<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/NCT02991495</url>
  </required_header>
  <id_info>
    <org_study_id>YEFE_2017</org_study_id>
    <nct_id>NCT02991495</nct_id>
  </id_info>
  <brief_title>Immunogenicity and Safety of Fractional Doses of Yellow Fever Vaccines (YEFE)</brief_title>
  <acronym>YEFE</acronym>
  <official_title>A Randomized, Blinded Non-inferiority Trial on the Immunogenicity and Safety of Fractional Doses of Yellow Fever Vaccines in Kenya and Uganda</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Epicentre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kenya Medical Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Epicentre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In July 2016, the demand for yellow fever vaccines in response to the large urban outbreaks&#xD;
      occurring concurrently and the risk of further spread through the African continent and even&#xD;
      to Asia, was larger than the available supply. In this situation, the World Health&#xD;
      Organization (WHO) developed recommendations for the use of fractional-dose of yellow fever&#xD;
      vaccine as a dose-sparing strategy. These recommendations were based on limited number of&#xD;
      clinical trials and additional studies should assess the applicability of the fractional dose&#xD;
      to all WHO-prequalified vaccines, the persistence of neutralizing antibodies and the&#xD;
      performance of the fractional dose in young children and populations in Africa including&#xD;
      those with HIV.&#xD;
&#xD;
      This study aims to respond to some of the research questions that would allow broadening the&#xD;
      recommendations on the use of fractional doses of yellow fever vaccine in emergency&#xD;
      situations. The study will be conducted in Uganda and Kenya and the main objective is to&#xD;
      assess the non-inferiority is seroconversion 28 days after vaccination of a fractional dose&#xD;
      compared to full dose for each WHO-prequalified manufacturer. As secondary objectives the&#xD;
      study will assess seroprotection 10 days and 1 year after vaccination, to assess rapidity and&#xD;
      persistence of protective antibody levels; describe the geometric mean titre and the change&#xD;
      in neutralizing antibody on Day 28 days after vaccination with fractional and full doses; and&#xD;
      assess the occurrence of adverse events and serious adverse events (SAE) during 28 days after&#xD;
      administration of fractional and full doses.&#xD;
&#xD;
      The study consists of a randomized non-inferiority trial. The study aims to start in April&#xD;
      2017 in the two sites and aims to recruit 960 adults. Results for the main outcome will be&#xD;
      reviewed by the study Data and Safety Monitoring Board and one vaccine will be selected for&#xD;
      the studies in children and HIV positive adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Yellow fever (YF) is a mosquito-borne viral disease that is endemic in 34 countries in the&#xD;
      African region and 14 in South America. YF virus infection can be asymptomatic or cause a&#xD;
      wide spectrum of disease, from mild symptoms to severe, potentially lethal illness with&#xD;
      jaundice, renal failure and haemorrhage. The vast majority of reported cases and deaths occur&#xD;
      in sub-Saharan Africa where yellow fever is a major health problem occurring in epidemic&#xD;
      patterns. There is no specific treatment for yellow fever infection. However, YF vaccine is&#xD;
      shown to be very effective for outbreak control as well as for the prevention of outbreaks.&#xD;
      YF vaccination confers protection in most vaccinated individuals and this is considered to be&#xD;
      life-long.&#xD;
&#xD;
      In 2016, YF outbreaks occurred in Africa (Angola, Democratic Republic of Congo (DRC) and&#xD;
      Uganda) as well as in South America (Brazil, Colombia and Peru). Factors such increased&#xD;
      urbanization in poor areas without proper water and sanitation systems and population&#xD;
      movements, have the potential to contribute to increasing incidence of yellow fever and large&#xD;
      epidemics. In July 2016, the demand for yellow fever vaccines in response to the large urban&#xD;
      outbreaks occurring concurrently and the risk of further spread through the African continent&#xD;
      and even to Asia, was larger than the available supply. In this situation, the World Health&#xD;
      Organization (WHO) developed recommendations for the use of fractional-dose of yellow fever&#xD;
      vaccine as a dose-sparing strategy. This strategy consisted on delivering 1/5th of the&#xD;
      conventional dose and was used to vaccinate over 7 million people in Kinshasa, the capital&#xD;
      city of DRC.&#xD;
&#xD;
      The evidence to recommend the use of fractional dosing was based on a limited number of&#xD;
      clinical studies. However this was considered sufficient to provide emergency&#xD;
      recommendations. In order to broaden and also possibly simplify WHO recommendations of&#xD;
      fractional dose use in case of need for emergency campaigns, additional data is needed to&#xD;
      respond to the important data gaps. These include the applicability of the fractional dose to&#xD;
