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/NCT06038617</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00113014</org_study_id>
      <nct_id>NCT06038617</nct_id>
    </id_info>
    <brief_title>Safety of Simultaneous mRNA COVID-19 Vaccine With Other Childhood Vaccines in Young Children</brief_title>
    <official_title>A Prospective, Randomized, Open-label Clinical Trial to Assess the Safety of Simultaneous Vaccination With Pfizer-BioNTech mRNA COVID-19 Vaccine and Other Vaccines in Young Children Aged 6 Months to &lt;5 Years.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Duke University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Kaiser Permanente</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Columbia University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Children's Hospital Medical Center, Cincinnati</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Centers for Disease Control and Prevention</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
    </sponsors>
    <source>Duke University</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>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a prospective, randomized, open-label clinical trial to evaluate the safety of&#xD;
        COVID-19 vaccination and other routine childhood vaccines given simultaneously at Visit 1, as&#xD;
        compared to sequential vaccination of COVID-19 vaccine and other vaccines at separate visits&#xD;
        (Visits 1 and 2).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Parent(s) or legal authorized representative(s) (LAR) will assess fever and other solicited&#xD;
        systemic adverse events on the day of vaccination (Day 1) and the next 6 days (through Day 7)&#xD;
        following Visit 1 and Visit 2 using either a web-based data collection system or a paper&#xD;
        memory aid. Serious adverse events and adverse events of special interest will be captured&#xD;
        during the entire study period. Parental/LAR perceptions about their child's vaccine schedule&#xD;
        will be assessed on Day 7 following Visit 2.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
    <phase>Phase 4</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Participants with Fever Following Vaccination</measure>
      <time_frame>2 Days Post-Administration</time_frame>
      <description>Number of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 1 and/or Visit 2.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Fever Following Visit 1</measure>
      <time_frame>2 Days Post Administration</time_frame>
      <description>Number of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Fever Following Visit 2</measure>
      <time_frame>2 Days Post Administration</time_frame>
      <description>Number of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 2</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Grade 2 and/or 3 Fever Following Visit 1</measure>
      <time_frame>2 Days Post Administration</time_frame>
      <description>Number of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 1. (Moderate/severe fever: ≥ 38.4°C or ≥ 101.2°F)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Grade 2 and/or 3 Fever Following Visit 2</measure>
      <time_frame>2 Days Post Administration</time_frame>
      <description>Number of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 2. (Moderate/severe fever: ≥ 38.4°C or ≥ 101.2°F)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Grade 2 and/or 3 Fever Following Visit 1 and Visit 2 Combined</measure>
      <time_frame>2 Days Post Administration</time_frame>
      <description>Number of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 1 and Visit 2 combined. (Moderate/severe fever: ≥ 38.4°C or ≥ 101.2°F)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Medical Care Utilization - Visit 1</measure>
      <time_frame>2 Days Post Administration</time_frame>
      <description>Number of children with medical care utilization (medical advice (telephone, patient portal),urgent care visit, emergency department visit, and hospital admission) for fever on day 1 and/or day 2 following Visit 1.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Medical Care Utilization - Visit 2</measure>
      <time_frame>2 Days Post Administration</time_frame>
      <description>Number of children with medical care utilization (medical advice (telephone, patient portal),urgent care visit, emergency department visit, and hospital admission) for fever on day 1 and/or day 2 following Visit 2.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Medical Care Utilization - Visit 1 and Visit 2 Combined</measure>
      <time_frame>2 Days Post Administration</time_frame>
      <description>Number of children with medical care utilization (medical advice (telephone, patient portal), urgent care visit, emergency department visit, and hospital admission) for fever on day 1 and /or day 2 following Visit 1 and Visit 2 combined.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants who Received Antipyretics - Visit 1</measure>
      <time_frame>2 Days Post Administration</time_frame>
      <description>Number of children who received antipyretics on day 1 and/or day 2 following Visit 1.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants who Received Antipyretics - Visit 2</measure>
      <time_frame>2 Days Post Administration</time_frame>
