<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/NCT02972957</url>
  </required_header>
  <id_info>
    <org_study_id>SCC 1502</org_study_id>
    <nct_id>NCT02972957</nct_id>
  </id_info>
  <brief_title>A Study of Intranasal Live Attenuated Influenza Vaccine Immunogenicity and Associations With the Nasopharyngeal Microbiome Among Children in the Gambia</brief_title>
  <acronym>NASIMMUNE</acronym>
  <official_title>A Study of Intranasal Live Attenuated Influenza Vaccine Immunogenicity and Associations With the Nasopharyngeal Microbiome Among Children in the Gambia - The NASIMMUNE Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>London School of Hygiene and Tropical Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Edinburgh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Public Health England</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute for Public Health and the Environment (RIVM)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>London School of Hygiene and Tropical Medicine</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The live attenuated influenza vaccine (LAIV) is made up of weakened influenza viruses given&#xD;
      into the nose and in early studies was shown to be better than the standard influenza vaccine&#xD;
      at preventing infections in children. However, more recently, it has performed less well and&#xD;
      it may also work less well in Sub-Saharan Africa. Not only do the investigators not know why&#xD;
      this is, but the investigators also do not fully understand why LAIV produces stronger nasal&#xD;
      antibody responses in some individuals but not others. Usually harmless bacteria that are&#xD;
      present in participants noses can influence how our immune system works and variations in&#xD;
      these may explain differences in how LAIV works. The project will recruit children given LAIV&#xD;
      in the Gambia to gain further understanding of these issues.&#xD;
&#xD;
      The investigators will measure a variety of responses to LAIV, including genes that can&#xD;
      change their expression early after vaccination and use advanced computational techniques to&#xD;
      identify new relationships between these genes and other LAIV responses. The investigators&#xD;
      will also see whether nasal bacterial profiles in children who respond to LAIV are different&#xD;
      from those who do not. In addition, the investigators will alter these bacteria in a subset&#xD;
      of children with antibiotics and see whether this affects both nasal gene expression and&#xD;
      later responses to LAIV.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose The overall goal of this study is to conduct at detailed immunogenicity study of&#xD;
      intranasal live attenuated influenza vaccine (LAIV; Nasovac-S, Serum Institute of India Pvt.&#xD;
      Ltd.), including identification of early molecular signatures associated with a robust&#xD;
      mucosal immune response. In addition, the study team will explore whether the nasopharyngeal&#xD;
      microbiome influences this immune response and whether LAIV has an impact on the microbiome.&#xD;
&#xD;
      A total of 365 healthy children aged 24 - 59 months will be recruited in The Gambia for this&#xD;
      study.&#xD;
&#xD;
      Background Both the burden of infection and use of influenza vaccines in children from&#xD;
      sub-Saharan Africa (SSA) have been neglected. There are limited immunogenicity or efficacy&#xD;
      data from SSA of the widely used Ann Arbor strain-derived LAIV. This LAIV was shown to have&#xD;
      greater relative efficacy compared to inactivated influenza vaccine in children in early&#xD;
      randomized-controlled trials. There has, however, been concern regarding lower vaccine&#xD;
      effectiveness in the US in recent years.&#xD;
&#xD;
      The Serum Institute of India Pvt. Ltd. has recently developed a trivalent LAIV (Nasovac-S)&#xD;
      via a WHO facilitated donation of a Russian-derived LAIV, with the intention of scaling up&#xD;
      provision of LAIV to resource-limited settings. Based on initial safety and immunogenicity&#xD;
      data, Nasovac-S was licensed in India and granted a WHO prequalification certificate in 2015.&#xD;
      Two placebo-controlled efficacy studies using Nasovac-S were recently undertaken in&#xD;
      Bangladesh and Senegal (in children aged 24 - 59 months and 24 - 71 months respectively),&#xD;
      providing mixed and contrasting results. In Senegal, no efficacy was found against the&#xD;
      circulating pandemic H1N1 influenza strain (-9.7%, 95% CI -62.6, 26.1). In Bangladesh the&#xD;
      overall vaccine efficacy to vaccine-matched strains, in a study of identical design, was&#xD;
      57.5% (95% CI 43.6, 68.0), with efficacy against H1N1 and H3N2, 50.0% (95% CI 9.2, 72.5) and&#xD;
      60.4% (95% CI 44.8, 71.6) respectively. The reason for the discrepancy in these studies or&#xD;
      the poorer performance of the H1N1 component is not clear and emphasizes the need to&#xD;
      undertake detailed immunogenicity studies of this vaccine in SSA. On a wider note, the exact&#xD;
      immunological mechanisms of action of LAIV are also under-explored.&#xD;
&#xD;
      Study type:&#xD;
&#xD;
      Interventional&#xD;
&#xD;
      Design:&#xD;
&#xD;
      All primary objectives will be addressed through the conduct of a phase 4, randomized,&#xD;
      controlled clinical vaccine trial. A total of 330 healthy children aged 24 - 59 months will&#xD;
      be enrolled into one of three groups of equal size (3 x 110 children):&#xD;
&#xD;
