RabiesPhase 3VRV12NCT04127786
Study of Purified Vero Rabies Vaccine Compared With Two Reference Rabies Vaccines, Given in a Pre-exposure Regimen to Children and Adults and as Single Booster Dose to a Subset of Adults
A Phase 3 study testing Purified vero rabies vaccine - serum free - VRVg-2, Purified inactivated rabies vaccine - Verorab® and Purified inactivated rabies vaccine - Imovax® Rabies in people with Rabies and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 4 sites in Thailand.
Trial summary
The primary objective of this study is: To demonstrate the VRVg-2 is non-inferior to Verorab and Imovax Rabies vaccines in each age group (pediatric and adult populations) when administered as a 3-dose PrEP regimen, in terms of proportion of participants achieving a rabies virus neutralizing antibody (RVNA) titer ≥… 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 - Verorab® and Purified inactivated rabies vaccine - Imovax® Rabies
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,708 participants
- Where
- 4 sitesThailand
- Study dates
- 21 Oct 2019to 24 Apr 2025
- 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 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
- Cohort 1 - pediatrics (>1 to 17 years old) and adult (≥18 years old)
- Cohort 2 - all adults (≥18 years old)
- Informed consent form has been signed and dated by the participant and /or and parent(s) or legally acceptable representative (LAR) and by an independent witness (if required by local regulations), as necessary; and assent form has been signed and dated by the participant, as required
- Participant (adult ≥18 years) or participant and parent/LAR (1 year to <18 years) are able to attend all scheduled visits and to comply with all study procedures.
Who cannot join
- Participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until 1 month after each vaccination. To be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, or surgically sterile.
- Participation at the time of study enrollment or, planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
- Receipt of any vaccine in the 4 weeks (28 days) preceding the first study vaccination or planned receipt of any vaccine prior to Visit 5 for pediatric participants and adult participants in Cohort 1, and prior to Visit 4 for adult participants in Cohort 2.
- Previous vaccination against rabies (in pre- or post-exposure regimen) with either the study vaccines or another vaccine.
- Bite by, or exposure to a potentially rabid animal in the previous 6 months with or without post-exposure prophylaxis.
- Receipt of immune globulins, blood or blood-derived products in the past 3 months.
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- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
- At high risk for rabies exposure during the study.
- Known systemic hypersensitivity to any of the study/control vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances.
- Self-reported thrombocytopenia, contraindicating intramuscular vaccination.
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
- Current alcohol or substance abuse that, in the opinion of the investigator, might interfere with the study conduct or completion.
- Chronic illness(1) that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion.
- Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
- Personal history of Guillain-Barré syndrome.
- Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
- Chronic illness may include, but is not limited to, neurological, cardiopulmonary, gastrointestinal, renal, genitourinary, metabolic, hematologic, auto-immune, or psychiatric disorders or infection
Trial locations and contacts
4 sites in 1 country.
Thailand4 sites
Investigational Site Number : 7640001
Bangkok, 10330
Investigational Site Number : 7640004
Bangkok, 10400
Investigational Site Number : 7640003
Bangkok, 10700
Investigational Site Number : 7640002
Khon Kaen, 40002
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 Pre-exposure Regimen in Both Pediatric and Adult Populations and a Single Booster Dose of Purified Vero Rabies Vaccine - Serum Free Administered at 1 Year Post-3-dose Primary Series, and Between 2 up to 3 Years Post-One Week 2-Dose Primary Series in a Subset of Adults in Thailand
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).
