<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/NCT03814720</url>
  </required_header>
  <id_info>
    <org_study_id>190032</org_study_id>
    <secondary_id>19-I-0032</secondary_id>
    <nct_id>NCT03814720</nct_id>
  </id_info>
  <brief_title>Dose, Safety, Tolerability and Immunogenicity of an Influenza H1 Stabilized Stem Ferritin Vaccine in Healthy Adults</brief_title>
  <official_title>VRC 321: A Phase I Open-Label Clinical Trial to Evaluate Dose, Safety, Tolerability, and Immunogenicity of an Influenza H1 Stabilized Stem Ferritin Vaccine, VRCFLUNPF099-00-VP, in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      The flu is a common viral infection that can be deadly for certain people. Vaccines against&#xD;
      flu have been developed to teach the body to prevent or fight the infection. A new vaccine&#xD;
      may help the body to make an immune response to H1 flu, a flu strain that infects humans.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To test the safety and effectiveness of the H1 Stabilized Stem Ferritin vaccine&#xD;
      (VRC-FLUNPF099-00-VP).&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      Healthy people ages 18-70 years old who got at least 1 licensed flu vaccine since January 1,&#xD;
      2014.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Participants received 1 or 2 vaccinations by injections (shots) in the upper arm muscle over&#xD;
      4 months. Participants received a thermometer and recorded their temperature and symptoms&#xD;
      every day a diary card for 7 days after each injection. The injection site was checked for&#xD;
      redness, swelling, or bruising.&#xD;
&#xD;
      Participants had 9-11 follow-up visits over 12-15 months. At follow-up visits, participants&#xD;
      had blood drawn and were checked for health changes or problems. Participants who reported&#xD;
      influenza-like illness had nose and throat swabs for evaluation of viral infection.&#xD;
&#xD;
      Some participants had apheresis. A needle was placed into a vein in both arms. Blood was&#xD;
      removed through a needle in the vein of one arm. A machine removed the white blood cells and&#xD;
      then the rest of the blood was returned to the participant through a needle in the other arm.&#xD;
&#xD;
      A separate consent was provided to participants for genetic testing on their samples.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Design: This was a Phase I, open-label, dose escalation study to evaluate the dose,&#xD;
      safety, tolerability, and immunogenicity of VRC-FLUNPF099-00-VP in two regimens. The&#xD;
      hypotheses were that the vaccine is safe and tolerable and will elicit an immune response.&#xD;
      The primary objective was to evaluate the safety and tolerability of the investigational&#xD;
      vaccine in healthy adults. Secondary objectives were related to immunogenicity of the&#xD;
      investigational vaccine and dosing regimen.&#xD;
&#xD;
      Study Products: The investigational vaccine, VRC-FLUNPF099-00-VP (H1ssF_3928), was developed&#xD;
      by the Vaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases&#xD;
      (NIAID) and is composed of Helicobacter pylori non-heme ferritin assembled with influenza&#xD;
      virus H1 haemagglutinin (HA) insert to form a nanoparticle displaying eight HA stabilized&#xD;
      stem trimers from A/New Caledonia/20/1999 (H1N1) influenza. The vaccine was supplied in&#xD;
      single-use vials at a concentration of 180 mcg/mL. H1ssF_3928 was administered&#xD;
      intramuscularly (IM) in the deltoid muscle via needle and syringe.&#xD;
&#xD;
      Participants: Healthy adults between the ages of 18-70 years, inclusive.&#xD;
&#xD;
      Study Plan: The study evaluated the safety, tolerability and immunogenicity of 1 or 2 doses&#xD;
      of the H1ssF_3928 vaccine in a dose-escalation design. In Group 1, five participants received&#xD;
      a single low dose (20 mcg) of H1ssF_3928 on Day 0. For Group 1, the protocol required 1&#xD;
      vaccination visit, about 9 follow-up visits, and a telephone contact after vaccination.&#xD;
&#xD;
      Once the low dose was assessed as safe and well tolerated, enrollment began for Group 2A.&#xD;
      Groups 2A, 2B, 2C, and 2D were stratified by age as shown in the vaccination schema below. In&#xD;
      Group 2A, participants received a higher dose (60 mcg) of H1ssF_3928 on Day 0. Once this&#xD;
      higher dose was assessed as safe and well tolerated, participants in Group 2A received a&#xD;
      second vaccination at Week 16 and enrollment began for Groups 2B, 2C, and 2D. For Groups 2A,&#xD;
      2B, 2C, and 2D, the protocol required 2 vaccination visits, about 11 follow-up visits, and a&#xD;
      telephone contact after each vaccination. Group 2A completed the product administration&#xD;
      schedule per protocol. While most participants in Groups 2B-2D completed the second dose&#xD;
      administration per protocol, one participant was not able to receive the second dose due to&#xD;
      moving out of the area and 11 participants were not able to receive their second dose due to&#xD;
      the COVID-19 pandemic.&#xD;
&#xD;
      For all groups, solicited reactogenicity was evaluated using a 7-day diary card. Assessment&#xD;
      of vaccine safety included clinical observation and monitoring of hematological and chemical&#xD;
      parameters at clinical visits throughout the study.&#xD;
&#xD;
      VRC 321 Vaccination Schema:&#xD;
&#xD;
      Group: 1; Age Cohort: 18-40; Participants: 5; Day 0: 20 mcg&#xD;
&#xD;
      Group: 2A; Age Cohort: 18-40; Participants: 12; Day 0: 60 mcg; Week 16: 60 mcg&#xD;
&#xD;
      Group: 2B; Age Cohort: 41-49; Participants: 12; Day 0: 60 mcg; Week 16: 60 mcg&#xD;
&#xD;
      Group: 2C; Age Cohort: 50-59; Participants: 12; Day 0: 60 mcg; Week 16: 60 mcg&#xD;
&#xD;
      Group: 2D; Age Cohort: 60-70; Participants: 11*; Day 0: 60 mcg; Week 16: 60 mcg&#xD;
&#xD;
      Total: 52*&#xD;
&#xD;
      *Recruitment for the final open group, Group 2D, was ongoing to meet the accrual target of 53&#xD;
      participants. However, due to the COVID-19 pandemic, enrollment was discontinued with a total&#xD;
      of 52 participants enrolled.&#xD;
&#xD;
      Study Duration:&#xD;
&#xD;
      Group 1: Participants were evaluated for 52 weeks following the vaccine administration and&#xD;
      through an influenza season.&#xD;
&#xD;
      Groups 2A, 2B, 2C, 2D: Participants were evaluated for 52 weeks following the last vaccine&#xD;
      administration and through an influenza season.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">April 6, 2021</completion_date>
  <primary_completion_date type="Actual">April 6, 2021</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration</measure>
    <time_frame>7 days after each H1ssF_3928 product administration, at approximately Week 1 and at approximately Week 17</time_frame>
    <description>Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for &quot;Any Local Symptom&quot; is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration</measure>
    <time_frame>7 days after each H1ssF_3928 product administration, at approximately Week 1 and at approximately Week 17</time_frame>
    <description>Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for &quot;Any Systemic Symptom&quot; is the number of participants reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following H1ssF_3928 Product Administration</measure>
    <time_frame>Day 0 through 4 weeks after each H1ssF_3928 product administration, up to Week 20</time_frame>
    <description>Unsolicited AEs and attribution assessments were recorded in the study database from receipt of the first study product administration through the visit scheduled for 4 weeks after each study product administration. At other time periods between study product administrations and when greater than 4 weeks after the last study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module), influenza-like illness (ILI) or influenza and new chronic medical conditions that required ongoing medical management (reported as separate outcomes) were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Serious Adverse Events (SAEs) Following H1ssF_3928 Product Administration</measure>
    <time_frame>Day 0 through the study participation, up to Week 68</time_frame>
    <description>SAEs were recorded from receipt of first study product administration through the last expected study visit at Week 68. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Influenza or Influenza-like Illness (ILIs) Following H1ssF_3928 Product Administration</measure>
    <time_frame>Day 0 through the study participation, up to Week 68</time_frame>
    <description>Influenza or influenza-like illness (ILI) were recorded in the study database from receipt of the first study product administration through the last study visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With New Chronic Medical Conditions Following H1ssF_3928 Product Administration</measure>
    <time_frame>Day 0 through the study participation, up to Week 68</time_frame>
    <description>New chronic medical conditions that required ongoing medical management were recorded from receipt of first study product administration through the last expected study visit at Week 68. The relationship between a new chronic medical condition and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration</measure>