      (i) LAIV-vaccinated (Group A - blood sample at day 0, 2, 21) (ii) LAIV-vaccinated (Group B -&#xD;
      blood sample at day 0, 7, 21) (iii) Control group (Group C)&#xD;
&#xD;
      The study is not blinded, but group allocation will be concealed from the investigator team&#xD;
      and block randomization stratified by sex will be undertaken.&#xD;
&#xD;
      Two LAIV-vaccinated groups are included in order to achieve several exploratory objectives,&#xD;
      which require blood sampling at different times following vaccination, whilst minimizing the&#xD;
      number of times children are bled. The unvaccinated subjects will serve as a control group&#xD;
      for the primary objective of assessing the impact of LAIV on the nasopharyngeal microbiome.&#xD;
&#xD;
      An additional 35 healthy children aged 24 - 59 months will be recruited in the 2nd phase of&#xD;
      recruitment (approximately Jan - June 2018) to assess how modulation of the nasopharyngeal&#xD;
      microbiome with antibiotics impacts the mucosal immunogenicity to LAIV. These subjects will&#xD;
      be matched as closely as possible by pre-antibiotic nasopharyngeal microbiome profile, age&#xD;
      and sex (in that order of preference), in an exploratory nested case-control study, to n = 35&#xD;
      children recruited in the main clinical trial.&#xD;
&#xD;
      Official title A Study of Intranasal Live Attenuated Influenza Vaccine Immunogenicity and&#xD;
      Associations with the Nasopharyngeal Microbiome Among Children in the Gambia (The NASIMMUNE&#xD;
      study)&#xD;
&#xD;
      Primary outcome measures&#xD;
&#xD;
        -  To identify novel early systemic and mucosal molecular signatures following LAIV that&#xD;
           are associated with subsequent robust nasal and oral influenza-specific immunoglobulin A&#xD;
           (IgA) responses, in order to provide insight into the mechanisms of successful mucosal&#xD;
           immunization&#xD;
&#xD;
        -  To identify associations between nasopharyngeal microbiota and nasal and oral&#xD;
           influenza-specific IgA responses post-LAIV in Gambian children, to explore whether&#xD;
           microbiome variability can explain suboptimal immune responses in some individuals to&#xD;
           live intranasal mucosal vaccines in Sub-Saharan Africa&#xD;
&#xD;
        -  To establish whether LAIV impacts the nasopharyngeal microbiome, with a specific focus&#xD;
           on the burden of S. pneumoniae&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2017</start_date>
  <completion_date type="Actual">May 23, 2019</completion_date>
  <primary_completion_date type="Actual">December 19, 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>nasal IgA response</measure>
    <time_frame>21 days post LAIV</time_frame>
    <description>Influenza specific nasal IgA responses</description>
  </primary_outcome>
  <primary_outcome>
    <measure>fold increase in oral fluid influenza-specific/total IgA ratio</measure>
    <time_frame>day 0 - Day 21</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>fold increase in oral fluid influenza-specific/total IgG ratio</measure>
    <time_frame>Day 0 - Day 21</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>density of S. Pneumoniae</measure>
    <time_frame>day 7 and day 21 after LAIV compared to day 0</time_frame>
    <description>density of S. Pneumoniae before and after LAIV as established by quantitative PCR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the relative abundance of different operational taxanomic units (OTUs) of nasopharyngeal microbiota</measure>
    <time_frame>day 7 and day 21 compared to day 0 in each participant</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>gene expression changes in nasal and systemic samples</measure>
    <time_frame>2 days after LAIV</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">364</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>LAIV-vaccinated group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nasovac-S vaccination group A , blood samples days 0, 2, 21</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LAIV-vaccinated group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nasovac-S vaccination group B, blood samples at days 0, 7, 21</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Unvaccinated</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>control group C</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral Azithromycin &amp; vaccination</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>group D - a single dose of oral Azithromycin will be given 28 days prior to Nasovac-S vaccination</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Nasovac-S</intervention_name>
    <description>one of 0.5ml intranasal dose of trivalent live attenuated vaccine (LAIV)</description>
    <arm_group_label>LAIV-vaccinated group 1</arm_group_label>
    <arm_group_label>LAIV-vaccinated group 2</arm_group_label>
    <arm_group_label>Oral Azithromycin &amp; vaccination</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azithromycin</intervention_name>
    <description>a single dose of Azithromycin (liquid formulation - Zithromax) at 20mg/Kg (up to a maximum adult dose 1g) to be given to a subset of subjects</description>
    <arm_group_label>Oral Azithromycin &amp; vaccination</arm_group_label>
    <other_name>Zithromax</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Healthy male or female child at least 24 months of age and less than 60 months of&#xD;
             age at the time of study entry.&#xD;
&#xD;
               -  Resident in the study area and with no plans to travel outside the study area&#xD;
