xml: <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/NCT05970744</url>
    </required_header>
    <id_info>
      <org_study_id>RSV-I-01/2022</org_study_id>
      <secondary_id>736 30.12.2022</secondary_id>
      <nct_id>NCT05970744</nct_id>
    </id_info>
    <brief_title>Evaluation of RSV/Flu-01E Vaccine for the Prevention of RSV Infection in Volunteers Aged 18 to 59 Years and Over 60 Years</brief_title>
    <official_title>Randomized, Double-blind, Placebo-controlled Phase 1 Trial of the RSV/Flu-01E Vaccine for the Prevention of Respiratory Syncytial Virus Infection in Volunteers Aged 18 to 59 Years and Over 60 Years</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tatyana Zubkova</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Research Institute of Influenza, Russia</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>
        The aim of the study is to investigate the safety and immunogenicity of the RSV/Flu-01E&#xD;
        vaccine for the prevention of respiratory syncytial virus infection in volunteers aged18 to&#xD;
        59 years and over 60 years.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Study includes 60 participants in three cohorts. First cohort includes 15 volunteers aged 18&#xD;
        to 59, randomized at 2:1 ratio, to receive low dose RSV/Flu-01E vaccine or placebo,&#xD;
        correspondingly. Second cohort includes 15 volunteers aged 18 to 59, randomized at 2:1 ratio,&#xD;
        to receive high dose RSV/Flu-01E vaccine or placebo, correspondingly. Third cohort includes&#xD;
        30 participants aged 60 years and older, randomized at 2:1 ratio to receive high dose&#xD;
        RSV/Flu-01E vaccine or placebo. Duration of the study for each participant is about 6 months&#xD;
        (no more than 190 days).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">May 10, 2023</start_date>
    <completion_date type="Anticipated">September 17, 2023</completion_date>
    <primary_completion_date type="Actual">June 19, 2023</primary_completion_date>
    <phase>Phase 1</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of participants with local and systemic adverse events (AEs) and serious adverse events (SAEs)</measure>
      <time_frame>Throughout the study, average of 6 months</time_frame>
      <description>Adverse events (AEs) and serious AEs (SAEs), both vaccine related and non-vaccine related.&#xD;
  AEs/SAEs of particular importance:&#xD;
  Immediate AEs (allergic reactions) occurring within two hours of vaccination.&#xD;
  Post-vaccination reactions (anticipated clinical manifestations of a local and systemic nature), usually due to intranasal vaccination between two hours and the next 7 days after vaccination.&#xD;
  Evaluation of influenza A virus shedding evaluated by immunochromatographic rapid test in nasal swab samples in control points after vaccination</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Level of RSV F antigen-specific cytokine producing T-cells</measure>
      <time_frame>Days 1, 7, 28, 90, 180</time_frame>
      <description>Change from baseline in the level of cytokine producing CD4+ and CD8+ T-cells upon in vitro stimulation of PBMC with RSV F-peptide epitopes measured by ICS/ELISPOT</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Level of RSV F antigen-specific cytokine release in whole blood assay</measure>
      <time_frame>Days 1, 7, 28</time_frame>
      <description>Change from baseline in the cytokine concentration in whole-blood cytokine release assay upon in vitro stimulation with RSV F-peptide epitopes measured in ELISA</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Level of RSV F antigen-specific mucosal IgA antibody in saliva/nasal secrets</measure>
      <time_frame>Days 1, 28</time_frame>
      <description>Change from baseline in the level of secretory IgA antibody specific to RSV F-antigen measured in ELISA in nasal secret/saliva</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Level of RSV F antigen-specific IgG antibody</measure>
      <time_frame>Days 1, 28, 90, 180</time_frame>
      <description>Changes in the levels of RSV F antigen-specific total serum IgG antibodies measured in ELISA in serum</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of responders to vaccination</measure>
      <time_frame>Days 7, 28</time_frame>
      <description>Proportion of participants who responded to vaccination by significant increase in any of the immunogenicity parameters at any of the time points. The increase is considered significant if the fold change of the parameter value exceeds the conventional threshold, measured as geometric mean fold change in Placebo group multiplied by two geometric mean standard deviations.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of cytokines in nasal secrets after vaccination</measure>
      <time_frame>Days 1, 2, 3</time_frame>