    <time_frame>Day 0 through the study participation, up to Week 68</time_frame>
    <description>Any abnormal laboratory results recorded after product administration as unsolicited adverse events (AEs) are summarized. Safety laboratory parameters included hematology (hemoglobin, hematocrit, platelets, and white blood cell (WBC), red blood cell (RBC), neutrophil, lymphocyte, monocyte, eosinophil and basophil percents/counts) and chemistry (alanine aminotransferase (ALT), alanine aspartate (AST), alkaline phosphate (ALP), creatinine and total bilirubin). Complete blood count (CBC) with differential, total bilirubin, AST, ALT, and ALP results were collected at Days 14, 28, 280, 364 and 476. Iron and serum ferritin were collected at Day 28. Creatinine results were collected at Day 14. Institutional laboratory normal ranges as well as the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials FDA Guidance, September 2007 were used.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pseudoviral Neutralization Assay Geometric Mean Titer (GMT) Against Homologous A/New Caledonia/20/1999 Virus (H1N1) Following the Completion of Each Vaccination Regimen</measure>
    <time_frame>Baseline to 2 weeks after 1st dose for participants who received a single injection, at Week 2 or From Baseline to 2 weeks after 1st dose and from Week 16 to 2 weeks after 2nd dose for participants who received two injections, at Weeks 2 and 18</time_frame>
    <description>Pseudoviral neutralization antibody titers were determined against the homologous H1N1 A/New Caledonia/20/99 virus, and were summarized using geometric mean 80% inhibitory concentration (IC80).</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Influenza Infection</condition>
  <arm_group>
    <arm_group_label>Group 1: H1ssF_3928 (20 mcg), ages 18-40 years</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>H1ssF_3928 (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2A: H1ssF_3928 (60 mcg), ages 18-40 years</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2B: H1ssF_3928 (60 mcg), ages 41-49 years</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2C: H1ssF_3928 (60 mcg), ages 50-59 years</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2D: H1ssF_3928 (60 mcg), ages 60-70 years</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>VRC-FLUNPF099-00-VP (H1ssF_3928)</intervention_name>
    <description>The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
    <arm_group_label>Group 1: H1ssF_3928 (20 mcg), ages 18-40 years</arm_group_label>
    <arm_group_label>Group 2A: H1ssF_3928 (60 mcg), ages 18-40 years</arm_group_label>
    <arm_group_label>Group 2B: H1ssF_3928 (60 mcg), ages 41-49 years</arm_group_label>
    <arm_group_label>Group 2C: H1ssF_3928 (60 mcg), ages 50-59 years</arm_group_label>
    <arm_group_label>Group 2D: H1ssF_3928 (60 mcg), ages 60-70 years</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        INCLUSION CRITERIA:&#xD;
&#xD;
          1. Healthy adults between the ages of 18-70 years inclusive&#xD;
&#xD;
          2. Based on history and examination, in good general health and without history of any of&#xD;
             the conditions listed in the exclusion criteria&#xD;
&#xD;
          3. Received at least one licensed influenza vaccine from 2014 to the present&#xD;
&#xD;
          4. Able and willing to complete the informed consent process&#xD;
&#xD;
          5. If enrolled in Group 1: Available for clinic visits for 52 weeks after enrollment and&#xD;
             through an influenza season&#xD;
&#xD;
          6. If enrolled in Group 2A, 2B, 2C, or 2D: Available for clinic visits for 68 weeks after&#xD;
             enrollment and through an influenza season&#xD;
&#xD;
          7. Willing to have blood samples collected, stored indefinitely, and used for research&#xD;
             purposes&#xD;
&#xD;
          8. Able to provide proof of identity to the satisfaction of the study clinician&#xD;
             completing the enrollment process&#xD;
&#xD;
          9. Physical examination and laboratory results without clinically significant findings&#xD;
             and a Body Mass Index (BMI) less than or equal to 40 within the 28 days before&#xD;
             enrollment&#xD;
&#xD;
             Laboratory Criteria within 28 days before enrollment&#xD;
&#xD;
         10. White blood cells (WBC) and differential either within institutional normal range or&#xD;
             accompanied by the site Principal Investigator (PI) or designee approval&#xD;
&#xD;
         11. Total lymphocyte count greater than or equal to 800 cells/mm^3&#xD;
&#xD;
         12. Platelets = 125,000 - 500,000/mm3&#xD;
&#xD;
         13. Hemoglobin within institutional normal range&#xD;
&#xD;
         14. Serum iron either within institutional normal range or accompanied by the site PI or&#xD;
             designee approval&#xD;
&#xD;
         15. Serum ferritin within institutional normal range or accompanied by the site PI or&#xD;
             designee approval&#xD;
&#xD;
         16. Alanine aminotransferase (ALT) less than or equal to 1.25 x institutional upper limit&#xD;
             of normal (ULN)&#xD;
&#xD;
         17. Aspartate aminotransferase (AST) less than or equal to 1.25 x institutional ULN&#xD;
&#xD;
         18. Alkaline phosphatase (ALP) &lt;1.1 x institutional ULN&#xD;
&#xD;
         19. Total bilirubin within institutional normal range&#xD;
&#xD;
         20. Serum creatinine less than or equal to 1.1 x institutional ULN&#xD;
&#xD;
         21. Negative for HIV infection by an FDA-approved method of detection&#xD;
&#xD;
             Criteria applicable to women of childbearing potential:&#xD;
&#xD;
         22. Negative beta-human chorionic gonadotropin (beta-HCG) pregnancy test (urine or serum)&#xD;
             on the day of enrollment&#xD;
&#xD;
         23. Agreed to use an effective means of birth control from at least 21 days prior to&#xD;
             enrollment through the end of the study&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          1. Breast-feeding or planning to become pregnant during the study.&#xD;
&#xD;
             Participant has received any of the following substances:&#xD;
&#xD;
          2. More than 10 days of systemic immunosuppressive medications or cytotoxic medications&#xD;
             within the 4 weeks prior to enrollment or any within the 14 days prior to enrollment&#xD;
&#xD;
          3. Blood products within 16 weeks prior to enrollment&#xD;
&#xD;
          4. Live attenuated vaccines within 4 weeks prior to enrollment&#xD;
&#xD;
          5. Inactivated vaccines within 2 weeks prior to enrollment&#xD;
&#xD;
          6. Investigational research agents within 4 weeks prior to enrollment or planned to&#xD;
             receive investigational products while on the study&#xD;
&#xD;
          7. Current allergy treatment with allergen immunotherapy with antigen injections, unless&#xD;
             on maintenance schedule&#xD;
&#xD;
          8. Current anti-TB (tuberculosis) prophylaxis or therapy&#xD;
&#xD;
          9. Previous investigational H1 influenza vaccine&#xD;
&#xD;
         10. Previous investigational ferritin-based vaccine&#xD;
&#xD;
         11. Receipt of a licensed influenza vaccine within 6 weeks before trial enrollment&#xD;
&#xD;
             Participant has a history of any of the following clinically significant conditions:&#xD;
&#xD;
         12. Serious reactions to vaccines that preclude receipt of study vaccinations as&#xD;
             determined by the investigator&#xD;
&#xD;
         13. Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema&#xD;
&#xD;
         14. Asthma that is not well controlled&#xD;
&#xD;
         15. Diabetes mellitus (type I or II), with the exception of gestational diabetes&#xD;
&#xD;
         16. Thyroid disease that is not well controlled&#xD;
&#xD;
         17. Idiopathic urticaria within the past year&#xD;
&#xD;
         18. Autoimmune disease or immunodeficiency&#xD;
&#xD;
         19. Hypertension that is not well controlled (baseline systolic &gt; 140 mmHg or diastolic &gt;&#xD;
             90 mmHg)&#xD;
&#xD;
         20. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or&#xD;
             platelet disorder requiring special precautions) or significant bruising or bleeding&#xD;
             difficulties with IM injections or blood draws&#xD;
&#xD;
         21. Malignancy that is active or history of malignancy that is likely to recur during the&#xD;
             period of the study.&#xD;
&#xD;
         22. Seizure disorder other than 1) febrile seizures, 2) seizures secondary to alcohol&#xD;
             withdrawal more than 3 years ago, or 3) seizures that have not required treatment&#xD;
             within the last 3 years&#xD;
&#xD;
         23. Asplenia, functional asplenia or any condition resulting in the absence or removal of&#xD;
             the spleen&#xD;
&#xD;
         24. Guillain-Barré Syndrome&#xD;
&#xD;
         25. Any medical, psychiatric, social condition, occupational reason or other&#xD;
             responsibility that, in the judgment of the investigator, is a contraindication to&#xD;
