<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/NCT04478084</url>
  </required_header>
  <id_info>
    <org_study_id>VRV09</org_study_id>
    <secondary_id>U1111-1227-4143</secondary_id>
    <nct_id>NCT04478084</nct_id>
  </id_info>
  <brief_title>Study of Purified Vero Rabies Vaccine Compared With a Reference Rabies Vaccine as Simulated Rabies Post-Exposure Prophylaxis in Adult and Pediatric Population in Thaïland</brief_title>
  <official_title>Immunogenicity and Safety of a Purified Vero Rabies Vaccine-Serum Free (VRVg) Assessed With the Institut Pasteur du Cambodge (IPC: 2-2-2-0-0) and the Thai Red Cross (TRC: 2-2-2-0-2) Intradermal Regimens as Simulated Rabies Post-exposure Prophylaxis in Healthy Subjects in Thailand</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanofi Pasteur, a Sanofi Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>No</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>
      Primary Objective:&#xD;
&#xD;
      To describe the immune response induced by VRVg-2 and Verorab vaccine at Day 14 (to assess&#xD;
      the immune response after 3 doses [2-2-2]) and Day 42 (to assess the immune response after 4&#xD;
      doses [2-2-2-0-2]) when administered as standalone in healthy pediatric population or&#xD;
      co-administered with HRIG (Group 5 and Group 6) at Day 0 in healthy adults.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To describe the immune response induced by VRVg-2 and Verorab vaccine at Day 14 (to&#xD;
           assess the immune response after 3 doses [2-2-2]) when co-administered with ERIG (Group&#xD;
           3 and Group 4) at Day 0 in healthy adults&#xD;
&#xD;
        -  To describe the immune response induced by VRVg-2 and Verorab vaccine at D90 (to assess&#xD;
           the immune response 90 days post-rabies simulated exposure) when administered as&#xD;
           standalone in healthy pediatric population or co-administered with HRIG (Group 5 and&#xD;
           Group 6) at Day 0 in healthy adults&#xD;
&#xD;
        -  To describe the safety profile of VRVg-2 and Verorab vaccine as standalone in pediatric&#xD;
           population or when co-administered with ERIG (Group 3 and Group 4) or HRIG (Group 5 and&#xD;
           Group 6) at Day 0 in adults, after each vaccination.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The duration of each participant's participation in the study is approximately 7 months (28&#xD;
      day-vaccination period followed by 6 month safety follow-up period).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 4, 2020</start_date>
  <completion_date type="Actual">July 21, 2022</completion_date>
  <primary_completion_date type="Actual">March 19, 2022</primary_completion_date>
  <phase>Phase 3</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>
    <masking_description>Modified double-blind: the participant (or legally acceptable representative) and the Investigator remain unaware of the treatment assignments throughout the study. An unblinded qualified trial staff member will prepare and administer the appropriate vaccine but will not be involved in the immunogenicity and safety evaluations.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of participants in Group 1, Group 2, Group 5 and Group 6 achieving rabies virus neutralizing antibody (RVNA) titer greater than or equal to (≥) 0.5 IU/mL</measure>
    <time_frame>Day 14 (post-vaccination)</time_frame>
    <description>RVNA titers will be measured by rapid fluorescent focus inhibition test (RFFIT)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants in Group 1, Group 2, Group 5 and Group 6 achieving RVNA titer greater than or equal to (≥) 0.5 IU/mL</measure>
    <time_frame>Day 42 (post-vaccination)</time_frame>
    <description>RVNA titers will be measured by RFFIT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants in Group 1, Group 2, Group 5 and Group 6 achieving RVNA titer greater than or equal to (≥) lower limit of quantification</measure>
    <time_frame>Day 14 (post-vaccination)</time_frame>
    <description>RVNA titers will be measured by RFFIT Lower limit of quantification for RFFIT assay is 0.2 IU/mL</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants in Group 1, Group 2, Group 5 and Group 6 achieving RVNA titer greater than or equal to (≥) lower limit of quantification</measure>
    <time_frame>Day 42 (post-vaccination)</time_frame>
    <description>RVNA titers will be measured by RFFIT Lower limit of quantification for RFFIT assay is 0.2 IU/mL</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination) in Group 1, Group 2, Group 5 and Group 6 Participants</measure>
    <time_frame>Day 14 (post-vaccination)</time_frame>
