Rabies (Healthy Volunteers)Phase 3NCT04478084
Study of Purified Vero Rabies Vaccine Compared With a Reference Rabies Vaccine as Simulated Rabies Post-Exposure Prophylaxis in Adult and Pediatric Population in Thaïland
A Phase 3 study testing Purified vero rabies vaccine - serum free VRVg-2, Purified inactivated rabies vaccine and Equine rabies immunoglobulins (ERIG) (only Group 3 and Group 4) in people with Rabies (Healthy Volunteers), run by Sanofi Pasteur, a Sanofi Company at 3 sites in Thailand.
Trial summary
Primary Objective: To describe the immune response induced by VRVg-2 and Verorab vaccine at Day 14 (to assess the immune response after 3 doses [2-2-2]) and Day 42 (to assess the immune response after 4 doses [2-2-2-0-2]) when administered as standalone in healthy pediatric population or co-administered with HRIG… Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Rabies (Healthy Volunteers)
- What is being tested?
- Purified vero rabies vaccine - serum free VRVg-2, Purified inactivated rabies vaccine and Equine rabies immunoglobulins (ERIG) (only Group 3 and Group 4)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 403 participants
- Where
- 3 sitesThailand
- Study dates
- 4 Aug 2020to 21 Jul 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Aged ≥ 1 year on the day of inclusion
- Participant (adult ≥ 18 years without upper age limit) or participant and participant's parent/LAR (child ≥ 1 to < 18 years) are able to attend all scheduled visits and to comply with all study procedures
- The following criterion only applies to healthy adults ≥ 18 years:
- Body Mass Index (BMI): 18.5 kg/m2 ≤ BMI ≤ 30 kg/m2
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 and until 1 month after each vaccination. To be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, or surgically sterile.
- Participation at the time of study enrollment or, planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
- Receipt of any vaccine in the 4 weeks (28 days) preceding the first study vaccination or planned receipt of any vaccine prior to Visit 8 (D90)
- Previous vaccination against rabies (in pre- or post-exposure regimen) with either the study vaccines or another vaccine
- Bite by, or exposure to a potentially rabid animal in the previous 6 months without post-exposure prophylaxis
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
Show all 20Show fewer
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- At high risk for rabies exposure
- Known systemic hypersensitivity to any of the study/control vaccine components or, for adults, to ERIG Group 3 and Group 4) or HRIG (Group 5 and Group 6), or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances
- Positive skin test to ERIG at Visit 1 for only adult participants enrolled in Group 3 and Group 4 as per superseded Protocol version 5.0
- Self-reported thrombocytopenia
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Current alcohol or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion
- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion
- Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0 C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
- Personal history of Guillain-Barré syndrome
- Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
- Receipt of chloroquine or hydroxychloroquine up to 2 months prior to the study or through to study until Visit 8
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
3 sites in 1 country.
Thailand3 sites
Investigational Site Number :7640004
Bangkok, 10400
Investigational Site Number :7640002
Bangkok
Investigational Site Number :7640003
Khon Kaen, 40002
About this study
Official title: Immunogenicity and Safety of a Purified Vero Rabies Vaccine-Serum Free (VRVg) Assessed With the Institut Pasteur du Cambodge (IPC: 2-2-2-0-0) and the Thai Red Cross (TRC: 2-2-2-0-2) Intradermal Regimens as Simulated Rabies Post-exposure Prophylaxis in Healthy Subjects in Thailand
Primary Objective:
To describe the immune response induced by VRVg-2 and Verorab vaccine at Day 14 (to assess the immune response after 3 doses [2-2-2]) and Day 42 (to assess the immune response after 4 doses [2-2-2-0-2]) when administered as standalone in healthy pediatric population or co-administered with HRIG (Group 5 and Group 6) at Day 0 in healthy adults.
Read more
Secondary Objectives:
- To describe the immune response induced by VRVg-2 and Verorab vaccine at Day 14 (to assess the immune response after 3 doses [2-2-2]) when co-administered with ERIG (Group 3 and Group 4) at Day 0 in healthy adults
- To describe the immune response induced by VRVg-2 and Verorab vaccine at D90 (to assess the immune response 90 days post-rabies simulated exposure) when administered as standalone in healthy pediatric population or co-administered with HRIG (Group 5 and Group 6) at Day 0 in healthy adults
- To describe the safety profile of VRVg-2 and Verorab vaccine as standalone in pediatric population or when co-administered with ERIG (Group 3 and Group 4) or HRIG (Group 5 and Group 6) at Day 0 in adults, after each vaccination.
