A Phase 3 interventional study of Purified vero rabies vaccine - serum free - VRVg-2 and Purified inactivated rabies vaccine - Verorab® in Rabies and Healthy Volunteers, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 4 sites in Thailand. Open to participants aged 1 Year and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-10.
Sponsored by Sanofi Pasteur, a Sanofi Company (part of Sanofi) · Phase 3, Interventional, and Prevention
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:
To describe:
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.
114 studies on the registry are indexed under Rabies; 15 are open to participants now.
This study's enrollment of 1,708 is above the median of 201 across 104 interventional studies indexed under Rabies.
Browse Rabies studies →Sanofi Pasteur, a Sanofi Company is the lead sponsor of 374 studies on the registry; 4 are open to participants now.
Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.
First submitted after Sanofi Pasteur became part of Sanofi.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Aged ≥1 year on the day of inclusion
Exclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
VRVg-2, 3 injections at Day 0, Day 7, and Day 28 Booster dose of VRVg-2 for a subset of 102 adult participants at Month 12
Biological: Purified vero rabies vaccine - serum free - VRVg-2
Verorab, 3 injections at Day 0, Day 7, and Day 28 Booster dose of VRVg-2 for a subset of 34 adult participants at Month 12
Biological: Purified vero rabies vaccine - serum free - VRVg-2 · Biological: Purified inactivated rabies vaccine - Verorab®
Imovax Rabies, 3 injections at Day 0, Day 7, and Day 28 Booster dose of VRVg-2 for a subset of 34 adult participants at Month 12
Biological: Purified vero rabies vaccine - serum free - VRVg-2 · Biological: Purified inactivated rabies vaccine - Imovax® Rabies
VRVg-2, 2 injections at Day 0 and Day 7 Booster dose of VRVg-2 for a subset of 138 adult participants between Month 24 up to Month 36
Biological: Purified vero rabies vaccine - serum free - VRVg-2
Verorab, 2 injections at Day 0 and Day 7 Booster dose of VRVg-2 for a subset of 46 adult participants between Month 24 up to Month 36
Biological: Purified vero rabies vaccine - serum free - VRVg-2 · Biological: Purified inactivated rabies vaccine - Verorab®
Imovax Rabies, 2 injections at Day 0 and Day 7 Booster dose of VRVg-2 for a subset of 46 adult participants between Month 24 up to Month 36
Biological: Purified vero rabies vaccine - serum free - VRVg-2 · Biological: Purified inactivated rabies vaccine - Imovax® Rabies
Pharmaceutical form: Freeze-dried Route of administration: Intramuscular
Pharmaceutical form:Freeze-dried Route of administration: Intramuscular
Pharmaceutical form: Freeze-dried Route of administration: Intramuscular
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)
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)
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)
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)
Primary Series: Groups 1 and 4: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population - Superiority 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 in this outcome measure.
Time frame: Day 28 (post-vaccination)
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)
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)
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)
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)
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)
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)
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)
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)
Primary Series Cohort 1: 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: Cohort 1: Day 0 (pre-vaccination), Day 28 and Day 42 (post-vaccination)
Primary Series Cohort 2: 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: Cohort 2: Day 0 (pre-vaccination) and Day 28 (post-vaccination)
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. GMTs were expressed in IU/mL.
Time frame: Month 12 (pre-booster dose) and Month 12 + Day 14 (post-booster dose)
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)
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)
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)
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)
Booster Phase Cohort 2: Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus
RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTs were expressed in International units/milliliter (IU/mL).
Time frame: Month 24 up to Month 36 (pre-booster dose) and Month 24 up to Month 36 + Day 14 (post-booster dose)
Booster Phase 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. Percentages are rounded off to the tenth decimal place.
Time frame: Month 24 up to Month 36 (pre-booster dose) and Month 24 up to Month 36 + Day 14 (post-booster dose)
Booster Phase 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. Percentages are rounded off to the tenth decimal place.
Time frame: Month 24 up to Month 36 (pre-booster dose) and Month 24 up to Month 36 + Day 14 (post-booster dose)
Booster Phase 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 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).
Time frame: 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)
Booster Phase Cohort 2: 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. Percentages are rounded off to the tenth decimal place.
Time frame: Month 24 up to Month 36 (pre-booster dose) and Month 24 up to Month 36 + Day 14 (post-booster dose)
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
Booster Phase Cohort 2: 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 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
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
Booster Phase Cohort 2: 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
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
Booster Phase Cohort 2: Number of Participants With Solicited Injection Site 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 injection site reactions included tenderness/pain, erythema and swelling.
Time frame: Within 7 Days after any vaccination
Number of Participants With Unsolicited Adverse Events
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.
Time frame: Within 28 Days after any vaccination
Booster Phase Cohort 2: Number of Participants With Unsolicited Adverse Events
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.