      <description>Number of children who received antipyretics on day 1 and/or day 2 following Visit 2.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants who Received Antipyretics - Visit 1 and Visit 2 Combined</measure>
      <time_frame>2 Days Post Administration</time_frame>
      <description>Number of children who received antipyretics on day 1 and/or day 2 following Visit 1 and Visit 2 combined.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Defined Systemic Reactogenicity Events</measure>
      <time_frame>Up to 7 Days Post Administration</time_frame>
      <description>Tables summarizing each solicited local and systemic reactogenicity event by maximum classification (none, mild, moderate, and severe), as well as by moderate or severe</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Number and Percent of Individuals with At Least One Serious Adverse Event</measure>
      <time_frame>Up to 105 Days Post Administration</time_frame>
      <description>The number and percent of serious adverse events observed and description of each event</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">600</enrollment>
    <condition>Fever After Vaccination</condition>
    <condition>Fever</condition>
    <condition>Seizures Fever</condition>
    <arm_group>
      <arm_group_label>Simultaneous vaccination arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sequential vaccination arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2.</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Pfizer-BioNTech COVID-19 Vaccine</intervention_name>
      <description>ACIP Recommended Vaccine</description>
      <arm_group_label>Sequential vaccination arm</arm_group_label>
      <arm_group_label>Simultaneous vaccination arm</arm_group_label>
      <other_name>Pfizer COVID-19 Vaccine</other_name>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Routine Childhood Vaccinations</intervention_name>
      <description>ACIP Recommended Vaccines</description>
      <arm_group_label>Sequential vaccination arm</arm_group_label>
      <arm_group_label>Simultaneous vaccination arm</arm_group_label>
      <other_name>Pneumococcal, DTaP, Haemophilus Influenzae Type B, MMR, Varicella, MMRV, Hepatitis A, Inactivated Poliovirus, Hepatitis B, Rotavirus, Influenza vaccines</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Child 6 months through &lt;5 years of age at time of enrollment.&#xD;
  &#xD;
            -  Child is due to receive Pfizer-BioNTech mRNA COVID-19 vaccine and at least one other&#xD;
               routinely recommended non-live vaccine per CDC or ACIP recommendations.&#xD;
  &#xD;
            -  Parental/LAR intention of child receiving mRNA COVID-19 vaccine and at least one&#xD;
               recommended non-live vaccine.&#xD;
  &#xD;
            -  The parent/LAR must be willing and capable of providing permission for their child to&#xD;
               participate through the written informed consent process.&#xD;
  &#xD;
            -  The parent/LAR must be available for follow-up and must at minimum have telephone&#xD;
               access.&#xD;
  &#xD;
            -  The parent/LAR must agree to sign a medical release for the child so that study&#xD;
               personnel may obtain medical information about the child's health (if needed).&#xD;
  &#xD;
            -  The parent/LAR must be willing to delay COVID-19 vaccination for their child for up to&#xD;
               3 weeks.&#xD;
  &#xD;
            -  The parent/LAR must be able to read English or Spanish.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of any seizure (including febrile seizure) or first degree relative (biologic&#xD;
               parent or biologic sibling including half-sibling) with a history of febrile seizure.&#xD;
  &#xD;
            -  Contraindication to mRNA COVID-19 vaccine: A history of a severe allergic reaction&#xD;
               (e.g., anaphylaxis) after a previous dose or to a component of the COVID-19 vaccine or&#xD;
               a known diagnosed allergy to a component of COVID-19 vaccine.&#xD;
  &#xD;
            -  A history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose or&#xD;
               to a component of a vaccine administered on the day of study enrollment.&#xD;
  &#xD;
            -  For children receiving DTaP vaccine (alone or combination vaccine): Encephalopathy&#xD;
               (e.g., coma, decreased level of consciousness, prolonged seizures), not attributable&#xD;
               to another identifiable cause, within 7 days of administration of previous dose of DTP&#xD;
               or DTaP.&#xD;
  &#xD;
            -  Received any other non-live vaccines within 14 days prior to enrollment or any other&#xD;
               live vaccines within 28 days prior to enrollment.&#xD;
  &#xD;
            -  Intention to receive non-COVID-19 non-live or live vaccines during the 4 weeks after&#xD;
               Visit 1; vaccines may be administered after enrollment if deemed a personal or public&#xD;
               health priority by the health care provider caring for this patient or the study team.&#xD;
  &#xD;
            -  Received prior COVID-19 vaccine as part of a clinical trial.&#xD;
  &#xD;
            -  Received any experimental/investigational agent (vaccine, drug, biologic, device,&#xD;
               blood product, or medication) within 28 days prior to enrollment in this study or&#xD;
               expects to receive an experimental/investigational agent during the study.&#xD;
