-CoV2373 + NVX-CoV2601 (1 on Day 0) All participants will&#xD;
             remain on study for immunogenicity and safety data collection through Day 180.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 16, 2023</start_date>
    <completion_date type="Anticipated">February 22, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 22, 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>Crossover Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Safety: Incidence, duration, and severity of solicited local and systemic AEs for 7 days following vaccination</measure>
      <time_frame>Day 7[ following 1st vaccination]</time_frame>
      <description>Incidence, duration, and severity of solicited local and systemic adverse events (AEs) To assess the overall safety of 1 heterologous booster dose of NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) for 7 days following vaccination</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Safety: Incidence, severity, and relationship of unsolicited AEs through 28 days after vaccination</measure>
      <time_frame>Day 28[ following 1st vaccination]</time_frame>
      <description>Incidence, severity, and relationship of unsolicited AEs to assess the overall safety of 1 heterologous booster dose of NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) through 28 days after vaccination.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Safety: Incidence and severity of (MAAEs) attributed to study vaccine, (AESIs) (PIMMCs), myocarditis and/or pericarditis, and complications specific to COVID-19), and serious adverse events (SAEs)</measure>
      <time_frame>Day 180</time_frame>
      <description>Incidence and severity of medically attended adverse events (MAAEs) attributed to study vaccine, adverse events of special interest (AESIs) (predefined list including potential immune-mediated medical conditions (PIMMCs), myocarditis and/or pericarditis, and complications specific to COVID-19), and serious adverse events (SAEs) o assess the overall safety of 1 heterologous booster dose of NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601)through day 180 or end of study (EOS).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Immunogenicity index- Neutralizing antibody (NAb) expressed as geometric mean titers (GMTs) to the Omicron XBB.1.5 strain.</measure>
      <time_frame>Day 28</time_frame>
      <description>The neutralizing antibody (NAb) response induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) against the Omicron XBB.1.5 strain assessed at Day 28 following initial study vaccination.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Immunogenicity index- The Neutralizing antibody (NAb) expressed as geometric mean fold rise (GMFR) to the Omicron XBB.1.5 strain.</measure>
      <time_frame>Day-28</time_frame>
      <description>the neutralizing antibody (NAb) response induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) against the Omicron XBB.1.5 strain, assessed at Day 28 from baseline (Day 0).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Neutralizing antibody (NAb) expressed as geometric mean titers (GMTs) to the Omicron XBB.1.5 strain.</measure>
      <time_frame>Day- 0,90, and 180</time_frame>
      <description>the neutralizing antibody NAb response induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) against the Omicron XBB.1.5 strain over time. at relevant time points (Days 0, 90, and 180).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neutralizing antibody (NAb) expressed as geometric mean fold rise (GMFR) to the Omicron XBB.1.5 strain.</measure>
      <time_frame>0,90, and 180</time_frame>
      <description>the neutralizing antibody NAb response induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) against the Omicron XBB.1.5 strain over time. at relevant time points (Days 0, 90, and 180).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>IgG geometric mean ELISA (enzyme-linked immunosorbent assay) units (GMEUs) to the Omicron XBB.1.5 S protein.</measure>
      <time_frame>Day 0, 28, 90, and 180</time_frame>
      <description>The immunoglobulin G (IgG) antibody levels induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) against the Omicron XBB.1.5 strain over time.at relevant time points (Days 0, 28, 90, and 180).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>NAb(neutralizing antibody titers) and IgG GMEUs levels are measured to the ancestral (Wuhan) strain .</measure>
      <time_frame>Day 0 to 180</time_frame>
      <description>The NAb and IgG antibody responses induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) against the ancestral (Wuhan) strain at relevant time points (Days 0, 28, 90, and 180).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>human angiotensin-converting enzyme-2 (hACE2) receptor binding assay of Omicron XBB.1.5 and ancestral (Wuhan) strains expressed as GMT.</measure>
      <time_frame>Day 0 to 180</time_frame>
      <description>The antibody responses in a human angiotensin-converting enzyme-2 (hACE2) receptor binding inhibition assay induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) to the Omicron XBB.1.5 and ancestral (Wuhan) strains to relevant time points (Days 0, 28, 90, and 180). expressed as GMT</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">400</enrollment>
    <condition>COVID-19</condition>
    <arm_group>
      <arm_group_label>Group-A NVX-CoV2601</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The Monovalent NVX-CoV2601 of 5 μg of antigen with 50 μg of Matrix-M adjuvant</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group-B Bivalent NVX CoV2373 + NVX CoV2601</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The Bivalent NVX CoV2373 + NVX CoV2601 of 5 μg of each antigen with a total of 50 μg of Matrix-M adjuvant</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>NVX-CoV2601 co-formulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine</intervention_name>
