A Phase 3 interventional study of Purified vero rabies vaccine - serum free VRVg-2 and Purified inactivated rabies vaccine in Rabies (Healthy Volunteers), sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 3 sites in Thailand. Open to participants aged 1 Year and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by Sanofi Pasteur, a Sanofi Company (part of Sanofi) · Phase 3, Interventional, and Prevention
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:
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).
114 studies on the registry are indexed under Rabies; 15 are open to participants now.
This study's enrollment of 403 is above the median of 201 across 104 interventional studies indexed under Rabies.
Browse Rabies studies →Sanofi Pasteur, a Sanofi Company is the lead sponsor of 374 studies on the registry; 4 are open to participants now.
Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.
First submitted after Sanofi Pasteur became part of Sanofi.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Inclusion criteria :
The following criterion only applies to healthy adults ≥ 18 years:
- (BMI): 18.5 kg/m2 ≤ BMI ≤ 30 kg/m2
Exclusion Criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
VRVg-2 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28
Biological: Purified vero rabies vaccine - serum free VRVg-2
Verorab 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28
Biological: Purified inactivated rabies vaccine
VRVg-2 8 injections: 2 at Day 0, 2 at Day 3 and 2 at Day 7 \+ ERIG at D0
Biological: Purified vero rabies vaccine - serum free VRVg-2 · 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
Biological: Purified inactivated rabies vaccine · Biological: Equine rabies immunoglobulins (ERIG) (only Group 3 and Group 4)
VRVg-2 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28 \+ HRIG at D0
Biological: Purified vero rabies vaccine - serum free VRVg-2 · 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
Biological: Purified inactivated rabies vaccine · Biological: Human rabies immunoglobulins (HRIG) (only Group 5 and Group 6)
Pharmaceutical form:freeze-dried Route of administration: intradermal
Pharmaceutical form:freeze-dried Route of administration: intradermal
Also known as: Verorab®
Pharmaceutical form: liquid/solution in 5 mL vials Route of administration: intramuscular
Also known as: ERIG
Pharmaceutical form: liquid/solution in 2 mL vials Route of administration: intramuscular
Also known as: IMOGAM® Rabies-HT
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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 42 (post-vaccination)
Number of participants reporting immediate adverse events (AEs)
Includes unsolicited (spontaneously reported) systemic AEs
Time frame: 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)
Time frame: 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)
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
Unsolicited (spontaneously reported) injection site AEs
Time frame: Within 28 days post-vaccination
Number of participants reporting unsolicited systemic AEs
Unsolicited (spontaneously reported) systemic AEs
Time frame: 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)
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
RVNA titers will be measured by RFFIT
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
RVNA titers will be measured by RFFIT Lower limit of quantification for RFFIT assay is 0.2 IU/mL
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
RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 14 RVNA ratios Day14/Day0 will be calculated
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
RVNA titers will be measured by RFFIT
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
RVNA titers will be measured by RFFIT Lower limit of quantification for RFFIT assay is 0.2 IU/mL
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
RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 90 RVNA ratios Day90/Day0 will be calculated
Time frame: Day 90 (post-vaccination)
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sanofi Pasteur, a Sanofi Company →