Read more
The secondary objectives of this study are: First 1-5 with hypotheses testing will be evaluated sequentially - only if the previous objective is achieved, will the next objective be tested
To demonstrate that:
- the observed proportion of participants in the VRVg2(VRVg) group at D42 is at least 99% with a lower limit of the 95% confidence interval (CI) of at least 97%
- VRVg is non inferior (NI) to Verorab and Imovax Rabies vaccines (Imovax) in each age group at D28
- 2-dose VRVg at D28 is NI to 3-dose Imovax at D42 in each age group
- the observed proportion of participants in the VRVg group at D28 is at least 99% with a lower limit of the 95% CI of at least 97%
- 2-dose Imovax at D28 is NI to 3-dose Imovax at D42 in overall participants (Cohort1)
To describe:
- the immune response induced by VRVg versus Verorab and Imovax at D28 and at D42 in all age groups
- the immune response induced by VRVg at D14 after a booster dose of VRVg administered at M12 (Cohort1) and between M24 up to M36 (Cohort2)
- the persistence of immune response at M6,12,18, and pre-booster between M24 up to M36 post-primary series vaccination (Cohort2)
- safety profile of VRVg versus Verorab and Imovax in primary series and after a booster dose of VRVg
Read the detailed description
The duration of each participant's participation in the primary series Cohort 1 of the study will be approximately 7 months (28 day-vaccination period followed by 6-month safety follow-up period). For the subset of adult participants in Booster Phase Cohort 1 who received a single booster dose of VRVg-2 (1 booster dose 365 days after primary series followed by 6-month safety follow-up period), the duration will be approximately 18 months.
For Primary Series Cohort 2, the duration of each participant's participation in the study will be approximately 7 months (one week vaccination period followed by 6-month safety follow-up period).
For the subset of adult participants in Immunogenicity Persistence and Booster Phase Cohort 2 who will be followed-up for evaluation of immunogenicity persistence after primary series (including blood samples collection at M6, M12, M18, and between 24 up to 36 months) and who will receive a single booster dose of VRVg-2 (after the blood sample collection between 24 up to 36 months), the duration will be approximately 30 to 42 months.
- Conditions
- Rabies, Healthy Volunteers
- Being tested
- Purified vero rabies vaccine - serum free - VRVg-2, Purified inactivated rabies vaccine - Verorab®, Purified inactivated rabies vaccine - Imovax® Rabies
- 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: Intramuscular
Purified inactivated rabies vaccine - Verorab®Biological
Pharmaceutical form:Freeze-dried Route of administration: Intramuscular
Purified inactivated rabies vaccine - Imovax® RabiesBiological
Pharmaceutical form: Freeze-dried Route of administration: Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Group1:VRVg2 Cohort1(C1)-1ry Series:pediatric&adult participants-Booster:102 adult participants | Experimental | 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 Receives: Biological: Purified vero rabies vaccine - serum free - VRVg-2 |
| Group 2:Verorab C1-1ry Series:pediatric&adult participants-Booster Phase:34 adult participants | Active comparator | 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 Receives: Biological: Purified vero rabies vaccine - serum free - VRVg-2; Biological: Purified inactivated rabies vaccine - Verorab® |
| Group 3:Imovax Rabies C1-1ry Series:pediatric&adult participants-Booster Phase:34 adult participants | Active comparator | 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 Receives: Biological: Purified vero rabies vaccine - serum free - VRVg-2; Biological: Purified inactivated rabies vaccine - Imovax® Rabies |
| Group 4:VRVg-2 Cohort 2(C2)-1ry Series:Adult participants-Booster Phase:138 adult participants | Experimental | 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 Receives: Biological: Purified vero rabies vaccine - serum free - VRVg-2 |
| Group 5:Verorab C2-1ry Series:adult participants-Booster Phase:46 adult participants | Active comparator | 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 Receives: Biological: Purified vero rabies vaccine - serum free - VRVg-2; Biological: Purified inactivated rabies vaccine - Verorab® |
| Group 6:Imovax Rabies C2-1ry Series:adult participants-Booster Phase:46 adult participants | Active comparator | 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 Receives: Biological: Purified vero rabies vaccine - serum free - VRVg-2; Biological: Purified inactivated rabies vaccine - Imovax® Rabies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 42 (post-vaccination)
Secondary outcomes (34)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 42)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start21 Oct 2019