      <description>Coformulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine with Matrix-M adjuvant: supplied as a solution for preparation for injection, at a concentration of 10 µg antigen and 100 µg adjuvant per mL. All injections will be administered in a 0.5 mL injection volume at a dose of 5 µg antigen with 50 µg Matrix-M adjuvant.</description>
      <arm_group_label>Group-A NVX-CoV2601</arm_group_label>
      <other_name>NVX-CoV2601</other_name>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Prototype/XBB.1.5 Bivalent Vaccine (5 µg)</intervention_name>
      <description>A site-mixed bivalent vaccine prepared by combining 0.25 mL of NVX-CoV2373 and 0.25 mL NVX-CoV2601. All injections will be administered in a 0.5 mL injection volume at a dose of 5 µg total antigen (2.5 µg prototype antigen + 2.5 µg Omicron XBB.1.5 antigen) with 50 µg Matrix-M adjuvant.</description>
      <arm_group_label>Group-B Bivalent NVX CoV2373 + NVX CoV2601</arm_group_label>
      <other_name>Omicron XBB.1.5 (sub-variant)SARS-CoV-2 rS /Matrix-M Adjuvant</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Adolescents ≥ 12 to &lt; 18 years of age at screening&#xD;
  &#xD;
            2. Participant and parent(s)/caregiver(s) or legally acceptable representative willing&#xD;
               and able to give in-formed consent and assent, as required, prior to study enrollment&#xD;
               and to comply with study procedures.&#xD;
  &#xD;
            3. Participants of childbearing potential (defined as any participant who has experienced&#xD;
               menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral tubal&#xD;
               ligation, or bilateral oophorectomy] or post-menopausal [defined as amenorrhea ≥ 12&#xD;
               consecutive months]) must agree to be heterosexually inactive from at least 28 days&#xD;
               prior to enrollment and through the end of the study OR agree to consistently use a&#xD;
               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 de-signed to protect against pregnancy&#xD;
  &#xD;
                 7. Abstinence, as a form of contraception, is acceptable if in line with the&#xD;
                    participant's lifestyle&#xD;
  &#xD;
               NOTE: Periodic abstinence (eg, calendar, ovulation, sympto-thermal, post-ovulation&#xD;
               methods) and withdrawal are not acceptable methods of contraception.&#xD;
  &#xD;
            4. Is medically stable, as determined by the investigator (based on review of health&#xD;
               status, vital signs [to in-clude body temperature], medical history, and targeted&#xD;
               physical examination [to include body weight]). Vital signs must be within medically&#xD;
               acceptable ranges prior to the vaccination.&#xD;
  &#xD;
            5. Agrees to not participate in any other SARS-CoV-2 prevention or treatment trials for&#xD;
               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;
            6. Have previously received ≥ 2 doses of the Moderna and/or Pfizer-BioNTech monovalent&#xD;
               and/or bivalent COVID-19 vaccines with the last dose having been given ≥ 90 days&#xD;
               previously prior to study vaccination.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Received COVID-19 vaccines other than Moderna and/or Pfizer-BioNTech in the past,&#xD;
               inclusive of clini-cal 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.&#xD;
  &#xD;
            3. Received influenza vaccination within 14 days prior to study vaccination.&#xD;
  &#xD;
            4. Received any vaccine ≤ 45 days prior to study vaccination, except for rabies, human&#xD;
               papilloma virus (HPV), tetanus-diphtheria (Td), tetanus, diphtheria, and pertussis&#xD;
               (TDaP/DTap), hepatitis B virus (HBV), and meningococcal vaccines which may be given as&#xD;
               medically indicated.&#xD;
  &#xD;
            5. Any known allergies to products contained in the investigational product.&#xD;
  &#xD;
            6. Any history of anaphylaxis to any prior vaccine.&#xD;
  &#xD;
            7. Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring&#xD;
               ongoing im-munomodulatory 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;
            8. 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.&#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;
  &#xD;
            9. Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90&#xD;
               days prior to study vaccination, except for rabies immunoglobulin which may be given&#xD;
               if medically indicated.&#xD;
  &#xD;
           10. Active cancer (malignancy) on therapy within 3 years prior to study vaccination (with&#xD;
               the exception of adequately treated non-melanomatous skin carcinoma or lentigo maligna&#xD;
               and uterine cervical carcinoma in situ without evidence of disease, at the discretion&#xD;
               of the investigator).&#xD;
  &#xD;
           11. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to&#xD;
               the end of study.&#xD;
  &#xD;
           12. Suspected or known history of alcohol abuse or drug addiction within 2 years prior to&#xD;
               the study vaccine dose that, in the opinion of the investigator, might interfere with&#xD;
               protocol compliance.&#xD;
  &#xD;
           13. 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;
           14. 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;