      all WHO-prequalified vaccines, the persistence of neutralizing antibodies and the performance&#xD;
      of the fractional dose in young children and populations in Africa including those with HIV.&#xD;
      Following these data gaps, WHO called for research to be conducted.&#xD;
&#xD;
      This study aims to respond to some of the research questions that would allow to broaden the&#xD;
      recommendations on the use of fractional doses of yellow fever vaccine in emergency&#xD;
      situations. The study will be conducted in Uganda and Kenya and the main objective is to&#xD;
      assess the non-inferiority is seroconversion 28 days after vaccination of a fractional dose&#xD;
      compared to full dose for each manufacturer. As secondary objectives the study will assess&#xD;
      seroprotection 10 days and 1 year after vaccination, to assess rapidity and persistence of&#xD;
      protective antibody levels; describe the geometric mean titre and the change in neutralizing&#xD;
      antibody on Day 28 after vaccination with fractional and full doses; and assess the&#xD;
      occurrence of adverse events and serious adverse events (SAE) during 28 days after&#xD;
      administration of fractional and full doses. The study aims to recruit 960 adults (480 in&#xD;
      Mbarara, Uganda, and 480 in Kilifi, Kenya). Results for the main outcome will be reviewed by&#xD;
      the study Data and Safety Monitoring Board (DSMB) and if results are considered satisfactory,&#xD;
      the study will continue with the recruitment of 420 children in Uganda and 250 HIV infected&#xD;
      adults in Kenya, to assess non-inferiority of one of the WHO prequalified vaccines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 6, 2017</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">February 21, 2018</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Seroconversion by PRNT50 (Plaque Reduction Neutralization Test 50 value)</measure>
    <time_frame>28 days post-vaccination</time_frame>
    <description>Plaque reduction neutralization test will be used to quantify the titer of neutralising antibody for the virus</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of protection by PRNT50 (Plaque Reduction Neutralization Test 50 value)</measure>
    <time_frame>10 days post-vaccination</time_frame>
    <description>Plaque reduction neutralization test will be used to quantify the titer of neutralising antibody for the virus</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of immunity</measure>
    <time_frame>1 year post-vaccination</time_frame>
    <description>Assessment of duration of immunity at 1 year after vaccination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of adverse events and serious adverse events</measure>
    <time_frame>28 days post-vaccination</time_frame>
  </secondary_outcome>
  <number_of_arms>12</number_of_arms>
  <enrollment type="Actual">1630</enrollment>
  <condition>Yellow Fever</condition>
  <arm_group>
    <arm_group_label>Stamaril, Sanofi Pasteur: Standard dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subcutaneous administration of 1 dose of a standard yellow fever vaccine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stamaril, Sanofi Pasteur: Fractional dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subcutaneous administration of 1/5th of a standard dose of yellow fever vaccine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Yellow fever vaccine, Bio-Manguinhos: Standard dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subcutaneous administration of 1 dose of a standard yellow fever vaccine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Yellow fever vaccine, Bio-Manguinhos: Fractional dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subcutaneous administration of 1/5th of a standard dose of yellow fever vaccine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Yellow fever vaccine, Institut Pasteur: Standard dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subcutaneous administration of 1 dose of a standard yellow fever vaccine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Yellow fever vaccine, Institut Pasteur: Fractional dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subcutaneous administration of 1/5th of a standard dose of yellow fever vaccine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Yellow fever vaccine, Chumakov Institute: Standard dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subcutaneous administration of 1 dose of a standard yellow fever vaccine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Yellow fever vaccine, Chumakov Institute: Fractional dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subcutaneous administration of 1/5th of a standard dose of yellow fever vaccine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>YF, Chumakov Institute: Standard dose in Children</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subcutaneous administration of 1 dose of the yellow fever vaccine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>YF, Chumakov Institute: Fractional dose in Children</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subcutaneous administration of 1/5th of a standard dose of yellow fever vaccine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>YF, Chumakov Institute: Standard dose in HIV+ adults</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subcutaneous administration of 1 dose of the yellow fever vaccine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>YF, Chumakov Institute: Fractional dose in HIV+ adults</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subcutaneous administration of 1/5th of a standard dose of yellow fever vaccine</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Stamaril, Sanofi Pasteur</intervention_name>