Time frame: Within 28 Days after any vaccination
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)
Booster Phase Cohort 2: 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 Month 42)
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).
| Milestone | Cohort-1 Group 1: VRVg-2/VRVg-2 | Cohort-1 Group 2: Verorab®/VRVg-2 | Cohort-1 Group 3: Imovax Rabies®/VRVg-2 | Cohort-2 Group 4: VRVg-2/VRVg-2 | Cohort-2 Group 5: Verorab®/VRVg-2 | Cohort-2 Group 6: Imovax Rabies®/VRVg-2 |
|---|---|---|---|---|---|---|
| Started | 607 | 203 | 200 | 420 | 139 | 139 |
| Safety analysis set (safas) | 607 | 202 | 200 | 419 | 139 | 139 |
| Per-protocol analysis set (ppas) for day 28 | 519 | 169 | 160 | 342 | 120 | 124 |
| Completed | 599 | 199 | 196 | 415 | 137 | 138 |
| Not completed | 8 | 4 | 4 | 5 | 2 | 1 |
| Withdrew: Adverse event | 1 | 0 | 0 | 1 | 0 | 1 |
| Withdrew: Protocol violation | 5 | 3 | 4 | 3 | 2 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Withdrawal by parent/guardian | 2 | 1 | 0 | 0 | 0 | 0 |
| Milestone | Cohort-1 Group 1: VRVg-2/VRVg-2 | Cohort-1 Group 2: Verorab®/VRVg-2 | Cohort-1 Group 3: Imovax Rabies®/VRVg-2 | Cohort-2 Group 4: VRVg-2/VRVg-2 | Cohort-2 Group 5: Verorab®/VRVg-2 | Cohort-2 Group 6: Imovax Rabies®/VRVg-2 |
|---|---|---|---|---|---|---|
| Started | 94 | 31 | 32 | 128 | 41 | 43 |
| Safas | 94 | 31 | 32 | 128 | 41 | 43 |
| Completed | 92 | 31 | 32 | 127 | 41 | 43 |
| Not completed | 2 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 | 0 | 1 | 0 | 0 |
RVNA titer against rabies virus was assessed using the RFFIT assay method.
| percentage of participants | Primary Series: Cohort-1 Group 1: VRVg-2 | Primary Series: Cohort-1 Group 2: Verorab® | Primary Series: Cohort-1 Group 3: Imovax Rabies® |
|---|---|---|---|
| Day 0 | 0 (0 to 0.7) | 0 (0 to 2.2) | 0 (0 to 2.3) |
| Day 28 | 100 (99.3 to 100) | 99.4 (96.7 to 100) | 98.8 (95.6 to 99.8) |
| Day 42 | 100 (99.3 to 100) | 99.4 (96.7 to 100) | 100 (97.7 to 100) |
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.
| percentage of participants | Pooled Groups 1 and 4: VRVg-2 | Pooled Groups 2 and 5: Verorab® | Pooled Groups 3 and 6: Imovax Rabies® |
|---|---|---|---|
| Pediatric (< 18 years) | 100 (98.6 to 100) | 100 (95.8 to 100) | 100 (95.5 to 100) |
| Adult (>= 18 years) | 98.3 (96.9 to 99.2) | 98.5 (95.7 to 99.7) | 96.6 (93.0 to 98.6) |
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.
| percentage of participants | Pooled Groups 1 and 4: VRVg-2 | Primary Series: Cohort-1 Group 3: Imovax Rabies® |
|---|---|---|
| Pediatric (< 18 years) | 100 (98.6 to 100) | 100 (95.7 to 100) |
| Adult (>= 18 years) | 98.3 (96.9 to 99.2) | 100 (95.4 to 100) |
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.
| percentage of participants | Pooled Groups 1 and 4: 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 (97.9 to 99.4) |
RVNA titer against rabies virus was assessed using the RFFIT assay method.
| percentage of participants | Primary Series: Cohort-1 Group 3: Imovax Rabies® |
|---|---|
| Day 0 | 0 (0 to 2.3) |
| Day 28 | 98.8 (95.6 to 99.8) |
| Day 42 | 100 (97.7 to 100) |
RVNA titer against rabies virus was assessed using the RFFIT assay method.
| IU/mL | Primary Series: Cohort-1 Group 1: VRVg-2 | Primary Series: Cohort-1 Group 2: Verorab® | Primary Series: Cohort-1 Group 3: Imovax Rabies® |
|---|---|---|---|
| Day 0 | 0.100 (0.100 to 0.100) | 0.101 (0.100 to 0.102) | 0.101 (0.100 to 0.101) |
| Day 28 | 7.16 (6.66 to 7.69) | 4.90 (4.31 to 5.57) | 5.13 (4.48 to 5.87) |
| Day 42 | 24.0 (22.4 to 25.7) | 20.0 (17.6 to 22.8) | 16.4 (14.7 to 18.3) |
RVNA titer against rabies virus was assessed using the RFFIT assay method.