- Primary completion25 Mar 2020
- Study completion24 Apr 2025
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 RabiesStudies 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
- Primary series will be observer-blinded for both Cohort 1 (3-dose pre-exposure prophylaxis \[PrEP\] regimen) and Cohort 2 (one week 2-dose PrEP regimen). Booster phase will be conducted in a blinded manner (vaccine received in the primary series) with an adult subset from Cohort 1 and hereafter referred as "Booster Phase Cohort 1" (with booster dose 1 year after the 1st primary series vaccine injection). Evaluation of immunogenicity persistence after primary series and a booster phase will be conducted in an open label manner with an adult subset from Cohort 2 and hereafter referred as "Immunogenicity Persistence and Booster Phase Cohort 2" (including blood samples collection at Month 6, Month 12, Month 18, pre-booster between Month 24 up to Month 36, and post-booster between Month 24 up to Month 36+Day 14; and a booster dose between Month 24 up to Month 36).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,708 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
- NCT04127786
- Sponsor's protocol ID
- VRV12
- Other IDs
- U1111-1217-3241, VRV12, 2019-000973-22, 2019
- Acronym
- VRV12
- Status last verified
- Feb 2026
- First submitted
- 11 Oct 2019
- Last updated
- 10 Feb 2026
- 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://www.clinicalstudydatarequest.com/
Publications
Chokephaibulkit K, Huoi C, Tantawichien T, Mootsikapun P, Kosalaraksa P, Kiertiburanakul S, Ratanasuwan W, Vangelisti M, Laot T, Huang Y, Petit C, Pineda-Pena AC, Frago C. Noninferiority Study of Purified Vero Rabies Vaccine-Serum Free in 3-dose and 2-dose Preexposure Prophylaxis Regimens in Comparison With Licensed Rabies Vaccines. Clin Infect Dis. 2025 Oct 6;81(3):654-666. doi: 10.1093/cid/ciae581.
PubMed 39587931
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. 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 Pre-exposure Regimen in Both Pediatric and Adult Populations and a Single Booster Dose of Purified Vero Rabies Vaccine - Serum Free Administered at 1 Year Post-3-dose Primary Series, and Between 2 up to 3 Years Post-One Week 2-Dose Primary Series in a Subset of Adults in Thailand
- ClinicalTrials.gov ID
- NCT04127786
- Acronym / sponsor ID
- VRV12 / VRV12
- Conditions
- Rabies, Healthy Volunteers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,708 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 25 Mar 2020 (actual)
- Study completion
- 24 Apr 2025 (actual)
- First posted
- 16 Oct 2019 (actual)
- Results
- Posted 9 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is:
To demonstrate the VRVg-2 is non-inferior to Verorab and Imovax Rabies vaccines in each age group (pediatric and adult populations) when administered as a 3-dose PrEP regimen, in terms of proportion of participants achieving a rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 IU/mL at Day 42, ie. 14 days after the 3rd injection (for Primary Series Cohort 1).
The secondary objectives of this study are: First 1-5 with hypotheses testing will be evaluated sequentially - only if the previous objective is achieved, will the next objective be tested
To demonstrate that:
- the observed proportion of participants in the VRVg2(VRVg) group at D42 is at least 99% with a lower limit of the 95% confidence interval (CI) of at least 97%
- VRVg is non inferior (NI) to Verorab and Imovax Rabies vaccines (Imovax) in each age group at D28
- 2-dose VRVg at D28 is NI to 3-dose Imovax at D42 in each age group
- the observed proportion of participants in the VRVg group at D28 is at least 99% with a lower limit of the 95% CI of at least 97%
- 2-dose Imovax at D28 is NI to 3-dose Imovax at D42 in overall participants (Cohort1)
To describe:
- the immune response induced by VRVg versus Verorab and Imovax at D28 and at D42 in all age groups
- the immune response induced by VRVg at D14 after a booster dose of VRVg administered at M12 (Cohort1) and between M24 up to M36 (Cohort2)
- the persistence of immune response at M6,12,18, and pre-booster between M24 up to M36 post-primary series vaccination (Cohort2)
- safety profile of VRVg versus Verorab and Imovax in primary series and after a booster dose of VRVg
Detailed description
The duration of each participant's participation in the primary series Cohort 1 of the study will be approximately 7 months (28 day-vaccination period followed by 6-month safety follow-up period). For the subset of adult participants in Booster Phase Cohort 1 who received a single booster dose of VRVg-2 (1 booster dose 365 days after primary series followed by 6-month safety follow-up period), the duration will be approximately 18 months.
