<?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>IRCT2015102124470N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-11-13</date_registration>
      <primary_sponsor>Center of Disease Control (CDC), Ministry of Health, Tehran, Iran</primary_sponsor>
      <public_title>Comparison of adverse reactions of two rabies vaccine</public_title>
      <acronym></acronym>
      <scientific_title>A comparative study on the adverse reactions of purified chick embryo cell vaccine (PCEC) and purified vero cell rabies vaccine (VERO) administered intramuscular as post exposure prophylaxis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>1800</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20648</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Rabies.</hc_freetext>
      <i_freetext>Intervention 1: In intervention group PCEC will be administered with 5 doses on days 0, 3, 7, 14, and 28, in animal bite subjects, who are classified in the second group (emergency vaccination) and third (routine vaccination against rabies serum) according to the World Health Organization's classification. Intervention 2: In control group Vero will be administered with 5 doses on days 0, 3, 7, 14, and 28, in animal bite subjects, who are classified in the second group (emergency vaccination) and third (routine vaccination against rabies serum) according to the World Health Organization's classification.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Roghieh Ramezankhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Eyvanak Blvd, Farahzadi Ave, Sanat Sq, Shahrake Qods (Gharb), Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8145 5016</telephone>
        <email>minoo.ramezani@gmail.com</email>
        <affiliation>Center of Disease Control (CDC), Ministry of Health, Tehran, Iran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Reza Shirzadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Eyvanak Blvd, Farahzadi Ave, Sanat Sq, Shahrake Qods (Gharb), Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8145 5014</telephone>
        <email>shirzadim@gmail.com</email>
        <affiliation>Center of Disease Control (CDC), Ministry of Health, Tehran, Iran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion criteria: age  between 5 and 55 years; volunteer to participate in the study. &#13;
exclusion criteria: have a history of previous animal bites; receiving  immunization against rabies previously; have a significant acute or chronic infectious disease; receiving transfusion with blood or blood products within the past month; concomitantly receiving corticosteroids or immunosuppressive drug therapy; have axillary temperature 37.5°C before injection; being pregnant in females</inclusion_criteria>
      <agemin>5 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>A82</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>animal bites</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>In intervention group PCEC will be administered with 5 doses on days 0, 3, 7, 14, and 28, in animal bite subjects, who are classified in the second group (emergency vaccination) and third (routine vaccination against rabies serum) according to the World Health Organization's classification.</i_keyword>
      <i_keyword>In control group Vero will be administered with 5 doses on days 0, 3, 7, 14, and 28, in animal bite subjects, who are classified in the second group (emergency vaccination) and third (routine vaccination against rabies serum) according to the World Health Organization's classification.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lymphadenopathy. Timepoint: 30 minutes after each injection. Method of measurement: By physician.</prim_outcome>
      <prim_outcome>Bruising. Timepoint: 30 minutes after each injection. Method of measurement: By physician.</prim_outcome>
      <prim_outcome>Ittching. Timepoint: 30 minutes after each injection. Method of measurement: By physician.</prim_outcome>
      <prim_outcome>Abscesses. Timepoint: 30 minutes after each injection. Method of measurement: b.</prim_outcome>
      <prim_outcome>Erythema. Timepoint: 30 minutes after each injection. Method of measurement: By physician.</prim_outcome>
      <prim_outcome>Swelling. Timepoint: 30 minutes after each injection. Method of measurement: By physician.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Dizziness. Timepoint: 3 day after each injection. Method of measurement: evaluate by the patirnt.</sec_outcome>
      <sec_outcome>Stomach ache. Timepoint: 3 day after each injection. Method of measurement: evaluate by the patirnt.</sec_outcome>
      <sec_outcome>Nausea. Timepoint: 3 day after each injection. Method of measurement: evaluate by the patirnt.</sec_outcome>
      <sec_outcome>Weakness. Timepoint: 3 day after each injection. Method of measurement: evaluate by the patirnt.</sec_outcome>
      <sec_outcome>Muscle aches. Timepoint: 3 day after each injection. Method of measurement: evaluate by the patirnt.</sec_outcome>
      <sec_outcome>Fever. Timepoint: 3 days after each injection. Method of measurement: evaluated daily by patients.</sec_outcome>
      <sec_outcome>Vomiting. Timepoint: 3 day after each injection. Method of measurement: evaluate by the patirnt.</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>Center of Disease Control (CDC), Ministry of Health, Tehran, Iran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-04-10</approval_date>
        <contact_name>The committee of rabies control, Ministry of Health and Medical Education, Tehran, I. R. of Iran.</contact_name>
        <contact_address>Eyvanak Blvd, Farahzadi Ave, Sanat Sq, Shahrake Qods (Gharb), Tehran, Iran. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
