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Study of Purified Vero Rabies Vaccine Compared With Two Reference Rabies Vaccines, Given in a Pre-exposure Regimen to Children and Adults and as Single Booster Dose to a Subset of Adults (VRV12)

Primary Purpose

Rabies (Healthy Volunteers)

Status
Recruiting
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Purified vero rabies vaccine - serum free - VRVg-2
Purified inactivated rabies vaccine - Verorab®
Purified inactivated rabies vaccine - Imovax® Rabies
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rabies (Healthy Volunteers)

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged ≥ 1 year on the day of inclusion
  • Informed consent form has been signed and dated by the participant and /or and parent(s) or legally acceptable representative (LAR) and by an independent witness (if required by local regulations), as necessary; and assent form has been signed and dated by the participant, as required
  • Participant (adult ≥ 18 years) or participant and parent/LAR (1 year to <18 years) are able to attend all scheduled visits and to comply with all study procedures.

Exclusion Criteria:

  • Participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until 1 month after each vaccination. To be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, or surgically sterile.
  • Participation at the time of study enrollment or, planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
  • Receipt of any vaccine in the 4 weeks (28 days) preceding the first study vaccination or planned receipt of any vaccine prior to Visit 5 for pediatric participants and adult participants in Cohort 1, and prior to Visit 4 for adult participants in Cohort 2.
  • Previous vaccination against rabies (in pre- or post-exposure regimen) with either the study vaccines or another vaccine.
  • Bite by, or exposure to a potentially rabid animal in the previous 6 months with or without post-exposure prophylaxis.
  • Receipt of immune globulins, blood or blood-derived products in the past 3 months.
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
  • At high risk for rabies exposure during the study.
  • Known systemic hypersensitivity to any of the study/control vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances
  • Self-reported thrombocytopenia, contraindicating intramuscular vaccination.
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
  • Current alcohol or substance abuse that, in the opinion of the investigator, might interfere with the study conduct or completion.
  • Chronic illness(1) that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion.
  • Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
  • Personal history of Guillain-Barré syndrome.
  • Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.

    1. Chronic illness may include, but is not limited to, neurological, cardiopulmonary, gastrointestinal, renal, genitourinary, metabolic, hematologic, auto-immune, or psychiatric disorders or infection

Sites / Locations

  • Investigational Site Number :7640001Recruiting
  • Investigational Site Number :7640004Recruiting
  • Investigational Site Number :7640003Recruiting
  • Investigational Site Number :7640002Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Active Comparator

Experimental

Active Comparator

Active Comparator

Arm Label

Group1:VRVg2 Cohort1(C1)-1ry Series:pediatric&adult participants-Booster:102 adult participants

Group 2:Verorab C1-1ry Series:pediatric&adult participants-Booster Phase:34 adult participants

Group 3:Imovax Rabies C1-1ry Series:pediatric&adult participants-Booster Phase:34 adult participants

Group 4:VRVg-2 Cohort 2(C2)-1ry Series:Adult participants-Booster Phase:138 adult participants

Group 5:Verorab C2-1ry Series:adult participants-Booster Phase:46 adult participants

Group 6:Imovax Rabies C2-1ry Series:adult participants-Booster Phase:46 adult participants

Arm Description

VRVg-2, 3 injections at Day 0, Day 7, and Day 28 Booster dose of VRVg-2 for a subset of 102 adult participants at Month 12

Verorab, 3 injections at Day 0, Day 7, and Day 28 Booster dose of VRVg-2 for a subset of 34 adult participants at Month 12

Imovax Rabies, 3 injections at Day 0, Day 7, and Day 28 Booster dose of VRVg-2 for a subset of 34 adult participants at Month 12

VRVg-2, 2 injections at Day 0 and Day 7 Booster dose of VRVg-2 for a subset of 138 adult participants between Month 24 up to Month 36

Verorab, 2 injections at Day 0 and Day 7 Booster dose of VRVg-2 for a subset of 46 adult participants between Month 24 up to Month 36