For Primary Series Cohort 2, the duration of each participant's participation in the study will be approximately 7 months (one week vaccination period followed by 6-month safety follow-up period).
For the subset of adult participants in Immunogenicity Persistence and Booster Phase Cohort 2 who will be followed-up for evaluation of immunogenicity persistence after primary series (including blood samples collection at M6, M12, M18, and between 24 up to 36 months) and who will receive a single booster dose of VRVg-2 (after the blood sample collection between 24 up to 36 months), the duration will be approximately 30 to 42 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Primary series will be observer-blinded for both Cohort 1 (3-dose pre-exposure prophylaxis [PrEP] regimen) and Cohort 2 (one week 2-dose PrEP regimen). Booster phase will be conducted in a blinded manner (vaccine received in the primary series) with an adult subset from Cohort 1 and hereafter referred as "Booster Phase Cohort 1" (with booster dose 1 year after the 1st primary series vaccine injection). Evaluation of immunogenicity persistence after primary series and a booster phase will be conducted in an open label manner with an adult subset from Cohort 2 and hereafter referred as "Immunogenicity Persistence and Booster Phase Cohort 2" (including blood samples collection at Month 6, Month 12, Month 18, pre-booster between Month 24 up to Month 36, and post-booster between Month 24 up to Month 36+Day 14; and a booster dose between Month 24 up to Month 36).
| Arm | Type | Receives |
|---|---|---|
| Group1:VRVg2 Cohort1(C1)-1ry Series:pediatric&adult participants-Booster:102 adult participants | Experimental | Biological: Purified vero rabies vaccine - serum free - VRVg-2VRVg-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 |
| Group 2:Verorab C1-1ry Series:pediatric&adult participants-Booster Phase:34 adult participants | Active comparator | Biological: Purified vero rabies vaccine - serum free - VRVg-2, Biological: Purified inactivated rabies vaccine - Verorab®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 |
| Group 3:Imovax Rabies C1-1ry Series:pediatric&adult participants-Booster Phase:34 adult participants | Active comparator | Biological: Purified vero rabies vaccine - serum free - VRVg-2, Biological: Purified inactivated rabies vaccine - Imovax® RabiesImovax 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 |
| Group 4:VRVg-2 Cohort 2(C2)-1ry Series:Adult participants-Booster Phase:138 adult participants | Experimental | Biological: Purified vero rabies vaccine - serum free - VRVg-2VRVg-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 |
| Group 5:Verorab C2-1ry Series:adult participants-Booster Phase:46 adult participants | Active comparator | Biological: Purified vero rabies vaccine - serum free - VRVg-2, Biological: Purified inactivated rabies vaccine - Verorab®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 |
| Group 6:Imovax Rabies C2-1ry Series:adult participants-Booster Phase:46 adult participants | Active comparator | Biological: Purified vero rabies vaccine - serum free - VRVg-2, Biological: Purified inactivated rabies vaccine - Imovax® RabiesImovax 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 |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Aged ≥1 year on the day of inclusion
- Informed consent form has been signed and dated by the participant and /or and parent(s) or legally acceptable representative (LAR) and by an independent witness (if required by local regulations), as necessary; and assent form has been signed and dated by the participant, as required
- Participant (adult ≥18 years) or participant and parent/LAR (1 year to <18 years) are able to attend all scheduled visits and to comply with all study procedures.
Key exclusion criteria (18 listed)
- Participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until 1 month after each vaccination. To be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, or surgically sterile.
- Participation at the time of study enrollment or, planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
- Receipt of any vaccine in the 4 weeks (28 days) preceding the first study vaccination or planned receipt of any vaccine prior to Visit 5 for pediatric participants and adult participants in Cohort 1, and prior to Visit 4 for adult participants in Cohort 2.