             protocol participation or impairs a participant's ability to give informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alicia T Widge, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute of Allergy and Infectious Diseases (NIAID)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2019-I-0032.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <reference>
    <citation>Krammer F, Palese P, Steel J. Advances in universal influenza virus vaccine design and antibody mediated therapies based on conserved regions of the hemagglutinin. Curr Top Microbiol Immunol. 2015;386:301-21. doi: 10.1007/82_2014_408.</citation>
    <PMID>25007847</PMID>
  </reference>
  <reference>
    <citation>Kanekiyo M, Wei CJ, Yassine HM, McTamney PM, Boyington JC, Whittle JR, Rao SS, Kong WP, Wang L, Nabel GJ. Self-assembling influenza nanoparticle vaccines elicit broadly neutralizing H1N1 antibodies. Nature. 2013 Jul 4;499(7456):102-6. doi: 10.1038/nature12202. Epub 2013 May 22.</citation>
    <PMID>23698367</PMID>
  </reference>
  <reference>
    <citation>Yassine HM, Boyington JC, McTamney PM, Wei CJ, Kanekiyo M, Kong WP, Gallagher JR, Wang L, Zhang Y, Joyce MG, Lingwood D, Moin SM, Andersen H, Okuno Y, Rao SS, Harris AK, Kwong PD, Mascola JR, Nabel GJ, Graham BS. Hemagglutinin-stem nanoparticles generate heterosubtypic influenza protection. Nat Med. 2015 Sep;21(9):1065-70. doi: 10.1038/nm.3927. Epub 2015 Aug 24.</citation>
    <PMID>26301691</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <results_first_submitted>April 4, 2022</results_first_submitted>
  <results_first_submitted_qc>April 4, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">April 29, 2022</results_first_posted>
  <last_update_submitted>April 4, 2022</last_update_submitted>
  <last_update_submitted_qc>April 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Flu</keyword>
  <keyword>Seasonal Allergy</keyword>
  <keyword>Respiratory Illness</keyword>
  <keyword>Flu Virus</keyword>
  <keyword>Viral Infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 18, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/20/NCT03814720/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Healthy adults were recruited at the NIH Clinical Center in Bethesda, Maryland.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years</title>
          <description>H1ssF_3928 (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
        </group>
        <group group_id="P2">
          <title>Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years</title>
          <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
        </group>
        <group group_id="P3">
          <title>Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years</title>
          <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
        </group>
        <group group_id="P4">
          <title>Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years</title>
          <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
        </group>
        <group group_id="P5">
          <title>Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years</title>
          <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="12"/>
                <participants group_id="P4" count="12"/>
                <participants group_id="P5" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received First Product Administration</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="12"/>
                <participants group_id="P4" count="12"/>
                <participants group_id="P5" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received All Product Administrations</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="7">One participant did not receive the second dose due to moving out of area and 4 participants did not receive the second dose due to the COVID-19 pandemic</participants>
                <participants group_id="P4" count="9">Three (3) participants did not receive the second dose due to the COVID-19 pandemic</participants>
                <participants group_id="P5" count="7">Four (4) participants did not receive the second dose due to the COVID-19 pandemic</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="12"/>
                <participants group_id="P4" count="12"/>
                <participants group_id="P5" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Population includes all enrolled participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years</title>
          <description>H1ssF_3928 (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
        </group>
        <group group_id="B2">
          <title>Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years</title>
          <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
        </group>
        <group group_id="B3">
          <title>Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years</title>
          <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
        </group>
        <group group_id="B4">
          <title>Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years</title>
          <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
        </group>
        <group group_id="B5">
          <title>Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years</title>
          <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
        </group>
        <group group_id="B6">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="5"/>
            <count group_id="B2" value="12"/>
            <count group_id="B3" value="12"/>
            <count group_id="B4" value="12"/>
            <count group_id="B5" value="11"/>
            <count group_id="B6" value="52"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34.0" spread="5.6"/>
                    <measurement group_id="B2" value="29.2" spread="5.2"/>
                    <measurement group_id="B3" value="45.3" spread="3.6"/>
                    <measurement group_id="B4" value="52.8" spread="2.7"/>
                    <measurement group_id="B5" value="63.0" spread="2.5"/>
                    <measurement group_id="B6" value="46.0" spread="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>21-30 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>31-40 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>41-50 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>51-60 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>61-70 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22.8" spread="2.9"/>
                    <measurement group_id="B2" value="27.0" spread="3.5"/>
                    <measurement group_id="B3" value="27.0" spread="3.7"/>
                    <measurement group_id="B4" value="27.6" spread="3.0"/>
                    <measurement group_id="B5" value="26.3" spread="4.3"/>
                    <measurement group_id="B6" value="26.6" spread="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration</title>
        <description>Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for &quot;Any Local Symptom&quot; is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007.</description>
        <time_frame>7 days after each H1ssF_3928 product administration, at approximately Week 1 and at approximately Week 17</time_frame>
        <population>Population included all enrolled participants who received at least one H1ssF_3928 study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=52).</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years</title>
            <description>H1ssF_3928 (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O2">
            <title>Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years</title>
            <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O3">
            <title>Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years</title>
            <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O4">
            <title>Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years</title>
            <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O5">
            <title>Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years</title>
            <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O6">
            <title>Overall Incidence H1ssF_3928 (20 mcg and 60 mcg)</title>
            <description>H1ssF_3928 dose groups included adults who received at least one dose of H1ssF_3928.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration</title>
          <description>Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for &quot;Any Local Symptom&quot; is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007.</description>
          <population>Population included all enrolled participants who received at least one H1ssF_3928 study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=52).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
                <count group_id="O5" value="11"/>
                <count group_id="O6" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pain/Tenderness</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="9"/>
                    <measurement group_id="O6" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="12"/>
                    <measurement group_id="O5" value="11"/>
                    <measurement group_id="O6" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="12"/>
                    <measurement group_id="O5" value="11"/>
