<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/NCT03765437</url>
  </required_header>
  <id_info>
    <org_study_id>GQM10</org_study_id>
    <secondary_id>U1111-1183-6274</secondary_id>
    <nct_id>NCT03765437</nct_id>
  </id_info>
  <brief_title>Safety of a Quadrivalent Influenza Vaccine (VaxigripTetra™) in Subjects Aged 6 Months and Older in Vietnam</brief_title>
  <acronym>GQM10</acronym>
  <official_title>Safety of a Quadrivalent Influenza Vaccine (VaxigripTetra™) in Subjects Aged 6 Months and Older in Vietnam</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanofi Pasteur, a Sanofi Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to describe the safety of the Quadrivalent Influenza&#xD;
      Vaccine (QIV). Safety is assessed throughout the study period, and includes solicited&#xD;
      injection site and systemic reactions (Day 0 to Day 7 post-vaccination); unsolicited adverse&#xD;
      events up to Day 28, and serious adverse events occurring throughout the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study duration for previously unvaccinated participants aged 6 months to 8 years is&#xD;
      approximately 56 days. Study duration for previously vaccinated participants aged 6 months to&#xD;
      8 years and any participant aged 9 years and older is approximately 28 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Actual">March 17, 2019</completion_date>
  <primary_completion_date type="Actual">March 17, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>The study design is considered Phase 3 for the purpose of registration. This is a safety assessment study designed to provide safety data in Vietnamese participants.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants reporting solicited injection site reactions or systemic reactions</measure>
    <time_frame>Within 7 days after vaccination</time_frame>
    <description>Injection site reactions: tenderness/pain, erythema, swelling, induration, and haemorrhage.&#xD;
Systemic reactions: participants ≤ 23 months: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability; participants 2 years and older: fever, headache, malaise, myalgia, and shivering.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">230</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Quadrivalent Influenza Vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Quadrivalent Influenza Vaccine (split-virion, inactivated) Northern hemisphere seasonal formulation 2018-2019</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Quadrivalent Influenza Vaccine</intervention_name>
    <description>Pharmaceutical form: Suspension for injection Route of administration: Intramuscular</description>
    <arm_group_label>Quadrivalent Influenza Vaccine</arm_group_label>
    <other_name>VaxigripTetra™</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
          -  Aged 6 months and older on the day of inclusion&#xD;
&#xD;
          -  Participants aged &lt; 18 years: ICF has been signed and dated by the parent or another&#xD;
             legally acceptable representative; Assent form has been signed and dated by the&#xD;
             participant aged 12 to 15 years.&#xD;
&#xD;
          -  Participants aged ≥ 16 years: ICF signed and dated by the participant.&#xD;
&#xD;
          -  Participants are able to attend all scheduled visits and to comply with all study&#xD;
             procedures. For participants aged 6 months to 17 years, parent/legally acceptable&#xD;
             representative are able to attend all scheduled visits and to comply with all study&#xD;
             procedures&#xD;
&#xD;
          -  For participants &lt; 2 years: Born at full term of pregnancy (≥ 37 weeks) and/or with a&#xD;
             birth weight ≥ 2.5 kg&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Participant is pregnant, or lactating, or of childbearing potential and not using an&#xD;
             effective method of contraception or abstinence from at least 4 weeks prior to&#xD;
             vaccination until at least 4 weeks after vaccination. To be considered of&#xD;
             non-childbearing potential, a woman must be pre-menarche or post-menopausal for at&#xD;
             least 1 year, or surgically sterile&#xD;
&#xD;
          -  Participation at the time of study enrollment (or in the 4 weeks preceding study&#xD;
             vaccination) or planned participation during the present study period in another&#xD;
             clinical study investigating a vaccine, drug, device, or medical procedure&#xD;
&#xD;
          -  Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned&#xD;
             receipt of any vaccine in the 4 weeks following the study vaccination.&#xD;
&#xD;
          -  Receipt of immune globulins, blood or blood-derived products in the past 3 months&#xD;
&#xD;
