xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05972174</url>
    </required_header>
    <id_info>
      <org_study_id>mRNA-1018-P101</org_study_id>
      <nct_id>NCT05972174</nct_id>
    </id_info>
    <brief_title>A Study of mRNA-1018 Pandemic Influenza Candidate Vaccines in Healthy Adults</brief_title>
    <official_title>Phase 1/2, Randomized, Observer-Blind, Parallel, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1018 Pandemic Influenza Candidate Vaccines in Healthy Adults ≥18 Years of Age</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>ModernaTX, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>ModernaTX, Inc.</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this Phase 1/2 study is to generate sufficient safety and immunogenicity data&#xD;
        of mRNA-1018 pandemic influenza candidate vaccines in healthy adults ≥18 years of age to&#xD;
        enable the initiation of a large Phase 3 trial with one selected vaccine candidate. The study&#xD;
        will be conducted in 2 Parts (Part A and Part B) that will enroll and run concurrently. Part&#xD;
        A of the study will evaluate 4 vaccine candidates (H5N8, H7N9, H5 only, and H7 only). Part B&#xD;
        of the study will evaluate a single vaccine candidate (H5 only-CG).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 10, 2023</start_date>
    <completion_date type="Anticipated">May 22, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 22, 2024</primary_completion_date>
    <phase>Phase 1/Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)</measure>
      <time_frame>Up to Day 29 (7 days after each injection)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants with Unsolicited Adverse Events (AEs)</measure>
      <time_frame>Up to Day 43 (21 days after each injection)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants with AEs Leading to Discontinuation From Study</measure>
      <time_frame>Day 1 to Day 205 (end of study [EoS])</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants with Medically-Attended AEs (MAAEs)</measure>
      <time_frame>Day 1 to Day 205 (EoS)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants with Serious Adverse Events (SAEs)</measure>
      <time_frame>Day 1 to Day 205 (EoS)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants with Adverse Events of Special Interest (AESIs)</measure>
      <time_frame>Day 1 to Day 205 (EoS)</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Days 22, 29, and 43, as Measured by Hemagglutination Inhibition (HAI) Assay</measure>
      <time_frame>Days 22, 29, and 43</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies From Baseline to Days 22, 29, and 43, as Measured by HAI Assay</measure>
      <time_frame>Baseline (Day 1), Days 22, 29, and 43</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Seroconversion at Days 22, 29, and 43, as Measured by HAI Assay</measure>
      <time_frame>Baseline (Day 1) to Days 22, 29, and 43</time_frame>
      <description>Seroconversion is defined as a Day 22, 29, or 43 titer ≥1:40 if baseline is &lt;1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA antibodies measured by HAI assay.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With HAI Titer ≥ 1:40 at Days 22, 29, and 43</measure>
      <time_frame>Days 22, 29, and 43</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>GMT of Anti-Neuraminidase (NA) Antibodies at Days 22, 29, and 43, as Measured by Neuraminidase Inhibition (NAI) Assay</measure>
      <time_frame>Days 22, 29, and 43</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>GMFR of Anti-NA Antibodies From Baseline to Days 22, 29, and 43, as Measured by NAI Assay</measure>
      <time_frame>Baseline (Day 1), Days 22, 29, and 43</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with a Change in the Days 22, 29, and 43 NAI Titer of at Least 2-/3-/4-Fold Rise</measure>
      <time_frame>Baseline (Day 1) to Days 22, 29, and 43</time_frame>
      <description>Number of participants with a change in the Days 22, 29, or 43 NAI titer of at least 2-/3-/4-fold rise, defined as ≥2-/3-/4-fold of the lower level of quantitation (LLOQ) if the Day 1 titer is &lt;LLOQ; or ≥2-/3-/4-fold of the Day 1 titer if the Day 1 titer is ≥LLOQ.</description>
    </secondary_outcome>
    <number_of_arms>15</number_of_arms>
    <enrollment type="Anticipated">1500</enrollment>
    <condition>Influenza</condition>
    <arm_group>
