A Phase 3 interventional study of VRVg-2 and Purified Inactivated Rabies Vaccine in Rabies (Healthy Volunteers), sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 2 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-18.
Sponsored by Sanofi Pasteur, a Sanofi Company (part of Sanofi) · Phase 3, Interventional, and Prevention
Primary Objective:
To demonstrate that Purified Vero Rabies Vaccine - Serum Free Vaccine generation 2 (VRVg-2) was non-inferior to Verorab and Imovax Rabies vaccines when co-administered with human rabies immunoglobulin (HRIG), in terms of proportion of participants achieving a rabies virus neutralizing antibody (RVNA) titer greater than or equal to (>=) 0.5 international units per milliliter (IU/mL) at Day 28, i.e., 14 days after the fourth vaccine injection.
Secondary Objective:
Study duration per participant was approximately 7 months including: 1 day of screening and vaccination, a total of 5 vaccine injections over a 28-day period, 1 safety-follow up visit at Day 42, 1 safety follow-up/end of study visit at Day 56 and a 6-month safety follow-up call after last vaccine administration.
114 studies on the registry are indexed under Rabies; 15 are open to participants now.
This study's enrollment of 640 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.
Exclusion criteria:
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
Participants received 0.5 milliliters (mL) intramuscular (IM) injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
Biological: VRVg-2 · Biological: Rabies immune globulin (human)
Participants received 0.5 mL IM injection of Verorab on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
Biological: Purified Inactivated Rabies Vaccine · Biological: Rabies immune globulin (human)
Participants received 1 mL IM injection of Imovax Rabies on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
Biological: Human Diploid Cell Vaccine (HDCV) · Biological: Rabies immune globulin (human)
Participants received 0.5 mL IM injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28.
Biological: VRVg-2
Pharmaceutical form: Powder and solvent for suspension for injection; Route of administration: IM
Pharmaceutical form: Powder and solvent for suspension for injection; Route of administration: IM
Also known as: Verorab®
Pharmaceutical form: Powder and solvent for suspension for injection; Route of administration: IM
Also known as: IMOVAX® Rabies
Pharmaceutical form: Solution for injection; Route of administration: IM
Also known as: IMOGAM® Rabies-HT
Percentage of Participants With Rabies Virus Neutralizing Antibody (RVNA) Titers Greater Than or Equal to (>=) 0.5 International Units Per Milliliter (IU/mL)-Non-Inferiority Analysis
RVNA titer against rabies virus was assessed using the Rapid Fluorescent Focus Inhibition test (RFFIT) assay method.
Time frame: Day 28
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. Immune response of VRVg-2 was considered sufficient if the lower limit of the 95% CI for percentage of participants in Group 1 with RVNA titers \>=0.5 IU/mL was not less than 95% at Day 28, when the primary non-inferiority objective was achieved at Day 28.
Time frame: Day 0 (pre-vaccination), Day 14, Day 28 and Day 42
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. Lower limit of quantitation (LLOQ) for the RFFIT assay was 0.2 IU/mL.
Time frame: Day 0 (pre-vaccination), Day 14, Day 28 and Day 42
Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus
RVNA GMT against rabies virus was assessed using the RFFIT assay method.
Time frame: Day 0 (pre-vaccination), Day 14, Day 28 and Day 42
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 14, 28 and Day 42) and pre-vaccination on Day 0.
Time frame: Day 0 (pre-vaccination), Day 14, Day 28 and Day 42
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: Day 0 (pre-vaccination), Day 14, Day 28 and Day 42
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 necessary had to have a causal relationship with 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. Immediate AEs considered as related to vaccination were recorded as immediate unsolicited adverse reactions (ARs).
Time frame: Within 30 minutes after any and each vaccination (Vaccination 1, 2, 3, 4 and 5)
Number of Participants With Solicited Injection Site Reactions
A solicited reaction (SR) was an expected AR observed and reported under conditions (nature and onset) prelisted (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 pain, erythema and swelling at and around the injection site.
Time frame: Within 7 days after any and each vaccination (Vaccination 1, 2, 3, 4 and 5)
Number of Participants With Solicited Systemic Reactions
SR was an expected AR observed and reported under conditions (nature and onset) prelisted (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, headache, malaise and myalgia.
Time frame: Up to 7 days after any and each vaccination (Vaccination 1, 2, 3, 4 and 5)
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 necessary had to have a causal relationship with 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.