| IU/mL | Primary Series: Cohort-2 Group 4: VRVg-2 | Primary Series: Cohort-2 Group 5: Verorab® | Primary Series: Cohort-2 Group 6: Imovax Rabies® |
|---|---|---|---|
| Day 0 | 0.101 (0.100 to 0.101) | 0.101 (0.100 to 0.101) | 0.100 (0.100 to 0.101) |
| Day 28 | 3.79 (3.42 to 4.20) | 2.92 (2.45 to 3.48) | 3.91 (3.25 to 4.70) |
RVNA titer against rabies virus was assessed using the RFFIT assay method.
| percentage of participants | Primary Series: Cohort-2 Group 4: VRVg-2 | Primary Series: Cohort-2 Group 5: Verorab® | Primary Series: Cohort-2 Group 6: Imovax Rabies® |
|---|---|---|---|
| Day 0 | 0 (0.0 to 1.1) | 0 (0.0 to 3.0) | 0 (0.0 to 2.9) |
| Day 28 | 97.1 (94.7 to 98.6) | 98.3 (94.1 to 99.8) | 96.0 (90.8 to 98.7) |
RVNA titer against rabies virus was assessed using the RFFIT assay method. LLOQ for the RFFIT assay was 0.2 IU/mL.
| percentage of participants | Primary Series: Cohort-1 Group 1: VRVg-2 | Primary Series: Cohort-1 Group 2: Verorab® | Primary Series: Cohort-1 Group 3: Imovax Rabies® |
|---|---|---|---|
| Day 0 | 0 (0 to 0.7) | 0 (0 to 2.2) | 0 (0 to 2.3) |
| Day 28 | 100 (99.3 to 100) | 99.4 (96.7 to 100) | 100 (97.7 to 100) |
| Day 42 | 100 (99.3 to 100) | 99.4 (96.7 to 100) | 100 (97.7 to 100) |
RVNA titer against rabies virus was assessed using the RFFIT assay method. LLOQ for the RFFIT assay was 0.2 IU/mL.
| percentage of participants | Primary Series: Cohort-2 Group 4: VRVg-2 | Primary Series: Cohort-2 Group 5: Verorab® | Primary Series: Cohort-2 Group 6: Imovax Rabies® |
|---|---|---|---|
| Day 0 | 0 (0 to 1.1) | 0 (0 to 3.0) | 0 (0 to 2.9) |
| Day 28 | 99.7 (98.4 to 100) | 100 (97.0 to 100) | 98.4 (94.3 to 99.8) |
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.
| ratio | Primary Series: Cohort-1 Group 1: VRVg-2 | Primary Series: Cohort-1 Group 2: Verorab® | Primary Series: Cohort-1 Group 3: Imovax Rabies® |
|---|---|---|---|
| Day 28/Day 0 | 71.5 (66.6 to 76.8) | 48.7 (42.8 to 55.3) | 51.0 (44.6 to 58.3) |
| Day 42/Day 0 | 240 (224 to 256) | 199 (174 to 226) | 163 (146 to 182) |
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.
| ratio | Primary Series: Cohort-2 Group 4: VRVg-2 | Primary Series: Cohort-2 Group 5: Verorab® | Primary Series: Cohort-2 Group 6: Imovax Rabies® |
|---|---|---|---|
| Primary Series Cohort 2: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers | 37.7 (34.0 to 41.8) | 29.0 (24.4 to 34.6) | 38.9 (32.4 to 46.7) |
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.
| percentage of participants | Primary Series: Cohort-1 Group 1: VRVg-2 | Primary Series: Cohort-1 Group 2: Verorab® | Primary Series: Cohort-1 Group 3: Imovax Rabies® |
|---|---|---|---|
| Day 0 - Complete neutralization | 0.2 (0 to 1.1) | 0.6 (0 to 3.3) | 1.3 (0.2 to 4.5) |
| Day 0 - Incomplete neutralization | 99.8 (98.9 to 100) | 99.4 (96.7 to 100) | 98.7 (95.5 to 99.8) |
| Day 28 - Complete neutralization | 100 (99.3 to 100) | 99.4 (96.7 to 100) | 99.4 (96.6 to 100) |
| Day 28 - Incomplete neutralization | 0 (0 to 0.7) | 0.6 (0 to 3.3) | 0.6 (0 to 3.4) |
| Day 42 - Complete neutralization | 100 (99.3 to 100) | 99.4 (96.7 to 100) | 100 (97.7 to 100) |
| Day 42 - Incomplete neutralization | 0 (0 to 0.7) | 0.6 (0 to 3.3) | 0 (0 to 2.3) |
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.
