<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/NCT01668745</url>
  </required_header>
  <id_info>
    <org_study_id>OPTIMUNISE_NOUNA_early MV</org_study_id>
    <nct_id>NCT01668745</nct_id>
  </id_info>
  <brief_title>Trial of Additional Measles Vaccine to Reduce Child Mortality. Burkina Faso.</brief_title>
  <official_title>A Two-site Randomised Trial of an Additional Measles Vaccine at 4 Months of Age to Reduce Child Mortality in Rural Areas of Burkina Faso and Guinea-Bissau</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bandim Health Project</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre de Recherche en Sante de Nouna, Burkina Faso</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Navrongo Health Research Centre, Ghana</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Heidelberg University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute for Public Health and the Environment, RIVM, Holland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bandim Health Project</source>
  <brief_summary>
    <textblock>
      Background: All observational studies and a few randomised controlled trials (RCT) suggest&#xD;
      that early measles vaccine (MV), in particular an early two-dose strategy, has a much better&#xD;
      effect on overall mortality than later MV. These results suggest that MV has a non-measles&#xD;
      related beneficial effect on child survival.&#xD;
&#xD;
      Objective: To evaluate in a multi-center RCT the effect on child survival and other health&#xD;
      indicators of a two-dose measles vaccination schedule by providing an additional dose of&#xD;
      Edmonston-Zagreb (EZ) MV as soon as possible after 4 months of age as well as the standard&#xD;
      measles vaccine at 9 months of age. Three trials are planned in Guinea-Bissau, Ghana and&#xD;
      Burkina Faso. The investigators will test a 40-43% reduction of mortality at each site&#xD;
      separately and a 32% reduction overall. Based on the results from the RCT, the investigators&#xD;
      will assess the cost-effectiveness of the intervention.&#xD;
&#xD;
      Design, Burkina Faso: Newborns are followed through the Health and Demographic Surveillance&#xD;
      System (HDSS) of the Centre de Recherche en Sante de Nouna. Information on routine and&#xD;
      campaign vaccinations will be collected regularly through home visits and health centre&#xD;
      registers. Four weeks after having received the third dose of pentavalent vaccine (Penta3),&#xD;
      the children will be eligible for enrollment in the trial if they are not severely ill.&#xD;
      Eligible children will be invited to take part in the trial. Provided parental informed&#xD;
      consent is given, the children will be randomised to MV at 4 and 9 months of age or only at 9&#xD;
      months. Cost estimates will be based on consumption of services and average cost per unit.&#xD;
      The incremental cost effectiveness ratio will be calculated.&#xD;
&#xD;
      Sample size, follow-up and analyses: To detect a 43% reduction in overall mortality at each&#xD;
      site the investigators intend to enroll at least 4050 children in Burkina Faso. The children&#xD;
      will be followed for survival and hospitalisations to 3 years of age or to the end of the&#xD;
      study after three years. The investigators will analyse the effects by site and combined; by&#xD;
      sex and season; possible interactions with other interventions like campaigns with drugs,&#xD;
      vaccines or micronutrients will be explored.&#xD;
&#xD;
      Antibody study: 450 children will be enrolled in a subgroup study to examine the effect of&#xD;
      maternal antibody levels on subsequent antibody responses to MV. The children will be&#xD;
      followed to 24 months of age and samples collected at 4, 9 and 24 months of age.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2013</start_date>
  <completion_date type="Anticipated">March 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>4 months - 3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>4 to 9 months of age and from 9 months to 3 years of age</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morbidity</measure>
    <time_frame>4 months - 3 years of age</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Growth</measure>
    <time_frame>4 months to 3 years of age</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antibody titres</measure>
    <time_frame>9 months to 3 years of age</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Immunological markers</measure>
    <time_frame>9 months to 3 years of age</time_frame>
    <description>Provided funding becomes available</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">4050</enrollment>
  <condition>Measles Vaccine</condition>
  <arm_group>
    <arm_group_label>Early measles vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention is about to administer an early standard dose of Edmonston-Zagreb (EZ) measles vaccine in addition to the conventional dose. As such children will be randomised to receive either an early measles vaccine at 4 months after DTP3 or not. Thereafter both groups of children will receive the recommended EZ measles vaccine at 9 months of age according to WHO policy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Early measles vaccine</intervention_name>
    <arm_group_label>Early measles vaccine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Children who&#xD;
&#xD;
          -  received the third dose of pentavalent vaccine at least 28 days before enrolment&#xD;
&#xD;
          -  are between 4 and 6 months old&#xD;
&#xD;
          -  belong to households of the existing HDSS&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Children&#xD;
&#xD;
          -  with serious malformation&#xD;
&#xD;
          -  who are severely sick (needing hospitalisation)&#xD;
&#xD;
          -  with high fever (&gt;38.5 C axillary temperature)&#xD;
&#xD;
          -  who are severely malnourished (mid-upper-arm-circumference (MUAC) &lt; 110 mm and/or&#xD;
             bilateral peripheral oedema)&#xD;
&#xD;
          -  who have received neonatal vitamin A supplementation&#xD;
&#xD;
          -  whose parents/guardians state that they intend to permanently move out of the study&#xD;
             area before the child reaches 9 months of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Months</minimum_age>
    <maximum_age>6 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ali Sié, MD</last_name>
    <phone>+22620537043</phone>
    <email>alisie.crsn@fasonet.bf</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maurice Yé, MD</last_name>
    <phone>+22670244811</phone>
    <email>yemaure@yahoo.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre de Recherche en Sante de Nouna</name>
      <address>
        <city>Nouna</city>
        <country>Burkina Faso</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ali Sie, MD, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Burkina Faso</country>
  </location_countries>
  <reference>
    <citation>Aaby P, Martins CL, Garly ML, Bale C, Andersen A, Rodrigues A, Ravn H, Lisse IM, Benn CS, Whittle HC. Non-specific effects of standard measles vaccine at 4.5 and 9 months of age on childhood mortality: randomised controlled trial. BMJ. 2010 Nov 30;341:c6495. doi: 10.1136/bmj.c6495.</citation>
    <PMID>21118875</PMID>
  </reference>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>August 6, 2014</last_update_submitted>
  <last_update_submitted_qc>August 6, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 7, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Child mortality</keyword>
  <keyword>Measles vaccine</keyword>
  <keyword>Non-specific effects</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Measles</mesh_term>
  </condition_browse>
  <!-- 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/NCT01668745
org study id: OPTIMUNISE_NOUNA_early MV
nct id: NCT01668745
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
Background: All observational studies and a few randomised controlled trials (RCT) suggest
      that early measles vaccine (MV), in particular an early two-dose strategy, has a much better
      effect on overall mortality than later MV. These results suggest that MV has a non-measles
      related beneficial effect on child survival.

