<?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>IRCT201409042639N14</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-10-10</date_registration>
      <primary_sponsor>Research Deputy of Shahid Sadoughi University of Medical Sciences , Yazd, Iran</primary_sponsor>
      <public_title>Effect of the order of injecting 18th month of age vaccines on pain</public_title>
      <acronym></acronym>
      <scientific_title>Clinical trial of evaluation of 18th month of age vaccines injection order (intramuscular first and then subcutaneous or subcutaneous first and then intramuscular) on pain of intramuscular injection of diphtheria, pertussis and tetanus vaccine</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-08-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/2446</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Other design features: The children in this trial will be  randomized by random numbers  table.</study_design>
      <phase>1</phase>
      <hc_freetext>vaccination.</hc_freetext>
      <i_freetext>Intervention 1: intramuscular injection of a single dose of DPT (diphtheria, pertussis and tetanus) vaccine and then subcutaneous injection of a single dose of  combination of measles, mumps and rubella vaccines. Intervention 2: subcutaneous injection of a single dose of combination of measles, mumps and rubella vaccines and then intramuscular injection of a single dose of DPT (diphtheria, pertussis and tetanus) vaccine.</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>Dr. Hosein Gholami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Sadoughi Hospital , Ave - Sina Blvd, Shahid Ghandi  Blvd, Yazd, I.R.Iran</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 35 1822 4000</telephone>
        <email>hgholami26@yahoo.com</email>
        <affiliation>Shahid Sadoughi University of Medical Sciences , Yazd , Iran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Razieh Fallah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Sadoughi Hospital , Ave - Sina Blvd, Shahid Ghandi  Blvd, Yazd, I.R.Iran</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 35 1822 4000</telephone>
        <email>FALLAH@ssu.ac.ir</email>
        <affiliation>Shahid Sadoughi University of Medical Sciences , Yazd , Iran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 18 months of age, being in a healthy medical condition and referring for vaccination to primary health care center&#13;
Exclusion criteria: neurodevelopmental delay, severe congenital malformation and receiving sedative hypnotic drugs within the past 24 hours</inclusion_criteria>
      <agemin>1 year</agemin>
      <agemax>1 year</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z27</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Need for immunization against combinations of infectious diseases</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intramuscular injection of a single dose of DPT (diphtheria, pertussis and tetanus) vaccine and then subcutaneous injection of a single dose of  combination of measles, mumps and rubella vaccines</i_keyword>
      <i_keyword>subcutaneous injection of a single dose of combination of measles, mumps and rubella vaccines and then intramuscular injection of a single dose of DPT (diphtheria, pertussis and tetanus) vaccine</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score during diphtheria, pertussis and tetanus (DPT) vaccine injection. Timepoint: time of  needle insertion to skin. Method of measurement: Modified Behavioral Pain Scale table.</prim_outcome>
      <prim_outcome>Pain score during measles, mumps and rubella (MMR) vaccine injection. Timepoint: time of measles, mumps and rubella (MMR) vaccine injection. Method of measurement: Modified Behavioral Pain Scale table.</prim_outcome>
      <prim_outcome>Obtaining of pain score of less than four during diphtheria, pertussis and tetanus (DPT) vaccine  injection. Timepoint: time of  diphtheria, pertussis and tetanus (DPT) vaccine injection. Method of measurement: Modified Behavioral Pain Scale table.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of baby crying after injection of  DPT vaccine. Timepoint: every 10 seconds after vaccine injection until stopping of crying. Method of measurement: by chronometer.</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>Research Deputy of Shahid Sadoughi University of Medical Sciences , Yazd, Iran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-08-24</approval_date>
        <contact_name>Ethics committee of Shahid Sadoughi University of Medical Sciences, Yazd, Iran</contact_name>
        <contact_address>central building of university, Bahonar square Yazd  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