      <arm_group_label>Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive mRNA-1018 for H5N8 at dose level 1 by intramuscular (IM) injection on Day 1 and Day 22.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive mRNA-1018 for H5N8 at dose level 2 by IM injection on Day 1 and Day 22.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive mRNA-1018 for H5N8 at dose level 3 by IM injection on Day 1 and Day 22.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive mRNA-1018 for H5 only at dose level 1 by IM injection on Day 1 and Day 22.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive mRNA-1018 for H5 only at dose level 2 by IM injection on Day 1 and Day 22.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive mRNA-1018 for H5 only at dose level 3 by IM injection on Day 1 and Day 22.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive mRNA-1018 for H7N9 at dose level 1 by IM injection on Day 1 and Day 22.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive mRNA-1018 for H7N9 at dose level 2 by IM injection on Day 1 and Day 22.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive mRNA-1018 for H7N9 at dose level 3 by IM injection on Day 1 and Day 22.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive mRNA-1018 for H7 only at dose level 1 by IM injection on Day 1 and Day 22.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive mRNA-1018 for H7 only at dose level 2 by IM injection on Day 1 and Day 22.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive mRNA-1018 for H7 only at dose level 3 by IM injection on Day 1 and Day 22.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive mRNA-1018 for H5 Only-CG at dose level 1 by IM injection on Day 1 and Day 22.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive mRNA-1018 for H5 Only-CG at dose level 2 by IM injection on Day 1 and Day 22.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive mRNA-1018 for H5 Only-CG at dose level 3 by IM injection on Day 1 and Day 22.</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>mRNA-1018 for H5N8</intervention_name>
      <description>Sterile liquid for injection</description>
      <arm_group_label>Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 1</arm_group_label>
      <arm_group_label>Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 2</arm_group_label>
      <arm_group_label>Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 3</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>mRNA-1018 for H7N9</intervention_name>
      <description>Sterile liquid for injection</description>
      <arm_group_label>Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 1</arm_group_label>
      <arm_group_label>Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 2</arm_group_label>
      <arm_group_label>Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 3</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>mRNA-1018 for H5 Only</intervention_name>
      <description>Sterile liquid for injection</description>
      <arm_group_label>Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 1</arm_group_label>
      <arm_group_label>Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 2</arm_group_label>
      <arm_group_label>Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 3</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>mRNA-1018 for H7 Only</intervention_name>
      <description>Sterile liquid for injection</description>
      <arm_group_label>Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 1</arm_group_label>
      <arm_group_label>Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 2</arm_group_label>
      <arm_group_label>Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 3</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>mRNA-1018 for H5 Only-CG</intervention_name>
      <description>Sterile liquid for injection</description>
      <arm_group_label>Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 1</arm_group_label>
      <arm_group_label>Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 2</arm_group_label>
      <arm_group_label>Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 3</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Key Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy as determined by medical evaluation including medical history, physical&#xD;
               examination, laboratory tests, and results of electrocardiogram testing.&#xD;
  &#xD;
            -  Body mass index of 18 kilograms (kg)/square meter (m^2) to 39 kg/m^2 (inclusive) at&#xD;
               the Screening visit.&#xD;
  &#xD;
            -  For female participants of childbearing potential: negative pregnancy test, adequate&#xD;
               contraception, and not currently breastfeeding.&#xD;
  &#xD;
          Key Exclusion Criteria:&#xD;
  &#xD;
            -  Participant is acutely ill or febrile (body temperature ≥ 38.0 degrees Celsius&#xD;
               [°C]/100.4 degrees Fahrenheit [°F]) 72 hours prior to or at the Screening Visit or Day&#xD;
               1.&#xD;
  &#xD;
            -  History of a diagnosis or condition that, in the judgment of the Investigator, is&#xD;
               clinically unstable or may affect participant safety, assessment of safety endpoints,&#xD;
               assessment of immune response, or adherence to study procedures.&#xD;
  &#xD;
            -  Any medical, psychiatric, or occupational condition, including reported history of&#xD;
               substance abuse, that, in the opinion of the Investigator, might pose additional risk&#xD;