    <description>RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 14 RVNA ratios Day14/Day0 will be calculated</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination) in Group 1, Group 2, Group 5 and Group 6 Participants</measure>
    <time_frame>Day 42 (post-vaccination)</time_frame>
    <description>RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 42 RVNA ratios Day42/Day0 will be calculated</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants reporting immediate adverse events (AEs)</measure>
    <time_frame>Within 30 minutes post-vaccination</time_frame>
    <description>Includes unsolicited (spontaneously reported) systemic AEs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants reporting solicited injection site reactions</measure>
    <time_frame>Within 7 days post-vaccination</time_frame>
    <description>Solicited injection site reactions:&#xD;
tenderness, erythema, swelling in toddlers (aged ≥ 1 year to &lt; 2 years)&#xD;
pain, erythema, and swelling in children (aged 2 years to &lt; 12 years), in adolescents and adults (aged ≥ 12 years)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants reporting solicited systemic reactions</measure>
    <time_frame>Between Day 0 and Day 3, between Day 3 and Day 7, and during the 7 days following the remaining vaccinations</time_frame>
    <description>Solicited systemic reactions:&#xD;
fever, vomiting, crying abnormal, drowsiness, appetite lost, irritability in toddlers (aged ≥ 1 year to &lt; 2 years)&#xD;
fever, headache, malaise and myalgia in children (aged 2 years to &lt; 12 years), adolescents or adults (aged ≥ 12 years)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants reporting unsolicited injection site AEs</measure>
    <time_frame>Within 28 days post-vaccination</time_frame>
    <description>Unsolicited (spontaneously reported) injection site AEs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants reporting unsolicited systemic AEs</measure>
    <time_frame>Between each vaccination and up to 28 days after the last vaccination</time_frame>
    <description>Unsolicited (spontaneously reported) systemic AEs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants reporting serious adverse events (SAEs)</measure>
    <time_frame>Up to 6 months post-vaccination</time_frame>
    <description>SAEs, including adverse event of special interest (AESIs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants in Group 3 and Group 4 achieving rabies virus neutralizing antibody (RVNA) titer greater than or equal to (≥) 0.5 IU/mL</measure>
    <time_frame>Day 14 (post-vaccination)</time_frame>
    <description>RVNA titers will be measured by RFFIT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants in Group 3 and Group 4 achieving RVNA titer greater than or equal to (≥) lower limit of quantification</measure>
    <time_frame>Day 14 (post-vaccination)</time_frame>
    <description>RVNA titers will be measured by RFFIT Lower limit of quantification for RFFIT assay is 0.2 IU/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination) in Group 3 and Group 4 Participants</measure>
    <time_frame>Day 14 (post-vaccination)</time_frame>
    <description>RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 14 RVNA ratios Day14/Day0 will be calculated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants in Group 1, Group 2, Group 5 and Group 6 achieving rabies virus neutralizing antibody (RVNA) titer greater than or equal to (≥) 0.5 IU/mL</measure>
    <time_frame>Day 90 (post-vaccination)</time_frame>
    <description>RVNA titers will be measured by RFFIT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants in Group 1, Group 2, Group 5 and Group 6 achieving RVNA titer greater than or equal to (≥) lower limit of quantification</measure>
    <time_frame>Day 90 (post-vaccination)</time_frame>
    <description>RVNA titers will be measured by RFFIT Lower limit of quantification for RFFIT assay is 0.2 IU/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination) in Group 1, Group 2, Group 5 and Group 6 Participants</measure>
    <time_frame>Day 90 (post-vaccination)</time_frame>
    <description>RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 90 RVNA ratios Day90/Day0 will be calculated</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">403</enrollment>
  <condition>Rabies (Healthy Volunteers)</condition>
  <arm_group>
    <arm_group_label>Group 1: pediatric participants; VRVg-2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VRVg-2 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: pediatric participants; Verorab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Verorab 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3: adult participants; VRVG-2 + ERIG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VRVg-2 8 injections: 2 at Day 0, 2 at Day 3 and 2 at Day 7&#xD;