Imovax Rabies, 2 injections at Day 0 and Day 7 Booster dose of VRVg-2 for a subset of 46 adult participants between Month 24 up to Month 36

Outcomes

Primary Outcome Measures

Participant (pediatrics and adults from Primary Series Cohort 1) with RVNA titer ≥ 0.5 IU/mL
Percentage of participants (pediatrics and adults from Primary Series Cohort 1) with RVNA titer above threshold (≥ 0.5 IU/mL). RVNA titers are measured by the rapid fluorescent focus inhibition test (RFFIT) assay

Secondary Outcome Measures

Number of participants with immediate adverse events
Percentage of participants reporting unsolicited systemic adverse events in the 30 minutes after vaccination
Number of participants with solicited injection site or systemic reactions
Percentage of participants reporting injection site reactions in participants aged <=23 months: tenderness, erythema, and swelling; in participants aged 2 years and above: pain, erythema and swelling systemic reactions in participants aged <=23 months: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability; in participants aged 2 years and above: fever, headache, malaise, and myalgia
Number of participants with unsolicited adverse events
Percentage of participants with unsolicited (spontaneously reported) injection site reactions occurring within 28 days after each injection and unsolicited systemic AEs between each injection and up to 28 days after the last injection
Number of participants with serious adverse events (SAEs) and adverse events of special interest (AESIs)
Percentage of participants with SAEs, including AESIs, throughout the study
RVNA titers
RVNA titers are measured by RFFIT and expressed as geometric mean titers (GMT)
RVNA titer ≥ 0.5 IU/mL
Percentage of participants with RVNA titers above threshold (≥ 0.5 IU/mL) RVNA titers are measured by RFFIT
RVNA titer above lower limit of quantification (LLOQ) IU/Ml
Percentage of participants with RVNA titers above LLOQ IU/ml are measured by RFFIT
RVNA titer ratio
Individual RVNA titer ratio
Participant with complete or incomplete neutralization at the starting dilution of the RFFIT assay
Percentage of participants with complete or incomplete neutralization at the dilution of 1/5 in RFFIT

Full Information

First Posted
October 11, 2019
Last Updated
September 5, 2023
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT04127786
Brief Title
Study of Purified Vero Rabies Vaccine Compared With Two Reference Rabies Vaccines, Given in a Pre-exposure Regimen to Children and Adults and as Single Booster Dose to a Subset of Adults
Acronym
VRV12
Official Title
Immunogenicity and Safety of a Purified Vero Rabies Vaccine - Serum Free in Comparison With Verorab® and Imovax® Rabies, in a Pre-exposure Regimen in Both Pediatric and Adult Populations and a Single Booster Dose of Purified Vero Rabies Vaccine - Serum Free Administered at 1 Year Post-3-dose Primary Series, and Between 2 up to 3 Years Post-One Week 2-Dose Primary Series in a Subset of Adults in Thailand
Study Type
Interventional