Read the detailed description
The duration of each participant's participation in the study is approximately 7 months (28 day-vaccination period followed by 6 month safety follow-up period).
- Conditions
- Rabies (Healthy Volunteers)
- Being tested
- Purified vero rabies vaccine - serum free VRVg-2, Purified inactivated rabies vaccine, Equine rabies immunoglobulins (ERIG) (only Group 3 and Group 4), Human rabies immunoglobulins (HRIG) (only Group 5 and Group 6)
- Keywords
- Rabies Vaccine
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Purified vero rabies vaccine - serum free VRVg-2Biological
Pharmaceutical form:freeze-dried Route of administration: intradermal
Purified inactivated rabies vaccineBiological
Also called Verorab®
Pharmaceutical form:freeze-dried Route of administration: intradermal
Equine rabies immunoglobulins (ERIG) (only Group 3 and Group 4)Biological
Also called ERIG
Pharmaceutical form: liquid/solution in 5 mL vials Route of administration: intramuscular
Human rabies immunoglobulins (HRIG) (only Group 5 and Group 6)Biological
Also called IMOGAM® Rabies-HT
Pharmaceutical form: liquid/solution in 2 mL vials Route of administration: intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Group 1: pediatric participants; VRVg-2 | Experimental | VRVg-2 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28 Receives: Biological: Purified vero rabies vaccine - serum free VRVg-2 |
| Group 2: pediatric participants; Verorab | Active comparator | Verorab 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28 Receives: Biological: Purified inactivated rabies vaccine |
| Group 3: adult participants; VRVG-2 + ERIG | Experimental | VRVg-2 8 injections: 2 at Day 0, 2 at Day 3 and 2 at Day 7
+ ERIG at D0 Receives: Biological: Purified vero rabies vaccine - serum free VRVg-2; Biological: Equine rabies immunoglobulins (ERIG) (only Group 3 and Group 4) |
| Group 4: adult participants; Verorab + ERIG | Active comparator | Verorab 8 injections: 2 at Day 0, 2 at Day 3 and 2 at Day 7
+ ERIG at D0 Receives: Biological: Purified inactivated rabies vaccine; Biological: Equine rabies immunoglobulins (ERIG) (only Group 3 and Group 4) |
| Group 5: adult participants; VRVG-2 + HRIG | Experimental | VRVg-2 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28
+ HRIG at D0 Receives: Biological: Purified vero rabies vaccine - serum free VRVg-2; Biological: Human rabies immunoglobulins (HRIG) (only Group 5 and Group 6) |
| Group 6: adult participants; Verorab + HRIG | Active comparator | Verorab 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28
+ HRIG at D0 Receives: Biological: Purified inactivated rabies vaccine; Biological: Human rabies immunoglobulins (HRIG) (only Group 5 and Group 6) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants in Group 1, Group 2, Group 5 and Group 6 achieving rabies virus neutralizing antibody (RVNA) titer greater than or equal to (≥) 0.5 IU/mL
RVNA titers will be measured by rapid fluorescent focus inhibition test (RFFIT)
Measured: Day 14 (post-vaccination)
Percentage of participants in Group 1, Group 2, Group 5 and Group 6 achieving RVNA titer greater than or equal to (≥) 0.5 IU/mL
RVNA titers will be measured by RFFIT
Measured: Day 42 (post-vaccination)
Number of Participants in Group 1, Group 2, Group 5 and Group 6 achieving RVNA titer greater than or equal to (≥) lower limit of quantification
RVNA titers will be measured by RFFIT Lower limit of quantification for RFFIT assay is 0.2 IU/mL
Measured: Day 14 (post-vaccination)
Number of Participants in Group 1, Group 2, Group 5 and Group 6 achieving RVNA titer greater than or equal to (≥) lower limit of quantification
RVNA titers will be measured by RFFIT Lower limit of quantification for RFFIT assay is 0.2 IU/mL
Measured: Day 42 (post-vaccination)
Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination) in Group 1, Group 2, Group 5 and Group 6 Participants
RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 14 RVNA ratios Day14/Day0 will be calculated
Measured: Day 14 (post-vaccination)
Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination) in Group 1, Group 2, Group 5 and Group 6 Participants
RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 42 RVNA ratios Day42/Day0 will be calculated
Measured: Day 42 (post-vaccination)
Secondary outcomes (12)
Number of participants reporting immediate adverse events (AEs)