Time frame: Up to 28 days after any and each vaccination (Vaccination 1, 2, 3, 4 and 5)
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessary had to have a causal relationship with treatment. An SAE 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 7)
The study was conducted at 2 active centers in France.
| Milestone | Group 1 VRVg-2+HRIG | Group 2 Verorab+HRIG | Group 3 Imovax Rabies+HRIG | Group 4 VRVg-2 |
|---|---|---|---|---|
| Started | 320 | 107 | 107 | 106 |
| Vaccination 1 (day 0) | 318 | 107 | 107 | 106 |
| Vaccination 2 (day 3) | 317 | 104 | 107 | 106 |
| Vaccination 3 (day 7) | 311 | 103 | 105 | 105 |
| Vaccination 4 (day 14) | 301 | 101 | 101 | 103 |
| Vaccination 5 (day 28) | 294 | 98 | 97 | 98 |
| Safety analysis set (safas) | 320 | 107 | 107 | 104 |
| Completed | 295 | 102 | 97 | 100 |
| Not completed | 25 | 5 | 10 | 6 |
| Withdrew: Adverse event | 1 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 21 | 4 | 10 | 5 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 3 | 0 | 0 | 1 |
RVNA titer against rabies virus was assessed using the Rapid Fluorescent Focus Inhibition test (RFFIT) assay method.
| percentage of participants | Group 1 VRVg-2+HRIG | Group 2 Verorab+HRIG | Group 3 Imovax Rabies+HRIG |
|---|---|---|---|
| Percentage of Participants With Rabies Virus Neutralizing Antibody (RVNA) Titers Greater Than or Equal to (>=) 0.5 International Units Per Milliliter (IU/mL)-Non-Inferiority Analysis | 99.6 (97.7 to 100) | 100 (95.3 to 100) | 98.7 (93.1 to 100) |
RVNA titer against rabies virus was assessed using the RFFIT assay method. Immune response of VRVg-2 was considered sufficient if the lower limit of the 95% CI for percentage of participants in Group 1 with RVNA titers \>=0.5 IU/mL was not less than 95% at Day 28, when the primary non-inferiority objective was achieved at Day 28.
| percentage of participants | Group 1 VRVg-2+HRIG | Group 2 Verorab+HRIG | Group 3 Imovax Rabies+HRIG | Group 4 VRVg-2 |
|---|---|---|---|---|
| Day 0 | 0 (0 to 1.5) | 0 (0 to 4.7) | 0 (0 to 4.6) | 0 (0 to 4.7) |
| Day 14 | 92.5 (88.1 to 95.6) | 88.0 (78.4 to 94.4) | 94.1 (85.6 to 98.4) | 97.1 (89.9 to 99.6) |
| Day 28 | 99.6 (97.7 to 100) | 100 (95.3 to 100) | 98.7 (93.1 to 100) | 100 (95.3 to 100) |
| Day 42 | 100 (98.4 to 100) | 100 (95.1 to 100) | 98.7 (92.9 to 100) | 100 (95.3 to 100) |
RVNA titer against rabies virus was assessed using the RFFIT assay method. Lower limit of quantitation (LLOQ) for the RFFIT assay was 0.2 IU/mL.
| percentage of participants | Group 1 VRVg-2+HRIG | Group 2 Verorab+HRIG | Group 3 Imovax Rabies+HRIG | Group 4 VRVg-2 |
|---|---|---|---|---|
| Day 0 | 0 (0 to 1.5) | 0 (0 to 4.7) | 0 (0 to 4.6) | 0 (0 to 4.7) |
| Day 14 | 99.5 (97.4 to 100) | 100 (95.2 to 100) | 98.5 (92.1 to 100) | 100 (94.8 to 100) |
| Day 28 | 100 (98.5 to 100) | 100 (95.3 to 100) | 98.7 (93.1 to 100) | 100 (95.3 to 100) |
| Day 42 | 100 (98.4 to 100) | 100 (95.1 to 100) | 100 (95.3 to 100) | 100 (95.3 to 100) |
RVNA GMT against rabies virus was assessed using the RFFIT assay method.