               due to participation in the study or could interfere with the interpretation of study&#xD;
               results.&#xD;
  &#xD;
            -  Participant has received systemic immunosuppressants or immune-modifying drugs for &gt;14&#xD;
               days in total within 180 days prior to Screening Visit (for corticosteroids ≥10&#xD;
               milligrams [mg]/day of prednisone equivalent) or is anticipating the need for&#xD;
               immunosuppressive treatment at any time during participation in the study.&#xD;
  &#xD;
            -  Participant has received any vaccine authorized or approved by local health agency&#xD;
               including mRNA vaccine ≤28 days prior to study intervention (Day 1) or plans to&#xD;
               receive a vaccine authorized or approved by local health agency within 28 days before&#xD;
               or after the study intervention.&#xD;
  &#xD;
            -  Participant has participated in an interventional clinical study within 28 days prior&#xD;
               to the Screening visit based on the medical history interview or plans to do so while&#xD;
               participating in this study.&#xD;
  &#xD;
          Other inclusion/exclusion criteria may apply.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Moderna Clinical Trials Support Center</last_name>
      <phone>1-877-777-7187</phone>
      <email>clinicaltrials@modernatx.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>J. Lewis Research, Inc/Jordan River Family Medicine</name>
        <address>
          <city>South Jordan</city>
          <state>Utah</state>
          <zip>84095</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Influenza vaccine</keyword>
    <keyword>Moderna</keyword>
    <keyword>mRNA-1018</keyword>
    <keyword>Virus Diseases</keyword>
    <keyword>Vaccines</keyword>
    <keyword>Pandemic influenza</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Influenza, Human</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05972174
  org study id: mRNA-1018-P101
  nct id: NCT05972174
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this Phase 1/2 study is to generate sufficient safety and immunogenicity data
        of mRNA-1018 pandemic influenza candidate vaccines in healthy adults ≥18 years of age to
        enable the initiation of a large Phase 3 trial with one selected vaccine candidate. The study
        will be conducted in 2 Parts (Part A and Part B) that will enroll and run concurrently. Part
        A of the study will evaluate 4 vaccine candidates (H5N8, H7N9, H5 only, and H7 only). Part B
        of the study will evaluate a single vaccine candidate (H5 only-CG).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
  time frame: Up to Day 29 (7 days after each injection)
  measure: Number of Participants with Unsolicited Adverse Events (AEs)
  time frame: Up to Day 43 (21 days after each injection)
  measure: Number of Participants with AEs Leading to Discontinuation From Study
  time frame: Day 1 to Day 205 (end of study [EoS])
  measure: Number of Participants with Medically-Attended AEs (MAAEs)
  time frame: Day 1 to Day 205 (EoS)
  measure: Number of Participants with Serious Adverse Events (SAEs)
  time frame: Day 1 to Day 205 (EoS)
  measure: Number of Participants with Adverse Events of Special Interest (AESIs)
  time frame: Day 1 to Day 205 (EoS)
  measure: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Days 22, 29, and 43, as Measured by Hemagglutination Inhibition (HAI) Assay
  time frame: Days 22, 29, and 43
  measure: Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies From Baseline to Days 22, 29, and 43, as Measured by HAI Assay
  time frame: Baseline (Day 1), Days 22, 29, and 43
  measure: Number of Participants With Seroconversion at Days 22, 29, and 43, as Measured by HAI Assay
  time frame: Baseline (Day 1) to Days 22, 29, and 43
  description: Seroconversion is defined as a Day 22, 29, or 43 titer ≥1:40 if baseline is <1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA antibodies measured by HAI assay.
  measure: Number of Participants With HAI Titer ≥ 1:40 at Days 22, 29, and 43
  time frame: Days 22, 29, and 43
  measure: GMT of Anti-Neuraminidase (NA) Antibodies at Days 22, 29, and 43, as Measured by Neuraminidase Inhibition (NAI) Assay
  time frame: Days 22, 29, and 43
  measure: GMFR of Anti-NA Antibodies From Baseline to Days 22, 29, and 43, as Measured by NAI Assay
  time frame: Baseline (Day 1), Days 22, 29, and 43
  measure: Number of Participants with a Change in the Days 22, 29, and 43 NAI Titer of at Least 2-/3-/4-Fold Rise
  time frame: Baseline (Day 1) to Days 22, 29, and 43
  description: Number of participants with a change in the Days 22, 29, or 43 NAI titer of at least 2-/3-/4-fold rise, defined as ≥2-/3-/4-fold of the lower level of quantitation (LLOQ) if the Day 1 titer is <LLOQ; or ≥2-/3-/4-fold of the Day 1 titer if the Day 1 titer is ≥LLOQ.