      <description>Change from baseline in the concentration of cytokines in nasal secrets measured in ELISA (pg/ml, 13-plex assay, IFN-α2, TSLP, IL-1α, IL-1β, GM-CSF, IL-11, IL-12p40, IL-12p70, IL-15, IL-18, IL-23, IL-27, IL-33)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Influenza specific systemic antibody immune response</measure>
      <time_frame>Days 1, 28</time_frame>
      <description>Change from baseline in the titer of influenza specific antibodies in serum measured in hemagglutination inhibition/microneutralization assay</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Influenza specific local antibody immune response</measure>
      <time_frame>Days 1, 28</time_frame>
      <description>Change from baseline in the level of influenza specific IgA antibodies in nasal secret/saliva measured in ELISA</description>
    </secondary_outcome>
    <number_of_arms>5</number_of_arms>
    <enrollment type="Actual">60</enrollment>
    <condition>Respiratory Syncytial Virus Infections</condition>
    <arm_group>
      <arm_group_label>RSV/Flu-01E low dose 18-59</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants aged 18 to 59 years will receive single injection of low dose RSV/Flu-01E Vaccine</description>
    </arm_group>
    <arm_group>
      <arm_group_label>RSV/Flu-01E high dose 18-59</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants aged 18 to 59 years will receive single injection of high dose RSV/Flu-01E Vaccine</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo 18-59</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Participants aged 18 to 59 years will receive single injection of Placebo</description>
    </arm_group>
    <arm_group>
      <arm_group_label>RSV/Flu-01E high dose over 60</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants aged over 60 years will receive single injection of high dose RSV/Flu-01E Vaccine</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo over 60</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Participants aged over 60 years will receive single injection of Placebo</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>RSV/Flu-01E low dose</intervention_name>
      <description>Participants will receive single intranasal injection of A/H1N1pdm09 recombinant attenuated influenza vector (7.7 lg EID50) with modified NS gene coding for the F antigen of respiratory syncytial virus</description>
      <arm_group_label>RSV/Flu-01E low dose 18-59</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>RSV/Flu-01E high dose</intervention_name>
      <description>Participants will receive single intranasal injection of A/H1N1pdm09 recombinant attenuated influenza vector (8.4 lg EID50) with modified NS gene coding for the F antigen of respiratory syncytial virus</description>
      <arm_group_label>RSV/Flu-01E high dose 18-59</arm_group_label>
      <arm_group_label>RSV/Flu-01E high dose over 60</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Participants will receive single intranasal injection of Placebo</description>
      <arm_group_label>Placebo 18-59</arm_group_label>
      <arm_group_label>Placebo over 60</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          For the first and second cohort:&#xD;
  &#xD;
            1. Availability of signed informed consent.&#xD;
  &#xD;
            2. Adult men and women aged 18-59 years.&#xD;
  &#xD;
            3. Diagnosed &quot;healthy&quot;, according to the data of standard clinical, laboratory and&#xD;
               instrumental examination methods provided for in this protocol, with the absence of&#xD;
               clinically significant changes.&#xD;
  &#xD;
            4. BMI from 18 to 30 kg/m2.&#xD;
  &#xD;
            5. Individuals with antibody titer to influenza A/H1N1pdm09 ≤1:20 according to HI assay.&#xD;
  &#xD;
            6. Ability and willingness to independently keep records in the diary of self-observation&#xD;
               and carry out all visits according to the protocol.&#xD;
  &#xD;
            7. Negative urine test for psychotropic and narcotic substances.&#xD;
  &#xD;
            8. Negative breath alcohol test.&#xD;
  &#xD;
            9. Consent of study participants to use effective contraceptive methods throughout their&#xD;
               participation in the study. In this study, volunteers can use the following methods of&#xD;
               contraception:&#xD;
  &#xD;
                 -  Combined methods:&#xD;
  &#xD;
                      -  male condom and spermicide&#xD;
  &#xD;
                      -  cervical cap and spermicide&#xD;
  &#xD;
                      -  vaginal diaphragm and spermicide&#xD;
  &#xD;
                 -  Intrauterine device&#xD;
  &#xD;
                 -  Hormonal intrauterine device&#xD;
  &#xD;
                 -  Hormonal contraceptives:&#xD;
  &#xD;
                      -  hormonal implants&#xD;
  &#xD;
                      -  hormone injections&#xD;
  &#xD;