| IU/mL | Group 1 VRVg-2+HRIG | Group 2 Verorab+HRIG | Group 3 Imovax Rabies+HRIG | Group 4 VRVg-2 |
|---|---|---|---|---|
| Day 0 | 0.100 (0.100 to 0.101) | 0.100 (NA to NA) | 0.100 (NA to NA) | 0.101 (0.099 to 0.102) |
| Day 14 | 2.40 (2.09 to 2.76) | 1.86 (1.44 to 2.41) | 1.83 (1.46 to 2.28) | 5.41 (4.24 to 6.90) |
| Day 28 | 6.49 (5.75 to 7.34) | 5.03 (3.94 to 6.44) | 5.51 (4.35 to 6.96) | 12.4 (10.5 to 14.5) |
| Day 42 | 13.6 (12.3 to 15.0) | 9.47 (7.96 to 11.3) | 10.7 (8.97 to 12.7) | 19.8 (17.5 to 22.5) |
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 14, 28 and Day 42) and pre-vaccination on Day 0.
| ratio | Group 1 VRVg-2+HRIG | Group 2 Verorab+HRIG | Group 3 Imovax Rabies+HRIG | Group 4 VRVg-2 |
|---|---|---|---|---|
| Day 14/Day 0 | 24.0 (20.8 to 27.6) | 18.6 (14.4 to 24.1) | 18.3 (14.6 to 22.8) | 53.7 (42.1 to 68.4) |
| Day 28/Day 0 | 64.8 (57.3 to 73.2) | 50.3 (39.4 to 64.4) | 55.1 (43.5 to 69.6) | 123 (105 to 144) |
| Day 42/Day 0 | 135 (122 to 149) | 94.7 (79.6 to 113) | 107 (89.7 to 127) | 197 (173 to 224) |
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 | Group 1 VRVg-2+HRIG | Group 2 Verorab+HRIG | Group 3 Imovax Rabies+HRIG | Group 4 VRVg-2 |
|---|---|---|---|---|
| Day 0: Complete Neutralization | 0.4 (0 to 2.4) | 0 (0 to 4.9) | 0 (0 to 5.0) | 1.4 (0 to 7.3) |
| Day 0: Incomplete Neutralization | 99.6 (97.6 to 100) | 100 (95.1 to 100) | 100 (95.0 to 100) | 98.6 (92.7 to 100) |
| Day 14: Complete Neutralization | 98.7 (96.2 to 99.7) | 100 (95.2 to 100) | 98.7 (92.8 to 100) | 98.7 (93.0 to 100) |
| Day 14: Incomplete Neutralization | 1.3 (0.3 to 3.8) | 0 (0 to 4.8) | 1.3 (0 to 7.2) | 1.3 (0 to 7.0) |
| Day 28: Complete Neutralization | 100 (98.5 to 100) | 100 (95.3 to 100) | 98.7 (93.1 to 100) | 100 (95.3 to 100) |
| Day 28: Incomplete Neutralization | 0 (0 to 1.5) | 0 (0 to 4.7) | 1.3 (0 to 6.9) | 0 (0 to 4.7) |
| Day 42: Complete Neutralization | 100 (98.4 to 100) | 100 (95.3 to 100) | 100 (95.4 to 100) | 100 (95.3 to 100) |
| Day 42: Incomplete Neutralization | 0 (0 to 1.6) | 0 (0 to 4.7) | 0 (0 to 4.6) | 0 (0 to 4.7) |
An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessary had to have a causal relationship with 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. Immediate AEs considered as related to vaccination were recorded as immediate unsolicited adverse reactions (ARs).
| Participants | Group 1 VRVg-2+HRIG | Group 2 Verorab+HRIG | Group 3 Imovax Rabies+HRIG | Group 4 VRVg-2 |
|---|---|---|---|---|
| Post-any vaccination | 3 | 0 | 0 | 1 |
| Post-vaccination 1 | 3 | 0 | 0 | 1 |
| Post-vaccination 2 | 0 | 0 | 0 | 0 |
| Post-vaccination 3 | 0 | 0 | 0 | 0 |
| Post-vaccination 4 | 0 | 0 | 0 | 0 |
| Post-vaccination 5 | 0 | 0 | 0 | 0 |
A solicited reaction (SR) was an expected AR observed and reported under conditions (nature and onset) prelisted (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 pain, erythema and swelling at and around the injection site.