| percentage of participants | Primary Series: Cohort-2 Group 4: VRVg-2 | Primary Series: Cohort-2 Group 5: Verorab® | Primary Series: Cohort-2 Group 6: Imovax Rabies® |
|---|---|---|---|
| Day 0 - Complete neutralization | 0.9 (0.2 to 2.6) | 4.2 (1.4 to 9.5) | 0 (0 to 3.1) |
| Day 0 - Incomplete neutralization | 99.1 (97.4 to 99.8) | 95.8 (90.5 to 98.6) | 100 (96.9 to 100) |
| Day 28 - Complete neutralization | 100 (98.9 to 100) | 100 (97.0 to 100) | 98.4 (94.3 to 99.8) |
| Day 28 - Incomplete neutralization | 0 (0 to 1.1) | 0 (0 to 3.0) | 1.6 (0.2 to 5.7) |
RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTs were expressed in IU/mL.
| IU/mL | Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) | Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) | Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) |
|---|---|---|---|
| Month 12 | 0.679 (0.526 to 0.878) | 0.540 (0.344 to 0.848) | 0.487 (0.311 to 0.764) |
| Month 12 + 14 Days | 56.5 (45.4 to 70.3) | 57.1 (42.6 to 76.7) | 33.7 (22.6 to 50.3) |
RVNA titer against rabies virus was assessed using the RFFIT assay method.
| percentage of participants | Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) | Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) | Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) |
|---|---|---|---|
| Month 12 | 53.8 (42.2 to 65.0) | 53.8 (33.4 to 73.4) | 35.7 (18.6 to 55.9) |
| Month 12 + 14 days | 100 (95.5 to 100) | 100 (86.8 to 100) | 100 (87.7 to 100) |
RVNA titer against rabies virus was assessed using the RFFIT assay method. LLOQ for the RFFIT assay was 0.2 IU/mL.
| percentage of participants | Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) | Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) | Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) |
|---|---|---|---|
| Month 12 | 86.3 (76.7 to 92.9) | 76.9 (56.4 to 91.0) | 85.7 (67.3 to 96.0) |
| Month 12 + 14 days | 100 (95.5 to 100) | 100 (86.8 to 100) | 100 (87.7 to 100) |
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.
| ratio | Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) | Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) | Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) |
|---|---|---|---|
| Month 12/Day 0 | 6.79 (5.26 to 8.78) | 5.40 (3.44 to 8.48) | 4.78 (3.10 to 7.37) |
| Month 12+14 days/Day 0 | 565 (454 to 703) | 571 (426 to 767) | 331 (219 to 500) |
| Month 12+14 days/Month 12 | 83.2 (62.0 to 112) | 106 (62.7 to 178) | 69.2 (39.6 to 121) |
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.
| percentage of participants | Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) | Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) | Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) |
|---|---|---|---|
| Month 12 - Complete neutralization | 96.1 (89.0 to 99.2) | 84.0 (63.9 to 95.5) | 95.7 (78.1 to 99.9) |
| Month 12 - Incomplete neutralization | 3.9 (0.8 to 11.0) | 16.0 (4.5 to 36.1) | 4.3 (0.1 to 21.9) |
| Month 12 + 14 days - Complete neutralization | 100 (95.5 to 100) | 100 (86.8 to 100) | 100 (87.2 to 100) |
| Month 12 + 14 days - Incomplete neutralization | 0 (0 to 4.5) | 0 (0 to 13.2) | 0 (0 to 12.8) |
RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTs were expressed in International units/milliliter (IU/mL).
| IU/mL | Booster Phase: Cohort-2 Group 4: VRVg-2 (Primed With VRVg-2) | Booster Phase: Cohort-2 Group 5: VRVg-2 (Verorab® Primed) | Booster Phase:Cohort-2 Group 6: VRVg-2 (Imovax Rabies® Primed) |
|---|---|---|---|
| Month 24 up to Month 36 | 0.761 (0.607 to 0.953) | 0.536 (0.385 to 0.747) | 0.903 (0.603 to 1.35) |
| Month 24 up to Month 36 + 14 Days | 95.4 (76.7 to 119) | 89.4 (55.8 to 143) | 64.7 (43.7 to 95.9) |
RVNA titer against rabies virus was assessed using the RFFIT assay method. Percentages are rounded off to the tenth decimal place.
| percentage of participants | Booster Phase: Cohort-2 Group 4: VRVg-2 (Primed With VRVg-2) | Booster Phase: Cohort-2 Group 5: VRVg-2 (Verorab® Primed) | Booster Phase:Cohort-2 Group 6: VRVg-2 (Imovax Rabies® Primed) |
|---|---|---|---|
| Month 24 up to Month 36 | 62.0 (52.2 to 71.2) | 51.5 (33.5 to 69.2) | 64.9 (47.5 to 79.8) |
| Month 24 up to Month 36 + 14 Days | 100 (96.6 to 100) | 100 (89.4 to 100) | 100 (90.5 to 100) |
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.