2. Study Status

Record Verification Date
September 1, 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 21, 2019 (Actual)
Primary Completion Date
March 25, 2020 (Actual)
Study Completion Date
May 12, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is: To demonstrate the VRVg-2 is non-inferior to Verorab and Imovax Rabies vaccines in each age group (pediatric and adult populations) when administered as a 3-dose PrEP regimen, in terms of proportion of participants achieving a rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 IU/mL at Day 42, ie. 14 days after the 3rd injection (for Primary Series Cohort 1). The secondary objectives of this study are: First 1-5 with hypotheses testing will be evaluated sequentially - only if the previous objective is achieved, will the next objective be tested To demonstrate that: the observed proportion of participants in the VRVg2(VRVg) group at D42 is at least 99% with a lower limit of the 95% confidence interval (CI) of at least 97% VRVg is non inferior (NI) to Verorab and Imovax Rabies vaccines (Imovax) in each age group at D28 2-dose VRVg at D28 is NI to 3-dose Imovax at D42 in each age group the observed proportion of participants in the VRVg group at D28 is at least 99% with a lower limit of the 95% CI of at least 97% 2-dose Imovax at D28 is NI to 3-dose Imovax at D42 in overall participants (Cohort1) To describe: the immune response induced by VRVg versus Verorab and Imovax at D28 and at D42 in all age groups the immune response induced by VRVg at D14 after a booster dose of VRVg administered at M12 (Cohort1) and between M24 up to M36 (Cohort2) the persistence of immune response at M6,12,18, and pre-booster between M24 up to M36 post-primary series vaccination (Cohort2) safety profile of VRVg versus Verorab and Imovax in primary series and after a booster dose of VRVg
Detailed Description
The duration of each participant's participation in the primary series Cohort 1 of the study will be approximately 7 months (28 day-vaccination period followed by 6-month safety follow-up period). For the subset of adult participants in Booster Phase Cohort 1 who received a single booster dose of VRVg-2 (1 booster dose 365 days after primary series followed by 6-month safety follow-up period), the duration will be approximately 18 months. For Primary Series Cohort 2, the duration of each participant's participation in the study will be approximately 7 months (one week vaccination period followed by 6-month safety follow-up period). For the subset of adult participants in Immunogenicity Persistence and Booster Phase Cohort 2 who will be followed-up for evaluation of immunogenicity persistence after primary series (including blood samples collection at M6, M12, M18, and between 24 up to 36 months) and who will receive a single booster dose of VRVg-2 (after the blood sample collection between 24 up to 36 months), the duration will be approximately 30 to 42 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rabies (Healthy Volunteers)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Primary series will be observer-blinded for both Cohort 1 (3-dose pre-exposure prophylaxis [PrEP] regimen) and Cohort 2 (one week 2-dose PrEP regimen). Booster phase will be conducted in a blinded manner (vaccine received in the primary series) with an adult subset from Cohort 1 and hereafter referred as "Booster Phase Cohort 1" (with booster dose 1 year after the 1st primary series vaccine injection). Evaluation of immunogenicity persistence after primary series and a booster phase will be conducted in an open label manner with an adult subset from Cohort 2 and hereafter referred as "Immunogenicity Persistence and Booster Phase Cohort 2" (including blood samples collection at Month 6, Month 12, Month 18, pre-booster between Month 24 up to Month 36, and post-booster between Month 24 up to Month 36+Day 14; and a booster dose between Month 24 up to Month 36).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
For cohort 1 primary series and booster dose and cohort 2 primary series. The study is conducted in an observer-blind manner. Unblinded staff members, independent of the safety evaluation and other study evaluations, prepare and administer the vaccine. The Investigator or delegate in charge of safety assessment as well as the participants are blinded and do not know which vaccine is administered. In addition to the participants, health care providers, data collectors, outcome assessors (eg, Investigator who assess the safety), the Sponsor personnel (eg, Clinician, Data Management, Biostatistician) will remain blinded until the first statistical analysis. For cohort 2 immunogenicity persistence and booster phase This phase is open label, however, the laboratory analysts who will be involved in the blood sample testing will remain blinded during the whole study.
