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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04127786

Acronym

VRV12

Enrollment

1708

Registered

2019-10-16

Start date

2019-10-21

Completion date

2025-04-24

Last updated

2026-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers, Rabies

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.

Interventions

BIOLOGICALPurified vero rabies vaccine - serum free - VRVg-2

Pharmaceutical form: Freeze-dried Route of administration: Intramuscular

BIOLOGICALPurified inactivated rabies vaccine - Verorab®

Pharmaceutical form:Freeze-dried Route of administration: Intramuscular

BIOLOGICALPurified inactivated rabies vaccine - Imovax® Rabies

Pharmaceutical form: Freeze-dried Route of administration: Intramuscular

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes 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.

Intervention 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).

Eligibility

Sex/Gender

ALL

Age

1 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody (RVNA) Titer Greater Than or Equal to (>=) 0.5 IU/mL	Day 42 (post-vaccination)	RVNA titer against rabies virus was assessed using the Rapid Fluorescent Focus Inhibition test (RFFIT) assay method.

Secondary

Measure	Time frame	Description
Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL	Cohort 1: Day 0 (pre-vaccination), Day 28 and Day 42 (post-vaccination)	RVNA titer against rabies virus was assessed using the RFFIT assay method.
Primary Series: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population	Cohort 1: Day 0 (pre-vaccination), Day 28 (post-vaccination); Cohort 2: Day 0 (pre-vaccination) and Day 28 (post-vaccination)	RVNA titer against rabies virus was assessed using the RFFIT assay method. At Baseline, Group 1 was equivalent to Group 4 (both groups received VRVg-2), Group 2 was equivalent to Group 5 (both groups received Verorab®), and Group 3 was equivalent to Group 6 (both groups received Imovax Rabies®), therefore it was planned to collect and present pooled data of specified Groups, and separately for adults and pediatric participants in this outcome measure.
Primary Series: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population (Groups 1 and 4) Versus Cohort 1: Group 3: Non-inferiority Analysis	Pooled Groups 1 and 4: Day 28 (post-vaccination) and Primary Series: Cohort-1 Group 3: Day 42 (post-vaccination)	RVNA titer against rabies virus was assessed using the RFFIT assay method. At Baseline, Group 1 was equivalent to Group 4 (both groups received VRVg-2), therefore it was planned to collect and present pooled data of specified Group, and separately for adults and pediatric participants in this outcome measure. Data for this outcome measure was planned to be collected at Day 28 for Pooled Groups 1 and 4 and at Day 42 for Primary Series: Cohort-1 Group 3: Imovax Rabies® and reported as overall data for the non-inferiority analysis in this outcome measure.
Primary Series: Groups 1 and 4: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population - Superiority Analysis	Day 28 (post-vaccination)	RVNA titer against rabies virus was assessed using the RFFIT assay method. At Baseline, Group 1 was equivalent to Group 4 (both groups received VRVg-2), therefore it was planned to collect and present pooled data of specified Group in this outcome measure.
Primary Series Cohort 1 Group 3: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Non-Inferiority Analysis	Cohort 1: Day 28 and Day 42 (post-vaccination)	RVNA titer against rabies virus was assessed using the RFFIT assay method.
Primary Series Cohort 1: Rabies Virus Neutralizing Antibody Geometric Mean Titers (GMTs) Against Rabies Virus	Cohort 1: Day 0 (pre-vaccination), Day 28 and Day 42 (post-vaccination)	RVNA titer against rabies virus was assessed using the RFFIT assay method.
Primary Series Cohort 2: Rabies Virus Neutralizing Antibody Geometric Mean Titers (GMTs) Against Rabies Virus	Cohort 2: Day 0 (pre-vaccination) and Day 28 (post-vaccination)	RVNA titer against rabies virus was assessed using the RFFIT assay method.
Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])	Cohort 1: Day 0 (pre-vaccination), Day 28 and Day 42 (post-vaccination)	RVNA titer against rabies virus was assessed using the RFFIT assay method. LLOQ for the RFFIT assay was 0.2 IU/mL.
Primary Series Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])	Cohort 2: Day 0 (pre-vaccination) and Day 28 (post-vaccination)	RVNA titer against rabies virus was assessed using the RFFIT assay method. LLOQ for the RFFIT assay was 0.2 IU/mL.
Primary Series Cohort 1: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers	Cohort 1: Day 0 (pre-vaccination), Day 28 and Day 42 (post-vaccination)	RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs post-vaccination (i.e., on Day 28 and Day 42) and pre-vaccination on Day 0.
Primary Series Cohort 2: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers	Cohort 2: Day 0 (pre-vaccination) and Day 28 (post-vaccination)	RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs post-vaccination (i.e., on Day 28) and pre-vaccination on Day 0.
Primary Series Cohort 1: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Cohort 1: Day 0 (pre-vaccination), Day 28 and Day 42 (post-vaccination)	Virus neutralization was defined as complete (absence of fluorescent cells) and incomplete (presence of fluorescent cells) at the participant/timepoint level at the starting dilution (1/5) of RFFIT assay. Percentage of participants with determined complete and determined incomplete virus neutralization were reported.
Primary Series Cohort 2: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Cohort 2: Day 0 (pre-vaccination) and Day 28 (post-vaccination)	Virus neutralization was defined as complete (absence of fluorescent cells) and incomplete (presence of fluorescent cells) at the participant/timepoint level at the starting dilution (1/5) of RFFIT assay. Percentage of participants with determined complete and determined incomplete virus neutralization were reported.
Booster Phase: Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus	Month 12 (pre-booster dose) and Month 12 + Day 14 (post-booster dose)	RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTs were expressed in IU/mL.
Booster Phase: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL	Month 12 (pre-booster dose) and Month 12 + Day 14 (post-booster dose)	RVNA titer against rabies virus was assessed using the RFFIT assay method.
Booster Phase: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (LLOQ)	Month 12 (pre-booster dose) and Month 12 + Day 14 (post-booster dose)	RVNA titer against rabies virus was assessed using the RFFIT assay method. LLOQ for the RFFIT assay was 0.2 IU/mL.
Booster Phase: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers	Day 0 (pre-vaccination), Month 12 (pre-booster dose) and Month 12 + Day 14 (post-booster dose)	RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs post vaccination (i.e., on Month 12 and Month 12 + Day 14) and pre-vaccination on Day 0, pre-booster dose on Month 12.
Booster Phase: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Month 12 (pre-booster dose) and Month 12 + Day 14 (post-booster dose)	Virus neutralization was defined as complete (absence of fluorescent cells) and incomplete (presence of fluorescent cells) at the participant/timepoint level at the starting dilution (1/5) of RFFIT assay. Percentage of participants with determined complete and determined incomplete virus neutralization were reported.
Booster Phase Cohort 2: Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus	Month 24 up to Month 36 (pre-booster dose) and Month 24 up to Month 36 + Day 14 (post-booster dose)	RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTs were expressed in International units/milliliter (IU/mL).
Booster Phase Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL	Month 24 up to Month 36 (pre-booster dose) and Month 24 up to Month 36 + Day 14 (post-booster dose)	RVNA titer against rabies virus was assessed using the RFFIT assay method. Percentages are rounded off to the tenth decimal place.
Booster Phase Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])	Month 24 up to Month 36 (pre-booster dose) and Month 24 up to Month 36 + Day 14 (post-booster dose)	RVNA titer against rabies virus was assessed using the RFFIT assay method. LLOQ for the RFFIT assay was 0.2 IU/mL. Percentages are rounded off to the tenth decimal place.
Booster Phase Cohort 2: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers	Day 0 (pre-vaccination), Month 24 up to Month 36 (pre-booster dose) and Month 24 up to Month 36 + Day 14 (post-booster dose)	RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs pre-booster/pre-vaccination (Month 24 up to Month 36/Day 0); post-booster/pre-vaccination (Month 24 up to Month 36 +14 days/Day 0); post-booster/pre-booster (Month 24 up to Month 36+14 days/Month 24 up to Month 36).
Booster Phase Cohort 2: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Month 24 up to Month 36 (pre-booster dose) and Month 24 up to Month 36 + Day 14 (post-booster dose)	Virus neutralization was defined as complete (absence of fluorescent cells) and incomplete (presence of fluorescent cells) at the participant/timepoint level at the starting dilution (1/5) of RFFIT assay. Percentage of participants with determined complete and determined incomplete virus neutralization were reported. Percentages are rounded off to the tenth decimal place.
Number of Participants With Immediate Unsolicited Adverse Events (AEs)	Within 30 minutes after any vaccination	An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessarily had to have a causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset post-vaccination. All participants were observed for 30 minutes after any vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.
Booster Phase Cohort 2: Number of Participants With Immediate Unsolicited Adverse Events (AEs)	Within 30 minutes after any vaccination	An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessarily had to have a causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset post-vaccination. All participants were observed for 30 minutes after any vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.
Number of Participants With Systemic Reactions	Within 7 Days after any vaccination	A SR was an expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite loss, irritability, headache, malaise and myalgia. Solicited systemic reactions were collected by different age groups: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability were collected for participants aged 12 to 23 months. Fever, Headache, Malaise and Myalgia were collected for participants aged \>= 2 years.
Booster Phase Cohort 2: Number of Participants With Systemic Reactions	Within 7 Days after any vaccination	A SR was an expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite loss, irritability, headache, malaise and myalgia. Solicited systemic reactions were collected by different age groups: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability were collected for participants aged 12 to 23 months. Fever, Headache, Malaise and Myalgia were collected for participants aged \>= 2 years.
Number of Participants With Solicited Injection Site Reactions	Within 7 Days after any vaccination	A solicited reaction (SR) was an expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited injection site reactions included tenderness/pain, erythema and swelling.
Booster Phase Cohort 2: Number of Participants With Solicited Injection Site Reactions	Within 7 Days after any vaccination	A SR was an expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited injection site reactions included tenderness/pain, erythema and swelling.
Number of Participants With Unsolicited Adverse Events	Within 28 Days after any vaccination	An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessarily had to have a causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset post-vaccination.
Booster Phase Cohort 2: Number of Participants With Unsolicited Adverse Events	Within 28 Days after any vaccination	An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessarily had to have a causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset post-vaccination.
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)	From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 & 2 and up to Month 18 for Booster Phase, Cohort 1)	An SAEs was any untoward medical occurrence that at any dose resulted in death, life-threatening, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or a medically important event. An AESI was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. All SAEs and AESIs occurring during the study that were related to the product administered were reported by the Investigator to the Independent Ethics Committee/Institutional Review Board. Relatedness to study vaccine was based on Investigator's discretion.
Primary Series Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL	Cohort 2: Day 0 (pre-vaccination) and Day 28 (post-vaccination)	RVNA titer against rabies virus was assessed using the RFFIT assay method.
Booster Phase Cohort 2: Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)	From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 42)	An SAEs was any untoward medical occurrence that at any dose resulted in death, life-threatening, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or a medically important event. An AESI was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. All SAEs and AESIs occurring during the study that were related to the product administered were reported by the Investigator to the Independent Ethics Committee/Institutional Review Board. Relatedness to study vaccine was based on Investigator's discretion.