                    <measurement group_id="O6" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skin Lesion</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="12"/>
                    <measurement group_id="O5" value="11"/>
                    <measurement group_id="O6" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Local Symptom</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="9"/>
                    <measurement group_id="O6" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration</title>
        <description>Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for &quot;Any Systemic Symptom&quot; is the number of participants reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007.</description>
        <time_frame>7 days after each H1ssF_3928 product administration, at approximately Week 1 and at approximately Week 17</time_frame>
        <population>Population included all enrolled participants who received at least one H1ssF_3928 study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=52).</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years</title>
            <description>H1ssF_3928 (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O2">
            <title>Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years</title>
            <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O3">
            <title>Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years</title>
            <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O4">
            <title>Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years</title>
            <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O5">
            <title>Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years</title>
            <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O6">
            <title>Overall Incidence H1ssF_3928 (20 mcg and 60 mcg)</title>
            <description>H1ssF_3928 dose groups included adults who received at least one dose of H1ssF_3928.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration</title>
          <description>Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for &quot;Any Systemic Symptom&quot; is the number of participants reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007.</description>
          <population>Population included all enrolled participants who received at least one H1ssF_3928 study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=52).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
                <count group_id="O5" value="11"/>
                <count group_id="O6" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Malaise</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="9"/>
                    <measurement group_id="O6" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="11"/>
                    <measurement group_id="O5" value="11"/>
                    <measurement group_id="O6" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="9"/>
                    <measurement group_id="O6" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chills</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="12"/>
                    <measurement group_id="O5" value="10"/>
                    <measurement group_id="O6" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="12"/>
                    <measurement group_id="O5" value="11"/>
                    <measurement group_id="O6" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Temperature (Fever)</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="12"/>
                    <measurement group_id="O5" value="11"/>
                    <measurement group_id="O6" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Joint Pain</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="12"/>
                    <measurement group_id="O5" value="11"/>
                    <measurement group_id="O6" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Systemic Symptom</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="8"/>
                    <measurement group_id="O6" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following H1ssF_3928 Product Administration</title>
        <description>Unsolicited AEs and attribution assessments were recorded in the study database from receipt of the first study product administration through the visit scheduled for 4 weeks after each study product administration. At other time periods between study product administrations and when greater than 4 weeks after the last study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module), influenza-like illness (ILI) or influenza and new chronic medical conditions that required ongoing medical management (reported as separate outcomes) were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.</description>
        <time_frame>Day 0 through 4 weeks after each H1ssF_3928 product administration, up to Week 20</time_frame>
        <population>Population included all enrolled participants who received at least one H1ssF_3928 study injection (N=52).</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years</title>
            <description>H1ssF_3928 (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O2">
            <title>Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years</title>
            <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O3">
            <title>Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years</title>
            <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O4">
            <title>Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years</title>
            <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O5">
            <title>Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years</title>
            <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O6">
            <title>Overall Incidence H1ssF_3928 (20 mcg and 60 mcg)</title>
            <description>H1ssF_3928 dose groups included adults who received at least one dose of H1ssF_3928.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following H1ssF_3928 Product Administration</title>
          <description>Unsolicited AEs and attribution assessments were recorded in the study database from receipt of the first study product administration through the visit scheduled for 4 weeks after each study product administration. At other time periods between study product administrations and when greater than 4 weeks after the last study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module), influenza-like illness (ILI) or influenza and new chronic medical conditions that required ongoing medical management (reported as separate outcomes) were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.</description>
          <population>Population included all enrolled participants who received at least one H1ssF_3928 study injection (N=52).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
                <count group_id="O5" value="11"/>
                <count group_id="O6" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Related to Study Product</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unrelated to Study Product</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Number of Participants who had One or More Non-Serious Unsolicited AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Serious Adverse Events (SAEs) Following H1ssF_3928 Product Administration</title>
        <description>SAEs were recorded from receipt of first study product administration through the last expected study visit at Week 68. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.</description>
        <time_frame>Day 0 through the study participation, up to Week 68</time_frame>
        <population>Population included all enrolled participants who received at least one H1ssF_3928 study injection (N=52).</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years</title>
            <description>H1ssF_3928 (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O2">
            <title>Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years</title>
            <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O3">
            <title>Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years</title>
            <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O4">
            <title>Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years</title>
            <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O5">
            <title>Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years</title>
            <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O6">
            <title>Overall Incidence H1ssF_3928 (20 mcg and 60 mcg)</title>
            <description>H1ssF_3928 dose groups included adults who received at least one dose of H1ssF_3928.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Serious Adverse Events (SAEs) Following H1ssF_3928 Product Administration</title>
          <description>SAEs were recorded from receipt of first study product administration through the last expected study visit at Week 68. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.</description>
          <population>Population included all enrolled participants who received at least one H1ssF_3928 study injection (N=52).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