                  during the period of subject participation.&#xD;
&#xD;
               -  Informed consent for the study participation obtained from a parent (or guardian&#xD;
                  only if neither parent is alive or if guardianship has been legally transferred&#xD;
                  (see section 11.2).&#xD;
&#xD;
               -  Willingness and capacity to comply with the study protocol as judged by a member&#xD;
                  of the clinical trial team.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Serious, active, medical condition, including but not limited to:&#xD;
&#xD;
               -  chronic disease of any body system&#xD;
&#xD;
               -  severe protein-energy malnutrition (weight-for-height Z-score of less than -3)&#xD;
&#xD;
               -  known genetic disorders, such as Down's syndrome or other cytogenetic disorder&#xD;
&#xD;
                    -  Active wheezing&#xD;
&#xD;
                    -  History of documented hypersensitivity to eggs or other components of the&#xD;
                       vaccine (including gelatin, sorbitol, lactalbumin and chicken protein), or&#xD;
                       with life-threatening reactions to previous influenza vaccinations.&#xD;
&#xD;
                    -  History of documented hypersensitivity to macrolide antibiotics&#xD;
&#xD;
                    -  History of Guillain-Barré syndrome.&#xD;
&#xD;
                    -  Receipt of aspirin therapy or aspirin-containing therapy within the two&#xD;
                       weeks before planned study vaccination.&#xD;
&#xD;
                    -  Any suspected or confirmed congenital or acquired state of immune deficiency&#xD;
                       including but not limited to primary immunodeficiencies including thymus&#xD;
                       disorders, HIV/AIDS, hematological or lymphoid malignancies (blood tests&#xD;
                       will not be routinely undertaken with this regard as part of the study).&#xD;
&#xD;
                    -  Any current immunosuppressive/immunomodulatory treatment or receipt of any&#xD;
                       such treatment within the six months preceding trial enrolment (for&#xD;
                       corticosteroids this is defined as a dose of prednisolone (or equivalent) of&#xD;
                       greater than 2mg/kg/day for one week or 1mg/kg/day for one month. The use of&#xD;
                       topical corticosteroids is not an exclusion criterion.&#xD;
&#xD;
                    -  The use of inhaled corticosteroids within the last one month.&#xD;
&#xD;
                    -  Receipt of an influenza vaccine within the past 12 months.&#xD;
&#xD;
                    -  Has any condition determined by investigator as likely to interfere with&#xD;
                       evaluation of the vaccine or be a significant potential health risk to the&#xD;
                       child or make it unlikely that the child would complete the study.&#xD;
&#xD;
                    -  Any significant signs or symptoms of an acute illness or infection&#xD;
                       including:&#xD;
&#xD;
               -  an axillary temperature of 38.0°C or above or documented fever of 38°C or above&#xD;
                  in the preceding 14 days.&#xD;
&#xD;
               -  Any acute respiratory infection within 14 days of enrollment visit. If the reason&#xD;
                  for ineligibility is likely to be temporary (e.g. a fever of 38°C or above or&#xD;
                  acute respiratory infection) and either will or may resolve before the infant&#xD;
                  reaches 60 months, they will not be recorded as a screening failure but instead&#xD;
                  will be re-screened within an appropriate future time-window (e.g. at least 14&#xD;
                  days after the last documented fever of 38°C or above or resolution of&#xD;
                  respiratory illness) and a decision made regarding eligibility at that point.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>24 Months</minimum_age>
    <maximum_age>59 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical Research Council unit The Gambia</name>
      <address>
        <city>Banjul</city>
        <country>Gambia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Gambia</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>February 20, 2020</last_update_submitted>
  <last_update_submitted_qc>February 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>intranasal</keyword>
  <keyword>flu vaccine</keyword>
  <keyword>Gambian children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Azithromycin</mesh_term>
  </intervention_browse>
  <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/NCT02972957
org study id: SCC 1502
nct id: NCT02972957
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The live attenuated influenza vaccine (LAIV) is made up of weakened influenza viruses given
      into the nose and in early studies was shown to be better than the standard influenza vaccine
      at preventing infections in children. However, more recently, it has performed less well and
      it may also work less well in Sub-Saharan Africa. Not only do the investigators not know why
      this is, but the investigators also do not fully understand why LAIV produces stronger nasal
      antibody responses in some individuals but not others. Usually harmless bacteria that are
      present in participants noses can influence how our immune system works and variations in
      these may explain differences in how LAIV works. The project will recruit children given LAIV
      in the Gambia to gain further understanding of these issues.