Countries

Thailand

Contacts

STUDY_DIRECTORClinical Sciences & Operations

Sanofi Pasteur, a Sanofi Company

Participant flow

Recruitment details

The study enrolled participants at 4 active sites in Thailand from 21 October 2019 to 23 January 2023. A total of 1708 participants were enrolled and randomized in the study. The study involves 2 phases: Primary series (Cohort 1: 3-dose pre-exposure prophylaxis \[PrEP\] regimen and Cohort 2: 1-week 2-dose PrEP regimen); and Booster Phase (Cohort 1: booster dose 1 year after first primary series vaccine injection and Cohort 2: Immunogenicity Persistence and Booster Phase Cohort 2).

Pre-assignment details

The analysis contains all data in the primary series and booster phase of Cohort (C)-1 and Cohort-2.

Participants by arm

Arm	Count
Primary Series: Cohort-1 Group 1: VRVg-2 Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	607
Primary Series: Cohort-1 Group 2: Verorab® Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	203
Primary Series: Cohort-1 Group 3: Imovax Rabies® Pediatric and adult participants received 3 IM injections of Imovax Rabies® vaccine at Day 0, Day 7, and Day 28 respectively.	200
Primary Series: Cohort-2 Group 4: VRVg-2 Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	420
Primary Series: Cohort-2 Group 5: Verorab® Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	139
Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	139
Total	1,708

Baseline characteristics

Characteristic	Primary Series: Cohort-1 Group 1: VRVg-2	Total	Primary Series: Cohort-2 Group 6: Imovax Rabies®	Primary Series: Cohort-2 Group 5: Verorab®	Primary Series: Cohort-2 Group 4: VRVg-2	Primary Series: Cohort-1 Group 3: Imovax Rabies®	Primary Series: Cohort-1 Group 2: Verorab®
Age, Continuous	22.9 years STANDARD_DEVIATION 17.1	28.8 years STANDARD_DEVIATION 16.4	37.3 years STANDARD_DEVIATION 10.9	38.4 years STANDARD_DEVIATION 11.1	37.4 years STANDARD_DEVIATION 11.3	22.4 years STANDARD_DEVIATION 16.1	22.6 years STANDARD_DEVIATION 16.1
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	607 Participants	1708 Participants	139 Participants	139 Participants	420 Participants	200 Participants	203 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Sex: Female, Male Female	399 Participants	1128 Participants	98 Participants	96 Participants	266 Participants	122 Participants	147 Participants
Sex: Female, Male Male	208 Participants	580 Participants	41 Participants	43 Participants	154 Participants	78 Participants	56 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk	EG009 affected / at risk	EG010 affected / at risk	EG011 affected / at risk
deaths Total, all-cause mortality	0 / 607	0 / 202	0 / 200	0 / 419	0 / 139	0 / 139	0 / 94	0 / 31	0 / 32	0 / 128	0 / 41	0 / 43
other Total, other adverse events	414 / 607	121 / 202	128 / 200	130 / 419	34 / 139	48 / 139	48 / 94	15 / 31	18 / 32	21 / 128	2 / 41	6 / 43
serious Total, serious adverse events	10 / 607	3 / 202	5 / 200	2 / 419	0 / 139	1 / 139	2 / 94	0 / 31	1 / 32	3 / 128	0 / 41	1 / 43

Outcome results

Primary

Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody (RVNA) Titer Greater Than or Equal to (>=) 0.5 IU/mL

RVNA titer against rabies virus was assessed using the Rapid Fluorescent Focus Inhibition test (RFFIT) assay method.