                      -  combined oral contraceptives&#xD;
  &#xD;
                      -  mini-pill&#xD;
  &#xD;
                      -  contraceptive patch&#xD;
  &#xD;
                 -  Abstinence from sexual activity.&#xD;
  &#xD;
           10. For women of childbearing potential - a negative pregnancy test.&#xD;
  &#xD;
           11. Indicators of general and biochemical blood tests at screening within 1.1 x the upper&#xD;
               limit - 0.9 x the lower limit of the reference intervals.&#xD;
  &#xD;
           12. Negative tests for HIV, hepatitis B and C, syphilis.&#xD;
  &#xD;
          For the third cohort:&#xD;
  &#xD;
            1. Availability of signed informed consent.&#xD;
  &#xD;
            2. Adult men and women over the age of 60.&#xD;
  &#xD;
            3. The diagnosis is &quot;healthy&quot;, verified according to standard clinical, laboratory and&#xD;
               instrumental methods of examination or the presence of a chronic disease, if the&#xD;
               researcher considers it to be compensated.&#xD;
  &#xD;
            4. BMI from 18 to 30 kg/m2.&#xD;
  &#xD;
            5. Individuals with antibody titer to influenza A/H1N1pdm09 ≤1:20 according to HI assay.&#xD;
  &#xD;
            6. The ability and readiness to independently keep records in the diary of&#xD;
               self-observation and carry out all the visits provided for in the study, provided for&#xD;
               by the protocol.&#xD;
  &#xD;
            7. Negative urine test for psychotropic and narcotic substances.&#xD;
  &#xD;
            8. Negative breath alcohol test.&#xD;
  &#xD;
            9. Indicators of general and biochemical blood tests for screening within 1.1 x the upper&#xD;
               limit - 0.9 x the lower limit of the reference intervals.&#xD;
  &#xD;
           10. Negative tests for HIV, hepatitis B and C, syphilis.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Participation in another clinical study within three months prior to the start of the&#xD;
               current study; planning to participate in another study during the current study&#xD;
               period.&#xD;
  &#xD;
            2. Contact with COVID-19 patients within 14 days prior to the start of the clinical&#xD;
               study.&#xD;
  &#xD;
            3. Positive rapid test result for SARS-CoV-2 antigen.&#xD;
  &#xD;
            4. Immunization with any other non-study vaccine product within three weeks prior to&#xD;
               enrollment in the current study, or refusal to postpone such until the end of the&#xD;
               three-week period after completion of the current study.&#xD;
  &#xD;
            5. Regular use of nasal irrigation therapy during the last six months prior to enrollment&#xD;
               in the current study or episodic use of the above method of treatment in the two weeks&#xD;
               prior to the screening.&#xD;
  &#xD;
            6. History of frequent nosebleeds (&gt;5) during the year prior to the current study&#xD;
  &#xD;
            7. Anatomical features of the nose that may interfere with intranasal administration of&#xD;
               the study drug&#xD;
  &#xD;
            8. The presence of surgical intervention in the sinus area, paranasal sinuses, or&#xD;
               traumatic injuries of the nose within a month before screening.&#xD;
  &#xD;
            9. Symptoms of acute respiratory disease at the time of screening or within two weeks&#xD;
               prior to screening.&#xD;
  &#xD;
           10. Treatment with immunoglobulins or other blood derived medications in the three months&#xD;
               prior to screening or planning such treatment during the period of participation in&#xD;
               the current study.&#xD;
  &#xD;
           11. Donation of blood/plasma (450 ml or more) less than 2 months prior to screening.&#xD;
  &#xD;
           12. The presence or suspicion of the presence of various immunosuppressive or&#xD;
               immunodeficiency conditions or continuous use (the drug was prescribed for more than&#xD;
               14 days without a break) of immunosuppressive drugs, immunomodulators for 6 months&#xD;
               before the screening.&#xD;
  &#xD;
           13. History of bronchial asthma.&#xD;
  &#xD;
           14. Hypersensitivity and the presence of severe allergic reactions, including Quincke's&#xD;
               edema, anaphylactic shock after the previous administration of any vaccine.&#xD;
  &#xD;
           15. History of wheezing after previous immunization with live influenza vaccine.&#xD;
  &#xD;
           16. Other adverse events after immunization (fever above 40°C, syncope, non-febrile&#xD;
               convulsions, anaphylaxis) when there is a minimal likelihood that they are associated&#xD;
               with a previous administration of any vaccine.&#xD;
  &#xD;