      Objective: To evaluate in a multi-center RCT the effect on child survival and other health
      indicators of a two-dose measles vaccination schedule by providing an additional dose of
      Edmonston-Zagreb (EZ) MV as soon as possible after 4 months of age as well as the standard
      measles vaccine at 9 months of age. Three trials are planned in Guinea-Bissau, Ghana and
      Burkina Faso. The investigators will test a 40-43% reduction of mortality at each site
      separately and a 32% reduction overall. Based on the results from the RCT, the investigators
      will assess the cost-effectiveness of the intervention.

      Design, Burkina Faso: Newborns are followed through the Health and Demographic Surveillance
      System (HDSS) of the Centre de Recherche en Sante de Nouna. Information on routine and
      campaign vaccinations will be collected regularly through home visits and health centre
      registers. Four weeks after having received the third dose of pentavalent vaccine (Penta3),
      the children will be eligible for enrollment in the trial if they are not severely ill.
      Eligible children will be invited to take part in the trial. Provided parental informed
      consent is given, the children will be randomised to MV at 4 and 9 months of age or only at 9
      months. Cost estimates will be based on consumption of services and average cost per unit.
      The incremental cost effectiveness ratio will be calculated.

      Sample size, follow-up and analyses: To detect a 43% reduction in overall mortality at each
      site the investigators intend to enroll at least 4050 children in Burkina Faso. The children
      will be followed for survival and hospitalisations to 3 years of age or to the end of the
      study after three years. The investigators will analyse the effects by site and combined; by
      sex and season; possible interactions with other interventions like campaigns with drugs,
      vaccines or micronutrients will be explored.

      Antibody study: 450 children will be enrolled in a subgroup study to examine the effect of
      maternal antibody levels on subsequent antibody responses to MV. The children will be
      followed to 24 months of age and samples collected at 4, 9 and 24 months of age.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Mortality
time frame: 4 months - 3 years
measure: Mortality
time frame: 4 to 9 months of age and from 9 months to 3 years of age
measure: Morbidity
time frame: 4 months - 3 years of age
measure: Growth
time frame: 4 months to 3 years of age
measure: Antibody titres
time frame: 9 months to 3 years of age
measure: Immunological markers
time frame: 9 months to 3 years of age
description: Provided funding becomes available
arm group label: Early measles vaccine
arm group type: Experimental
description: The intervention is about to administer an early standard dose of Edmonston-Zagreb (EZ) measles vaccine in addition to the conventional dose. As such children will be randomised to receive either an early measles vaccine at 4 months after DTP3 or not. Thereafter both groups of children will receive the recommended EZ measles vaccine at 9 months of age according to WHO policy.
arm group label: Control
arm group type: No Intervention
intervention type: Biological
intervention name: Early measles vaccine
arm group label: Early measles vaccine
criteria: 
gender: All
minimum age: 4 Months
maximum age: 6 Months
healthy volunteers: No
last name: Ali Sié, MD
phone: +22620537043
email: alisie.crsn@fasonet.bf
last name: Maurice Yé, MD
phone: +22670244811
email: yemaure@yahoo.fr
facility: 
status: Recruiting
contact: 
country: Burkina Faso
citation: Aaby P, Martins CL, Garly ML, Bale C, Andersen A, Rodrigues A, Ravn H, Lisse IM, Benn CS, Whittle HC. Non-specific effects of standard measles vaccine at 4.5 and 9 months of age on childhood mortality: randomised controlled trial. BMJ. 2010 Nov 30;341:c6495. doi: 10.1136/bmj.c6495.
PMID: 21118875
responsible party type: Sponsor
mesh term: Measles