Time frame: Day 42 (post-vaccination)

Population: Analysis was performed on the per-protocol analysis set (PPAS) for Day 42 that included all participants who received at least 1 dose of the study vaccine in the primary series, with no relevant protocol deviation before Day 42. Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was planned to be collected and analyzed only for Primary series cohort-1 and separately for adults and pediatric participants.

Arm	Measure	Group	Value (NUMBER)
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody (RVNA) Titer Greater Than or Equal to (>=) 0.5 IU/mL	Pediatric (< 18 years)	100 percentage of participants
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody (RVNA) Titer Greater Than or Equal to (>=) 0.5 IU/mL	Adult (>= 18 years)	100 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody (RVNA) Titer Greater Than or Equal to (>=) 0.5 IU/mL	Pediatric (< 18 years)	100 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody (RVNA) Titer Greater Than or Equal to (>=) 0.5 IU/mL	Adult (>= 18 years)	98.8 percentage of participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody (RVNA) Titer Greater Than or Equal to (>=) 0.5 IU/mL	Pediatric (< 18 years)	100 percentage of participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody (RVNA) Titer Greater Than or Equal to (>=) 0.5 IU/mL	Adult (>= 18 years)	100 percentage of participants

Comparison: Primary Series: Cohort-I Group 1: VRVg-2 versus Primary Series: Cohort-I Group 2: Verorab®: Pediatric (\< 18 years)95% CI: [-1.4, 4.3]

Comparison: Primary Series: Cohort-I Group 1: VRVg-2 versus Primary Series: Cohort-I Group 2: Verorab®: Adult (\>=18 years)95% CI: [-0.6, 6.4]

Comparison: Primary Series: Cohort-I Group 1: VRVg-2 versus Primary Series: Cohort-I Group 3: Imovax Rabies: Pediatric (\< 18 years)95% CI: [-1.4, 4.4]

Comparison: Primary Series: Cohort-I Group 1: VRVg-2 versus Primary Series: Cohort-I Group 3: Imovax Rabies: Adult (\>= 18 years)95% CI: [-1.5, 4.6]

Secondary

Booster Phase: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers

RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs post vaccination (i.e., on Month 12 and Month 12 + Day 14) and pre-vaccination on Day 0, pre-booster dose on Month 12.

Time frame: Day 0 (pre-vaccination), Month 12 (pre-booster dose) and Month 12 + Day 14 (post-booster dose)

Population: Analysis was performed on the PPAS for Booster at Month 12.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Primary Series: Cohort-1 Group 1: VRVg-2	Booster Phase: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers	Month 12/Day 0	6.79 ratio
Primary Series: Cohort-1 Group 1: VRVg-2	Booster Phase: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers	Month 12+14 days/Month 12	83.2 ratio
Primary Series: Cohort-1 Group 1: VRVg-2	Booster Phase: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers	Month 12+14 days/Day 0	565 ratio
Primary Series: Cohort-1 Group 2: Verorab®	Booster Phase: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers	Month 12/Day 0	5.40 ratio
Primary Series: Cohort-1 Group 2: Verorab®	Booster Phase: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers	Month 12+14 days/Month 12	106 ratio
Primary Series: Cohort-1 Group 2: Verorab®	Booster Phase: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers	Month 12+14 days/Day 0	571 ratio
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Booster Phase: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers	Month 12+14 days/Month 12	69.2 ratio
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Booster Phase: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers	Month 12+14 days/Day 0	331 ratio
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Booster Phase: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers	Month 12/Day 0	4.78 ratio

Secondary

Booster Phase: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization

Virus neutralization was defined as complete (absence of fluorescent cells) and incomplete (presence of fluorescent cells) at the participant/timepoint level at the starting dilution (1/5) of RFFIT assay. Percentage of participants with determined complete and determined incomplete virus neutralization were reported.

Time frame: Month 12 (pre-booster dose) and Month 12 + Day 14 (post-booster dose)

Population: Analysis was performed on the PPAS for Booster at Month 12. Here, 'number analyzed' signifies participants with available data for each specified category.

Arm	Measure	Group	Value (NUMBER)
Primary Series: Cohort-1 Group 1: VRVg-2	Booster Phase: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Month 12 - Complete neutralization	96.1 percentage of participants
Primary Series: Cohort-1 Group 1: VRVg-2	Booster Phase: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Month 12 - Incomplete neutralization	3.9 percentage of participants
Primary Series: Cohort-1 Group 1: VRVg-2	Booster Phase: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Month 12 + 14 days - Complete neutralization	100 percentage of participants
Primary Series: Cohort-1 Group 1: VRVg-2	Booster Phase: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Month 12 + 14 days - Incomplete neutralization	0 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Booster Phase: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Month 12 + 14 days - Incomplete neutralization	0 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Booster Phase: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Month 12 - Complete neutralization	84.0 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Booster Phase: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Month 12 + 14 days - Complete neutralization	100 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Booster Phase: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Month 12 - Incomplete neutralization	16.0 percentage of participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Booster Phase: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Month 12 + 14 days - Incomplete neutralization	0 percentage of participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Booster Phase: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Month 12 - Incomplete neutralization	4.3 percentage of participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Booster Phase: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Month 12 + 14 days - Complete neutralization	100 percentage of participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Booster Phase: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Month 12 - Complete neutralization	95.7 percentage of participants

Secondary

Booster Phase: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (LLOQ)

RVNA titer against rabies virus was assessed using the RFFIT assay method. LLOQ for the RFFIT assay was 0.2 IU/mL.

Time frame: Month 12 (pre-booster dose) and Month 12 + Day 14 (post-booster dose)

Population: Analysis was performed on the PPAS for Booster at Month 12.

Arm	Measure	Group	Value (NUMBER)
Primary Series: Cohort-1 Group 1: VRVg-2	Booster Phase: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (LLOQ)	Month 12	86.3 percentage of participants
Primary Series: Cohort-1 Group 1: VRVg-2	Booster Phase: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (LLOQ)	Month 12 + 14 days	100 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Booster Phase: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (LLOQ)	Month 12	76.9 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Booster Phase: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (LLOQ)	Month 12 + 14 days	100 percentage of participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Booster Phase: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (LLOQ)	Month 12	85.7 percentage of participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Booster Phase: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (LLOQ)	Month 12 + 14 days	100 percentage of participants

Secondary

Booster Phase: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL

RVNA titer against rabies virus was assessed using the RFFIT assay method.