           17. Suspicion of hypersensitivity to any component of the study vaccine, including egg&#xD;
               protein.&#xD;
  &#xD;
           18. Burdened allergic anamnesis.&#xD;
  &#xD;
           19. Acute or chronic clinically significant lung, cardiovascular, hepatic, endocrine,&#xD;
               neurological, or psychiatric disorders, or impaired renal function identified by&#xD;
               history, physical examination, or clinical laboratory findings that, in the opinion of&#xD;
               the investigator, may influence the outcome of the study.&#xD;
  &#xD;
           20. History of oncological diseases.&#xD;
  &#xD;
           21. History of thrombocytopenic purpura or bleeding disorders.&#xD;
  &#xD;
           22. History of convulsions&#xD;
  &#xD;
           23. Tuberculosis or residual changes after tuberculosis according to the anamnesis and /&#xD;
               or available medical documentation.&#xD;
  &#xD;
           24. Chronic alcohol dependence or chronic use of illicit drugs, drug abuse.&#xD;
  &#xD;
           25. Claustrophobia and social phobia according to history and / or available medical&#xD;
               records.&#xD;
  &#xD;
           26. For women of reproductive age - lactation, pregnancy or suspected pregnancy, early&#xD;
               postpartum period.&#xD;
  &#xD;
           27. Inability to read in Russian; inability or unwillingness to understand the essence of&#xD;
               the study. Any other condition that limits the eligibility of obtaining informed&#xD;
               consent or may affect the volunteer's ability to participate in the study.&#xD;
  &#xD;
           28. Military or law enforcement officers, persons serving sentences in places of&#xD;
               deprivation of liberty or in custody.&#xD;
  &#xD;
           29. Special diet (eg, vegetarian, vegan, salt-restricted) or lifestyle (night work,&#xD;
               extreme physical activity)&#xD;
  &#xD;
           30. Any condition that, in the opinion of the investigator, may increase the risk to the&#xD;
               health of a volunteer participating in the study or affect the results of the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tatiana Zubkova, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Smorodintsev Research Institute of Influenza</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Smorodintsev Research Institute of Influenza</name>
        <address>
          <city>Saint Petersburg</city>
          <country>Russian Federation</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Russian Federation</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Research Institute of Influenza, Russia</investigator_affiliation>
      <investigator_full_name>Tatyana Zubkova</investigator_full_name>
      <investigator_title>Head of the clinical department</investigator_title>
    </responsible_party>
    <keyword>Respiratory syncytial virus infection</keyword>
    <keyword>Vaccine</keyword>
    <keyword>Influenza vector</keyword>
    <keyword>Intranasal immunization</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infections</mesh_term>
      <mesh_term>Communicable Diseases</mesh_term>
      <mesh_term>Virus Diseases</mesh_term>
      <mesh_term>Respiratory Syncytial Virus Infections</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05970744
  org study id: RSV-I-01/2022
  secondary id: 736 30.12.2022
  nct id: NCT05970744
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study is to investigate the safety and immunogenicity of the RSV/Flu-01E
        vaccine for the prevention of respiratory syncytial virus infection in volunteers aged18 to
        59 years and over 60 years.
  Study includes 60 participants in three cohorts. First cohort includes 15 volunteers aged 18
        to 59, randomized at 2:1 ratio, to receive low dose RSV/Flu-01E vaccine or placebo,
        correspondingly. Second cohort includes 15 volunteers aged 18 to 59, randomized at 2:1 ratio,
        to receive high dose RSV/Flu-01E vaccine or placebo, correspondingly. Third cohort includes
        30 participants aged 60 years and older, randomized at 2:1 ratio to receive high dose
        RSV/Flu-01E vaccine or placebo. Duration of the study for each participant is about 6 months
        (no more than 190 days).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Number of participants with local and systemic adverse events (AEs) and serious adverse events (SAEs)
  time frame: Throughout the study, average of 6 months
  description: Adverse events (AEs) and serious AEs (SAEs), both vaccine related and non-vaccine related.
  AEs/SAEs of particular importance:
  Immediate AEs (allergic reactions) occurring within two hours of vaccination.
  Post-vaccination reactions (anticipated clinical manifestations of a local and systemic nature), usually due to intranasal vaccination between two hours and the next 7 days after vaccination.