  arm group label: Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 1
  arm group type: Experimental
  description: Participants will receive mRNA-1018 for H5N8 at dose level 1 by intramuscular (IM) injection on Day 1 and Day 22.
  arm group label: Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 2
  arm group type: Experimental
  description: Participants will receive mRNA-1018 for H5N8 at dose level 2 by IM injection on Day 1 and Day 22.
  arm group label: Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 3
  arm group type: Experimental
  description: Participants will receive mRNA-1018 for H5N8 at dose level 3 by IM injection on Day 1 and Day 22.
  arm group label: Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 1
  arm group type: Experimental
  description: Participants will receive mRNA-1018 for H5 only at dose level 1 by IM injection on Day 1 and Day 22.
  arm group label: Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 2
  arm group type: Experimental
  description: Participants will receive mRNA-1018 for H5 only at dose level 2 by IM injection on Day 1 and Day 22.
  arm group label: Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 3
  arm group type: Experimental
  description: Participants will receive mRNA-1018 for H5 only at dose level 3 by IM injection on Day 1 and Day 22.
  arm group label: Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 1
  arm group type: Experimental
  description: Participants will receive mRNA-1018 for H7N9 at dose level 1 by IM injection on Day 1 and Day 22.
  arm group label: Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 2
  arm group type: Experimental
  description: Participants will receive mRNA-1018 for H7N9 at dose level 2 by IM injection on Day 1 and Day 22.
  arm group label: Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 3
  arm group type: Experimental
  description: Participants will receive mRNA-1018 for H7N9 at dose level 3 by IM injection on Day 1 and Day 22.
  arm group label: Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 1
  arm group type: Experimental
  description: Participants will receive mRNA-1018 for H7 only at dose level 1 by IM injection on Day 1 and Day 22.
  arm group label: Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 2
  arm group type: Experimental
  description: Participants will receive mRNA-1018 for H7 only at dose level 2 by IM injection on Day 1 and Day 22.
  arm group label: Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 3
  arm group type: Experimental
  description: Participants will receive mRNA-1018 for H7 only at dose level 3 by IM injection on Day 1 and Day 22.
  arm group label: Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 1
  arm group type: Experimental
  description: Participants will receive mRNA-1018 for H5 Only-CG at dose level 1 by IM injection on Day 1 and Day 22.
  arm group label: Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 2
  arm group type: Experimental
  description: Participants will receive mRNA-1018 for H5 Only-CG at dose level 2 by IM injection on Day 1 and Day 22.
  arm group label: Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 3
  arm group type: Experimental
  description: Participants will receive mRNA-1018 for H5 Only-CG at dose level 3 by IM injection on Day 1 and Day 22.
  intervention type: Biological
  intervention name: mRNA-1018 for H5N8
  description: Sterile liquid for injection
  arm group label: Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 1
  arm group label: Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 2
  arm group label: Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 3
  intervention type: Biological
  intervention name: mRNA-1018 for H7N9
  description: Sterile liquid for injection
  arm group label: Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 1
  arm group label: Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 2
  arm group label: Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 3
  intervention type: Biological
  intervention name: mRNA-1018 for H5 Only
  description: Sterile liquid for injection
  arm group label: Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 1
  arm group label: Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 2
  arm group label: Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 3
  intervention type: Biological
  intervention name: mRNA-1018 for H7 Only
  description: Sterile liquid for injection
  arm group label: Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 1
  arm group label: Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 2
  arm group label: Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 3
  intervention type: Biological
  intervention name: mRNA-1018 for H5 Only-CG
  description: Sterile liquid for injection
  arm group label: Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 1
  arm group label: Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 2
  arm group label: Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 3
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Moderna Clinical Trials Support Center
  phone: 1-877-777-7187
  email: clinicaltrials@modernatx.com
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Sponsor
  mesh term: Influenza, Human