    <description>Full dose&#xD;
Fractional dose: one fifth (1/5)</description>
    <arm_group_label>Stamaril, Sanofi Pasteur: Fractional dose</arm_group_label>
    <arm_group_label>Stamaril, Sanofi Pasteur: Standard dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Yellow fever vaccine, Bio-Manguinhos</intervention_name>
    <description>Full dose&#xD;
Fractional dose: one fifth (1/5)</description>
    <arm_group_label>Yellow fever vaccine, Bio-Manguinhos: Fractional dose</arm_group_label>
    <arm_group_label>Yellow fever vaccine, Bio-Manguinhos: Standard dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Yellow fever vaccine, Institut Pasteur</intervention_name>
    <description>Full dose&#xD;
Fractional dose: one fifth (1/5)</description>
    <arm_group_label>Yellow fever vaccine, Institut Pasteur: Fractional dose</arm_group_label>
    <arm_group_label>Yellow fever vaccine, Institut Pasteur: Standard dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Yellow fever vaccine, Chumakov Institute</intervention_name>
    <description>Full dose&#xD;
Fractional dose: one fifth (1/5)</description>
    <arm_group_label>Yellow fever vaccine, Chumakov Institute: Fractional dose</arm_group_label>
    <arm_group_label>Yellow fever vaccine, Chumakov Institute: Standard dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Yellow fever vaccine, Chumakov Institute</intervention_name>
    <description>Full dose&#xD;
Fractional dose: one fifth (1/5)</description>
    <arm_group_label>YF, Chumakov Institute: Fractional dose in Children</arm_group_label>
    <arm_group_label>YF, Chumakov Institute: Standard dose in Children</arm_group_label>
    <other_name>Children sub-study</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Yellow fever vaccine, Chumakov Institute</intervention_name>
    <description>Full dose&#xD;
Fractional dose: one fifth (1/5)</description>
    <arm_group_label>YF, Chumakov Institute: Fractional dose in HIV+ adults</arm_group_label>
    <arm_group_label>YF, Chumakov Institute: Standard dose in HIV+ adults</arm_group_label>
    <other_name>HIV + adults</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults population: 18 to 60 years of age&#xD;
&#xD;
          -  Children population: 9 to 59 months of age&#xD;
&#xD;
          -  For HIV positive population: HIV positive on serological testing&#xD;
&#xD;
          -  If HIV infection, CD4 T-cell counts ≥200 cells/mm³ for adults or CD4 percentage &gt;25%&#xD;
             for children&#xD;
&#xD;
          -  Providing informed consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to yellow fever vaccination:&#xD;
&#xD;
          -  History of yellow fever vaccination&#xD;
&#xD;
          -  Previous yellow fever infection&#xD;
&#xD;
          -  Requiring yellow fever vaccination for travelling purposes&#xD;
&#xD;
          -  Pregnancy (as determined by a urine test on the proposed day of vaccination) and&#xD;
             lactating women&#xD;
&#xD;
          -  Refusal to participate in the study&#xD;
&#xD;
          -  Planning to move out of the study area before the end of the study follow-up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Months</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>KEMRI</name>
      <address>
        <city>Kilifi</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Epicentre</name>
      <address>
        <city>Mbarara</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kenya</country>
    <country>Uganda</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>January 31, 2022</last_update_submitted>
  <last_update_submitted_qc>January 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Epidemic response</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Yellow Fever</mesh_term>
    <mesh_term>Fever</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02991495
org study id: YEFE_2017
nct id: NCT02991495
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In July 2016, the demand for yellow fever vaccines in response to the large urban outbreaks
      occurring concurrently and the risk of further spread through the African continent and even
      to Asia, was larger than the available supply. In this situation, the World Health
      Organization (WHO) developed recommendations for the use of fractional-dose of yellow fever
      vaccine as a dose-sparing strategy. These recommendations were based on limited number of
      clinical trials and additional studies should assess the applicability of the fractional dose
      to all WHO-prequalified vaccines, the persistence of neutralizing antibodies and the
      performance of the fractional dose in young children and populations in Africa including
      those with HIV.