  &#xD;
            -  A moderate to severe acute illness and/or a reported temperature ≥ 100.4°F (≥38.0°C)&#xD;
               within 48 hours prior to enrollment or a temperature (measured by temporal artery&#xD;
               thermometer) ≥100.4°F (≥38.0°C) at the time of enrollment. (This may result in a&#xD;
               temporary delay of vaccination).&#xD;
  &#xD;
            -  Receipt of an antipyretic medication (acetaminophen or ibuprofen) within 72 hours&#xD;
               prior to enrollment (this may result in a temporary delay of vaccination) or planned&#xD;
               receipt of a prophylactic antipyretic medication on the day of and/or days following&#xD;
               vaccination prior to any measured increase in temperature in anticipation of a fever&#xD;
               (this exclusion does not apply if the Parent/LAR indicates they might administer&#xD;
               antipyretics or analgesics after vaccination to reduce a fever or pain).&#xD;
  &#xD;
            -  Immunosuppression as a result of an underlying illness or treatment, or use of&#xD;
               anti-cancer chemotherapy or radiation therapy since birth.&#xD;
  &#xD;
            -  Long term (at least 14 days of prednisone 2 mg/kg/day or equivalent other&#xD;
               glucocorticoid) use of any parenteral steroids or high-dose inhaled steroids (&gt;800&#xD;
               mcg/day of beclomethasone dipropionate or equivalent) within the 6 months prior to&#xD;
               enrollment (topical and nasal steroids are allowed).&#xD;
  &#xD;
            -  Has an active case of COVID-19 infection.&#xD;
  &#xD;
            -  History of multisystem inflammatory syndrome (MIS-C).&#xD;
  &#xD;
            -  History of myocarditis or pericarditis.&#xD;
  &#xD;
            -  Has any condition that would, in the opinion of the site investigator, place the&#xD;
               participant at an unacceptable risk of injury or render the participant unable to meet&#xD;
               the requirements of the protocol.&#xD;
  &#xD;
            -  Any child or grandchild of a study investigator or study team member.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Months</minimum_age>
      <maximum_age>4 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Michael J Smith, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Duke University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Michael J Smith, MD</last_name>
      <phone>919-684-6335</phone>
      <email>michael.j.smith@duke.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Emily A Randolph, MBA</last_name>
      <phone>919-353-5785</phone>
      <email>emily.randolph@duke.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Kaiser Permanente Northern California</name>
        <address>
          <city>Oakland</city>
          <state>California</state>
          <zip>94612</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Nicola Klein, MD</last_name>
        <phone>510-267-7540</phone>
        <email>nicola.klein@kp.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Centers for Disease Control and Prevention</name>
        <address>
          <city>Atlanta</city>
          <state>Georgia</state>
          <zip>30333</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Columbia University</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10027</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Melissa Stockwell, MD</last_name>
        <phone>212-342-5732</phone>
        <email>mss2112@cumc.columbia.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Duke University</name>
        <address>
          <city>Durham</city>
          <state>North Carolina</state>
          <zip>27710</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Michael J Smith, MD</last_name>
        <phone>919-684-6335</phone>
        <email>michael.j.smith@duke.edu</email>
      </contact>
      <contact_backup>
        <last_name>Emily A Randolph, MBA</last_name>
        <phone>919-385-5785</phone>
        <email>emily.randolph@duke.edu</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Cincinnati Children's Hospital Medical Center</name>
        <address>
          <city>Cincinnati</city>
          <state>Ohio</state>
          <zip>45229</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Elizabeth Schlaudecker, MD</last_name>
        <phone>513-803-0747</phone>
        <email>elizabeth.schlaudecker@ccmc.org</email>
      </contact>
      <contact_backup>
        <last_name>Mary Staat, MD</last_name>
        <phone>513-636-2877</phone>
        <email>mary.staat@cchmc.org</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>COVID vaccine</keyword>
    <keyword>Fever following vaccination</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Seizures</mesh_term>
      <mesh_term>Fever</mesh_term>
      <mesh_term>Hyperthermia</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vaccines</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06038617
  org study id: Pro00113014
  nct id: NCT06038617
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  This is a prospective, randomized, open-label clinical trial to evaluate the safety of
        COVID-19 vaccination and other routine childhood vaccines given simultaneously at Visit 1, as
        compared to sequential vaccination of COVID-19 vaccine and other vaccines at separate visits
        (Visits 1 and 2).