           15. Participants with a history of myocarditis or pericarditis.&#xD;
  &#xD;
           16. Respiratory symptoms in the past 3 days (ie, cough, sore throat, difficulty&#xD;
               breathing).&#xD;
  &#xD;
           17. Temperature of &gt; 38°C within 24 hours of planned study vaccination (site measured or&#xD;
               participant meas-ured).&#xD;
  &#xD;
           18. Blood pressure of ≥ 160/100 mmHg.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Clinical Development</last_name>
      <role>Study Director</role>
      <affiliation>Novavax</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>Alfa Medical Research</name>
        <address>
          <city>Davie</city>
          <state>Florida</state>
          <zip>33024</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>David Benson</last_name>
      </contact>
      <investigator>
        <last_name>David Benson</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Westside Center for Clinical Research</name>
        <address>
          <city>Jacksonville</city>
          <state>Florida</state>
          <zip>32205</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Matthew Braddock</last_name>
        <phone>904-693-1490</phone>
        <email>kramos@encoredocs.com</email>
      </contact>
      <investigator>
        <last_name>Matthew Braddock</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>ITB Research</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33173</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Antonio Gordon</last_name>
      </contact>
      <investigator>
        <last_name>Antonio Gordon</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Velocity Clinical Research</name>
        <address>
          <city>Meridian</city>
          <state>Idaho</state>
          <zip>83642</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Marian Shaw</last_name>
        <phone>208-377-8653</phone>
        <email>info@velocityclinical.com</email>
      </contact>
      <investigator>
        <last_name>Marian Shaw</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>DM Clinical Research - Chicago</name>
        <address>
          <city>River Forest</city>
          <state>Illinois</state>
          <zip>60305</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Mary Brown</last_name>
      </contact>
      <investigator>
        <last_name>Mary Brown</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Johnson County Clinical Trials</name>
        <address>
          <city>Lenexa</city>
          <state>Kansas</state>
          <zip>66219</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Carlos Fierro</last_name>
        <phone>913-825-4400</phone>
        <email>cfierro@jcct.com</email>
      </contact>
      <investigator>
        <last_name>Carlos Fierro</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Alliance for Multispecialty Research, LLC (AMR)</name>
        <address>
          <city>Newton</city>
          <state>Kansas</state>
          <zip>67114</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Robyn Hartvickson</last_name>
        <phone>316-804-7304</phone>
        <email>rhartvickson@heartlandresearch.com</email>
      </contact>
      <investigator>
        <last_name>Robyn Hartvickson</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>AMR</name>
        <address>
          <city>Wichita</city>
          <state>Kansas</state>
          <zip>67207</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Terry Poling</last_name>
        <phone>316-689-6629</phone>
        <email>shannen.lassiter@amrllc.com</email>
      </contact>
      <investigator>
        <last_name>Terry Poling</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Velocity Clinical Research</name>
        <address>
          <city>Lafayette</city>
          <state>Louisiana</state>
          <zip>70508</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jibran Atwi</last_name>
        <phone>337-451-0663</phone>
        <email>Hangluong@medpharmics.com</email>
      </contact>
      <investigator>
        <last_name>Jibran Atwi</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Velocity Clinical Research</name>
        <address>
          <city>Vestal</city>
          <state>New York</state>
          <zip>13850</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Suchet Patel</last_name>
      </contact>
      <investigator>
        <last_name>Suchet Patel</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Velocity Clinical Research</name>
        <address>
          <city>Cincinnati</city>
          <state>Ohio</state>
          <zip>45246</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Douglas Logan</last_name>
        <phone>513-671-8080</phone>
        <email>dlogan@mcrmed.com</email>
      </contact>
      <investigator>
        <last_name>Douglas Logan</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Tekton Research</name>
        <address>
          <city>Tulsa</city>
          <state>Oklahoma</state>
          <zip>74137</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Divina Roman</last_name>
      </contact>
      <investigator>
        <last_name>Divina Roman</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Clinical Research Associates, Inc</name>
        <address>
          <city>Nashville</city>
          <state>Tennessee</state>
          <zip>37203</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Stephan Sharp</last_name>
        <phone>615-329-0197</phone>
        <email>Pam@CRAnashville.com</email>
      </contact>
      <investigator>
        <last_name>Stephan Sharp</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>
      <contact>
        <last_name>Laurence Chu</last_name>
