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
NCT ID: NCT04478084
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
403 participants
INTERVENTIONAL
2020-08-04
2022-07-21
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Group 1: pediatric participants; VRVg-2
VRVg-2 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28
Purified vero rabies vaccine - serum free VRVg-2
Pharmaceutical form:freeze-dried Route of administration: intradermal
Group 2: pediatric participants; Verorab
Verorab 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28
Purified inactivated rabies vaccine
Pharmaceutical form:freeze-dried Route of administration: intradermal
Group 3: adult participants; VRVG-2 + ERIG
VRVg-2 8 injections: 2 at Day 0, 2 at Day 3 and 2 at Day 7
\+ ERIG at D0
Purified vero rabies vaccine - serum free VRVg-2
Pharmaceutical form:freeze-dried Route of administration: intradermal
Equine rabies immunoglobulins (ERIG) (only Group 3 and Group 4)
Pharmaceutical form: liquid/solution in 5 mL vials Route of administration: intramuscular
Group 4: adult participants; Verorab + ERIG
Verorab 8 injections: 2 at Day 0, 2 at Day 3 and 2 at Day 7
\+ ERIG at D0
Purified inactivated rabies vaccine
Pharmaceutical form:freeze-dried Route of administration: intradermal
Equine rabies immunoglobulins (ERIG) (only Group 3 and Group 4)
Pharmaceutical form: liquid/solution in 5 mL vials Route of administration: intramuscular
Group 5: adult participants; VRVG-2 + HRIG
VRVg-2 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28
\+ HRIG at D0
Purified vero rabies vaccine - serum free VRVg-2
Pharmaceutical form:freeze-dried Route of administration: intradermal
Human rabies immunoglobulins (HRIG) (only Group 5 and Group 6)
Pharmaceutical form: liquid/solution in 2 mL vials Route of administration: intramuscular
Group 6: adult participants; Verorab + HRIG
Verorab 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28
\+ HRIG at D0
Purified inactivated rabies vaccine
Pharmaceutical form:freeze-dried Route of administration: intradermal
Human rabies immunoglobulins (HRIG) (only Group 5 and Group 6)
Pharmaceutical form: liquid/solution in 2 mL vials Route of administration: intramuscular
Interventions
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Purified vero rabies vaccine - serum free VRVg-2
Pharmaceutical form:freeze-dried Route of administration: intradermal
Purified inactivated rabies vaccine
Pharmaceutical form:freeze-dried Route of administration: intradermal
Equine rabies immunoglobulins (ERIG) (only Group 3 and Group 4)
Pharmaceutical form: liquid/solution in 5 mL vials Route of administration: intramuscular
Human rabies immunoglobulins (HRIG) (only Group 5 and Group 6)
Pharmaceutical form: liquid/solution in 2 mL vials Route of administration: intramuscular
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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.
1 Year
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi Pasteur, a Sanofi Company
Locations
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Investigational Site Number :7640004
Bangkok, , Thailand
Investigational Site Number :7640002
Bangkok, , Thailand
Investigational Site Number :7640003
Khon Kaen, , Thailand
Countries
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Related Links
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VRV09 Plain Language Results Summary
Other Identifiers
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U1111-1227-4143
Identifier Type: REGISTRY
Identifier Source: secondary_id
VRV09
Identifier Type: -
Identifier Source: org_study_id
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