  Parent(s) or legal authorized representative(s) (LAR) will assess fever and other solicited
        systemic adverse events on the day of vaccination (Day 1) and the next 6 days (through Day 7)
        following Visit 1 and Visit 2 using either a web-based data collection system or a paper
        memory aid. Serious adverse events and adverse events of special interest will be captured
        during the entire study period. Parental/LAR perceptions about their child's vaccine schedule
        will be assessed on Day 7 following Visit 2.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Number of Participants with Fever Following Vaccination
  time frame: 2 Days Post-Administration
  description: Number of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 1 and/or Visit 2.
  measure: Number of Participants with Fever Following Visit 1
  time frame: 2 Days Post Administration
  description: Number of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 1
  measure: Number of Participants with Fever Following Visit 2
  time frame: 2 Days Post Administration
  description: Number of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 2
  measure: Number of Participants with Grade 2 and/or 3 Fever Following Visit 1
  time frame: 2 Days Post Administration
  description: Number of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 1. (Moderate/severe fever: ≥ 38.4°C or ≥ 101.2°F)
  measure: Number of Participants with Grade 2 and/or 3 Fever Following Visit 2
  time frame: 2 Days Post Administration
  description: Number of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 2. (Moderate/severe fever: ≥ 38.4°C or ≥ 101.2°F)
  measure: Number of Participants with Grade 2 and/or 3 Fever Following Visit 1 and Visit 2 Combined
  time frame: 2 Days Post Administration
  description: Number of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 1 and Visit 2 combined. (Moderate/severe fever: ≥ 38.4°C or ≥ 101.2°F)
  measure: Number of Participants with Medical Care Utilization - Visit 1
  time frame: 2 Days Post Administration
  description: Number of children with medical care utilization (medical advice (telephone, patient portal),urgent care visit, emergency department visit, and hospital admission) for fever on day 1 and/or day 2 following Visit 1.
  measure: Number of Participants with Medical Care Utilization - Visit 2
  time frame: 2 Days Post Administration
  description: Number of children with medical care utilization (medical advice (telephone, patient portal),urgent care visit, emergency department visit, and hospital admission) for fever on day 1 and/or day 2 following Visit 2.
  measure: Number of Participants with Medical Care Utilization - Visit 1 and Visit 2 Combined
  time frame: 2 Days Post Administration
  description: Number of children with medical care utilization (medical advice (telephone, patient portal), urgent care visit, emergency department visit, and hospital admission) for fever on day 1 and /or day 2 following Visit 1 and Visit 2 combined.
  measure: Number of Participants who Received Antipyretics - Visit 1
  time frame: 2 Days Post Administration
  description: Number of children who received antipyretics on day 1 and/or day 2 following Visit 1.
  measure: Number of Participants who Received Antipyretics - Visit 2
  time frame: 2 Days Post Administration
  description: Number of children who received antipyretics on day 1 and/or day 2 following Visit 2.
  measure: Number of Participants who Received Antipyretics - Visit 1 and Visit 2 Combined
  time frame: 2 Days Post Administration
  description: Number of children who received antipyretics on day 1 and/or day 2 following Visit 1 and Visit 2 combined.
  measure: Number of Participants with Defined Systemic Reactogenicity Events
  time frame: Up to 7 Days Post Administration
  description: Tables summarizing each solicited local and systemic reactogenicity event by maximum classification (none, mild, moderate, and severe), as well as by moderate or severe
  measure: The Number and Percent of Individuals with At Least One Serious Adverse Event
  time frame: Up to 105 Days Post Administration
  description: The number and percent of serious adverse events observed and description of each event
  arm group label: Simultaneous vaccination arm
  arm group type: Experimental
  description: The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2.
  arm group label: Sequential vaccination arm
  arm group type: Experimental
  description: The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2.
  intervention type: Biological
  intervention name: Pfizer-BioNTech COVID-19 Vaccine
  description: ACIP Recommended Vaccine
  arm group label: Sequential vaccination arm
  arm group label: Simultaneous vaccination arm
  other name: Pfizer COVID-19 Vaccine
  intervention type: Biological
  intervention name: Routine Childhood Vaccinations
  description: ACIP Recommended Vaccines
  arm group label: Sequential vaccination arm
  arm group label: Simultaneous vaccination arm
  other name: Pneumococcal, DTaP, Haemophilus Influenzae Type B, MMR, Varicella, MMRV, Hepatitis A, Inactivated Poliovirus, Hepatitis B, Rotavirus, Influenza vaccines
  criteria: 
  gender: All
  minimum age: 6 Months
  maximum age: 4 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Michael J Smith, MD
  role: Principal Investigator
  affiliation: Duke University
  last name: Michael J Smith, MD
  phone: 919-684-6335
  email: michael.j.smith@duke.edu
  last name: Emily A Randolph, MBA
  phone: 919-353-5785
  email: emily.randolph@duke.edu
  facility: 
  contact: 
  facility: 
  facility: 
  contact: 
  facility: 
  contact: 
  contact backup: 
  facility: 
  contact: 
  contact backup: 
  country: United States
  responsible party type: Sponsor
  mesh term: Seizures
  mesh term: Fever
  mesh term: Hyperthermia
  mesh term: Vaccines
  sharing ipd: No