                <count group_id="O5" value="11"/>
                <count group_id="O6" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Influenza or Influenza-like Illness (ILIs) Following H1ssF_3928 Product Administration</title>
        <description>Influenza or influenza-like illness (ILI) were recorded in the study database from receipt of the first study product administration through the last study visit.</description>
        <time_frame>Day 0 through the study participation, up to Week 68</time_frame>
        <population>Population included all enrolled participants who received at least one H1ssF_3928 study injection (N=52).</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years</title>
            <description>H1ssF_3928 (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O2">
            <title>Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years</title>
            <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O3">
            <title>Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years</title>
            <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O4">
            <title>Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years</title>
            <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O5">
            <title>Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years</title>
            <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O6">
            <title>Overall Incidence H1ssF_3928 (20 mcg and 60 mcg)</title>
            <description>H1ssF_3928 dose groups included adults who received at least one dose of H1ssF_3928.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Influenza or Influenza-like Illness (ILIs) Following H1ssF_3928 Product Administration</title>
          <description>Influenza or influenza-like illness (ILI) were recorded in the study database from receipt of the first study product administration through the last study visit.</description>
          <population>Population included all enrolled participants who received at least one H1ssF_3928 study injection (N=52).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
                <count group_id="O5" value="11"/>
                <count group_id="O6" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With New Chronic Medical Conditions Following H1ssF_3928 Product Administration</title>
        <description>New chronic medical conditions that required ongoing medical management were recorded from receipt of first study product administration through the last expected study visit at Week 68. The relationship between a new chronic medical condition and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.</description>
        <time_frame>Day 0 through the study participation, up to Week 68</time_frame>
        <population>Population included all enrolled participants who received at least one H1ssF_3928 study injection (N=52).</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years</title>
            <description>H1ssF_3928 (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O2">
            <title>Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years</title>
            <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O3">
            <title>Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years</title>
            <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O4">
            <title>Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years</title>
            <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O5">
            <title>Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years</title>
            <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O6">
            <title>Overall Incidence H1ssF_3928 (20 mcg and 60 mcg)</title>
            <description>H1ssF_3928 dose groups included adults who received at least one dose of H1ssF_3928.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With New Chronic Medical Conditions Following H1ssF_3928 Product Administration</title>
          <description>New chronic medical conditions that required ongoing medical management were recorded from receipt of first study product administration through the last expected study visit at Week 68. The relationship between a new chronic medical condition and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.</description>
          <population>Population included all enrolled participants who received at least one H1ssF_3928 study injection (N=52).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
                <count group_id="O5" value="11"/>
                <count group_id="O6" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Related to Study Product</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unrelated to Study Product</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Number of Participants with New Chronic Medical Conditions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration</title>
        <description>Any abnormal laboratory results recorded after product administration as unsolicited adverse events (AEs) are summarized. Safety laboratory parameters included hematology (hemoglobin, hematocrit, platelets, and white blood cell (WBC), red blood cell (RBC), neutrophil, lymphocyte, monocyte, eosinophil and basophil percents/counts) and chemistry (alanine aminotransferase (ALT), alanine aspartate (AST), alkaline phosphate (ALP), creatinine and total bilirubin). Complete blood count (CBC) with differential, total bilirubin, AST, ALT, and ALP results were collected at Days 14, 28, 280, 364 and 476. Iron and serum ferritin were collected at Day 28. Creatinine results were collected at Day 14. Institutional laboratory normal ranges as well as the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials FDA Guidance, September 2007 were used.</description>
        <time_frame>Day 0 through the study participation, up to Week 68</time_frame>
        <population>Population included all enrolled participants who had laboratory results available at any study visit post product administration.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years</title>
            <description>H1ssF_3928 (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O2">
            <title>Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years</title>
            <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O3">
            <title>Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years</title>
            <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O4">
            <title>Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years</title>
            <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O5">
            <title>Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years</title>
            <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O6">
            <title>Overall Incidence H1ssF_3928 (20 mcg and 60 mcg)</title>
            <description>H1ssF_3928 dose groups included adults who received at least one dose of H1ssF_3928.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration</title>
          <description>Any abnormal laboratory results recorded after product administration as unsolicited adverse events (AEs) are summarized. Safety laboratory parameters included hematology (hemoglobin, hematocrit, platelets, and white blood cell (WBC), red blood cell (RBC), neutrophil, lymphocyte, monocyte, eosinophil and basophil percents/counts) and chemistry (alanine aminotransferase (ALT), alanine aspartate (AST), alkaline phosphate (ALP), creatinine and total bilirubin). Complete blood count (CBC) with differential, total bilirubin, AST, ALT, and ALP results were collected at Days 14, 28, 280, 364 and 476. Iron and serum ferritin were collected at Day 28. Creatinine results were collected at Day 14. Institutional laboratory normal ranges as well as the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials FDA Guidance, September 2007 were used.</description>
          <population>Population included all enrolled participants who had laboratory results available at any study visit post product administration.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
                <count group_id="O5" value="11"/>
                <count group_id="O6" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ALT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WBC Count</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophil Count</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocyte Count</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of Participants with one or more Abnormal Laboratory Results AE Related to Study Product</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of Participants with one or more Abnormal Laboratory Results AE Unrelated to Study Product</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Number of Participants who had Any Abnormal Laboratory Results Reported as AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pseudoviral Neutralization Assay Geometric Mean Titer (GMT) Against Homologous A/New Caledonia/20/1999 Virus (H1N1) Following the Completion of Each Vaccination Regimen</title>
        <description>Pseudoviral neutralization antibody titers were determined against the homologous H1N1 A/New Caledonia/20/99 virus, and were summarized using geometric mean 80% inhibitory concentration (IC80).</description>