+ ERIG at D0</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4: adult participants; Verorab + ERIG</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Verorab 8 injections: 2 at Day 0, 2 at Day 3 and 2 at Day 7&#xD;
+ ERIG at D0</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 5: adult participants; VRVG-2 + HRIG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VRVg-2 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28&#xD;
+ HRIG at D0</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 6: adult participants; Verorab + HRIG</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Verorab 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28&#xD;
+ HRIG at D0</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Purified vero rabies vaccine - serum free VRVg-2</intervention_name>
    <description>Pharmaceutical form:freeze-dried Route of administration: intradermal</description>
    <arm_group_label>Group 1: pediatric participants; VRVg-2</arm_group_label>
    <arm_group_label>Group 3: adult participants; VRVG-2 + ERIG</arm_group_label>
    <arm_group_label>Group 5: adult participants; VRVG-2 + HRIG</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Purified inactivated rabies vaccine</intervention_name>
    <description>Pharmaceutical form:freeze-dried Route of administration: intradermal</description>
    <arm_group_label>Group 2: pediatric participants; Verorab</arm_group_label>
    <arm_group_label>Group 4: adult participants; Verorab + ERIG</arm_group_label>
    <arm_group_label>Group 6: adult participants; Verorab + HRIG</arm_group_label>
    <other_name>Verorab®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Equine rabies immunoglobulins (ERIG) (only Group 3 and Group 4)</intervention_name>
    <description>Pharmaceutical form: liquid/solution in 5 mL vials Route of administration: intramuscular</description>
    <arm_group_label>Group 3: adult participants; VRVG-2 + ERIG</arm_group_label>
    <arm_group_label>Group 4: adult participants; Verorab + ERIG</arm_group_label>
    <other_name>ERIG</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Human rabies immunoglobulins (HRIG) (only Group 5 and Group 6)</intervention_name>
    <description>Pharmaceutical form: liquid/solution in 2 mL vials Route of administration: intramuscular</description>
    <arm_group_label>Group 5: adult participants; VRVG-2 + HRIG</arm_group_label>
    <arm_group_label>Group 6: adult participants; Verorab + HRIG</arm_group_label>
    <other_name>IMOGAM® Rabies-HT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion criteria :&#xD;
&#xD;
          -  Aged ≥ 1 year on the day of inclusion&#xD;
&#xD;
          -  Participant (adult ≥ 18 years without upper age limit) or participant and&#xD;
             participant's parent/LAR (child ≥ 1 to &lt; 18 years) are able to attend all scheduled&#xD;
             visits and to comply with all study procedures&#xD;
&#xD;
        The following criterion only applies to healthy adults ≥ 18 years:&#xD;
&#xD;
        - Body Mass Index (BMI): 18.5 kg/m2 ≤ BMI ≤ 30 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Pregnant, or lactating, or of childbearing potential and not using an effective method&#xD;
             of contraception or abstinence from at least 4 weeks prior to the first vaccination&#xD;
             and until 1 month after each vaccination. To be considered of non-childbearing&#xD;
             potential, a female must be pre-menarche or post-menopausal for at least 1 year, or&#xD;
             surgically sterile.&#xD;
&#xD;
          -  Participation at the time of study enrollment or, planned participation during the&#xD;
             present study period in another clinical study investigating a vaccine, drug, medical&#xD;
             device, or medical procedure&#xD;
&#xD;
          -  Receipt of any vaccine in the 4 weeks (28 days) preceding the first study vaccination&#xD;
             or planned receipt of any vaccine prior to Visit 8 (D90)&#xD;
&#xD;
          -  Previous vaccination against rabies (in pre- or post-exposure regimen) with either the&#xD;
             study vaccines or another vaccine&#xD;
&#xD;
          -  Bite by, or exposure to a potentially rabid animal in the previous 6 months without&#xD;
             post-exposure prophylaxis&#xD;
&#xD;
          -  Receipt of immune globulins, blood or blood-derived products in the past 3 months&#xD;
&#xD;
          -  Known or suspected congenital or acquired immunodeficiency; or receipt of&#xD;
             immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,&#xD;
             within the preceding 6 months; or long-term systemic corticosteroid therapy&#xD;
             (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)&#xD;
&#xD;