- Previous vaccination against rabies (in pre- or post-exposure regimen) with either the study vaccines or another vaccine.
- Bite by, or exposure to a potentially rabid animal in the previous 6 months with or without post-exposure prophylaxis.
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: Intramuscular | Biological | Group 2:Verorab C1-1ry Series:pediatric&adult participants-Booster Phase:34 adult participants, Group 3:Imovax Rabies C1-1ry Series:pediatric&adult participants-Booster Phase:34 adult participants, Group 4:VRVg-2 Cohort 2(C2)-1ry Series:Adult participants-Booster Phase:138 adult participants, Group 5:Verorab C2-1ry Series:adult participants-Booster Phase:46 adult participants, Group 6:Imovax Rabies C2-1ry Series:adult participants-Booster Phase:46 adult participants, Group1:VRVg2 Cohort1(C1)-1ry Series:pediatric&adult participants-Booster:102 adult participants |
| Purified inactivated rabies vaccine - Verorab®Pharmaceutical form:Freeze-dried Route of administration: Intramuscular | Biological | Group 2:Verorab C1-1ry Series:pediatric&adult participants-Booster Phase:34 adult participants, Group 5:Verorab C2-1ry Series:adult participants-Booster Phase:46 adult participants |
| Purified inactivated rabies vaccine - Imovax® RabiesPharmaceutical form: Freeze-dried Route of administration: Intramuscular | Biological | Group 3:Imovax Rabies C1-1ry Series:pediatric&adult participants-Booster Phase:34 adult participants, Group 6:Imovax Rabies C2-1ry Series:adult participants-Booster Phase:46 adult participants |
Primary outcome
Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody (RVNA) Titer Greater Than or Equal to (>=) 0.5 IU/mL
Time frame: Day 42 (post-vaccination)
RVNA titer against rabies virus was assessed using the Rapid Fluorescent Focus Inhibition test (RFFIT) assay method.
34 secondary outcomes
Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL
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
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
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
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
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
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
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
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])
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])
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
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
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
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
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
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
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)
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
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
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
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
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])
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
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
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)
Time frame: Within 30 minutes after any vaccination
Booster Phase Cohort 2: Number of Participants With Immediate Unsolicited Adverse Events (AEs)
Time frame: Within 30 minutes after any vaccination
Number of Participants With Systemic Reactions
Time frame: Within 7 Days after any vaccination
Booster Phase Cohort 2: Number of Participants With Systemic Reactions
Time frame: Within 7 Days after any vaccination
Number of Participants With Solicited Injection Site Reactions
Time frame: Within 7 Days after any vaccination
Booster Phase Cohort 2: Number of Participants With Solicited Injection Site Reactions
Time frame: Within 7 Days after any vaccination
Number of Participants With Unsolicited Adverse Events
Time frame: Within 28 Days after any vaccination
Booster Phase Cohort 2: Number of Participants With Unsolicited Adverse Events
Time frame: Within 28 Days after any vaccination
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 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)
Time frame: From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 42)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39587931Chokephaibulkit K, Huoi C, Tantawichien T, Mootsikapun P, Kosalaraksa P, Kiertiburanakul S, Ratanasuwan W, Vangelisti M, Laot T, Huang Y, Petit C, Pineda-Pena AC, Frago C. Noninferiority Study of Purified Vero Rabies Vaccine-Serum Free in 3-dose and 2-dose Preexposure Prophylaxis Regimens in Comparison With Licensed Rabies Vaccines. Clin Infect Dis. 2025 Oct 6;81(3):654-666. doi: 10.1093/cid/ciae581.
- VRV12 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://www.clinicalstudydatarequest.com/
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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
4 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 - Verorab® and Purified inactivated rabies vaccine - Imovax® Rabies in people with Rabies and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 4 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 5 inclusion and 18 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 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Yes. Results are posted in the registry (first posted 9 Feb 2024). 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?
Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody (RVNA) Titer Greater Than or Equal to (>=) 0.5 IU/mL (time frame: Day 42 (post-vaccination)). 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 NCT04127786, 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 10 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.