Includes unsolicited (spontaneously reported) systemic AEs
Measured: Within 30 minutes post-vaccination
Percentage of participants reporting solicited injection site reactions
Solicited injection site reactions:
- tenderness, erythema, swelling in toddlers (aged ≥ 1 year to < 2 years)
- pain, erythema, and swelling in children (aged 2 years to < 12 years), in adolescents and adults (aged ≥ 12 years)
Measured: Within 7 days post-vaccination
Percentage of participants reporting solicited systemic reactions
Solicited systemic reactions:
- fever, vomiting, crying abnormal, drowsiness, appetite lost, irritability in toddlers (aged ≥ 1 year to < 2 years)
- fever, headache, malaise and myalgia in children (aged 2 years to < 12 years), adolescents or adults (aged ≥ 12 years)
Measured: Between Day 0 and Day 3, between Day 3 and Day 7, and during the 7 days following the remaining vaccinations
Number of participants reporting unsolicited injection site AEs
Unsolicited (spontaneously reported) injection site AEs
Measured: Within 28 days post-vaccination
Number of participants reporting unsolicited systemic AEs
Unsolicited (spontaneously reported) systemic AEs
Measured: Between each vaccination and up to 28 days after the last vaccination
Number of participants reporting serious adverse events (SAEs)
SAEs, including adverse event of special interest (AESIs)
Measured: Up to 6 months post-vaccination
Percentage of participants in Group 3 and Group 4 achieving rabies virus neutralizing antibody (RVNA) titer greater than or equal to (≥) 0.5 IU/mL
RVNA titers will be measured by RFFIT
Measured: Day 14 (post-vaccination)
Number of Participants in Group 3 and Group 4 achieving RVNA titer greater than or equal to (≥) lower limit of quantification
RVNA titers will be measured by RFFIT Lower limit of quantification for RFFIT assay is 0.2 IU/mL
Measured: Day 14 (post-vaccination)
Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination) in Group 3 and Group 4 Participants
RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 14 RVNA ratios Day14/Day0 will be calculated
Measured: Day 14 (post-vaccination)
Percentage of participants in Group 1, Group 2, Group 5 and Group 6 achieving rabies virus neutralizing antibody (RVNA) titer greater than or equal to (≥) 0.5 IU/mL
RVNA titers will be measured by RFFIT
Measured: Day 90 (post-vaccination)
Number of Participants in Group 1, Group 2, Group 5 and Group 6 achieving RVNA titer greater than or equal to (≥) lower limit of quantification
RVNA titers will be measured by RFFIT Lower limit of quantification for RFFIT assay is 0.2 IU/mL
Measured: Day 90 (post-vaccination)
Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination) in Group 1, Group 2, Group 5 and Group 6 Participants
RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 90 RVNA ratios Day90/Day0 will be calculated
Measured: Day 90 (post-vaccination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start4 Aug 2020
- Primary completion19 Mar 2022
- Study completion21 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 403 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
- NCT04478084
- Sponsor's protocol ID
- VRV09
- Other IDs
- U1111-1227-4143
- Status last verified
- Sep 2025
- First submitted
- 15 Jul 2020
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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
Study at a glance
From the registry record, last updated by the sponsor on 19 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 (VRVg) Assessed With the Institut Pasteur du Cambodge (IPC: 2-2-2-0-0) and the Thai Red Cross (TRC: 2-2-2-0-2) Intradermal Regimens as Simulated Rabies Post-exposure Prophylaxis in Healthy Subjects in Thailand
- ClinicalTrials.gov ID
- NCT04478084
- Acronym / sponsor ID
- VRV09
- Conditions
- Rabies (Healthy Volunteers)
- Keywords
- Rabies Vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 19 Mar 2022 (actual)
- Study completion
- 21 Jul 2022 (actual)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
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 describe the immune response induced by VRVg-2 and Verorab vaccine at Day 14 (to assess the immune response after 3 doses [2-2-2]) and Day 42 (to assess the immune response after 4 doses [2-2-2-0-2]) when administered as standalone in healthy pediatric population or co-administered with HRIG (Group 5 and Group 6) at Day 0 in healthy adults.
