Rabies (Healthy Volunteers)Phase 3NCT03965962
Study of Purified Vero Rabies Vaccine Compared With Two Reference Rabies Vaccines in a Simulated Post-Exposure Regimen in Adults
A Phase 3 study testing VRVg-2, Purified Inactivated Rabies Vaccine and Human Diploid Cell Vaccine (HDCV) in people with Rabies (Healthy Volunteers), run by Sanofi Pasteur, a Sanofi Company at 2 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rabies (Healthy Volunteers)
- What is being tested?
- VRVg-2, Purified Inactivated Rabies Vaccine and Human Diploid Cell Vaccine (HDCV)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jul 2019to 1 Jul 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women aged >=18 years on the day of inclusion (>= 18 years means from the day of the 18th birthday onwards, with no upper age limit).
- Able to attend all scheduled visits and to comply with all trial procedures.
- Body Mass Index (BMI): 18.5 kilograms per square meter (kg/m^2) less than or equal to (<=) BMI <=30 kg/m^2.
Who cannot join
- Pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile.
- Participation at the time of study enrollment or, planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
- Receipt of any vaccine in the 4 weeks (28 days) preceding the first trial vaccination or planned receipt of any vaccine prior to Visit 7.
- Previous vaccination against rabies (in pre- or post-exposure regimen) with either the trial vaccines or another vaccine.
- Receipt of immune globulins, blood or blood-derived products in the past 3 months.
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
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- At high risk for rabies exposure during the trial (veterinarians and their staff, animal handlers, rabies researchers, and certain laboratory workers, persons whose activities bring them into frequent contact with rabies virus or potentially rabid bats, raccoons, skunks, cats, dogs, or other species at risk for having rabies, people travelling where rabies was enzootic).
- Known systemic hypersensitivity to any of the vaccine or HRIG components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances.
- Self-reported thrombocytopenia, contraindicating IM vaccination.
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination.
- Current alcohol or substance abuse that, in the opinion of the investigator, might interfere with the trial conduct of completion.
- Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion.
- Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature >=38.0 degree Celsius). A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided.
- Personal history of Guillain-Barré syndrome.
- Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
- The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Investigational Site Number 2500002
Gières, 38610
Investigational Site Number 2500001
Rennes, 35000
About this study
Official title: Immunogenicity and Safety of a Purified Vero Rabies Vaccine - Serum Free in Comparison With Verorab® and Imovax® Rabies, in a Simulated Rabies Post-exposure Regimen in Healthy Adults in France
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.
Read more
Secondary Objective:
- To describe the safety profile of VRVg-2 versus Verorab and Imovax Rabies vaccines when co-administered with HRIG, as well as that of VRVg-2, after each vaccine injection.
- To demonstrate that the proportion of participants in the VRVg-2 + HRIG group achieving an RVNA titer >= 0.5 IU/mL at Day 28 was at least 95 percent (%).
- To describe the immune response induced by VRVg-2 versus Verorab and Imovax Rabies vaccines when co-administered with HRIG, as well as that induced by VRVg-2, at Day 14 (7 days after the third injection), at Day 28 (14 days after the fourth injection) and at Day 42 (14 days after the last injection).
Read the detailed description
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.
- Conditions
- Rabies (Healthy Volunteers)
- Being tested
- VRVg-2, Purified Inactivated Rabies Vaccine, Human Diploid Cell Vaccine (HDCV), Rabies immune globulin (human)
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRVg-2Biological
Pharmaceutical form: Powder and solvent for suspension for injection;
Route of administration: IM
Purified Inactivated Rabies VaccineBiological
Also called Verorab®
Pharmaceutical form: Powder and solvent for suspension for injection;
Route of administration: IM
Human Diploid Cell Vaccine (HDCV)Biological
Also called IMOVAX® Rabies
Pharmaceutical form: Powder and solvent for suspension for injection;
Route of administration: IM
Rabies immune globulin (human)Biological
Also called IMOGAM® Rabies-HT
Pharmaceutical form: Solution for injection;
Route of administration: IM
| Study group | Role | What they receive |
|---|---|---|
| Group 1: VRVg-2 + HRIG | Experimental | 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. Receives: Biological: VRVg-2; Biological: Rabies immune globulin (human) |
| Group 2: Verorab + HRIG | Active comparator | Participants received 0.5 mL IM injection of Verorab on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0. Receives: Biological: Purified Inactivated Rabies Vaccine; Biological: Rabies immune globulin (human) |
| Group 3: Imovax Rabies + HRIG | Active comparator | Participants received 1 mL IM injection of Imovax Rabies on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0. Receives: Biological: Human Diploid Cell Vaccine (HDCV); Biological: Rabies immune globulin (human) |
| Group 4: VRVg-2 | Experimental | Participants received 0.5 mL IM injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28. Receives: Biological: VRVg-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 28
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start1 Jul 2019
- Primary completion22 Dec 2020
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rabies (Healthy Volunteers)Studies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was divided into 4 groups: groups 1 to 3 (VRVg-2 + HRIG; Verorab + HRIG; Imovax Rabies + HRIG) were modified double-blind and group 4 (VRVg-2 standalone) was open-label.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 640 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi Pasteur, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965962
- Sponsor's protocol ID
- VRV13
- Other IDs
- 2018-004055-20, U1111-1216-6151, 2018
- Status last verified
- Sep 2025
- First submitted
- 24 May 2019
- Last updated
- 18 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
Publications
Pineda-Pena AC, Jiang Q, Petit C, Korejwo-Peyramond J, Donazzolo Y, Latreille M, Homery MC, Babin V, Benamor S, Pichon S, Guinet-Morlot F, Minutello AM. Immunogenicity and Safety of a Purified Vero Rabies Vaccine-Serum Free, Compared With 2 Licensed Vaccines, in a Simulated Rabies Post-Exposure Regimen in Healthy Adults in France: A Randomized, Controlled, Phase 3 Trial. Clin Infect Dis. 2024 Jun 14;78(6):1748-1756. doi: 10.1093/cid/ciae137.