| Participants | Group 1 VRVg-2+HRIG | Group 2 Verorab+HRIG | Group 3 Imovax Rabies+HRIG | Group 4 VRVg-2 |
|---|---|---|---|---|
| Pain Post-any vaccination | 142 | 37 | 49 | 44 |
| Pain Post-vaccination 1 | 71 | 19 | 25 | 23 |
| Pain Post-vaccination 2 | 84 | 17 | 17 | 20 |
| Pain Post-vaccination 3 | 73 | 14 | 23 | 23 |
| Pain Post-vaccination 4 | 69 | 12 | 29 | 27 |
| Pain Post-vaccination 5 | 40 | 12 | 24 | 21 |
| Erythema Post-any vaccination | 5 | 5 | 3 | 1 |
| Erythema Post-vaccination 1 | 0 | 1 | 1 | 0 |
| Erythema Post-vaccination 2 | 0 | 0 | 0 | 0 |
| Erythema Post-vaccination 3 | 0 | 1 | 1 | 0 |
| Erythema Post-vaccination 4 | 3 | 3 | 1 | 1 |
| Erythema Post-vaccination 5 | 2 | 1 | 1 | 0 |
| Swelling Post-any vaccination | 5 | 1 | 1 | 0 |
| Swelling Post-vaccination 1 | 1 | 0 | 0 | 0 |
| Swelling Post-vaccination 2 | 0 | 0 | 0 | 0 |
| Swelling Post-vaccination 3 | 2 | 0 | 1 | 0 |
| Swelling Post-vaccination 4 | 2 | 0 | 0 | 0 |
| Swelling Post-vaccination 5 | 1 | 1 | 0 | 0 |
SR was an expected AR observed and reported under conditions (nature and onset) prelisted (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, headache, malaise and myalgia.
| Participants | Group 1 VRVg-2+HRIG | Group 2 Verorab+HRIG | Group 3 Imovax Rabies+HRIG | Group 4 VRVg-2 |
|---|---|---|---|---|
| Fever Post-any vaccination | 4 | 2 | 4 | 1 |
| Fever Post-vaccination 1 | 0 | 0 | 1 | 0 |
| Fever Post-vaccination 2 | 0 | 0 | 1 | 0 |
| Fever Post-vaccination 3 | 2 | 1 | 1 | 0 |
| Fever Post-vaccination 4 | 0 | 0 | 2 | 1 |
| Fever Post-vaccination 5 | 2 | 1 | 1 | 0 |
| Headache Post-any vaccination | 107 | 35 | 38 | 36 |
| Headache Post-vaccination 1 | 44 | 20 | 18 | 17 |
| Headache Post-vaccination 2 | 26 | 10 | 10 | 6 |
| Headache Post-vaccination 3 | 38 | 13 | 16 | 14 |
| Headache Post-vaccination 4 | 29 | 10 | 5 | 14 |
| Headache Post-vaccination 5 | 23 | 7 | 5 | 13 |
| Malaise Post-any vaccination | 34 | 13 | 14 | 13 |
| Malaise Post-vaccination 1 | 20 | 7 | 5 | 4 |
| Malaise Post-vaccination 2 | 7 | 3 | 5 | 1 |
| Malaise Post-vaccination 3 | 9 | 4 | 4 | 6 |
| Malaise Post-vaccination 4 | 8 | 1 | 1 | 6 |
| Malaise Post-vaccination 5 | 6 | 0 | 2 | 2 |
| Myalgia Post-any vaccination | 118 | 37 | 38 | 33 |
| Myalgia Post-vaccination 1 | 58 | 17 | 23 | 20 |
| Myalgia Post-vaccination 2 | 50 | 11 | 9 | 14 |
| Myalgia Post-vaccination 3 | 50 | 13 | 15 | 12 |
| Myalgia Post-vaccination 4 | 35 | 8 | 14 | 17 |
| Myalgia Post-vaccination 5 | 26 | 8 | 10 | 11 |
An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessary had to have a causal relationship with 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.