  Evaluation of influenza A virus shedding evaluated by immunochromatographic rapid test in nasal swab samples in control points after vaccination
  measure: Level of RSV F antigen-specific cytokine producing T-cells
  time frame: Days 1, 7, 28, 90, 180
  description: Change from baseline in the level of cytokine producing CD4+ and CD8+ T-cells upon in vitro stimulation of PBMC with RSV F-peptide epitopes measured by ICS/ELISPOT
  measure: Level of RSV F antigen-specific cytokine release in whole blood assay
  time frame: Days 1, 7, 28
  description: Change from baseline in the cytokine concentration in whole-blood cytokine release assay upon in vitro stimulation with RSV F-peptide epitopes measured in ELISA
  measure: Level of RSV F antigen-specific mucosal IgA antibody in saliva/nasal secrets
  time frame: Days 1, 28
  description: Change from baseline in the level of secretory IgA antibody specific to RSV F-antigen measured in ELISA in nasal secret/saliva
  measure: Level of RSV F antigen-specific IgG antibody
  time frame: Days 1, 28, 90, 180
  description: Changes in the levels of RSV F antigen-specific total serum IgG antibodies measured in ELISA in serum
  measure: Proportion of responders to vaccination
  time frame: Days 7, 28
  description: Proportion of participants who responded to vaccination by significant increase in any of the immunogenicity parameters at any of the time points. The increase is considered significant if the fold change of the parameter value exceeds the conventional threshold, measured as geometric mean fold change in Placebo group multiplied by two geometric mean standard deviations.
  measure: Concentration of cytokines in nasal secrets after vaccination
  time frame: Days 1, 2, 3
  description: Change from baseline in the concentration of cytokines in nasal secrets measured in ELISA (pg/ml, 13-plex assay, IFN-α2, TSLP, IL-1α, IL-1β, GM-CSF, IL-11, IL-12p40, IL-12p70, IL-15, IL-18, IL-23, IL-27, IL-33)
  measure: Influenza specific systemic antibody immune response
  time frame: Days 1, 28
  description: Change from baseline in the titer of influenza specific antibodies in serum measured in hemagglutination inhibition/microneutralization assay
  measure: Influenza specific local antibody immune response
  time frame: Days 1, 28
  description: Change from baseline in the level of influenza specific IgA antibodies in nasal secret/saliva measured in ELISA
  arm group label: RSV/Flu-01E low dose 18-59
  arm group type: Experimental
  description: Participants aged 18 to 59 years will receive single injection of low dose RSV/Flu-01E Vaccine
  arm group label: RSV/Flu-01E high dose 18-59
  arm group type: Experimental
  description: Participants aged 18 to 59 years will receive single injection of high dose RSV/Flu-01E Vaccine
  arm group label: Placebo 18-59
  arm group type: Placebo Comparator
  description: Participants aged 18 to 59 years will receive single injection of Placebo
  arm group label: RSV/Flu-01E high dose over 60
  arm group type: Experimental
  description: Participants aged over 60 years will receive single injection of high dose RSV/Flu-01E Vaccine
  arm group label: Placebo over 60
  arm group type: Placebo Comparator
  description: Participants aged over 60 years will receive single injection of Placebo
  intervention type: Biological
  intervention name: RSV/Flu-01E low dose
  description: Participants will receive single intranasal injection of A/H1N1pdm09 recombinant attenuated influenza vector (7.7 lg EID50) with modified NS gene coding for the F antigen of respiratory syncytial virus
  arm group label: RSV/Flu-01E low dose 18-59
  intervention type: Biological
  intervention name: RSV/Flu-01E high dose
  description: Participants will receive single intranasal injection of A/H1N1pdm09 recombinant attenuated influenza vector (8.4 lg EID50) with modified NS gene coding for the F antigen of respiratory syncytial virus
  arm group label: RSV/Flu-01E high dose 18-59
  arm group label: RSV/Flu-01E high dose over 60
  intervention type: Biological
  intervention name: Placebo
  description: Participants will receive single intranasal injection of Placebo
  arm group label: Placebo 18-59
  arm group label: Placebo over 60
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Tatiana Zubkova, PhD
  role: Principal Investigator
  affiliation: Smorodintsev Research Institute of Influenza
  facility: 
  country: Russian Federation
  responsible party type: Sponsor-Investigator
  investigator affiliation: Research Institute of Influenza, Russia
  investigator full name: Tatyana Zubkova
  investigator title: Head of the clinical department
  mesh term: Infections
  mesh term: Communicable Diseases
  mesh term: Virus Diseases
  mesh term: Respiratory Syncytial Virus Infections
  sharing ipd: No