      This study aims to respond to some of the research questions that would allow broadening the
      recommendations on the use of fractional doses of yellow fever vaccine in emergency
      situations. The study will be conducted in Uganda and Kenya and the main objective is to
      assess the non-inferiority is seroconversion 28 days after vaccination of a fractional dose
      compared to full dose for each WHO-prequalified manufacturer. As secondary objectives the
      study will assess seroprotection 10 days and 1 year after vaccination, to assess rapidity and
      persistence of protective antibody levels; describe the geometric mean titre and the change
      in neutralizing antibody on Day 28 days after vaccination with fractional and full doses; and
      assess the occurrence of adverse events and serious adverse events (SAE) during 28 days after
      administration of fractional and full doses.

      The study consists of a randomized non-inferiority trial. The study aims to start in April
      2017 in the two sites and aims to recruit 960 adults. Results for the main outcome will be
      reviewed by the study Data and Safety Monitoring Board and one vaccine will be selected for
      the studies in children and HIV positive adults.
Yellow fever (YF) is a mosquito-borne viral disease that is endemic in 34 countries in the
      African region and 14 in South America. YF virus infection can be asymptomatic or cause a
      wide spectrum of disease, from mild symptoms to severe, potentially lethal illness with
      jaundice, renal failure and haemorrhage. The vast majority of reported cases and deaths occur
      in sub-Saharan Africa where yellow fever is a major health problem occurring in epidemic
      patterns. There is no specific treatment for yellow fever infection. However, YF vaccine is
      shown to be very effective for outbreak control as well as for the prevention of outbreaks.
      YF vaccination confers protection in most vaccinated individuals and this is considered to be
      life-long.

      In 2016, YF outbreaks occurred in Africa (Angola, Democratic Republic of Congo (DRC) and
      Uganda) as well as in South America (Brazil, Colombia and Peru). Factors such increased
      urbanization in poor areas without proper water and sanitation systems and population
      movements, have the potential to contribute to increasing incidence of yellow fever and large
      epidemics. In July 2016, the demand for yellow fever vaccines in response to the large urban
      outbreaks occurring concurrently and the risk of further spread through the African continent
      and even to Asia, was larger than the available supply. In this situation, the World Health
      Organization (WHO) developed recommendations for the use of fractional-dose of yellow fever
      vaccine as a dose-sparing strategy. This strategy consisted on delivering 1/5th of the
      conventional dose and was used to vaccinate over 7 million people in Kinshasa, the capital
      city of DRC.

      The evidence to recommend the use of fractional dosing was based on a limited number of
      clinical studies. However this was considered sufficient to provide emergency
      recommendations. In order to broaden and also possibly simplify WHO recommendations of
      fractional dose use in case of need for emergency campaigns, additional data is needed to
      respond to the important data gaps. These include the applicability of the fractional dose to
      all WHO-prequalified vaccines, the persistence of neutralizing antibodies and the performance
      of the fractional dose in young children and populations in Africa including those with HIV.
      Following these data gaps, WHO called for research to be conducted.

      This study aims to respond to some of the research questions that would allow to broaden the
      recommendations on the use of fractional doses of yellow fever vaccine in emergency
      situations. The study will be conducted in Uganda and Kenya and the main objective is to
      assess the non-inferiority is seroconversion 28 days after vaccination of a fractional dose
      compared to full dose for each manufacturer. As secondary objectives the study will assess
      seroprotection 10 days and 1 year after vaccination, to assess rapidity and persistence of
      protective antibody levels; describe the geometric mean titre and the change in neutralizing
      antibody on Day 28 after vaccination with fractional and full doses; and assess the
      occurrence of adverse events and serious adverse events (SAE) during 28 days after
      administration of fractional and full doses. The study aims to recruit 960 adults (480 in
      Mbarara, Uganda, and 480 in Kilifi, Kenya). Results for the main outcome will be reviewed by
      the study Data and Safety Monitoring Board (DSMB) and if results are considered satisfactory,
      the study will continue with the recruitment of 420 children in Uganda and 250 HIV infected