        <phone>512-478-5416</phone>
        <email>laurencechu@benchmarkresearch.net</email>
      </contact>
      <investigator>
        <last_name>Laurence Chu</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>South Texas Clinical Research</name>
        <address>
          <city>Corpus Christi</city>
          <state>Texas</state>
          <zip>78404</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Celia Reyes-Acuna</last_name>
        <phone>361-288-4668</phone>
        <email>Lquiroz@3cra.com</email>
      </contact>
      <investigator>
        <last_name>Celia Reyes-Acuna</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>DM Clinical Research</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77065</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Khozema Palanpurwala</last_name>
        <phone>281-517-0550</phone>
        <email>alefiyah@dmclinicalresearch.com</email>
      </contact>
      <investigator>
        <last_name>Khozema Palanpurwala</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Medical Colleagues of Texas, LLP</name>
        <address>
          <city>Katy</city>
          <state>Texas</state>
          <zip>77450</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>John Adams</last_name>
      </contact>
      <investigator>
        <last_name>John Adams</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Research Your Health</name>
        <address>
          <city>Plano</city>
          <state>Texas</state>
          <zip>75093</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jeffrey M Adelglass</last_name>
        <phone>214-550-0354</phone>
        <email>dra@researchyourhealth.com</email>
      </contact>
      <investigator>
        <last_name>Jeffrey M Adelglass</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Tekton Research</name>
        <address>
          <city>San Antonio</city>
          <state>Texas</state>
          <zip>78244</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Kenneth Etokhana</last_name>
        <phone>512-388-5717</phone>
        <email>feasibility@tektonresearch.com</email>
      </contact>
      <investigator>
        <last_name>Kenneth Etokhana</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Mountain View CCT Research</name>
        <address>
          <city>Pleasant View</city>
          <state>Utah</state>
          <zip>84404</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Darek Eggleston</last_name>
      </contact>
      <investigator>
        <last_name>Darek Eggleston</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 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>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>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05973006
  org study id: 2019nCoV-314
  nct id: NCT05973006
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This is a Phase 3, Randomized, Double-Blinded Study to Evaluate the Safety and Immunogenicity
        of Omicron Subvariant and Bivalent SARS-CoV-2 rS Vaccines in Adolescents Previously
        Vaccinated with mRNA COVID-19 Vaccines.
  This is a Phase 3, randomized, double-blinded study to evaluate the safety and immunogenicity
        of booster doses of Omicron subvariant severe acute respiratory syndrome coronavirus 2
        (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle vaccines (SARS-CoV-2 rS)
        adjuvanted with Matrix-M™ adjuvant (NVX-CoV2601 [Omicron XBB.1.5]) and bivalent (NVX-CoV2373
        [prototype] + NVX CoV2601) in previously vaccinated adolescent participants ≥ 12 to < 18
        years of age.
  
        Approximately 400 adolescents who have received a regimen of ≥ 2 doses of the Moderna and/or
        Pfizer-BioNTech monovalent and/or bivalent COVID-19 vaccines ≥ 90 days previously will be
        randomized 1:1 to Group A or Group B:
  
          -  Group A: 1 dose of NVX-CoV2601 (1 on Day 0)
  
          -  Group B: 1 dose of bivalent NVX-CoV2373 + NVX-CoV2601 (1 on Day 0) All participants will
             remain on study for immunogenicity and safety data collection through Day 180.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Prevention
  masking: Double (Participant, Investigator)
  measure: Safety: Incidence, duration, and severity of solicited local and systemic AEs for 7 days following vaccination
  time frame: Day 7[ following 1st vaccination]
  description: Incidence, duration, and severity of solicited local and systemic adverse events (AEs) To assess the overall safety of 1 heterologous booster dose of NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) for 7 days following vaccination
  measure: Safety: Incidence, severity, and relationship of unsolicited AEs through 28 days after vaccination
  time frame: Day 28[ following 1st vaccination]
  description: Incidence, severity, and relationship of unsolicited AEs to assess the overall safety of 1 heterologous booster dose of NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) through 28 days after vaccination.
  measure: Safety: Incidence and severity of (MAAEs) attributed to study vaccine, (AESIs) (PIMMCs), myocarditis and/or pericarditis, and complications specific to COVID-19), and serious adverse events (SAEs)
  time frame: Day 180
  description: Incidence and severity of medically attended adverse events (MAAEs) attributed to study vaccine, adverse events of special interest (AESIs) (predefined list including potential immune-mediated medical conditions (PIMMCs), myocarditis and/or pericarditis, and complications specific to COVID-19), and serious adverse events (SAEs) o assess the overall safety of 1 heterologous booster dose of NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601)through day 180 or end of study (EOS).
