<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/NCT03792022</url>
  </required_header>
  <id_info>
    <org_study_id>002</org_study_id>
    <nct_id>NCT03792022</nct_id>
  </id_info>
  <brief_title>Timeliness and Completeness of Routine Childhood Vaccinations by 2 Years of Age in Nigeria.</brief_title>
  <official_title>Fully Vaccinated Yet Under-vaccinated: Timeliness and Completeness of Routine Childhood Vaccinations by 2 Years of Age in Nigeria</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lifespan Healthcare Resource Limited</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bill and Melinda Gates Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Lifespan Healthcare Resource Limited</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The timeliness of routine childhood immunization should be an important component in&#xD;
      measuring vaccination coverage rates especially in LMIC countries like Nigeria, yet this is&#xD;
      overlooked. This study will determine the age- specific immunization timely uptake rates for&#xD;
      the various vaccines covered in the routine childhood immunization and seek out factors that&#xD;
      affect timely vaccine uptake among Nigerian children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will determine the extent of timely and complete routine childhood vaccination&#xD;
      uptake in Nigeria. The investigators will also seek to understand the factors that influence&#xD;
      timely/complete uptake and make recommendations. this study will also determine if the&#xD;
      present immunization records system in Nigeria is capable of measuring timely immunization&#xD;
      uptake.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 10, 2019</start_date>
  <completion_date type="Anticipated">April 2, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Age specific timely vaccination rate for all vaccines in routine vaccination schedule</measure>
    <time_frame>24 months</time_frame>
    <description>The primary outcome measure, age- appropriate immunization is defined as receipt of a scheduled vaccine dose within 30 days of the recommended age. Timeliness will be calculated using child health card data as at 31st December 2018. Descriptive statistics will be produced to describe the characteristics of the sample using frequencies and proportions. Descriptive outcome measures for each dose will be coded as either 'no delay'- age appropriately immunized, delay of 1-6 months' , 'delay greater than 6 months', vaccine received 'acceptably early' (within 30 days prior to when it was due), vaccines received 'too early' (within 30 days prior to when it was due) or vaccine dose not recorded.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1800</enrollment>
  <condition>Vaccination Failure</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>Adherence to timely vaccine uptake</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Adherence to timely vaccine uptake</intervention_name>
    <description>Adherence to timely vaccine uptake</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Vaccination records of children who have attended immunization clinics for the last 24&#xD;
        months.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Received all vaccines Available immunization records&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Did not receive all vaccines Non- available immunization records&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>24 Months</maximum_age>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 31, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>December 31, 2018</last_update_submitted>
  <last_update_submitted_qc>December 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lifespan Healthcare Resource Limited</investigator_affiliation>
    <investigator_full_name>Dr.Ihedioha Emmanuel Chukwunwike</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03792022
org study id: 002
nct id: NCT03792022
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The timeliness of routine childhood immunization should be an important component in
      measuring vaccination coverage rates especially in LMIC countries like Nigeria, yet this is
      overlooked. This study will determine the age- specific immunization timely uptake rates for
      the various vaccines covered in the routine childhood immunization and seek out factors that
      affect timely vaccine uptake among Nigerian children.
This study will determine the extent of timely and complete routine childhood vaccination
      uptake in Nigeria. The investigators will also seek to understand the factors that influence
      timely/complete uptake and make recommendations. this study will also determine if the
      present immunization records system in Nigeria is capable of measuring timely immunization
      uptake.
observational model: Cohort
time perspective: Retrospective
measure: Age specific timely vaccination rate for all vaccines in routine vaccination schedule
time frame: 24 months
description: The primary outcome measure, age- appropriate immunization is defined as receipt of a scheduled vaccine dose within 30 days of the recommended age. Timeliness will be calculated using child health card data as at 31st December 2018. Descriptive statistics will be produced to describe the characteristics of the sample using frequencies and proportions. Descriptive outcome measures for each dose will be coded as either 'no delay'- age appropriately immunized, delay of 1-6 months' , 'delay greater than 6 months', vaccine received 'acceptably early' (within 30 days prior to when it was due), vaccines received 'too early' (within 30 days prior to when it was due) or vaccine dose not recorded.
arm group label: Group 1
description: Adherence to timely vaccine uptake
intervention type: Behavioral
intervention name: Adherence to timely vaccine uptake
description: Adherence to timely vaccine uptake
arm group label: Group 1
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 24 Months
responsible party type: Principal Investigator
investigator affiliation: Lifespan Healthcare Resource Limited
investigator full name: Dr.Ihedioha Emmanuel Chukwunwike
investigator title: Principal Investigator
sharing ipd: No