| percentage of participants | Booster Phase: Cohort-2 Group 4: VRVg-2 (Primed With VRVg-2) | Booster Phase: Cohort-2 Group 5: VRVg-2 (Verorab® Primed) | Booster Phase:Cohort-2 Group 6: VRVg-2 (Imovax Rabies® Primed) |
|---|---|---|---|
| Month 24 up to Month 36 | 89.8 (82.5 to 94.8) | 87.9 (71.8 to 96.6) | 89.2 (74.6 to 97.0) |
| Month 24 up to Month 36 + 14 Days | 100 (96.6 to 100) | 100 (89.4 to 100) | 100 (90.5 to 100) |
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).
| ratio | Booster Phase: Cohort-2 Group 4: VRVg-2 (Primed With VRVg-2) | Booster Phase: Cohort-2 Group 5: VRVg-2 (Verorab® Primed) | Booster Phase:Cohort-2 Group 6: VRVg-2 (Imovax Rabies® Primed) |
|---|---|---|---|
| Month 24 up to Month 36/Day 0 | 7.58 (6.06 to 9.48) | 5.30 (3.80 to 7.40) | 9.03 (6.03 to 13.5) |
| Month 24 up to Month 36 +14 days/Day 0 | 951 (764 to 1184) | 885 (548 to 1430) | 647 (437 to 959) |
| Month 24 up to Month 36+14 days/Month 24 up to Month 36 | 125 (98.1 to 160) | 167 (101 to 276) | 71.7 (42.3 to 122) |
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.
| percentage of participants | Booster Phase: Cohort-2 Group 4: VRVg-2 (Primed With VRVg-2) | Booster Phase: Cohort-2 Group 5: VRVg-2 (Verorab® Primed) | Booster Phase:Cohort-2 Group 6: VRVg-2 (Imovax Rabies® Primed) |
|---|---|---|---|
| Month 24 up to Month 36- Complete neutralization | 94.1 (87.5 to 97.8) | 93.8 (79.2 to 99.2) | 91.9 (78.1 to 98.3) |
| Month 24 up to Month 36- Incomplete neutralization | 5.9 (2.2 to 12.5) | 6.3 (0.8 to 20.8) | 8.1 (1.7 to 21.9) |
| Month 24 up to Month 36 + 14 days- Complete neutralization | 100 (96.6 to 100) | 100 (89.4 to 100) | 100 (90.5 to 100) |
| Month 24 up to Month 36 + 14 days- Incomplete neutralization | 0 (0 to 3.4) | 0 (0 to 10.6) | 0 (0 to 9.5) |
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.
| Participants | Primary Series: Cohort-1 Group 1: VRVg-2 | Primary Series: Cohort-1 Group 2: Verorab® | Primary Series: Cohort-1 Group 3: Imovax Rabies® | Primary Series: Cohort-2 Group 4: VRVg-2 | Primary Series: Cohort-2 Group 5: Verorab® | Primary Series: Cohort-2 Group 6: Imovax Rabies® | Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) | Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) | Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) |
|---|---|---|---|---|---|---|---|---|---|
| Number of Participants With Immediate Unsolicited Adverse Events (AEs) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | Booster Phase: Cohort-2 Group 4: VRVg-2 (Primed With VRVg-2) | Booster Phase: Cohort-2 Group 5: VRVg-2 (Verorab® Primed) | Booster Phase:Cohort-2 Group 6: VRVg-2 (Imovax Rabies® Primed) |
|---|---|---|---|
| Booster Phase Cohort 2: Number of Participants With Immediate Unsolicited Adverse Events (AEs) | 0 | 0 | 0 |
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.
| Participants | Primary Series: Cohort-1 Group 1: VRVg-2 | Primary Series: Cohort-1 Group 2: Verorab® | Primary Series: Cohort-1 Group 3: Imovax Rabies® | Primary Series: Cohort-2 Group 4: VRVg-2 | Primary Series: Cohort-2 Group 5: Verorab® | Primary Series: Cohort-2 Group 6: Imovax Rabies® | Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) | Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) | Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) |
|---|---|---|---|---|---|---|---|---|---|
| Fever | 50 | 11 | 4 | 2 | 0 | 0 | 0 | 0 | 0 |
| Vomiting | 4 | 1 | 1 | — | — | — | — | — | — |
| Crying abnormal | 8 | 0 | 1 | — | — | — | — | — | — |
| Drowsiness | 4 | 1 | 0 | — | — | — | — | — | — |
| Appetite lost | 3 | 1 | 0 | — | — | — | — | — | — |
| Irritability | 8 | 1 | 0 | — | — | — | — | — | — |
| Headache | 128 | 49 | 46 | 39 | 9 | 8 | 4 | 3 | 5 |
| Malaise | 161 | 45 | 48 | 37 | 10 | 12 | 8 | 3 | 7 |
| Myalgia | 249 | 66 | 78 | 78 | 12 | 29 | 23 | 9 | 15 |
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.