Time frame: Month 12 (pre-booster dose) and Month 12 + Day 14 (post-booster dose)

Population: Analysis was performed on the PPAS for Booster at Month 12.

Arm	Measure	Group	Value (NUMBER)
Primary Series: Cohort-1 Group 1: VRVg-2	Booster Phase: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL	Month 12	53.8 percentage of participants
Primary Series: Cohort-1 Group 1: VRVg-2	Booster Phase: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL	Month 12 + 14 days	100 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Booster Phase: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL	Month 12	53.8 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Booster Phase: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL	Month 12 + 14 days	100 percentage of participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Booster Phase: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL	Month 12	35.7 percentage of participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Booster Phase: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL	Month 12 + 14 days	100 percentage of participants

Secondary

Booster Phase: Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus

RVNA titer against rabies virus was assessed using the RFFIT assay method.

Time frame: Month 12 (pre-booster dose) and Month 12 + Day 14 (post-booster dose)

Population: Analysis was performed on PPAS for Booster at Month 12 that included a subset of adults who received a 3 doses regimen and received a single booster dose of VRVg-2 one year after the first vaccination of the primary series (i.e., at Month 12), with no relevant protocol deviation before Month 12 + Day 14.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Primary Series: Cohort-1 Group 1: VRVg-2	Booster Phase: Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus	Month 12 + 14 Days	56.5 IU/mL
Primary Series: Cohort-1 Group 1: VRVg-2	Booster Phase: Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus	Month 12	0.679 IU/mL
Primary Series: Cohort-1 Group 2: Verorab®	Booster Phase: Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus	Month 12	0.540 IU/mL
Primary Series: Cohort-1 Group 2: Verorab®	Booster Phase: Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus	Month 12 + 14 Days	57.1 IU/mL
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Booster Phase: Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus	Month 12	0.487 IU/mL
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Booster Phase: Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus	Month 12 + 14 Days	33.7 IU/mL

Secondary

Number of Participants With Immediate Unsolicited Adverse Events (AEs)

An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessarily had to have a causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset post-vaccination. All participants were observed for 30 minutes after any vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.

Time frame: Within 30 minutes after any vaccination

Population: Analysis was performed on the safety analysis set (SafAS) that included participant who had received at least one dose of the study vaccine and were analyzed according to the actual treatment received. The Booster Phase for Cohort-2 has not yet started, and data for that phase will be reported at time of final results posting.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Primary Series: Cohort-1 Group 1: VRVg-2	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	0 Participants
Primary Series: Cohort-1 Group 2: Verorab®	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	0 Participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	0 Participants
Primary Series: Cohort-2 Group 4: VRVg-2	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	0 Participants
Primary Series: Cohort-2 Group 5: Verorab®	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	0 Participants
Primary Series: Cohort-2 Group 6: Imovax Rabies®	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	0 Participants
Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2)	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	0 Participants
Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed)	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	0 Participants
Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed)	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	0 Participants

Secondary

Number of Participants With Immediate Unsolicited Adverse Events (AEs) - Booster Phase Cohort-2

Time frame: Within 30 minutes after any vaccination

Secondary

Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)

An SAEs was any untoward medical occurrence that at any dose resulted in death, life-threatening, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or a medically important event. An AESI was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. All SAEs and AESIs occurring during the study that were related to the product administered were reported by the Investigator to the Independent Ethics Committee/Institutional Review Board. Relatedness to study vaccine was based on Investigator's discretion.

Time frame: From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 & 2 and up to Month 18 for Booster Phase, Cohort 1)

Population: Analysis was performed on SafAS. The Booster Phase for Cohort-2 has not yet started, and data for that phase will be reported at time of final results posting.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Primary Series: Cohort-1 Group 1: VRVg-2	Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)	SAEs	10 Participants
Primary Series: Cohort-1 Group 1: VRVg-2	Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)	AESIs	0 Participants
Primary Series: Cohort-1 Group 2: Verorab®	Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)	AESIs	0 Participants
Primary Series: Cohort-1 Group 2: Verorab®	Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)	SAEs	3 Participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)	AESIs	0 Participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)	SAEs	5 Participants
Primary Series: Cohort-2 Group 4: VRVg-2	Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)	AESIs	0 Participants
Primary Series: Cohort-2 Group 4: VRVg-2	Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)	SAEs	0 Participants
Primary Series: Cohort-2 Group 5: Verorab®	Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)	SAEs	0 Participants
Primary Series: Cohort-2 Group 5: Verorab®	Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)	AESIs	0 Participants
Primary Series: Cohort-2 Group 6: Imovax Rabies®	Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)	SAEs	0 Participants
Primary Series: Cohort-2 Group 6: Imovax Rabies®	Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)	AESIs	0 Participants
Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2)	Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)	SAEs	2 Participants
Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2)	Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)	AESIs	0 Participants
Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed)	Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)	SAEs	0 Participants
Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed)	Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)	AESIs	0 Participants
Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed)	Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)	AESIs	0 Participants
Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed)	Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)	SAEs	1 Participants

Secondary

Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) - Booster Phase Cohort-2

Time frame: From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 42 for Booster Phase, Cohort 2)

Secondary

Number of Participants With Solicited Injection Site Reactions

A solicited reaction (SR) was an expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited injection site reactions included tenderness/pain, erythema and swelling.