          -  Known or suspected congenital or acquired immunodeficiency; or receipt of&#xD;
             immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,&#xD;
             within the preceding 6 months; or long-term systemic corticosteroid therapy&#xD;
             (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)&#xD;
&#xD;
          -  Known systemic hypersensitivity to any of the vaccine components, or history of a&#xD;
             life-threatening reaction to the vaccine used in the study or to a vaccine containing&#xD;
             any of the same substances&#xD;
&#xD;
          -  Known thrombocytopenia, contraindicating intramuscular vaccination based on&#xD;
             investigator's judgment&#xD;
&#xD;
          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,&#xD;
             contraindicating IM vaccination based on investigator's judgment&#xD;
&#xD;
          -  Deprived of freedom by an administrative or court order, or in an emergency setting,&#xD;
             or hospitalized involuntarily&#xD;
&#xD;
          -  Current alcohol abuse or drug addiction&#xD;
&#xD;
          -  Chronic illness that, in the opinion of the investigator, is at a stage where it might&#xD;
             interfere with study conduct or completion&#xD;
&#xD;
          -  Moderate or severe acute illness/infection (according to Investigator judgment) on the&#xD;
             day of vaccination or febrile illness/body temperature (temperature ≥ 37.5 C or ≤ 35.5&#xD;
             C). A prospective subject should not be included in the study until the condition has&#xD;
             resolved or the febrile event has subsided&#xD;
&#xD;
          -  Identified as Investigator or employee of the Investigator or study center with direct&#xD;
             involvement in the proposed study, or identified as an immediate family member (i.e.&#xD;
             parent, spouse, natural or adopted child) of the Investigator or employee with direct&#xD;
             involvement in the proposed study&#xD;
&#xD;
        The above information is not intended to contain all considerations relevant to a patient's&#xD;
        potential participation in a clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Sciences &amp; Operations</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi Pasteur, a Sanofi Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigational Site Number 7040001</name>
      <address>
        <city>Viet Tri</city>
        <zip>84</zip>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Vietnam</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>April 21, 2022</last_update_submitted>
  <last_update_submitted_qc>April 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03765437
org study id: GQM10
secondary id: U1111-1183-6274
nct id: NCT03765437
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of this study is to describe the safety of the Quadrivalent Influenza
      Vaccine (QIV). Safety is assessed throughout the study period, and includes solicited
      injection site and systemic reactions (Day 0 to Day 7 post-vaccination); unsolicited adverse
      events up to Day 28, and serious adverse events occurring throughout the study.
Study duration for previously unvaccinated participants aged 6 months to 8 years is
      approximately 56 days. Study duration for previously vaccinated participants aged 6 months to
      8 years and any participant aged 9 years and older is approximately 28 days.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: The study design is considered Phase 3 for the purpose of registration. This is a safety assessment study designed to provide safety data in Vietnamese participants.
primary purpose: Prevention
masking: None (Open Label)
measure: Number of participants reporting solicited injection site reactions or systemic reactions
time frame: Within 7 days after vaccination
description: Injection site reactions: tenderness/pain, erythema, swelling, induration, and haemorrhage.
Systemic reactions: participants ≤ 23 months: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability; participants 2 years and older: fever, headache, malaise, myalgia, and shivering.
arm group label: Quadrivalent Influenza Vaccine
arm group type: Experimental
description: Quadrivalent Influenza Vaccine (split-virion, inactivated) Northern hemisphere seasonal formulation 2018-2019
intervention type: Biological
intervention name: Quadrivalent Influenza Vaccine
description: Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
arm group label: Quadrivalent Influenza Vaccine
other name: VaxigripTetra™
criteria: 
gender: All
minimum age: 6 Months
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi Pasteur, a Sanofi Company
facility: 
country: Vietnam
responsible party type: Sponsor
mesh term: Influenza, Human
sharing ipd: Yes
ipd description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org