Secondary Objectives:
- To describe the immune response induced by VRVg-2 and Verorab vaccine at Day 14 (to assess the immune response after 3 doses [2-2-2]) when co-administered with ERIG (Group 3 and Group 4) at Day 0 in healthy adults
- To describe the immune response induced by VRVg-2 and Verorab vaccine at D90 (to assess the immune response 90 days post-rabies simulated exposure) when administered as standalone in healthy pediatric population or co-administered with HRIG (Group 5 and Group 6) at Day 0 in healthy adults
- To describe the safety profile of VRVg-2 and Verorab vaccine as standalone in pediatric population or when co-administered with ERIG (Group 3 and Group 4) or HRIG (Group 5 and Group 6) at Day 0 in adults, after each vaccination.
Detailed description
The duration of each participant's participation in the study is approximately 7 months (28 day-vaccination period followed by 6 month safety follow-up period).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1: pediatric participants; VRVg-2 | Experimental | Biological: Purified vero rabies vaccine - serum free VRVg-2VRVg-2 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28 |
| Group 2: pediatric participants; Verorab | Active comparator | Biological: Purified inactivated rabies vaccineVerorab 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28 |
| Group 3: adult participants; VRVG-2 + ERIG | Experimental | Biological: Purified vero rabies vaccine - serum free VRVg-2, Biological: Equine rabies immunoglobulins (ERIG) (only Group 3 and Group 4)VRVg-2 8 injections: 2 at Day 0, 2 at Day 3 and 2 at Day 7 + ERIG at D0 |
| Group 4: adult participants; Verorab + ERIG | Active comparator | Biological: Purified inactivated rabies vaccine, Biological: Equine rabies immunoglobulins (ERIG) (only Group 3 and Group 4)Verorab 8 injections: 2 at Day 0, 2 at Day 3 and 2 at Day 7 + ERIG at D0 |
| Group 5: adult participants; VRVG-2 + HRIG | Experimental | Biological: Purified vero rabies vaccine - serum free VRVg-2, Biological: Human rabies immunoglobulins (HRIG) (only Group 5 and Group 6)VRVg-2 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28 + HRIG at D0 |
| Group 6: adult participants; Verorab + HRIG | Active comparator | Biological: Purified inactivated rabies vaccine, Biological: Human rabies immunoglobulins (HRIG) (only Group 5 and Group 6)Verorab 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28 + HRIG at D0 |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Aged ≥ 1 year on the day of inclusion
- Participant (adult ≥ 18 years without upper age limit) or participant and participant's parent/LAR (child ≥ 1 to < 18 years) are able to attend all scheduled visits and to comply with all study procedures
- Body Mass Index (BMI): 18.5 kg/m2 ≤ BMI ≤ 30 kg/m2
Key exclusion criteria (20 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 and until 1 month after each vaccination. To be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, or surgically sterile.
- Participation at the time of study enrollment or, planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
- Receipt of any vaccine in the 4 weeks (28 days) preceding the first study vaccination or planned receipt of any vaccine prior to Visit 8 (D90)
- Previous vaccination against rabies (in pre- or post-exposure regimen) with either the study vaccines or another vaccine
- Bite by, or exposure to a potentially rabid animal in the previous 6 months without post-exposure prophylaxis
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 |
|---|---|---|
| Purified vero rabies vaccine - serum free VRVg-2Pharmaceutical form:freeze-dried Route of administration: intradermal | Biological | Group 1: pediatric participants; VRVg-2, Group 3: adult participants; VRVG-2 + ERIG, Group 5: adult participants; VRVG-2 + HRIG |
| Purified inactivated rabies vaccineAlso: Verorab®Pharmaceutical form:freeze-dried Route of administration: intradermal | Biological | Group 2: pediatric participants; Verorab, Group 4: adult participants; Verorab + ERIG, Group 6: adult participants; Verorab + HRIG |
| Equine rabies immunoglobulins (ERIG) (only Group 3 and Group 4)Also: ERIGPharmaceutical form: liquid/solution in 5 mL vials Route of administration: intramuscular | Biological | Group 3: adult participants; VRVG-2 + ERIG, Group 4: adult participants; Verorab + ERIG |