PubMed 38478634
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of a Purified Vero Rabies Vaccine - Serum Free in Comparison With Verorab® and Imovax® Rabies, in a Simulated Rabies Post-exposure Regimen in Healthy Adults in France
- ClinicalTrials.gov ID
- NCT03965962
- Acronym / sponsor ID
- VRV13
- Conditions
- Rabies (Healthy Volunteers)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 640 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 22 Dec 2020 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 29 May 2019 (actual)
- Results
- Posted 11 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To describe the safety profile of VRVg-2 versus Verorab and Imovax Rabies vaccines when co-administered with HRIG, as well as that of VRVg-2, after each vaccine injection.
- To demonstrate that the proportion of participants in the VRVg-2 + HRIG group achieving an RVNA titer >= 0.5 IU/mL at Day 28 was at least 95 percent (%).
- To describe the immune response induced by VRVg-2 versus Verorab and Imovax Rabies vaccines when co-administered with HRIG, as well as that induced by VRVg-2, at Day 14 (7 days after the third injection), at Day 28 (14 days after the fourth injection) and at Day 42 (14 days after the last injection).
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The study was divided into 4 groups: groups 1 to 3 (VRVg-2 + HRIG; Verorab + HRIG; Imovax Rabies + HRIG) were modified double-blind and group 4 (VRVg-2 standalone) was open-label.
| Arm | Type | Receives |
|---|---|---|
| Group 1: VRVg-2 + HRIG | Experimental | Biological: VRVg-2, Biological: Rabies immune globulin (human)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. |
| Group 2: Verorab + HRIG | Active comparator | Biological: Purified Inactivated Rabies Vaccine, 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. |
| Group 3: Imovax Rabies + HRIG | Active comparator | Biological: Human Diploid Cell Vaccine (HDCV), 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. |
| Group 4: VRVg-2 | Experimental | Biological: VRVg-2Participants received 0.5 mL IM injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women aged >=18 years on the day of inclusion (>= 18 years means from the day of the 18th birthday onwards, with no upper age limit).
- Able to attend all scheduled visits and to comply with all trial procedures.
- Body Mass Index (BMI): 18.5 kilograms per square meter (kg/m^2) less than or equal to (<=) BMI <=30 kg/m^2.
Key exclusion criteria (16 listed)
- Pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile.
- Participation at the time of study enrollment or, planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
- Receipt of any vaccine in the 4 weeks (28 days) preceding the first trial vaccination or planned receipt of any vaccine prior to Visit 7.
- Previous vaccination against rabies (in pre- or post-exposure regimen) with either the trial vaccines or another vaccine.
- Receipt of immune globulins, blood or blood-derived products in the past 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VRVg-2Pharmaceutical form: Powder and solvent for suspension for injection; Route of administration: IM | Biological | Group 1: VRVg-2 + HRIG, Group 4: VRVg-2 |
| Purified Inactivated Rabies VaccineAlso: Verorab®Pharmaceutical form: Powder and solvent for suspension for injection; Route of administration: IM | Biological | Group 2: Verorab + HRIG |
| Human Diploid Cell Vaccine (HDCV)Also: IMOVAX® RabiesPharmaceutical form: Powder and solvent for suspension for injection; Route of administration: IM | Biological | Group 3: Imovax Rabies + HRIG |
| Rabies immune globulin (human)Also: IMOGAM® Rabies-HTPharmaceutical form: Solution for injection; Route of administration: IM | Biological | Group 1: VRVg-2 + HRIG, Group 2: Verorab + HRIG, Group 3: Imovax Rabies + HRIG |
Primary outcome
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
Time frame: Day 28
RVNA titer against rabies virus was assessed using the Rapid Fluorescent Focus Inhibition test (RFFIT) assay method.
10 secondary outcomes
Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL
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])
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
Time frame: Day 0 (pre-vaccination), Day 14, Day 28 and Day 42
Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers
Time frame: Day 0 (pre-vaccination), Day 14, Day 28 and Day 42
Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization
Time frame: Day 0 (pre-vaccination), Day 14, Day 28 and Day 42
Number of Participants With Immediate Unsolicited Adverse Events (AEs)
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
Time frame: Within 7 days after any and each vaccination (Vaccination 1, 2, 3, 4 and 5)
Number of Participants With Solicited Systemic Reactions
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
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)
Time frame: From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38478634Pineda-Pena AC, Jiang Q, Petit C, Korejwo-Peyramond J, Donazzolo Y, Latreille M, Homery MC, Babin V, Benamor S, Pichon S, Guinet-Morlot F, Minutello AM. Immunogenicity and Safety of a Purified Vero Rabies Vaccine-Serum Free, Compared With 2 Licensed Vaccines, in a Simulated Rabies Post-Exposure Regimen in Healthy Adults in France: A Randomized, Controlled, Phase 3 Trial. Clin Infect Dis. 2024 Jun 14;78(6):1748-1756. doi: 10.1093/cid/ciae137.
- VRV13 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi Pasteur, a Sanofi Company
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VRVg-2, Purified Inactivated Rabies Vaccine and Human Diploid Cell Vaccine (HDCV) in people with Rabies (Healthy Volunteers), run by Sanofi Pasteur, a Sanofi Company at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03965962, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.