          -  At high risk for rabies exposure&#xD;
&#xD;
          -  Known systemic hypersensitivity to any of the study/control vaccine components or, for&#xD;
             adults, to ERIG Group 3 and Group 4) or HRIG (Group 5 and Group 6), or history of a&#xD;
             life-threatening reaction to the vaccines used in the study or to a vaccine containing&#xD;
             any of the same substances&#xD;
&#xD;
          -  Positive skin test to ERIG at Visit 1 for only adult participants enrolled in Group 3&#xD;
             and Group 4 as per superseded Protocol version 5.0&#xD;
&#xD;
          -  Self-reported thrombocytopenia&#xD;
&#xD;
          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion&#xD;
&#xD;
          -  Deprived of freedom by an administrative or court order, or in an emergency setting,&#xD;
             or hospitalized involuntarily&#xD;
&#xD;
          -  Current alcohol or substance abuse that, in the opinion of the Investigator, might&#xD;
             interfere with the study conduct or completion&#xD;
&#xD;
          -  Chronic illness that, in the opinion of the Investigator, is at a stage where it might&#xD;
             interfere with study conduct or completion&#xD;
&#xD;
          -  Moderate or severe acute illness/infection (according to Investigator judgment) on the&#xD;
             day of vaccination or febrile illness (temperature ≥ 38.0 C). A prospective subject&#xD;
             should not be included in the study until the condition has resolved or the febrile&#xD;
             event has subsided&#xD;
&#xD;
          -  Personal history of Guillain-Barré syndrome&#xD;
&#xD;
          -  Identified as an Investigator or employee of the Investigator or study center with&#xD;
             direct involvement in the proposed study, or identified as an immediate family member&#xD;
             (ie, parent, spouse, natural or adopted child) of the Investigator or employee with&#xD;
             direct involvement in the proposed study&#xD;
&#xD;
          -  Receipt of chloroquine or hydroxychloroquine up to 2 months prior to the study or&#xD;
             through to study until Visit 8&#xD;
&#xD;
        The above information is not intended to contain all considerations relevant to a patient's&#xD;
        potential participation in a clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Sciences &amp; Operations</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi Pasteur, a Sanofi Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigational Site Number :7640004</name>
      <address>
        <city>Bangkok</city>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7640002</name>
      <address>
        <city>Bangkok</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7640003</name>
      <address>
        <city>Khon Kaen</city>
        <zip>40002</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 11, 2023</last_update_submitted>
  <last_update_submitted_qc>July 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rabies Vaccine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rabies</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
    <mesh_term>Immunoglobulins</mesh_term>
    <mesh_term>Immunoglobulins, Intravenous</mesh_term>
    <mesh_term>Antibodies</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org</ipd_description>
  </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/NCT04478084
org study id: VRV09
secondary id: U1111-1227-4143
nct id: NCT04478084
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Primary Objective:

      To describe the immune response induced by VRVg-2 and Verorab vaccine at Day 14 (to assess
      the immune response after 3 doses [2-2-2]) and Day 42 (to assess the immune response after 4
      doses [2-2-2-0-2]) when administered as standalone in healthy pediatric population or
      co-administered with HRIG (Group 5 and Group 6) at Day 0 in healthy adults.

      Secondary Objectives:

        -  To describe the immune response induced by VRVg-2 and Verorab vaccine at Day 14 (to
           assess the immune response after 3 doses [2-2-2]) when co-administered with ERIG (Group
           3 and Group 4) at Day 0 in healthy adults

        -  To describe the immune response induced by VRVg-2 and Verorab vaccine at D90 (to assess
           the immune response 90 days post-rabies simulated exposure) when administered as
           standalone in healthy pediatric population or co-administered with HRIG (Group 5 and
           Group 6) at Day 0 in healthy adults

        -  To describe the safety profile of VRVg-2 and Verorab vaccine as standalone in pediatric
           population or when co-administered with ERIG (Group 3 and Group 4) or HRIG (Group 5 and
           Group 6) at Day 0 in adults, after each vaccination.