        <time_frame>Baseline to 2 weeks after 1st dose for participants who received a single injection, at Week 2 or From Baseline to 2 weeks after 1st dose and from Week 16 to 2 weeks after 2nd dose for participants who received two injections, at Weeks 2 and 18</time_frame>
        <population>Baseline, Week 2, and Week 16 analyses included all who received at least one H1ssF_3928 study injection for which samples were available (N=52, 51, and 36 respectively). Week 18 analysis included all who received two H1ssF_3928 injections for which samples were available (N=32). Twelve (12) participants did not receive the 2nd injection: one Group 2B participant due to moving out of the area and 11 participants (4 in Group 2B, 3 in Group 2C and 4 in Group 2D) due to the COVID-19 pandemic.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years</title>
            <description>H1ssF_3928 (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O2">
            <title>Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years</title>
            <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O3">
            <title>Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years</title>
            <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O4">
            <title>Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years</title>
            <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
          <group group_id="O5">
            <title>Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years</title>
            <description>H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)&#xD;
VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.</description>
          </group>
        </group_list>
        <measure>
          <title>Pseudoviral Neutralization Assay Geometric Mean Titer (GMT) Against Homologous A/New Caledonia/20/1999 Virus (H1N1) Following the Completion of Each Vaccination Regimen</title>
          <description>Pseudoviral neutralization antibody titers were determined against the homologous H1N1 A/New Caledonia/20/99 virus, and were summarized using geometric mean 80% inhibitory concentration (IC80).</description>
          <population>Baseline, Week 2, and Week 16 analyses included all who received at least one H1ssF_3928 study injection for which samples were available (N=52, 51, and 36 respectively). Week 18 analysis included all who received two H1ssF_3928 injections for which samples were available (N=32). Twelve (12) participants did not receive the 2nd injection: one Group 2B participant due to moving out of the area and 11 participants (4 in Group 2B, 3 in Group 2C and 4 in Group 2D) due to the COVID-19 pandemic.</population>
          <units>titer</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
                <count group_id="O5" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 0 (Baseline, Pre-Administration)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="618" lower_limit="181" upper_limit="2111"/>
                    <measurement group_id="O2" value="536" lower_limit="276" upper_limit="1038"/>
                    <measurement group_id="O3" value="212" lower_limit="67" upper_limit="674"/>
                    <measurement group_id="O4" value="170" lower_limit="108" upper_limit="269"/>
                    <measurement group_id="O5" value="283" lower_limit="100" upper_limit="799"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (14 Days After First Product Administration)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="916" lower_limit="243" upper_limit="3454"/>
                    <measurement group_id="O2" value="888" lower_limit="404" upper_limit="1949"/>
                    <measurement group_id="O3" value="566" lower_limit="196" upper_limit="1632"/>
                    <measurement group_id="O4" value="651" lower_limit="404" upper_limit="1051"/>
                    <measurement group_id="O5" value="741" lower_limit="281" upper_limit="1955"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 (Second Product Administration)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="982" lower_limit="500" upper_limit="1928"/>
                    <measurement group_id="O3" value="725" lower_limit="413" upper_limit="1270"/>
                    <measurement group_id="O4" value="484" lower_limit="232" upper_limit="1011"/>
                    <measurement group_id="O5" value="792" lower_limit="228" upper_limit="2747"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 18 (14 Days After Second Product Administration)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="602" lower_limit="193" upper_limit="1876"/>
                    <measurement group_id="O3" value="780" lower_limit="399" upper_limit="1526"/>
                    <measurement group_id="O4" value="543" lower_limit="265" upper_limit="1112"/>
                    <measurement group_id="O5" value="894" lower_limit="295" upper_limit="2706"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.</time_frame>
      <desc>The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.</desc>
      <group_list>
        <group group_id="E1">
          <title>Overall Incidence H1ssF_3928 (20 mcg), Ages 18-40 Years</title>
          <description>H1ssF_3928 (20 mcg) dose group included adults (ages 18-40 years) who received a single 20 mcg dose of H1ssF_3928.&#xD;
Population included all enrolled subjects who received a H1ssF_3928 (20 mcg) study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=5).</description>
        </group>
        <group group_id="E2">
          <title>Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years</title>
          <description>H1ssF_3928 (60 mcg) dose groups included adults (ages 18-40 years) who were randomized to receive two doses of 60 mcg H1ssF_3928 16 weeks apart.&#xD;
Population included all enrolled subjects who received at least one H1ssF_3928 (60 mcg) study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=12).</description>
        </group>
        <group group_id="E3">
          <title>Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years</title>
          <description>H1ssF_3928 (60 mcg) dose groups included adults (ages 41-49 years) who were randomized to receive two doses of 60 mcg H1ssF_3928 16 weeks apart.&#xD;
Population included all enrolled subjects who received at least one H1ssF_3928 (60 mcg) study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=12).</description>
        </group>
        <group group_id="E4">
          <title>Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years</title>
          <description>H1ssF_3928 (60 mcg) dose groups included adults (ages 50-59 years) who were randomized to receive two doses of 60 mcg H1ssF_3928 16 weeks apart.&#xD;
Population included all enrolled subjects who received at least one H1ssF_3928 (60 mcg) study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=12).</description>
        </group>
        <group group_id="E5">
          <title>Group 2D: H1ssF_3928 (60 mcg), Ages 60-70</title>
          <description>H1ssF_3928 (60 mcg) dose groups included adults (ages 60-70 years) who were randomized to receive two doses of 60 mcg H1ssF_3928 16 weeks apart.&#xD;
Population included all enrolled subjects who received at least one H1ssF_3928 (60 mcg) study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=11).</description>
        </group>
        <group group_id="E6">
          <title>Overall Incidence H1ssF_3928 (60 mcg)</title>
          <description>H1ssF_3928 (60 mcg) dose groups included adults stratified by age (ages 18-40 years, ages 41-49 years, ages 50-59 years, and ages 60-70 years) who were randomized to receive two doses of 60 mcg H1ssF_3928 16 weeks apart.&#xD;
Population included all enrolled subjects who received at least one H1ssF_3928 (60 mcg) study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=47).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="12"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="30" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Coeliac disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Administration site pain</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Viral Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Epicondylitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <description>Joint Pain</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal dreams</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Anxiety disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>All 52 participants received at least one study product administration. Groups 1 and 2A completed the product administration schedule per protocol. While most participants in Groups 2B-2D completed the second product administration per protocol, one participant was not able to receive the second dose due to moving out of the area and 11 participants were not able to receive their second dose because of visit interruptions due to the COVID-19 pandemic.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Alicia T Widge, M.D.</name_or_title>
      <organization>Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health</organization>
      <phone>301-451-8715</phone>
      <email>alicia.widge@nih.gov</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