Time frame: Within 7 Days after any vaccination

Population: Analysis was performed on the SafAS. The Booster Phase for Cohort-2 has not yet started, and data for that phase will be reported at time of final results posting.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Primary Series: Cohort-1 Group 1: VRVg-2	Number of Participants With Solicited Injection Site Reactions	Injection site tenderness/pain	344 Participants
Primary Series: Cohort-1 Group 1: VRVg-2	Number of Participants With Solicited Injection Site Reactions	Injection site swelling	14 Participants
Primary Series: Cohort-1 Group 1: VRVg-2	Number of Participants With Solicited Injection Site Reactions	Injection site erythema	24 Participants
Primary Series: Cohort-1 Group 2: Verorab®	Number of Participants With Solicited Injection Site Reactions	Injection site tenderness/pain	95 Participants
Primary Series: Cohort-1 Group 2: Verorab®	Number of Participants With Solicited Injection Site Reactions	Injection site erythema	6 Participants
Primary Series: Cohort-1 Group 2: Verorab®	Number of Participants With Solicited Injection Site Reactions	Injection site swelling	4 Participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Number of Participants With Solicited Injection Site Reactions	Injection site erythema	6 Participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Number of Participants With Solicited Injection Site Reactions	Injection site tenderness/pain	106 Participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Number of Participants With Solicited Injection Site Reactions	Injection site swelling	13 Participants
Primary Series: Cohort-2 Group 4: VRVg-2	Number of Participants With Solicited Injection Site Reactions	Injection site swelling	1 Participants
Primary Series: Cohort-2 Group 4: VRVg-2	Number of Participants With Solicited Injection Site Reactions	Injection site tenderness/pain	111 Participants
Primary Series: Cohort-2 Group 4: VRVg-2	Number of Participants With Solicited Injection Site Reactions	Injection site erythema	0 Participants
Primary Series: Cohort-2 Group 5: Verorab®	Number of Participants With Solicited Injection Site Reactions	Injection site tenderness/pain	30 Participants
Primary Series: Cohort-2 Group 5: Verorab®	Number of Participants With Solicited Injection Site Reactions	Injection site swelling	0 Participants
Primary Series: Cohort-2 Group 5: Verorab®	Number of Participants With Solicited Injection Site Reactions	Injection site erythema	0 Participants
Primary Series: Cohort-2 Group 6: Imovax Rabies®	Number of Participants With Solicited Injection Site Reactions	Injection site erythema	1 Participants
Primary Series: Cohort-2 Group 6: Imovax Rabies®	Number of Participants With Solicited Injection Site Reactions	Injection site swelling	1 Participants
Primary Series: Cohort-2 Group 6: Imovax Rabies®	Number of Participants With Solicited Injection Site Reactions	Injection site tenderness/pain	43 Participants
Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2)	Number of Participants With Solicited Injection Site Reactions	Injection site swelling	0 Participants
Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2)	Number of Participants With Solicited Injection Site Reactions	Injection site tenderness/pain	44 Participants
Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2)	Number of Participants With Solicited Injection Site Reactions	Injection site erythema	0 Participants
Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed)	Number of Participants With Solicited Injection Site Reactions	Injection site erythema	0 Participants
Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed)	Number of Participants With Solicited Injection Site Reactions	Injection site tenderness/pain	12 Participants
Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed)	Number of Participants With Solicited Injection Site Reactions	Injection site swelling	1 Participants
Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed)	Number of Participants With Solicited Injection Site Reactions	Injection site erythema	0 Participants
Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed)	Number of Participants With Solicited Injection Site Reactions	Injection site tenderness/pain	17 Participants
Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed)	Number of Participants With Solicited Injection Site Reactions	Injection site swelling	0 Participants

Secondary

Number of Participants With Solicited Injection Site Reactions - Booster Phase Cohort-2

Time frame: Within 7 Days after any vaccination

Secondary

Number of Participants With Systemic Reactions

A SR was an expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite loss, irritability, headache, malaise and myalgia. Solicited systemic reactions were collected by different age groups: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability were collected for participants aged 12 to 23 months. Fever, Headache, Malaise and Myalgia were collected for participants aged \>= 2 years.

Time frame: Within 7 Days after any vaccination

Population: Analysis was performed on the SafAS. Here, 'number analyzed' signifies participants with available data for each specified category and 0 in the number analyzed denotes that data was not collected and analyzed for the specified category as no pediatric participants were available for analysis in the specified groups. The Booster Phase for Cohort-2 has not yet started, and data for that phase will be reported at time of final results posting.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Primary Series: Cohort-1 Group 1: VRVg-2	Number of Participants With Systemic Reactions	Drowsiness	4 Participants
Primary Series: Cohort-1 Group 1: VRVg-2	Number of Participants With Systemic Reactions	Malaise	161 Participants
Primary Series: Cohort-1 Group 1: VRVg-2	Number of Participants With Systemic Reactions	Appetite lost	3 Participants
Primary Series: Cohort-1 Group 1: VRVg-2	Number of Participants With Systemic Reactions	Vomiting	4 Participants
Primary Series: Cohort-1 Group 1: VRVg-2	Number of Participants With Systemic Reactions	Fever	50 Participants
Primary Series: Cohort-1 Group 1: VRVg-2	Number of Participants With Systemic Reactions	Headache	128 Participants
Primary Series: Cohort-1 Group 1: VRVg-2	Number of Participants With Systemic Reactions	Crying abnormal	8 Participants
Primary Series: Cohort-1 Group 1: VRVg-2	Number of Participants With Systemic Reactions	Myalgia	249 Participants
Primary Series: Cohort-1 Group 1: VRVg-2	Number of Participants With Systemic Reactions	Irritability	8 Participants
Primary Series: Cohort-1 Group 2: Verorab®	Number of Participants With Systemic Reactions	Irritability	1 Participants
Primary Series: Cohort-1 Group 2: Verorab®	Number of Participants With Systemic Reactions	Crying abnormal	0 Participants
Primary Series: Cohort-1 Group 2: Verorab®	Number of Participants With Systemic Reactions	Drowsiness	1 Participants
Primary Series: Cohort-1 Group 2: Verorab®	Number of Participants With Systemic Reactions	Appetite lost	1 Participants
Primary Series: Cohort-1 Group 2: Verorab®	Number of Participants With Systemic Reactions	Headache	49 Participants
Primary Series: Cohort-1 Group 2: Verorab®	Number of Participants With Systemic Reactions	Fever	11 Participants
Primary Series: Cohort-1 Group 2: Verorab®	Number of Participants With Systemic Reactions	Vomiting	1 Participants
Primary Series: Cohort-1 Group 2: Verorab®	Number of Participants With Systemic Reactions	Malaise	45 Participants
Primary Series: Cohort-1 Group 2: Verorab®	Number of Participants With Systemic Reactions	Myalgia	66 Participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Number of Participants With Systemic Reactions	Fever	4 Participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Number of Participants With Systemic Reactions	Crying abnormal	1 Participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Number of Participants With Systemic Reactions	Appetite lost	0 Participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Number of Participants With Systemic Reactions	Drowsiness	0 Participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Number of Participants With Systemic Reactions	Myalgia	78 Participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Number of Participants With Systemic Reactions	Malaise	48 Participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Number of Participants With Systemic Reactions	Vomiting	1 Participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Number of Participants With Systemic Reactions	Irritability	0 Participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Number of Participants With Systemic Reactions	Headache	46 Participants
Primary Series: Cohort-2 Group 4: VRVg-2	Number of Participants With Systemic Reactions	Headache	39 Participants
Primary Series: Cohort-2 Group 4: VRVg-2	Number of Participants With Systemic Reactions	Malaise	37 Participants
Primary Series: Cohort-2 Group 4: VRVg-2	Number of Participants With Systemic Reactions	Fever	2 Participants
Primary Series: Cohort-2 Group 4: VRVg-2	Number of Participants With Systemic Reactions	Myalgia	78 Participants
Primary Series: Cohort-2 Group 5: Verorab®	Number of Participants With Systemic Reactions	Myalgia	12 Participants
Primary Series: Cohort-2 Group 5: Verorab®	Number of Participants With Systemic Reactions	Malaise	10 Participants
Primary Series: Cohort-2 Group 5: Verorab®	Number of Participants With Systemic Reactions	Headache	9 Participants
Primary Series: Cohort-2 Group 5: Verorab®	Number of Participants With Systemic Reactions	Fever	0 Participants
Primary Series: Cohort-2 Group 6: Imovax Rabies®	Number of Participants With Systemic Reactions	Myalgia	29 Participants
Primary Series: Cohort-2 Group 6: Imovax Rabies®	Number of Participants With Systemic Reactions	Malaise	12 Participants
Primary Series: Cohort-2 Group 6: Imovax Rabies®	Number of Participants With Systemic Reactions	Fever	0 Participants
Primary Series: Cohort-2 Group 6: Imovax Rabies®	Number of Participants With Systemic Reactions	Headache	8 Participants
Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2)	Number of Participants With Systemic Reactions	Fever	0 Participants
Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2)	Number of Participants With Systemic Reactions	Headache	4 Participants
Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2)	Number of Participants With Systemic Reactions	Malaise	8 Participants
Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2)	Number of Participants With Systemic Reactions	Myalgia	23 Participants
Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed)	Number of Participants With Systemic Reactions	Headache	3 Participants
Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed)	Number of Participants With Systemic Reactions	Myalgia	9 Participants
Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed)	Number of Participants With Systemic Reactions	Malaise	3 Participants
Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed)	Number of Participants With Systemic Reactions	Fever	0 Participants
Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed)	Number of Participants With Systemic Reactions	Headache	5 Participants
Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed)	Number of Participants With Systemic Reactions	Malaise	7 Participants
Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed)	Number of Participants With Systemic Reactions	Myalgia	15 Participants
Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed)	Number of Participants With Systemic Reactions	Fever	0 Participants