      The investigators will measure a variety of responses to LAIV, including genes that can
      change their expression early after vaccination and use advanced computational techniques to
      identify new relationships between these genes and other LAIV responses. The investigators
      will also see whether nasal bacterial profiles in children who respond to LAIV are different
      from those who do not. In addition, the investigators will alter these bacteria in a subset
      of children with antibiotics and see whether this affects both nasal gene expression and
      later responses to LAIV.
Purpose The overall goal of this study is to conduct at detailed immunogenicity study of
      intranasal live attenuated influenza vaccine (LAIV; Nasovac-S, Serum Institute of India Pvt.
      Ltd.), including identification of early molecular signatures associated with a robust
      mucosal immune response. In addition, the study team will explore whether the nasopharyngeal
      microbiome influences this immune response and whether LAIV has an impact on the microbiome.

      A total of 365 healthy children aged 24 - 59 months will be recruited in The Gambia for this
      study.

      Background Both the burden of infection and use of influenza vaccines in children from
      sub-Saharan Africa (SSA) have been neglected. There are limited immunogenicity or efficacy
      data from SSA of the widely used Ann Arbor strain-derived LAIV. This LAIV was shown to have
      greater relative efficacy compared to inactivated influenza vaccine in children in early
      randomized-controlled trials. There has, however, been concern regarding lower vaccine
      effectiveness in the US in recent years.

      The Serum Institute of India Pvt. Ltd. has recently developed a trivalent LAIV (Nasovac-S)
      via a WHO facilitated donation of a Russian-derived LAIV, with the intention of scaling up
      provision of LAIV to resource-limited settings. Based on initial safety and immunogenicity
      data, Nasovac-S was licensed in India and granted a WHO prequalification certificate in 2015.
      Two placebo-controlled efficacy studies using Nasovac-S were recently undertaken in
      Bangladesh and Senegal (in children aged 24 - 59 months and 24 - 71 months respectively),
      providing mixed and contrasting results. In Senegal, no efficacy was found against the
      circulating pandemic H1N1 influenza strain (-9.7%, 95% CI -62.6, 26.1). In Bangladesh the
      overall vaccine efficacy to vaccine-matched strains, in a study of identical design, was
      57.5% (95% CI 43.6, 68.0), with efficacy against H1N1 and H3N2, 50.0% (95% CI 9.2, 72.5) and
      60.4% (95% CI 44.8, 71.6) respectively. The reason for the discrepancy in these studies or
      the poorer performance of the H1N1 component is not clear and emphasizes the need to
      undertake detailed immunogenicity studies of this vaccine in SSA. On a wider note, the exact
      immunological mechanisms of action of LAIV are also under-explored.