| Human rabies immunoglobulins (HRIG) (only Group 5 and Group 6)Also: IMOGAM® Rabies-HTPharmaceutical form: liquid/solution in 2 mL vials Route of administration: intramuscular | Biological | Group 5: adult participants; VRVG-2 + HRIG, Group 6: adult participants; Verorab + HRIG |
Primary outcome
Percentage of participants in Group 1, Group 2, Group 5 and Group 6 achieving rabies virus neutralizing antibody (RVNA) titer greater than or equal to (≥) 0.5 IU/mL
Time frame: Day 14 (post-vaccination)
RVNA titers will be measured by rapid fluorescent focus inhibition test (RFFIT)
Percentage of participants in Group 1, Group 2, Group 5 and Group 6 achieving RVNA titer greater than or equal to (≥) 0.5 IU/mL
Time frame: Day 42 (post-vaccination)
RVNA titers will be measured by RFFIT
Number of Participants in Group 1, Group 2, Group 5 and Group 6 achieving RVNA titer greater than or equal to (≥) lower limit of quantification
Time frame: Day 14 (post-vaccination)
RVNA titers will be measured by RFFIT Lower limit of quantification for RFFIT assay is 0.2 IU/mL
Number of Participants in Group 1, Group 2, Group 5 and Group 6 achieving RVNA titer greater than or equal to (≥) lower limit of quantification
Time frame: Day 42 (post-vaccination)
RVNA titers will be measured by RFFIT Lower limit of quantification for RFFIT assay is 0.2 IU/mL
Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination) in Group 1, Group 2, Group 5 and Group 6 Participants
Time frame: Day 14 (post-vaccination)
RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 14 RVNA ratios Day14/Day0 will be calculated
Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination) in Group 1, Group 2, Group 5 and Group 6 Participants
Time frame: Day 42 (post-vaccination)
RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 42 RVNA ratios Day42/Day0 will be calculated
12 secondary outcomes
Number of participants reporting immediate adverse events (AEs)
Time frame: Within 30 minutes post-vaccination
Percentage of participants reporting solicited injection site reactions
Time frame: Within 7 days post-vaccination
Percentage of participants reporting solicited systemic reactions
Time frame: Between Day 0 and Day 3, between Day 3 and Day 7, and during the 7 days following the remaining vaccinations
Number of participants reporting unsolicited injection site AEs
Time frame: Within 28 days post-vaccination
Number of participants reporting unsolicited systemic AEs
Time frame: Between each vaccination and up to 28 days after the last vaccination
Number of participants reporting serious adverse events (SAEs)
Time frame: Up to 6 months post-vaccination
Percentage of participants in Group 3 and Group 4 achieving rabies virus neutralizing antibody (RVNA) titer greater than or equal to (≥) 0.5 IU/mL
Time frame: Day 14 (post-vaccination)
Number of Participants in Group 3 and Group 4 achieving RVNA titer greater than or equal to (≥) lower limit of quantification
Time frame: Day 14 (post-vaccination)
Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination) in Group 3 and Group 4 Participants
Time frame: Day 14 (post-vaccination)
Percentage of participants in Group 1, Group 2, Group 5 and Group 6 achieving rabies virus neutralizing antibody (RVNA) titer greater than or equal to (≥) 0.5 IU/mL
Time frame: Day 90 (post-vaccination)
Number of Participants in Group 1, Group 2, Group 5 and Group 6 achieving RVNA titer greater than or equal to (≥) lower limit of quantification
Time frame: Day 90 (post-vaccination)
Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination) in Group 1, Group 2, Group 5 and Group 6 Participants
Time frame: Day 90 (post-vaccination)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- VRV09 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
3 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 Purified vero rabies vaccine - serum free VRVg-2, Purified inactivated rabies vaccine and Equine rabies immunoglobulins (ERIG) (only Group 3 and Group 4) in people with Rabies (Healthy Volunteers), run by Sanofi Pasteur, a Sanofi Company at 3 sites in Thailand.
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 4 inclusion and 20 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 19 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 3 sites in Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in Group 1, Group 2, Group 5 and Group 6 achieving rabies virus neutralizing antibody (RVNA) titer greater than or equal to (≥) 0.5 IU/mL (time frame: Day 14 (post-vaccination)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2025.