| Participants | Booster Phase: Cohort-2 Group 4: VRVg-2 (Primed With VRVg-2) | Booster Phase: Cohort-2 Group 5: VRVg-2 (Verorab® Primed) | Booster Phase:Cohort-2 Group 6: VRVg-2 (Imovax Rabies® Primed) |
|---|---|---|---|
| Fever | 0 | 0 | 0 |
| Headache | 3 | 0 | 0 |
| Malaise | 5 | 1 | 0 |
| Myalgia | 10 | 0 | 0 |
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.
| Participants | Primary Series: Cohort-1 Group 1: VRVg-2 | Primary Series: Cohort-1 Group 2: Verorab® | Primary Series: Cohort-1 Group 3: Imovax Rabies® | Primary Series: Cohort-2 Group 4: VRVg-2 | Primary Series: Cohort-2 Group 5: Verorab® | Primary Series: Cohort-2 Group 6: Imovax Rabies® | Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) | Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) | Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) |
|---|---|---|---|---|---|---|---|---|---|
| Injection site tenderness/pain | 344 | 95 | 106 | 111 | 30 | 43 | 44 | 12 | 17 |
| Injection site erythema | 24 | 6 | 6 | 0 | 0 | 1 | 0 | 0 | 0 |
| Injection site swelling | 14 | 4 | 13 | 1 | 0 | 1 | 0 | 1 | 0 |
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.
| Participants | Booster Phase: Cohort-2 Group 4: VRVg-2 (Primed With VRVg-2) | Booster Phase: Cohort-2 Group 5: VRVg-2 (Verorab® Primed) | Booster Phase:Cohort-2 Group 6: VRVg-2 (Imovax Rabies® Primed) |
|---|---|---|---|
| Injection site tenderness/pain | 20 | 2 | 6 |
| Injection site erythema | 0 | 0 | 0 |
| Injection site swelling | 0 | 0 | 0 |
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.
| Participants | Primary Series: Cohort-1 Group 1: VRVg-2 | Primary Series: Cohort-1 Group 2: Verorab® | Primary Series: Cohort-1 Group 3: Imovax Rabies® | Primary Series: Cohort-2 Group 4: VRVg-2 | Primary Series: Cohort-2 Group 5: Verorab® | Primary Series: Cohort-2 Group 6: Imovax Rabies® | Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) | Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) | Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) |
|---|---|---|---|---|---|---|---|---|---|
| Number of Participants With Unsolicited Adverse Events | 137 | 45 | 40 | 44 | 18 | 12 | 13 | 3 | 5 |
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.
| Participants | Booster Phase: Cohort-2 Group 4: VRVg-2 (Primed With VRVg-2) | Booster Phase: Cohort-2 Group 5: VRVg-2 (Verorab® Primed) | Booster Phase:Cohort-2 Group 6: VRVg-2 (Imovax Rabies® Primed) |
|---|---|---|---|
| Booster Phase Cohort 2: Number of Participants With Unsolicited Adverse Events | 15 | 1 | 3 |
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.
| Participants | Primary Series: Cohort-1 Group 1: VRVg-2 | Primary Series: Cohort-1 Group 2: Verorab® | Primary Series: Cohort-1 Group 3: Imovax Rabies® | Primary Series: Cohort-2 Group 4: VRVg-2 | Primary Series: Cohort-2 Group 5: Verorab® | Primary Series: Cohort-2 Group 6: Imovax Rabies® | Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) | Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) | Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) |
|---|---|---|---|---|---|---|---|---|---|
| SAEs | 10 | 3 | 5 | 2 | 0 | 1 | 2 | 0 | 1 |
| AESIs | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | Booster Phase: Cohort-2 Group 4: VRVg-2 (Primed With VRVg-2) | Booster Phase: Cohort-2 Group 5: VRVg-2 (Verorab® Primed) | Booster Phase:Cohort-2 Group 6: VRVg-2 (Imovax Rabies® Primed) |
|---|---|---|---|
| SAEs | 3 | 0 | 1 |
| AESIs | 0 | 0 | 0 |
RVNA titer against rabies virus was assessed using the Rapid Fluorescent Focus Inhibition test (RFFIT) assay method.