Secondary

Number of Participants With Systemic Reactions - Booster Phase Cohort-2

Time frame: Within 7 Days after any vaccination

Secondary

Number of Participants With Unsolicited Adverse Events

Time frame: Within 28 Days after any vaccination

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Primary Series: Cohort-1 Group 1: VRVg-2	Number of Participants With Unsolicited Adverse Events	137 Participants
Primary Series: Cohort-1 Group 2: Verorab®	Number of Participants With Unsolicited Adverse Events	45 Participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Number of Participants With Unsolicited Adverse Events	40 Participants
Primary Series: Cohort-2 Group 4: VRVg-2	Number of Participants With Unsolicited Adverse Events	44 Participants
Primary Series: Cohort-2 Group 5: Verorab®	Number of Participants With Unsolicited Adverse Events	18 Participants
Primary Series: Cohort-2 Group 6: Imovax Rabies®	Number of Participants With Unsolicited Adverse Events	12 Participants
Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2)	Number of Participants With Unsolicited Adverse Events	13 Participants
Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed)	Number of Participants With Unsolicited Adverse Events	3 Participants
Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed)	Number of Participants With Unsolicited Adverse Events	5 Participants

Secondary

Number of Participants With Unsolicited Adverse Events - Booster Phase Cohort-2

Time frame: Within 28 Days after any vaccination

Secondary

Primary Series Cohort 1: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers

RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs post-vaccination (i.e., on Day 28 and Day 42) and pre-vaccination on Day 0.

Time frame: Cohort 1: Day 0 (pre-vaccination), Day 28 and Day 42 (post-vaccination)

Population: Analysis was performed on the PPAS for Day 42. Here, 'number analyzed' signifies participants with available data for each specified category.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series Cohort 1: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers	Day 28/Day 0	71.5 ratio
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series Cohort 1: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers	Day 42/Day 0	240 ratio
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series Cohort 1: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers	Day 28/Day 0	48.7 ratio
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series Cohort 1: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers	Day 42/Day 0	199 ratio
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Primary Series Cohort 1: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers	Day 28/Day 0	51.0 ratio
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Primary Series Cohort 1: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers	Day 42/Day 0	163 ratio

Secondary

Primary Series Cohort 1 Group 3: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Non-Inferiority Analysis

RVNA titer against rabies virus was assessed using the RFFIT assay method.

Time frame: Cohort 1: Day 28 and Day 42 (post-vaccination)

Population: Analysis was performed on the PPAS. Here, 'number analyzed' signifies participants with available data for each specified category.

Arm	Measure	Group	Value (NUMBER)
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series Cohort 1 Group 3: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Non-Inferiority Analysis	Day 0	0 percentage of participants
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series Cohort 1 Group 3: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Non-Inferiority Analysis	Day 28	98.8 percentage of participants
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series Cohort 1 Group 3: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Non-Inferiority Analysis	Day 42	100 percentage of participants

Comparison: Imovax Rabies® at Day 28 versus Imovax Rabies® at Day 4295% CI: [-4.4, 1.3]

Secondary

Primary Series Cohort 1: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization

Time frame: Cohort 1: Day 0 (pre-vaccination), Day 28 and Day 42 (post-vaccination)

Population: Analysis was performed on the PPAS for Day 42. Here, 'number analyzed' signifies participants with available data for each specified category.

Arm	Measure	Group	Value (NUMBER)
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series Cohort 1: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Day 0 - Incomplete neutralization	99.8 percentage of participants
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series Cohort 1: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Day 28 - Incomplete neutralization	0 percentage of participants
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series Cohort 1: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Day 28 - Complete neutralization	100 percentage of participants
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series Cohort 1: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Day 0 - Complete neutralization	0.2 percentage of participants
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series Cohort 1: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Day 42 - Incomplete neutralization	0 percentage of participants
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series Cohort 1: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Day 42 - Complete neutralization	100 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series Cohort 1: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Day 28 - Complete neutralization	99.4 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series Cohort 1: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Day 0 - Complete neutralization	0.6 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series Cohort 1: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Day 0 - Incomplete neutralization	99.4 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series Cohort 1: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Day 28 - Incomplete neutralization	0.6 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series Cohort 1: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Day 42 - Complete neutralization	99.4 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series Cohort 1: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Day 42 - Incomplete neutralization	0.6 percentage of participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Primary Series Cohort 1: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Day 0 - Complete neutralization	1.3 percentage of participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Primary Series Cohort 1: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Day 42 - Incomplete neutralization	0 percentage of participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Primary Series Cohort 1: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Day 42 - Complete neutralization	100 percentage of participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Primary Series Cohort 1: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Day 0 - Incomplete neutralization	98.7 percentage of participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Primary Series Cohort 1: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Day 28 - Complete neutralization	99.4 percentage of participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Primary Series Cohort 1: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Day 28 - Incomplete neutralization	0.6 percentage of participants

Secondary

Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])

RVNA titer against rabies virus was assessed using the RFFIT assay method. LLOQ for the RFFIT assay was 0.2 IU/mL.

Time frame: Cohort 1: Day 0 (pre-vaccination), Day 28 and Day 42 (post-vaccination)

Population: Analysis was performed on the PPAS for Day 42. Here, 'number analyzed' signifies participants with available data for each specified category.