| Participants | Group 1 VRVg-2+HRIG | Group 2 Verorab+HRIG | Group 3 Imovax Rabies+HRIG | Group 4 VRVg-2 |
|---|---|---|---|---|
| Post-any vaccination | 145 | 46 | 39 | 42 |
| Post-vaccination 1 | 47 | 22 | 12 | 10 |
| Post-vaccination 2 | 27 | 5 | 11 | 5 |
| Post-vaccination 3 | 31 | 9 | 7 | 8 |
| Post-vaccination 4 | 37 | 9 | 14 | 11 |
| Post-vaccination 5 | 60 | 11 | 12 | 21 |
An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessary had to have a causal relationship with treatment. An SAE 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 | Group 1 VRVg-2+HRIG | Group 2 Verorab+HRIG | Group 3 Imovax Rabies+HRIG | Group 4 VRVg-2 |
|---|---|---|---|---|
| SAE | 4 | 4 | 0 | 3 |
| SAE related to study vaccine | 0 | 2 | 0 | 0 |
| AESI | 0 | 0 | 0 | 0 |
| AESI related to study vaccine | 0 | 0 | 0 | 0 |
Collected over Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 VRVg-2+HRIG | 0/320 (0%) | 4/320 (1.3%) | 204/320 (63.8%) |
| Group 2 Verorab+HRIG | 0/107 (0%) | 4/107 (3.7%) | 59/107 (55.1%) |
| Group 3 Imovax Rabies+HRIG | 0/107 (0%) | 0/107 (0%) | 66/107 (61.7%) |
| Group 4 VRVg-2 | 0/104 (0%) | 3/104 (2.9%) | 67/104 (64.4%) |
| Event | Group 1 VRVg-2+HRIG | Group 2 Verorab+HRIG | Group 3 Imovax Rabies+HRIG | Group 4 VRVg-2 |
|---|---|---|---|---|
| Meningioma BenignNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/320 | 0/107 | 0/107 | 1/104 |
| Ischaemic StrokeNervous system disorders | 0/320 | 0/107 | 0/107 | 1/104 |
| EndometriosisReproductive system and breast disorders | 0/320 | 0/107 | 0/107 | 1/104 |
| General Physical Health DeteriorationGeneral disorders | 0/320 | 1/107 | 0/107 | 0/104 |
| ErysipelasInfections and infestations | 0/320 | 1/107 | 0/107 | 0/104 |
| DyskinesiaNervous system disorders | 0/320 | 1/107 | 0/107 | 0/104 |
| SciaticaNervous system disorders | 0/320 | 1/107 | 0/107 | 0/104 |
| Abortion SpontaneousPregnancy, puerperium and perinatal conditions | 0/320 | 1/107 | 0/107 | 0/104 |
| Ligament InjuryInjury, poisoning and procedural complications | 1/320 | 0/107 | 0/107 | 0/104 |
| Cervical RadiculopathyNervous system disorders | 1/320 | 0/107 | 0/107 | 0/104 |
| Event | Group 1 VRVg-2+HRIG | Group 2 Verorab+HRIG | Group 3 Imovax Rabies+HRIG | Group 4 VRVg-2 |
|---|---|---|---|---|
| Injection Site PainGeneral disorders | 142/320 | 37/107 | 49/107 | 44/104 |
| HeadacheNervous system disorders | 113/320 | 35/107 | 41/107 | 40/104 |
| MyalgiaMusculoskeletal and connective tissue disorders | 118/320 | 37/107 | 38/107 | 34/104 |
| MalaiseGeneral disorders | 34/320 | 13/107 | 14/107 | 13/104 |
| FatigueGeneral disorders | 3/320 | 6/107 | 1/107 | 1/104 |
Analysis was performed on all randomized participants.
| Age, Continuous(years) | Group 1 VRVg-2+HRIG | Group 2 Verorab+HRIG | Group 3 Imovax Rabies+HRIG | Group 4 VRVg-2 | Total Title |
|---|---|---|---|---|---|
| Mean | 46.0 ± 14.7 | 46.2 ± 14.8 | 46.3 ± 15.6 | 46.4 ± 15.0 | 46.1 ± 14.9 |
| Sex: Female, Male(Participants) | Group 1 VRVg-2+HRIG | Group 2 Verorab+HRIG | Group 3 Imovax Rabies+HRIG | Group 4 VRVg-2 | Total Title |
|---|---|---|---|---|---|
| Female | 196 | 61 | 65 | 60 | 382 |
| Male | 124 | 46 | 42 | 46 | 258 |
| Race (NIH/OMB)(Participants) | Group 1 VRVg-2+HRIG | Group 2 Verorab+HRIG | Group 3 Imovax Rabies+HRIG | Group 4 VRVg-2 | Total Title |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 2 | 2 | 0 | 0 | 4 |
| Asian | 4 | 1 | 3 | 0 | 8 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 9 | 1 | 0 | 1 | 11 |
| White | 301 | 102 | 104 | 105 | 612 |
| More than one race | 1 | 1 | 0 | 0 | 2 |
| Unknown or Not Reported | 3 | 0 | 0 | 0 | 3 |
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://vivli.org
Ran from Jul 2019 to primary completion in Dec 2020, 17 months.
Results were first posted in Mar 2022, 1 year 2 months after primary completion.
Of 19 phase 3 interventional studies under Rabies, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 21. This study's 17 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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