| percentage of participants | Primary Series: Cohort-1 Group 1: VRVg-2 | Primary Series: Cohort-1 Group 2: Verorab® | Primary Series: Cohort-1 Group 3: Imovax Rabies® |
|---|---|---|---|
| Pediatric (< 18 years) | 100 (98.6 to 100) | 100 (95.8 to 100) | 100 (95.7 to 100) |
| Adult (>= 18 years) | 100 (98.6 to 100) | 98.8 (93.5 to 100) | 100 (95.4 to 100) |
Collected over From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Primary Series: Cohort-1 Group 1: VRVg-2 | 0/607 (0%) | 10/607 (1.6%) | 414/607 (68.2%) |
| Primary Series: Cohort-1 Group 2: Verorab® | 0/202 (0%) | 3/202 (1.5%) | 121/202 (59.9%) |
| Primary Series: Cohort-1 Group 3: Imovax Rabies® | 0/200 (0%) | 5/200 (2.5%) | 128/200 (64%) |
| Primary Series: Cohort-2 Group 4: VRVg-2 | 0/419 (0%) | 2/419 (0.5%) | 130/419 (31%) |
| Primary Series: Cohort-2 Group 5: Verorab® | 0/139 (0%) | 0/139 (0%) | 34/139 (24.5%) |
| Primary Series: Cohort-2 Group 6: Imovax Rabies® | 0/139 (0%) | 1/139 (0.7%) | 48/139 (34.5%) |
| Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) | 0/94 (0%) | 2/94 (2.1%) | 48/94 (51.1%) |
| Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) | 0/31 (0%) | 0/31 (0%) | 15/31 (48.4%) |
| Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) | 0/32 (0%) | 1/32 (3.1%) | 18/32 (56.3%) |
| Booster Phase: Cohort-2 Group 4: VRVg-2 (Primed With VRVg-2) | 0/128 (0%) | 3/128 (2.3%) | 21/128 (16.4%) |
| Booster Phase: Cohort-2 Group 5: VRVg-2 (Verorab® Primed) | 0/41 (0%) | 0/41 (0%) | 2/41 (4.9%) |
| Booster Phase:Cohort-2 Group 6: VRVg-2 (Imovax Rabies® Primed) | 0/43 (0%) | 1/43 (2.3%) | 6/43 (14%) |
| Event | Primary Series: Cohort-1 Group 1: VRVg-2 | Primary Series: Cohort-1 Group 2: Verorab® | Primary Series: Cohort-1 Group 3: Imovax Rabies® | Primary Series: Cohort-2 Group 4: VRVg-2 | Primary Series: Cohort-2 Group 5: Verorab® | Primary Series: Cohort-2 Group 6: Imovax Rabies® | Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) | Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) | Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) | Booster Phase: Cohort-2 Group 4: VRVg-2 (Primed With VRVg-2) | Booster Phase: Cohort-2 Group 5: VRVg-2 (Verorab® Primed) | Booster Phase:Cohort-2 Group 6: VRVg-2 (Imovax Rabies® Primed) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| MyalgiaMusculoskeletal and connective tissue disorders | 0/607 | 0/202 | 0/200 | 0/419 | 0/139 | 0/139 | 0/94 | 0/31 | 1/32 | 0/128 | 0/41 | 0/43 |
| Uterine LeiomyomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/607 | 0/202 | 0/200 | 0/419 | 0/139 | 1/139 | 0/94 | 0/31 | 0/32 | 0/128 | 0/41 | 1/43 |
| Uterine PolypReproductive system and breast disorders | 0/607 | 0/202 | 0/200 | 0/419 | 0/139 | 0/139 | 0/94 | 0/31 | 0/32 | 0/128 | 0/41 | 1/43 |
| HemiplegiaNervous system disorders | 0/607 | 0/202 | 0/200 | 0/419 | 0/139 | 0/139 | 1/94 | 0/31 | 0/32 | 0/128 | 0/41 | 0/43 |
| Ectopic PregnancyPregnancy, puerperium and perinatal conditions | 0/607 | 0/202 | 0/200 | 0/419 | 0/139 | 0/139 | 1/94 | 0/31 | 0/32 | 0/128 | 0/41 | 0/43 |
| InfluenzaInfections and infestations | 0/607 | 0/202 | 0/200 | 0/419 | 0/139 | 0/139 | 0/94 | 0/31 | 0/32 | 1/128 | 0/41 | 0/43 |
| Septic ShockInfections and infestations | 0/607 | 0/202 | 0/200 | 0/419 | 0/139 | 0/139 | 0/94 | 0/31 | 0/32 | 1/128 | 0/41 | 0/43 |
| Adenocarcinoma Of The CervixNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/607 | 0/202 | 0/200 | 0/419 | 0/139 | 0/139 | 0/94 | 0/31 | 0/32 | 1/128 | 0/41 | 0/43 |