Arm	Measure	Group	Value (NUMBER)
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])	Day 28	100 percentage of participants
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])	Day 0	0 percentage of participants
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])	Day 42	100 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])	Day 28	99.4 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])	Day 0	0 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])	Day 42	99.4 percentage of participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])	Day 0	0 percentage of participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])	Day 42	100 percentage of participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])	Day 28	100 percentage of participants

Secondary

Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL

RVNA titer against rabies virus was assessed using the RFFIT assay method.

Time frame: Cohort 1: Day 0 (pre-vaccination), Day 28 and Day 42 (post-vaccination)

Population: Analysis was performed on the PPAS for Day 42. Here, 'number analyzed' signifies participants with available data for each specified category.

Arm	Measure	Group	Value (NUMBER)
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL	Day 42	100 percentage of participants
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL	Day 0	0 percentage of participants
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL	Day 28	100 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL	Day 28	99.4 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL	Day 42	99.4 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL	Day 0	0 percentage of participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL	Day 0	0 percentage of participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL	Day 42	100 percentage of participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL	Day 28	98.8 percentage of participants

Comparison: The secondary immunogenicity outcome measures were evaluated sequentially following a fixed-sequence method.95% CI: [99.3, 100]

Secondary

Primary Series Cohort 1: Rabies Virus Neutralizing Antibody Geometric Mean Titers (GMTs) Against Rabies Virus

RVNA titer against rabies virus was assessed using the RFFIT assay method.

Time frame: Cohort 1: Day 0 (pre-vaccination), Day 28 and Day 42 (post-vaccination)

Population: Analysis was performed on the PPAS for Day 42. Here, 'number analyzed' signifies participants with available data for each specified category.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series Cohort 1: Rabies Virus Neutralizing Antibody Geometric Mean Titers (GMTs) Against Rabies Virus	Day 28	7.16 IU/mL
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series Cohort 1: Rabies Virus Neutralizing Antibody Geometric Mean Titers (GMTs) Against Rabies Virus	Day 0	0.100 IU/mL
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series Cohort 1: Rabies Virus Neutralizing Antibody Geometric Mean Titers (GMTs) Against Rabies Virus	Day 42	24.0 IU/mL
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series Cohort 1: Rabies Virus Neutralizing Antibody Geometric Mean Titers (GMTs) Against Rabies Virus	Day 28	4.90 IU/mL
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series Cohort 1: Rabies Virus Neutralizing Antibody Geometric Mean Titers (GMTs) Against Rabies Virus	Day 0	0.101 IU/mL
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series Cohort 1: Rabies Virus Neutralizing Antibody Geometric Mean Titers (GMTs) Against Rabies Virus	Day 42	20.0 IU/mL
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Primary Series Cohort 1: Rabies Virus Neutralizing Antibody Geometric Mean Titers (GMTs) Against Rabies Virus	Day 0	0.101 IU/mL
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Primary Series Cohort 1: Rabies Virus Neutralizing Antibody Geometric Mean Titers (GMTs) Against Rabies Virus	Day 42	16.4 IU/mL
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Primary Series Cohort 1: Rabies Virus Neutralizing Antibody Geometric Mean Titers (GMTs) Against Rabies Virus	Day 28	5.13 IU/mL

Secondary

Primary Series Cohort 2: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers

RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs post-vaccination (i.e., on Day 28) and pre-vaccination on Day 0.

Time frame: Cohort 2: Day 0 (pre-vaccination) and Day 28 (post-vaccination)

Population: Analysis was performed on the PPAS for Day 28.

Arm	Measure	Value (GEOMETRIC_MEAN)
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series Cohort 2: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers	37.7 ratio
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series Cohort 2: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers	29.0 ratio
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Primary Series Cohort 2: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers	38.9 ratio

Secondary

Primary Series Cohort 2: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization

Time frame: Cohort 2: Day 0 (pre-vaccination) and Day 28 (post-vaccination)

Population: Analysis was performed on the PPAS for Day 28. Here, 'number analyzed' signifies participants with available data for each specified category.

Arm	Measure	Group	Value (NUMBER)
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series Cohort 2: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Day 0 - Complete neutralization	0.9 percentage of participants
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series Cohort 2: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Day 0 - Incomplete neutralization	99.1 percentage of participants
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series Cohort 2: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Day 28 - Complete neutralization	100 percentage of participants
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series Cohort 2: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Day 28 - Incomplete neutralization	0 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series Cohort 2: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Day 28 - Incomplete neutralization	0 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series Cohort 2: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Day 0 - Complete neutralization	4.2 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series Cohort 2: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Day 28 - Complete neutralization	100 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series Cohort 2: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Day 0 - Incomplete neutralization	95.8 percentage of participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Primary Series Cohort 2: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Day 28 - Incomplete neutralization	1.6 percentage of participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Primary Series Cohort 2: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Day 0 - Incomplete neutralization	100 percentage of participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Primary Series Cohort 2: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Day 28 - Complete neutralization	98.4 percentage of participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Primary Series Cohort 2: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	Day 0 - Complete neutralization	0 percentage of participants

Secondary

Primary Series Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])

RVNA titer against rabies virus was assessed using the RFFIT assay method. LLOQ for the RFFIT assay was 0.2 IU/mL.

Time frame: Cohort 2: Day 0 (pre-vaccination) and Day 28 (post-vaccination)

Population: Analysis was performed on the PPAS for Day 28.

Arm	Measure	Group	Value (NUMBER)
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])	Day 28	99.7 percentage of participants
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])	Day 0	0 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])	Day 0	0 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])	Day 28	100 percentage of participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Primary Series Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])	Day 0	0 percentage of participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Primary Series Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])	Day 28	98.4 percentage of participants

Secondary

Primary Series Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL

RVNA titer against rabies virus was assessed using the RFFIT assay method.

Time frame: Cohort 2: Day 0 (pre-vaccination) and Day 28 (post-vaccination)

Population: Analysis was performed on PPAS for Day 28.

Arm	Measure	Group	Value (NUMBER)
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL	Day 0	0 percentage of participants
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL	Day 28	97.1 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL	Day 0	0 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL	Day 28	98.3 percentage of participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Primary Series Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL	Day 0	0 percentage of participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Primary Series Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL	Day 28	96.0 percentage of participants

Secondary

Primary Series Cohort 2: Rabies Virus Neutralizing Antibody Geometric Mean Titers (GMTs) Against Rabies Virus

RVNA titer against rabies virus was assessed using the RFFIT assay method.