The duration of each participant's participation in the study is approximately 7 months (28
      day-vaccination period followed by 6 month safety follow-up period).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Modified double-blind: the participant (or legally acceptable representative) and the Investigator remain unaware of the treatment assignments throughout the study. An unblinded qualified trial staff member will prepare and administer the appropriate vaccine but will not be involved in the immunogenicity and safety evaluations.
measure: Percentage of participants in Group 1, Group 2, Group 5 and Group 6 achieving rabies virus neutralizing antibody (RVNA) titer greater than or equal to (≥) 0.5 IU/mL
time frame: Day 14 (post-vaccination)
description: RVNA titers will be measured by rapid fluorescent focus inhibition test (RFFIT)
measure: Percentage of participants in Group 1, Group 2, Group 5 and Group 6 achieving RVNA titer greater than or equal to (≥) 0.5 IU/mL
time frame: Day 42 (post-vaccination)
description: RVNA titers will be measured by RFFIT
measure: Number of Participants in Group 1, Group 2, Group 5 and Group 6 achieving RVNA titer greater than or equal to (≥) lower limit of quantification
time frame: Day 14 (post-vaccination)
description: RVNA titers will be measured by RFFIT Lower limit of quantification for RFFIT assay is 0.2 IU/mL
measure: Number of Participants in Group 1, Group 2, Group 5 and Group 6 achieving RVNA titer greater than or equal to (≥) lower limit of quantification
time frame: Day 42 (post-vaccination)
description: RVNA titers will be measured by RFFIT Lower limit of quantification for RFFIT assay is 0.2 IU/mL
measure: Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination) in Group 1, Group 2, Group 5 and Group 6 Participants
time frame: Day 14 (post-vaccination)
description: RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 14 RVNA ratios Day14/Day0 will be calculated
measure: Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination) in Group 1, Group 2, Group 5 and Group 6 Participants
time frame: Day 42 (post-vaccination)
description: RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 42 RVNA ratios Day42/Day0 will be calculated
measure: Number of participants reporting immediate adverse events (AEs)
time frame: Within 30 minutes post-vaccination
description: Includes unsolicited (spontaneously reported) systemic AEs
measure: Percentage of participants reporting solicited injection site reactions
time frame: Within 7 days post-vaccination
description: Solicited injection site reactions:
tenderness, erythema, swelling in toddlers (aged ≥ 1 year to < 2 years)
pain, erythema, and swelling in children (aged 2 years to < 12 years), in adolescents and adults (aged ≥ 12 years)
measure: Percentage of participants reporting solicited systemic reactions
time frame: Between Day 0 and Day 3, between Day 3 and Day 7, and during the 7 days following the remaining vaccinations
description: Solicited systemic reactions:
fever, vomiting, crying abnormal, drowsiness, appetite lost, irritability in toddlers (aged ≥ 1 year to < 2 years)
fever, headache, malaise and myalgia in children (aged 2 years to < 12 years), adolescents or adults (aged ≥ 12 years)
measure: Number of participants reporting unsolicited injection site AEs
time frame: Within 28 days post-vaccination
description: Unsolicited (spontaneously reported) injection site AEs
measure: Number of participants reporting unsolicited systemic AEs
time frame: Between each vaccination and up to 28 days after the last vaccination
description: Unsolicited (spontaneously reported) systemic AEs
measure: Number of participants reporting serious adverse events (SAEs)
time frame: Up to 6 months post-vaccination
description: SAEs, including adverse event of special interest (AESIs)
measure: Percentage of participants in Group 3 and Group 4 achieving rabies virus neutralizing antibody (RVNA) titer greater than or equal to (≥) 0.5 IU/mL
time frame: Day 14 (post-vaccination)
description: RVNA titers will be measured by RFFIT
measure: Number of Participants in Group 3 and Group 4 achieving RVNA titer greater than or equal to (≥) lower limit of quantification