Allocation
Randomized
Enrollment
1700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group1:VRVg2 Cohort1(C1)-1ry Series:pediatric&adult participants-Booster:102 adult participants
Arm Type
Experimental
Arm Description
VRVg-2, 3 injections at Day 0, Day 7, and Day 28 Booster dose of VRVg-2 for a subset of 102 adult participants at Month 12
Arm Title
Group 2:Verorab C1-1ry Series:pediatric&adult participants-Booster Phase:34 adult participants
Arm Type
Active Comparator
Arm Description
Verorab, 3 injections at Day 0, Day 7, and Day 28 Booster dose of VRVg-2 for a subset of 34 adult participants at Month 12
Arm Title
Group 3:Imovax Rabies C1-1ry Series:pediatric&adult participants-Booster Phase:34 adult participants
Arm Type
Active Comparator
Arm Description
Imovax Rabies, 3 injections at Day 0, Day 7, and Day 28 Booster dose of VRVg-2 for a subset of 34 adult participants at Month 12
Arm Title
Group 4:VRVg-2 Cohort 2(C2)-1ry Series:Adult participants-Booster Phase:138 adult participants
Arm Type
Experimental
Arm Description
VRVg-2, 2 injections at Day 0 and Day 7 Booster dose of VRVg-2 for a subset of 138 adult participants between Month 24 up to Month 36
Arm Title
Group 5:Verorab C2-1ry Series:adult participants-Booster Phase:46 adult participants
Arm Type
Active Comparator
Arm Description
Verorab, 2 injections at Day 0 and Day 7 Booster dose of VRVg-2 for a subset of 46 adult participants between Month 24 up to Month 36
Arm Title
Group 6:Imovax Rabies C2-1ry Series:adult participants-Booster Phase:46 adult participants
Arm Type
Active Comparator
Arm Description
Imovax Rabies, 2 injections at Day 0 and Day 7 Booster dose of VRVg-2 for a subset of 46 adult participants between Month 24 up to Month 36
Intervention Type
Biological
Intervention Name(s)
Purified vero rabies vaccine - serum free - VRVg-2
Intervention Description
Pharmaceutical form: Freeze-dried Route of administration: Intramuscular
Intervention Type
Biological
Intervention Name(s)
Purified inactivated rabies vaccine - Verorab®
Intervention Description
Pharmaceutical form:Freeze-dried Route of administration: Intramuscular
Intervention Type
Biological
Intervention Name(s)
Purified inactivated rabies vaccine - Imovax® Rabies
Intervention Description
Pharmaceutical form: Freeze-dried Route of administration: Intramuscular
Primary Outcome Measure Information:
Title
Participant (pediatrics and adults from Primary Series Cohort 1) with RVNA titer ≥ 0.5 IU/mL
Description
Percentage of participants (pediatrics and adults from Primary Series Cohort 1) with RVNA titer above threshold (≥ 0.5 IU/mL). RVNA titers are measured by the rapid fluorescent focus inhibition test (RFFIT) assay
Time Frame
Day(D) 42 for participants in Primary Series Cohort 1
Secondary Outcome Measure Information:
Title
Number of participants with immediate adverse events
Description
Percentage of participants reporting unsolicited systemic adverse events in the 30 minutes after vaccination
Time Frame
Within 30 minutes after vaccination
Title
Number of participants with solicited injection site or systemic reactions
Description
Percentage of participants reporting injection site reactions in participants aged <=23 months: tenderness, erythema, and swelling; in participants aged 2 years and above: pain, erythema and swelling systemic reactions in participants aged <=23 months: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability; in participants aged 2 years and above: fever, headache, malaise, and myalgia
Time Frame
Within 7 days after vaccination
Title
Number of participants with unsolicited adverse events
Description
Percentage of participants with unsolicited (spontaneously reported) injection site reactions occurring within 28 days after each injection and unsolicited systemic AEs between each injection and up to 28 days after the last injection
Time Frame
Within 28 days after vaccination
Title
Number of participants with serious adverse events (SAEs) and adverse events of special interest (AESIs)
Description
Percentage of participants with SAEs, including AESIs, throughout the study
Time Frame
Within at least 6 months(M) after each vaccination as applicable to Cohort 1(C1) and Cohort 2 (C2)
Title
RVNA titers
Description
RVNA titers are measured by RFFIT and expressed as geometric mean titers (GMT)
Time Frame
D0 & D28 for participants in 1ry Series C1 & C2;D42 for participants in 1ry Series C1;M12 & 12+D14 for participants in Booster C1;M6,M12,M18;Between M24 up to M36 & between M24 up to M36+D14 for participants in Immunogenicity Persistence & BoosterC2
Title
RVNA titer ≥ 0.5 IU/mL
Description
Percentage of participants with RVNA titers above threshold (≥ 0.5 IU/mL) RVNA titers are measured by RFFIT
Time Frame