  measure: Immunogenicity index- Neutralizing antibody (NAb) expressed as geometric mean titers (GMTs) to the Omicron XBB.1.5 strain.
  time frame: Day 28
  description: The neutralizing antibody (NAb) response induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) against the Omicron XBB.1.5 strain assessed at Day 28 following initial study vaccination.
  measure: Immunogenicity index- The Neutralizing antibody (NAb) expressed as geometric mean fold rise (GMFR) to the Omicron XBB.1.5 strain.
  time frame: Day-28
  description: the neutralizing antibody (NAb) response induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) against the Omicron XBB.1.5 strain, assessed at Day 28 from baseline (Day 0).
  measure: Neutralizing antibody (NAb) expressed as geometric mean titers (GMTs) to the Omicron XBB.1.5 strain.
  time frame: Day- 0,90, and 180
  description: the neutralizing antibody NAb response induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) against the Omicron XBB.1.5 strain over time. at relevant time points (Days 0, 90, and 180).
  measure: Neutralizing antibody (NAb) expressed as geometric mean fold rise (GMFR) to the Omicron XBB.1.5 strain.
  time frame: 0,90, and 180
  description: the neutralizing antibody NAb response induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) against the Omicron XBB.1.5 strain over time. at relevant time points (Days 0, 90, and 180).
  measure: IgG geometric mean ELISA (enzyme-linked immunosorbent assay) units (GMEUs) to the Omicron XBB.1.5 S protein.
  time frame: Day 0, 28, 90, and 180
  description: The immunoglobulin G (IgG) antibody levels induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) against the Omicron XBB.1.5 strain over time.at relevant time points (Days 0, 28, 90, and 180).
  measure: NAb(neutralizing antibody titers) and IgG GMEUs levels are measured to the ancestral (Wuhan) strain .
  time frame: Day 0 to 180
  description: The NAb and IgG antibody responses induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) against the ancestral (Wuhan) strain at relevant time points (Days 0, 28, 90, and 180).
  measure: human angiotensin-converting enzyme-2 (hACE2) receptor binding assay of Omicron XBB.1.5 and ancestral (Wuhan) strains expressed as GMT.
  time frame: Day 0 to 180
  description: The antibody responses in a human angiotensin-converting enzyme-2 (hACE2) receptor binding inhibition assay induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) to the Omicron XBB.1.5 and ancestral (Wuhan) strains to relevant time points (Days 0, 28, 90, and 180). expressed as GMT
  arm group label: Group-A NVX-CoV2601
  arm group type: Experimental
  description: The Monovalent NVX-CoV2601 of 5 μg of antigen with 50 μg of Matrix-M adjuvant
  arm group label: Group-B Bivalent NVX CoV2373 + NVX CoV2601
  arm group type: Active Comparator
  description: The Bivalent NVX CoV2373 + NVX CoV2601 of 5 μg of each antigen with a total of 50 μg of Matrix-M adjuvant
  intervention type: Biological
  intervention name: NVX-CoV2601 co-formulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine
  description: Coformulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine with Matrix-M adjuvant: supplied as a solution for preparation for injection, at a concentration of 10 µg antigen and 100 µg adjuvant per mL. All injections will be administered in a 0.5 mL injection volume at a dose of 5 µg antigen with 50 µg Matrix-M adjuvant.
  arm group label: Group-A NVX-CoV2601
  other name: NVX-CoV2601
  intervention type: Biological
  intervention name: Prototype/XBB.1.5 Bivalent Vaccine (5 µg)
  description: A site-mixed bivalent vaccine prepared by combining 0.25 mL of NVX-CoV2373 and 0.25 mL NVX-CoV2601. All injections will be administered in a 0.5 mL injection volume at a dose of 5 µg total antigen (2.5 µg prototype antigen + 2.5 µg Omicron XBB.1.5 antigen) with 50 µg Matrix-M adjuvant.
  arm group label: Group-B Bivalent NVX CoV2373 + NVX CoV2601
  other name: Omicron XBB.1.5 (sub-variant)SARS-CoV-2 rS /Matrix-M Adjuvant
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: 18 Years
  healthy volunteers: No
  last name: Clinical Development
  role: Study Director
  affiliation: Novavax
  last name: Novavax Customer Service Center
  phone: 1-844-Novavax (668-2829)
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  country: United States
  responsible party type: Sponsor
  mesh term: COVID-19
  mesh term: Vaccines
  sharing ipd: No