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/NCT03814720
org study id: 190032
secondary id: 19-I-0032
nct id: NCT03814720
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Background:

      The flu is a common viral infection that can be deadly for certain people. Vaccines against
      flu have been developed to teach the body to prevent or fight the infection. A new vaccine
      may help the body to make an immune response to H1 flu, a flu strain that infects humans.

      Objective:

      To test the safety and effectiveness of the H1 Stabilized Stem Ferritin vaccine
      (VRC-FLUNPF099-00-VP).

      Eligibility:

      Healthy people ages 18-70 years old who got at least 1 licensed flu vaccine since January 1,
      2014.

      Design:

      Participants received 1 or 2 vaccinations by injections (shots) in the upper arm muscle over
      4 months. Participants received a thermometer and recorded their temperature and symptoms
      every day a diary card for 7 days after each injection. The injection site was checked for
      redness, swelling, or bruising.

      Participants had 9-11 follow-up visits over 12-15 months. At follow-up visits, participants
      had blood drawn and were checked for health changes or problems. Participants who reported
      influenza-like illness had nose and throat swabs for evaluation of viral infection.

      Some participants had apheresis. A needle was placed into a vein in both arms. Blood was
      removed through a needle in the vein of one arm. A machine removed the white blood cells and
      then the rest of the blood was returned to the participant through a needle in the other arm.

      A separate consent was provided to participants for genetic testing on their samples.
Study Design: This was a Phase I, open-label, dose escalation study to evaluate the dose,
      safety, tolerability, and immunogenicity of VRC-FLUNPF099-00-VP in two regimens. The
      hypotheses were that the vaccine is safe and tolerable and will elicit an immune response.
      The primary objective was to evaluate the safety and tolerability of the investigational
      vaccine in healthy adults. Secondary objectives were related to immunogenicity of the
      investigational vaccine and dosing regimen.

      Study Products: The investigational vaccine, VRC-FLUNPF099-00-VP (H1ssF_3928), was developed
      by the Vaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases
      (NIAID) and is composed of Helicobacter pylori non-heme ferritin assembled with influenza
      virus H1 haemagglutinin (HA) insert to form a nanoparticle displaying eight HA stabilized
      stem trimers from A/New Caledonia/20/1999 (H1N1) influenza. The vaccine was supplied in
      single-use vials at a concentration of 180 mcg/mL. H1ssF_3928 was administered
      intramuscularly (IM) in the deltoid muscle via needle and syringe.

      Participants: Healthy adults between the ages of 18-70 years, inclusive.

      Study Plan: The study evaluated the safety, tolerability and immunogenicity of 1 or 2 doses
      of the H1ssF_3928 vaccine in a dose-escalation design. In Group 1, five participants received
      a single low dose (20 mcg) of H1ssF_3928 on Day 0. For Group 1, the protocol required 1
      vaccination visit, about 9 follow-up visits, and a telephone contact after vaccination.

      Once the low dose was assessed as safe and well tolerated, enrollment began for Group 2A.
      Groups 2A, 2B, 2C, and 2D were stratified by age as shown in the vaccination schema below. In
      Group 2A, participants received a higher dose (60 mcg) of H1ssF_3928 on Day 0. Once this
      higher dose was assessed as safe and well tolerated, participants in Group 2A received a
      second vaccination at Week 16 and enrollment began for Groups 2B, 2C, and 2D. For Groups 2A,
      2B, 2C, and 2D, the protocol required 2 vaccination visits, about 11 follow-up visits, and a
      telephone contact after each vaccination. Group 2A completed the product administration
      schedule per protocol. While most participants in Groups 2B-2D completed the second dose
      administration per protocol, one participant was not able to receive the second dose due to
      moving out of the area and 11 participants were not able to receive their second dose due to
      the COVID-19 pandemic.

      For all groups, solicited reactogenicity was evaluated using a 7-day diary card. Assessment
      of vaccine safety included clinical observation and monitoring of hematological and chemical
      parameters at clinical visits throughout the study.

      VRC 321 Vaccination Schema:

      Group: 1; Age Cohort: 18-40; Participants: 5; Day 0: 20 mcg

      Group: 2A; Age Cohort: 18-40; Participants: 12; Day 0: 60 mcg; Week 16: 60 mcg

      Group: 2B; Age Cohort: 41-49; Participants: 12; Day 0: 60 mcg; Week 16: 60 mcg

      Group: 2C; Age Cohort: 50-59; Participants: 12; Day 0: 60 mcg; Week 16: 60 mcg

      Group: 2D; Age Cohort: 60-70; Participants: 11*; Day 0: 60 mcg; Week 16: 60 mcg

      Total: 52*

      *Recruitment for the final open group, Group 2D, was ongoing to meet the accrual target of 53
      participants. However, due to the COVID-19 pandemic, enrollment was discontinued with a total
      of 52 participants enrolled.

