<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20210121050096N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-21</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluating the effectiveness of influenza vaccine in kidney transplant recipients in Imam Khomeini Hospital</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of safety and efficacy of standard dose and doubling of seasonal flu vaccine in patients receiving kidney transplantation in Imam Khomeini Hospital, 2021</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54007</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention, Randomization description: Blocking is commonly used to balance the number of samples assigned to each of the study groups and helps to ensure that the number of samples assigned to each of the study groups is equal. The tool for generating random block sequences in this study is Random allocation software. In this clinical trial of 60 people (including 30 people in the double dose group of influenza vaccine and 30 people in the single dose group of influenza vaccine) 10 blocks of 6 will be formed. In each block, 6 people including 3 participants will be assigned to the Double dose group and 3 participants to the Single dose group.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Kidney Transplant Recipients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Receiving a standard dose of seasonal influenzae tetravalent vaccine (15μg of Hemophilus Influenza Antigen). This 2021-2022 vaccine is inactivated and is made by the Dutch company Abbott. The brand name of this vaccine is Influvac. The viral strains of this vaccine include the following: A/Victoria/2570/2019 (H1N1)pdm09-like strainA/Cambodia/e0826360/2020 (H3N2)-like strainB/Washington/02/2019-like strainB/Phuket/3073/2013-like strain. Intervention 2: Intervention group:  Receiving a double dose of seasonal influenzae tetravalent vaccine (30μg of Hemophilus Influenza Antigen). This 2021-2022 vaccine is inactivated and is made by the Dutch company Abbott. The brand name of this vaccine is Influvac. The viral strains of this vaccine include the following: A/Victoria/2570/2019 (H1N1)pdm09-like strainA/Cambodia/e0826360/2020 (H3N2)-like strainB/Washington/02/2019-like strainB/Phuket/3073/2013-like strain.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No further information is available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>SeyedAhmad SeyedAlinaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iranian Research Center for HIV/AIDS, Imam Khomeini Hospital Complex, Qarib Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۱۹۷۳۳۱۴۱</zip>
        <telephone>+98 21 6658 1583</telephone>
        <email>s_a_alinaghi@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohsen Meidani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Infectious Disease Department, Imam Khomeini Hospital Complex, Qarib Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۱۹۷۳۳۱۴۱</zip>
        <telephone>+98 21 6658 1598</telephone>
        <email>meidani@med.mui.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>At least 18 years old
At least three months have passed since their transplant.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Treatment for acute transplantation reject
Acute febrile illness in the last two weeks
Previous life-threatening reactions to vaccine products (such as Guillain-Barré syndrome)
Patients with any autoimmune disease receiving corticosteroids or immunosuppressive drugs.
Patients who have recently underwent kidney transplant.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T86.19</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other complication of kidney transplant</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Receiving a standard dose of seasonal influenzae tetravalent vaccine (15μg of Hemophilus Influenza Antigen). This 2021-2022 vaccine is inactivated and is made by the Dutch company Abbott. The brand name of this vaccine is Influvac. The viral strains of this vaccine include the following: A/Victoria/2570/2019 (H1N1)pdm09-like strainA/Cambodia/e0826360/2020 (H3N2)-like strainB/Washington/02/2019-like strainB/Phuket/3073/2013-like strain</i_keyword>
      <i_keyword>Intervention group:  Receiving a double dose of seasonal influenzae tetravalent vaccine (30μg of Hemophilus Influenza Antigen). This 2021-2022 vaccine is inactivated and is made by the Dutch company Abbott. The brand name of this vaccine is Influvac. The viral strains of this vaccine include the following: A/Victoria/2570/2019 (H1N1)pdm09-like strainA/Cambodia/e0826360/2020 (H3N2)-like strainB/Washington/02/2019-like strainB/Phuket/3073/2013-like strain</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Influenza A's Antibody. Timepoint: Before intervention and four weeks after vaccination. Method of measurement: Evaluating the influenzas' antibodies by serology.</prim_outcome>
      <prim_outcome>Influenza B's Antibody. Timepoint: Before intervention and four weeks after vaccination. Method of measurement: Evaluating the influenzas' antibodies by serology.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fever. Timepoint: 3 days after injection. Method of measurement: Clinical Examination.</sec_outcome>
      <sec_outcome>Getting the flu. Timepoint: 3 days after injection. Method of measurement: Evaluation of the patient's clinical symptoms.</sec_outcome>
      <sec_outcome>Existence of pain at the injection site. Timepoint: 3 days after injection. Method of measurement: Clinical Examination.</sec_outcome>
      <sec_outcome>Redness at the injection site. Timepoint: 3 days after injection. Method of measurement: Clinical Examination.</sec_outcome>
      <sec_outcome>Systemic side effects. Timepoint: 3 days after injection. Method of measurement: Clinical Examination.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-04-21</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Qarib Ave., Imam Khomeini hospital complex Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