time frame: Day 14 (post-vaccination)
description: RVNA titers will be measured by RFFIT Lower limit of quantification for RFFIT assay is 0.2 IU/mL
measure: Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination) in Group 3 and Group 4 Participants
time frame: Day 14 (post-vaccination)
description: RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 14 RVNA ratios Day14/Day0 will be calculated
measure: Percentage of participants in Group 1, Group 2, Group 5 and Group 6 achieving rabies virus neutralizing antibody (RVNA) titer greater than or equal to (≥) 0.5 IU/mL
time frame: Day 90 (post-vaccination)
description: RVNA titers will be measured by RFFIT
measure: Number of Participants in Group 1, Group 2, Group 5 and Group 6 achieving RVNA titer greater than or equal to (≥) lower limit of quantification
time frame: Day 90 (post-vaccination)
description: RVNA titers will be measured by RFFIT Lower limit of quantification for RFFIT assay is 0.2 IU/mL
measure: Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination) in Group 1, Group 2, Group 5 and Group 6 Participants
time frame: Day 90 (post-vaccination)
description: RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 90 RVNA ratios Day90/Day0 will be calculated
arm group label: Group 1: pediatric participants; VRVg-2
arm group type: Experimental
description: VRVg-2 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28
arm group label: Group 2: pediatric participants; Verorab
arm group type: Active Comparator
description: Verorab 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28
arm group label: Group 3: adult participants; VRVG-2 + ERIG
arm group type: Experimental
description: VRVg-2 8 injections: 2 at Day 0, 2 at Day 3 and 2 at Day 7
+ ERIG at D0
arm group label: Group 4: adult participants; Verorab + ERIG
arm group type: Active Comparator
description: Verorab 8 injections: 2 at Day 0, 2 at Day 3 and 2 at Day 7
+ ERIG at D0
arm group label: Group 5: adult participants; VRVG-2 + HRIG
arm group type: Experimental
description: VRVg-2 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28
+ HRIG at D0
arm group label: Group 6: adult participants; Verorab + HRIG
arm group type: Active Comparator
description: Verorab 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28
+ HRIG at D0
intervention type: Biological
intervention name: Purified vero rabies vaccine - serum free VRVg-2
description: Pharmaceutical form:freeze-dried Route of administration: intradermal
arm group label: Group 1: pediatric participants; VRVg-2
arm group label: Group 3: adult participants; VRVG-2 + ERIG
arm group label: Group 5: adult participants; VRVG-2 + HRIG
intervention type: Biological
intervention name: Purified inactivated rabies vaccine
description: Pharmaceutical form:freeze-dried Route of administration: intradermal
arm group label: Group 2: pediatric participants; Verorab
arm group label: Group 4: adult participants; Verorab + ERIG
arm group label: Group 6: adult participants; Verorab + HRIG
other name: Verorab®
intervention type: Biological
intervention name: Equine rabies immunoglobulins (ERIG) (only Group 3 and Group 4)
description: Pharmaceutical form: liquid/solution in 5 mL vials Route of administration: intramuscular
arm group label: Group 3: adult participants; VRVG-2 + ERIG
arm group label: Group 4: adult participants; Verorab + ERIG
other name: ERIG
intervention type: Biological
intervention name: Human rabies immunoglobulins (HRIG) (only Group 5 and Group 6)
description: Pharmaceutical form: liquid/solution in 2 mL vials Route of administration: intramuscular
arm group label: Group 5: adult participants; VRVG-2 + HRIG
arm group label: Group 6: adult participants; Verorab + HRIG
other name: IMOGAM® Rabies-HT
criteria: 
gender: All
minimum age: 1 Year
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi Pasteur, a Sanofi Company
facility: 
facility: 
facility: 
country: Thailand
responsible party type: Sponsor
mesh term: Rabies
mesh term: Vaccines
mesh term: Immunoglobulins
mesh term: Immunoglobulins, Intravenous
mesh term: Antibodies
sharing ipd: Yes
ipd description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org