D0 & D28 for participants in 1ry Series C1 & C2;D42 for participants in 1ry Series C1;M12 & 12+D14 for participants in Booster C1;M6,M12,M18;Between M24 up to M36 & between M24 up to M36+D14 for participants in Immunogenicity Persistence & BoosterC2
Title
RVNA titer above lower limit of quantification (LLOQ) IU/Ml
Description
Percentage of participants with RVNA titers above LLOQ IU/ml are measured by RFFIT
Time Frame
D0 & D28 for participants in 1ry Series C1 & C2;D42 for participants in 1ry Series C1;M12 & 12+D14 for participants in Booster C1;M6,M12,M18;Between:M24 up to M36 & between M24 up to M36+D14 for participants in Immunogenicity Persistence & BoosterC2
Title
RVNA titer ratio
Description
Individual RVNA titer ratio
Time Frame
Day 28/Day 0 on Primary Series Cohort 1 and Cohort 2 Day 42/Day 0 for participants in Primary Series Cohort 1 Month 12/Day 0, 14 days after Month 12/Day 0, and 14 days after Month12/Month12, for participants in Booster Phase Cohort 1 Month 6/Day 0, Month
Title
Participant with complete or incomplete neutralization at the starting dilution of the RFFIT assay
Description
Percentage of participants with complete or incomplete neutralization at the dilution of 1/5 in RFFIT
Time Frame
D0 & D28 for participants in 1ry Series C1 & C2;D42 for participants in 1ry Series C1;M12 & 12+D14 for participants in Booster C1;M6,M12,M18;Between:M24 up to M36 & between M24 up to M36+D14 for participants in Immunogenicity Persistence & BoosterC2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged ≥1 year on the day of inclusion Cohort 1 - pediatrics (>1 to 17 years old) and adult (≥18 years old) Cohort 2 - all adults (≥18 years old) Informed consent form has been signed and dated by the participant and /or and parent(s) or legally acceptable representative (LAR) and by an independent witness (if required by local regulations), as necessary; and assent form has been signed and dated by the participant, as required Participant (adult ≥18 years) or participant and parent/LAR (1 year to <18 years) are able to attend all scheduled visits and to comply with all study procedures. Exclusion Criteria: Participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until 1 month after each vaccination. To be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, or surgically sterile. Participation at the time of study enrollment or, planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. Receipt of any vaccine in the 4 weeks (28 days) preceding the first study vaccination or planned receipt of any vaccine prior to Visit 5 for pediatric participants and adult participants in Cohort 1, and prior to Visit 4 for adult participants in Cohort 2. Previous vaccination against rabies (in pre- or post-exposure regimen) with either the study vaccines or another vaccine. Bite by, or exposure to a potentially rabid animal in the previous 6 months with or without post-exposure prophylaxis. Receipt of immune globulins, blood or blood-derived products in the past 3 months. Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). At high risk for rabies exposure during the study. Known systemic hypersensitivity to any of the study/control vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances. Self-reported thrombocytopenia, contraindicating intramuscular vaccination. Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination. Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. Current alcohol or substance abuse that, in the opinion of the investigator, might interfere with the study conduct or completion. Chronic illness(1) that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion. Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided. Personal history of Guillain-Barré syndrome. Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study. Chronic illness may include, but is not limited to, neurological, cardiopulmonary, gastrointestinal, renal, genitourinary, metabolic, hematologic, auto-immune, or psychiatric disorders or infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trial Transparency email recommended (Toll free number for US & Canada)
Email
Contact-US@sanofi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi Pasteur, a Sanofi Company
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number :7640001
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7640004
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7640003
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7640002
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan 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://www.clinicalstudydatarequest.com/

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Study of Purified Vero Rabies Vaccine Compared With Two Reference Rabies Vaccines, Given in a Pre-exposure Regimen to Children and Adults and as Single Booster Dose to a Subset of Adults

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