      adults in Kenya, to assess non-inferiority of one of the WHO prequalified vaccines.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Seroconversion by PRNT50 (Plaque Reduction Neutralization Test 50 value)
time frame: 28 days post-vaccination
description: Plaque reduction neutralization test will be used to quantify the titer of neutralising antibody for the virus
measure: Assessment of protection by PRNT50 (Plaque Reduction Neutralization Test 50 value)
time frame: 10 days post-vaccination
description: Plaque reduction neutralization test will be used to quantify the titer of neutralising antibody for the virus
measure: Duration of immunity
time frame: 1 year post-vaccination
description: Assessment of duration of immunity at 1 year after vaccination
measure: Assessment of adverse events and serious adverse events
time frame: 28 days post-vaccination
arm group label: Stamaril, Sanofi Pasteur: Standard dose
arm group type: Active Comparator
description: Subcutaneous administration of 1 dose of a standard yellow fever vaccine
arm group label: Stamaril, Sanofi Pasteur: Fractional dose
arm group type: Experimental
description: Subcutaneous administration of 1/5th of a standard dose of yellow fever vaccine
arm group label: Yellow fever vaccine, Bio-Manguinhos: Standard dose
arm group type: Active Comparator
description: Subcutaneous administration of 1 dose of a standard yellow fever vaccine
arm group label: Yellow fever vaccine, Bio-Manguinhos: Fractional dose
arm group type: Experimental
description: Subcutaneous administration of 1/5th of a standard dose of yellow fever vaccine
arm group label: Yellow fever vaccine, Institut Pasteur: Standard dose
arm group type: Active Comparator
description: Subcutaneous administration of 1 dose of a standard yellow fever vaccine
arm group label: Yellow fever vaccine, Institut Pasteur: Fractional dose
arm group type: Experimental
description: Subcutaneous administration of 1/5th of a standard dose of yellow fever vaccine
arm group label: Yellow fever vaccine, Chumakov Institute: Standard dose
arm group type: Active Comparator
description: Subcutaneous administration of 1 dose of a standard yellow fever vaccine
arm group label: Yellow fever vaccine, Chumakov Institute: Fractional dose
arm group type: Experimental
description: Subcutaneous administration of 1/5th of a standard dose of yellow fever vaccine
arm group label: YF, Chumakov Institute: Standard dose in Children
arm group type: Active Comparator
description: Subcutaneous administration of 1 dose of the yellow fever vaccine
arm group label: YF, Chumakov Institute: Fractional dose in Children
arm group type: Experimental
description: Subcutaneous administration of 1/5th of a standard dose of yellow fever vaccine
arm group label: YF, Chumakov Institute: Standard dose in HIV+ adults
arm group type: Active Comparator
description: Subcutaneous administration of 1 dose of the yellow fever vaccine
arm group label: YF, Chumakov Institute: Fractional dose in HIV+ adults
arm group type: Experimental
description: Subcutaneous administration of 1/5th of a standard dose of yellow fever vaccine
intervention type: Biological
intervention name: Stamaril, Sanofi Pasteur
description: Full dose
Fractional dose: one fifth (1/5)
arm group label: Stamaril, Sanofi Pasteur: Fractional dose
arm group label: Stamaril, Sanofi Pasteur: Standard dose
intervention type: Biological
intervention name: Yellow fever vaccine, Bio-Manguinhos
description: Full dose
Fractional dose: one fifth (1/5)
arm group label: Yellow fever vaccine, Bio-Manguinhos: Fractional dose
arm group label: Yellow fever vaccine, Bio-Manguinhos: Standard dose
intervention type: Biological
intervention name: Yellow fever vaccine, Institut Pasteur
description: Full dose
Fractional dose: one fifth (1/5)
arm group label: Yellow fever vaccine, Institut Pasteur: Fractional dose
arm group label: Yellow fever vaccine, Institut Pasteur: Standard dose
intervention type: Biological
intervention name: Yellow fever vaccine, Chumakov Institute
description: Full dose
Fractional dose: one fifth (1/5)
arm group label: Yellow fever vaccine, Chumakov Institute: Fractional dose
arm group label: Yellow fever vaccine, Chumakov Institute: Standard dose
intervention type: Biological
intervention name: Yellow fever vaccine, Chumakov Institute
description: Full dose
Fractional dose: one fifth (1/5)
arm group label: YF, Chumakov Institute: Fractional dose in Children
arm group label: YF, Chumakov Institute: Standard dose in Children
other name: Children sub-study
intervention type: Biological
intervention name: Yellow fever vaccine, Chumakov Institute
description: Full dose
Fractional dose: one fifth (1/5)
arm group label: YF, Chumakov Institute: Fractional dose in HIV+ adults
arm group label: YF, Chumakov Institute: Standard dose in HIV+ adults
other name: HIV + adults
criteria: 
gender: All
minimum age: 9 Months
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: Kenya
country: Uganda
responsible party type: Sponsor
mesh term: Yellow Fever
mesh term: Fever
mesh term: Vaccines
sharing ipd: Undecided