      Study Duration:

      Group 1: Participants were evaluated for 52 weeks following the vaccine administration and
      through an influenza season.

      Groups 2A, 2B, 2C, 2D: Participants were evaluated for 52 weeks following the last vaccine
      administration and through an influenza season.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration
time frame: 7 days after each H1ssF_3928 product administration, at approximately Week 1 and at approximately Week 17
description: Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007.
measure: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration
time frame: 7 days after each H1ssF_3928 product administration, at approximately Week 1 and at approximately Week 17
description: Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of participants reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007.
measure: Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following H1ssF_3928 Product Administration
time frame: Day 0 through 4 weeks after each H1ssF_3928 product administration, up to Week 20
description: Unsolicited AEs and attribution assessments were recorded in the study database from receipt of the first study product administration through the visit scheduled for 4 weeks after each study product administration. At other time periods between study product administrations and when greater than 4 weeks after the last study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module), influenza-like illness (ILI) or influenza and new chronic medical conditions that required ongoing medical management (reported as separate outcomes) were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
measure: Number of Participants With Serious Adverse Events (SAEs) Following H1ssF_3928 Product Administration
time frame: Day 0 through the study participation, up to Week 68
description: SAEs were recorded from receipt of first study product administration through the last expected study visit at Week 68. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
measure: Number of Participants With Influenza or Influenza-like Illness (ILIs) Following H1ssF_3928 Product Administration
time frame: Day 0 through the study participation, up to Week 68
description: Influenza or influenza-like illness (ILI) were recorded in the study database from receipt of the first study product administration through the last study visit.
measure: Number of Participants With New Chronic Medical Conditions Following H1ssF_3928 Product Administration
time frame: Day 0 through the study participation, up to Week 68
description: New chronic medical conditions that required ongoing medical management were recorded from receipt of first study product administration through the last expected study visit at Week 68. The relationship between a new chronic medical condition and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
measure: Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration
time frame: Day 0 through the study participation, up to Week 68
description: Any abnormal laboratory results recorded after product administration as unsolicited adverse events (AEs) are summarized. Safety laboratory parameters included hematology (hemoglobin, hematocrit, platelets, and white blood cell (WBC), red blood cell (RBC), neutrophil, lymphocyte, monocyte, eosinophil and basophil percents/counts) and chemistry (alanine aminotransferase (ALT), alanine aspartate (AST), alkaline phosphate (ALP), creatinine and total bilirubin). Complete blood count (CBC) with differential, total bilirubin, AST, ALT, and ALP results were collected at Days 14, 28, 280, 364 and 476. Iron and serum ferritin were collected at Day 28. Creatinine results were collected at Day 14. Institutional laboratory normal ranges as well as the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials FDA Guidance, September 2007 were used.
measure: Pseudoviral Neutralization Assay Geometric Mean Titer (GMT) Against Homologous A/New Caledonia/20/1999 Virus (H1N1) Following the Completion of Each Vaccination Regimen
time frame: Baseline to 2 weeks after 1st dose for participants who received a single injection, at Week 2 or From Baseline to 2 weeks after 1st dose and from Week 16 to 2 weeks after 2nd dose for participants who received two injections, at Weeks 2 and 18
description: Pseudoviral neutralization antibody titers were determined against the homologous H1N1 A/New Caledonia/20/99 virus, and were summarized using geometric mean 80% inhibitory concentration (IC80).
arm group label: Group 1: H1ssF_3928 (20 mcg), ages 18-40 years
arm group type: Experimental
description: H1ssF_3928 (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0)
arm group label: Group 2A: H1ssF_3928 (60 mcg), ages 18-40 years
arm group type: Experimental
description: H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)
arm group label: Group 2B: H1ssF_3928 (60 mcg), ages 41-49 years
arm group type: Experimental
description: H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)
arm group label: Group 2C: H1ssF_3928 (60 mcg), ages 50-59 years
arm group type: Experimental
description: H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)
arm group label: Group 2D: H1ssF_3928 (60 mcg), ages 60-70 years
arm group type: Experimental
description: H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)
intervention type: Biological
intervention name: VRC-FLUNPF099-00-VP (H1ssF_3928)
description: The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.
arm group label: Group 1: H1ssF_3928 (20 mcg), ages 18-40 years
arm group label: Group 2A: H1ssF_3928 (60 mcg), ages 18-40 years
arm group label: Group 2B: H1ssF_3928 (60 mcg), ages 41-49 years
arm group label: Group 2C: H1ssF_3928 (60 mcg), ages 50-59 years
arm group label: Group 2D: H1ssF_3928 (60 mcg), ages 60-70 years
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alicia T Widge, M.D.
role: Principal Investigator
affiliation: National Institute of Allergy and Infectious Diseases (NIAID)
facility: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2019-I-0032.html
description: NIH Clinical Center Detailed Web Page
citation: Krammer F, Palese P, Steel J. Advances in universal influenza virus vaccine design and antibody mediated therapies based on conserved regions of the hemagglutinin. Curr Top Microbiol Immunol. 2015;386:301-21. doi: 10.1007/82_2014_408.
PMID: 25007847
citation: Kanekiyo M, Wei CJ, Yassine HM, McTamney PM, Boyington JC, Whittle JR, Rao SS, Kong WP, Wang L, Nabel GJ. Self-assembling influenza nanoparticle vaccines elicit broadly neutralizing H1N1 antibodies. Nature. 2013 Jul 4;499(7456):102-6. doi: 10.1038/nature12202. Epub 2013 May 22.
PMID: 23698367
citation: Yassine HM, Boyington JC, McTamney PM, Wei CJ, Kanekiyo M, Kong WP, Gallagher JR, Wang L, Zhang Y, Joyce MG, Lingwood D, Moin SM, Andersen H, Okuno Y, Rao SS, Harris AK, Kwong PD, Mascola JR, Nabel GJ, Graham BS. Hemagglutinin-stem nanoparticles generate heterosubtypic influenza protection. Nat Med. 2015 Sep;21(9):1065-70. doi: 10.1038/nm.3927. Epub 2015 Aug 24.
PMID: 26301691
responsible party type: Sponsor
mesh term: Influenza, Human
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: All 52 participants received at least one study product administration. Groups 1 and 2A completed the product administration schedule per protocol. While most participants in Groups 2B-2D completed the second product administration per protocol, one participant was not able to receive the second dose due to moving out of the area and 11 participants were not able to receive their second dose because of visit interruptions due to the COVID-19 pandemic.
point of contact: 