| HeadacheNervous system disorders | 0/607 | 0/202 | 0/200 | 0/419 | 0/139 | 0/139 | 0/94 | 0/31 | 0/32 | 1/128 | 0/41 | 0/43 |
| Exposure To Communicable DiseaseInjury, poisoning and procedural complications | 4/607 | 0/202 | 0/200 | 0/419 | 0/139 | 0/139 | 0/94 | 0/31 | 0/32 | 0/128 | 0/41 | 0/43 |
| Event | Primary Series: Cohort-1 Group 1: VRVg-2 | Primary Series: Cohort-1 Group 2: Verorab® | Primary Series: Cohort-1 Group 3: Imovax Rabies® | Primary Series: Cohort-2 Group 4: VRVg-2 | Primary Series: Cohort-2 Group 5: Verorab® | Primary Series: Cohort-2 Group 6: Imovax Rabies® | Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) | Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) | Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) | Booster Phase: Cohort-2 Group 4: VRVg-2 (Primed With VRVg-2) | Booster Phase: Cohort-2 Group 5: VRVg-2 (Verorab® Primed) | Booster Phase:Cohort-2 Group 6: VRVg-2 (Imovax Rabies® Primed) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Injection Site PainGeneral disorders | 344/607 | 95/202 | 106/200 | 111/419 | 30/139 | 43/139 | 44/94 | 12/31 | 17/32 | 20/128 | 2/41 | 6/43 |
| MyalgiaMusculoskeletal and connective tissue disorders | 249/607 | 67/202 | 79/200 | 78/419 | 12/139 | 30/139 | 24/94 | 9/31 | 15/32 | 10/128 | 0/41 | 0/43 |
| MalaiseGeneral disorders | 161/607 | 45/202 | 48/200 | 37/419 | 10/139 | 12/139 | 8/94 | 3/31 | 7/32 | 5/128 | 1/41 | 0/43 |
| HeadacheNervous system disorders | 130/607 | 50/202 | 47/200 | 40/419 | 10/139 | 8/139 | 4/94 | 3/31 | 7/32 | 3/128 | 0/41 | 0/43 |
| PyrexiaGeneral disorders | 51/607 | 12/202 | 5/200 | 3/419 | 0/139 | 0/139 | 0/94 | 0/31 | 0/32 | 0/128 | 0/41 | 0/43 |
| Injection Site SwellingGeneral disorders | 14/607 | 4/202 | 13/200 | 1/419 | 0/139 | 1/139 | 0/94 | 0/31 | 0/32 | 0/128 | 0/41 | 0/43 |
| NasopharyngitisInfections and infestations | 27/607 | 9/202 | 12/200 | 3/419 | 0/139 | 0/139 | 0/94 | 0/31 | 0/32 | 0/128 | 0/41 | 0/43 |
Analysis was performed on all randomized participants in the primary series cohorts.
| Age, Continuous(years) | Primary Series: Cohort-1 Group 1: VRVg-2 | Primary Series: Cohort-1 Group 2: Verorab® | Primary Series: Cohort-1 Group 3: Imovax Rabies® | Primary Series: Cohort-2 Group 4: VRVg-2 | Primary Series: Cohort-2 Group 5: Verorab® | Primary Series: Cohort-2 Group 6: Imovax Rabies® | Total |
|---|---|---|---|---|---|---|---|
| Mean | 22.9 ± 17.1 | 22.6 ± 16.1 | 22.4 ± 16.1 | 37.4 ± 11.3 | 38.4 ± 11.1 | 37.3 ± 10.9 | 28.8 ± 16.4 |
| Sex: Female, Male(Participants) | Primary Series: Cohort-1 Group 1: VRVg-2 | Primary Series: Cohort-1 Group 2: Verorab® | Primary Series: Cohort-1 Group 3: Imovax Rabies® | Primary Series: Cohort-2 Group 4: VRVg-2 | Primary Series: Cohort-2 Group 5: Verorab® | Primary Series: Cohort-2 Group 6: Imovax Rabies® | Total |
|---|---|---|---|---|---|---|---|
| Female | 399 | 147 | 122 | 266 | 96 | 98 | 1128 |
| Male | 208 | 56 | 78 | 154 | 43 | 41 | 580 |
| Race (NIH/OMB)(Participants) | Primary Series: Cohort-1 Group 1: VRVg-2 | Primary Series: Cohort-1 Group 2: Verorab® | Primary Series: Cohort-1 Group 3: Imovax Rabies® | Primary Series: Cohort-2 Group 4: VRVg-2 | Primary Series: Cohort-2 Group 5: Verorab® | Primary Series: Cohort-2 Group 6: Imovax Rabies® | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 607 | 203 | 200 | 420 | 139 | 139 | 1708 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| White | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/
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