Time frame: Cohort 2: Day 0 (pre-vaccination) and Day 28 (post-vaccination)

Population: Analysis was performed on the PPAS for Day 28 that included all participants who received at least 1 dose of the study vaccine in the primary series, with no relevant protocol deviation before Day 28.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series Cohort 2: Rabies Virus Neutralizing Antibody Geometric Mean Titers (GMTs) Against Rabies Virus	Day 0	0.101 IU/mL
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series Cohort 2: Rabies Virus Neutralizing Antibody Geometric Mean Titers (GMTs) Against Rabies Virus	Day 28	3.79 IU/mL
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series Cohort 2: Rabies Virus Neutralizing Antibody Geometric Mean Titers (GMTs) Against Rabies Virus	Day 0	0.101 IU/mL
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series Cohort 2: Rabies Virus Neutralizing Antibody Geometric Mean Titers (GMTs) Against Rabies Virus	Day 28	2.92 IU/mL
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Primary Series Cohort 2: Rabies Virus Neutralizing Antibody Geometric Mean Titers (GMTs) Against Rabies Virus	Day 0	0.100 IU/mL
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Primary Series Cohort 2: Rabies Virus Neutralizing Antibody Geometric Mean Titers (GMTs) Against Rabies Virus	Day 28	3.91 IU/mL

Secondary

Primary Series: Groups 1 and 4: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population - Superiority Analysis

Time frame: Day 28 (post-vaccination)

Population: Analysis was performed on the PPAS for Day 28.

Arm	Measure	Value (NUMBER)
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series: Groups 1 and 4: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population - Superiority Analysis	98.8 percentage of participants

Secondary

Primary Series: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population

RVNA titer against rabies virus was assessed using the RFFIT assay method. At Baseline, Group 1 was equivalent to Group 4 (both groups received VRVg-2), Group 2 was equivalent to Group 5 (both groups received Verorab®), and Group 3 was equivalent to Group 6 (both groups received Imovax Rabies®), therefore it was planned to collect and present pooled data of specified Groups, and separately for adults and pediatric participants in this outcome measure.

Time frame: Cohort 1: Day 0 (pre-vaccination), Day 28 (post-vaccination); Cohort 2: Day 0 (pre-vaccination) and Day 28 (post-vaccination)

Population: Analysis was performed on the PPAS for Day 28. Here, 'overall number of participants analyzed' signifies participants with available data for this outcome measure and 'number analyzed' signifies participants with available data for each specified category.

Arm	Measure	Group	Value (NUMBER)
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population	Adult (>= 18 years)	98.3 percentage of participants
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population	Pediatric (< 18 years)	100 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population	Pediatric (< 18 years)	100 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population	Adult (>= 18 years)	98.5 percentage of participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Primary Series: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population	Pediatric (< 18 years)	100 percentage of participants
Primary Series: Cohort-1 Group 3: Imovax Rabies®	Primary Series: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population	Adult (>= 18 years)	96.6 percentage of participants

Comparison: Pooled Groups 1 and 4: VRVg-2 versus Pooled Groups 2 and 5: Verorab®: Pediatric (\< 18 years)95% CI: [-1.4, 4.3]

Comparison: Pooled Groups 1 and 4: VRVg-2 versus Pooled Groups 2 and 5: Verorab®: Adult (\>=18 years)95% CI: [-1.9, 2.7]

Comparison: Pooled Groups 1 and 4: VRVg-2 versus Pooled Groups 3 and 6: Imovax Rabies®: Pediatric (\< 18 years)95% CI: [-1.4, 4.5]

Comparison: Pooled Groups 1 and 4: VRVg-2 versus Pooled Groups 3 and 6: Imovax Rabies®: Adult (\>= 18 years)95% CI: [-0.5, 5.3]

Secondary

Primary Series: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population (Groups 1 and 4) Versus Cohort 1: Group 3: Non-inferiority Analysis

RVNA titer against rabies virus was assessed using the RFFIT assay method. At Baseline, Group 1 was equivalent to Group 4 (both groups received VRVg-2), therefore it was planned to collect and present pooled data of specified Group, and separately for adults and pediatric participants in this outcome measure. Data for this outcome measure was planned to be collected at Day 28 for Pooled Groups 1 and 4 and at Day 42 for Primary Series: Cohort-1 Group 3: Imovax Rabies® and reported as overall data for the non-inferiority analysis in this outcome measure.

Time frame: Pooled Groups 1 and 4: Day 28 (post-vaccination) and Primary Series: Cohort-1 Group 3: Day 42 (post-vaccination)

Population: Analysis was performed on the PPAS that included all participants who received at least 1 dose of the study with no relevant protocol deviation. Here, 'overall number of participants analyzed' signifies participants with available data for this outcome measure and 'number analyzed' signifies participants with available data for each specified category.

Arm	Measure	Group	Value (NUMBER)
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population (Groups 1 and 4) Versus Cohort 1: Group 3: Non-inferiority Analysis	Pediatric (< 18 years)	100 percentage of participants
Primary Series: Cohort-1 Group 1: VRVg-2	Primary Series: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population (Groups 1 and 4) Versus Cohort 1: Group 3: Non-inferiority Analysis	Adult (>= 18 years)	98.3 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population (Groups 1 and 4) Versus Cohort 1: Group 3: Non-inferiority Analysis	Pediatric (< 18 years)	100 percentage of participants
Primary Series: Cohort-1 Group 2: Verorab®	Primary Series: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population (Groups 1 and 4) Versus Cohort 1: Group 3: Non-inferiority Analysis	Adult (>= 18 years)	100 percentage of participants

Comparison: Pooled Groups 1 and 4: VRVg-2 at Day 28 versus Primary Series: Cohort-1 Group 3: Imovax Rabies® at Day 42: Pediatric (\< 18 years)95% CI: [-1.4, 4.4]

Comparison: Pooled Groups 1 and 4: VRVg-2 at Day 28 versus Primary Series: Cohort-1 Group 3: Imovax Rabies® at Day 42: Adult (\>= 18 years)95% CI: [-3.1, 3]

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026

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

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Masking description

Intervention model description

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Contacts

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody (RVNA) Titer Greater Than or Equal to (>=) 0.5 IU/mL

Booster Phase: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers

Booster Phase: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization

Booster Phase: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (LLOQ)

Booster Phase: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL

Booster Phase: Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus

Number of Participants With Immediate Unsolicited Adverse Events (AEs)

Number of Participants With Immediate Unsolicited Adverse Events (AEs) - Booster Phase Cohort-2

Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)

Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) - Booster Phase Cohort-2

Number of Participants With Solicited Injection Site Reactions

Number of Participants With Solicited Injection Site Reactions - Booster Phase Cohort-2

Number of Participants With Systemic Reactions

Number of Participants With Systemic Reactions - Booster Phase Cohort-2

Number of Participants With Unsolicited Adverse Events

Number of Participants With Unsolicited Adverse Events - Booster Phase Cohort-2

Primary Series Cohort 1: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers

Primary Series Cohort 1 Group 3: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Non-Inferiority Analysis

Primary Series Cohort 1: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization

Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])

Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL

Primary Series Cohort 1: Rabies Virus Neutralizing Antibody Geometric Mean Titers (GMTs) Against Rabies Virus

Primary Series Cohort 2: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers

Primary Series Cohort 2: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization

Primary Series Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])

Primary Series Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL

Primary Series Cohort 2: Rabies Virus Neutralizing Antibody Geometric Mean Titers (GMTs) Against Rabies Virus

Primary Series: Groups 1 and 4: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population - Superiority Analysis

Primary Series: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population

Primary Series: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population (Groups 1 and 4) Versus Cohort 1: Group 3: Non-inferiority Analysis