      Study type:

      Interventional

      Design:

      All primary objectives will be addressed through the conduct of a phase 4, randomized,
      controlled clinical vaccine trial. A total of 330 healthy children aged 24 - 59 months will
      be enrolled into one of three groups of equal size (3 x 110 children):

      (i) LAIV-vaccinated (Group A - blood sample at day 0, 2, 21) (ii) LAIV-vaccinated (Group B -
      blood sample at day 0, 7, 21) (iii) Control group (Group C)

      The study is not blinded, but group allocation will be concealed from the investigator team
      and block randomization stratified by sex will be undertaken.

      Two LAIV-vaccinated groups are included in order to achieve several exploratory objectives,
      which require blood sampling at different times following vaccination, whilst minimizing the
      number of times children are bled. The unvaccinated subjects will serve as a control group
      for the primary objective of assessing the impact of LAIV on the nasopharyngeal microbiome.

      An additional 35 healthy children aged 24 - 59 months will be recruited in the 2nd phase of
      recruitment (approximately Jan - June 2018) to assess how modulation of the nasopharyngeal
      microbiome with antibiotics impacts the mucosal immunogenicity to LAIV. These subjects will
      be matched as closely as possible by pre-antibiotic nasopharyngeal microbiome profile, age
      and sex (in that order of preference), in an exploratory nested case-control study, to n = 35
      children recruited in the main clinical trial.

      Official title A Study of Intranasal Live Attenuated Influenza Vaccine Immunogenicity and
      Associations with the Nasopharyngeal Microbiome Among Children in the Gambia (The NASIMMUNE
      study)

      Primary outcome measures

        -  To identify novel early systemic and mucosal molecular signatures following LAIV that
           are associated with subsequent robust nasal and oral influenza-specific immunoglobulin A
           (IgA) responses, in order to provide insight into the mechanisms of successful mucosal
           immunization

        -  To identify associations between nasopharyngeal microbiota and nasal and oral
           influenza-specific IgA responses post-LAIV in Gambian children, to explore whether
           microbiome variability can explain suboptimal immune responses in some individuals to
           live intranasal mucosal vaccines in Sub-Saharan Africa

        -  To establish whether LAIV impacts the nasopharyngeal microbiome, with a specific focus
           on the burden of S. pneumoniae
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: nasal IgA response
time frame: 21 days post LAIV
description: Influenza specific nasal IgA responses
measure: fold increase in oral fluid influenza-specific/total IgA ratio
time frame: day 0 - Day 21
measure: fold increase in oral fluid influenza-specific/total IgG ratio
time frame: Day 0 - Day 21
measure: density of S. Pneumoniae
time frame: day 7 and day 21 after LAIV compared to day 0
description: density of S. Pneumoniae before and after LAIV as established by quantitative PCR
measure: Changes in the relative abundance of different operational taxanomic units (OTUs) of nasopharyngeal microbiota
time frame: day 7 and day 21 compared to day 0 in each participant
measure: gene expression changes in nasal and systemic samples
time frame: 2 days after LAIV
arm group label: LAIV-vaccinated group 1
arm group type: Experimental
description: Nasovac-S vaccination group A , blood samples days 0, 2, 21
arm group label: LAIV-vaccinated group 2
arm group type: Experimental
description: Nasovac-S vaccination group B, blood samples at days 0, 7, 21
arm group label: Unvaccinated
arm group type: No Intervention
description: control group C
arm group label: Oral Azithromycin & vaccination
arm group type: Experimental
description: group D - a single dose of oral Azithromycin will be given 28 days prior to Nasovac-S vaccination
intervention type: Biological
intervention name: Nasovac-S
description: one of 0.5ml intranasal dose of trivalent live attenuated vaccine (LAIV)
arm group label: LAIV-vaccinated group 1
arm group label: LAIV-vaccinated group 2
arm group label: Oral Azithromycin & vaccination
intervention type: Drug
intervention name: Azithromycin
description: a single dose of Azithromycin (liquid formulation - Zithromax) at 20mg/Kg (up to a maximum adult dose 1g) to be given to a subset of subjects
arm group label: Oral Azithromycin & vaccination
other name: Zithromax
criteria: 
gender: All
minimum age: 24 Months
maximum age: 59 Months
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Gambia
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Azithromycin
sharing ipd: No