Last updated: February 7, 2024
Sponsor: Sanofi Pasteur, a Sanofi Company
Overall Status: Active - Not Recruiting
Phase
3
Condition
N/ATreatment
Purified vero rabies vaccine - serum free - VRVg-2
Purified inactivated rabies vaccine - Verorab®
Purified inactivated rabies vaccine - Imovax® Rabies
Clinical Study ID
NCT04127786
VRV12
U1111-1217-3241
2019-000973-22
Ages > 1 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Aged >=1 year on the day of inclusion
- Cohort 1 - pediatrics (>=1 to 17 years old) and adults (>=18 years old)
- Cohort 2 - all adults (>=18 years old)
- Informed consent form has been signed and dated by the participant and /or andparent(s) or legally acceptable representative (LAR) and by an independent witness (ifrequired by local regulations), as necessary; and assent form has been signed anddated by the participant, as required
- Participant (adult >=18 years) or participant and parent/LAR (1 year to less than [<]18 years) are able to attend all scheduled visits and to comply with all studyprocedures.
Exclusion
Exclusion Criteria:
- Participant is pregnant, or lactating, or of childbearing potential and not using aneffective method of contraception or abstinence from at least 4 weeks prior to thefirst vaccination until 1 month after each vaccination. To be considered ofnon-childbearing potential, a female must be pre-menarche or post-menopausal for atleast 1 year, or surgically sterile.
- Participation at the time of study enrollment or, planned participation during thepresent study period in another clinical study investigating a vaccine, drug, medicaldevice, or medical procedure.
- Receipt of any vaccine in the 4 weeks (28 days) preceding the first study vaccinationor planned receipt of any vaccine prior to Visit 5 for pediatric participants andadult participants in Cohort 1, and prior to Visit 4 for adult participants in Cohort
- Previous vaccination against rabies (in pre- or post-exposure regimen) with either thestudy vaccines or another vaccine.
- Bite by, or exposure to a potentially rabid animal in the previous 6 months with orwithout 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 ofimmunosuppressive 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, orhistory of a life-threatening reaction to the vaccines used in the study or to avaccine 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, mightinterfere with the study conduct or completion.
- Chronic illness(1) that, in the opinion of the Investigator, is at a stage where itmight interfere with study conduct or completion.
- Moderate or severe acute illness/infection (according to Investigator judgment) on theday of vaccination or febrile illness (temperature >=38.0°C). A prospectiveparticipant should not be included in the study until the condition has resolved orthe febrile event has subsided.
- Personal history of Guillain-Barré syndrome.
- Identified as an Investigator or employee of the Investigator or study center withdirect involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee withdirect 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
Study Design
Total Participants: 1708
Treatment Group(s): 3
Primary Treatment: Purified vero rabies vaccine - serum free - VRVg-2
Phase: 3
Study Start date:
October 21, 2019
Estimated Completion Date:
May 12, 2025
Study Description
Connect with a study center
Investigational Site Number :7640001
Bangkok, 10330
ThailandSite Not Available
Investigational Site Number :7640003
Bangkok, 10700
ThailandSite Not Available
Investigational Site Number :7640004
Bangkok, 10400
ThailandSite Not Available
Investigational Site Number :7640002
Khon Kaen, 40002
ThailandSite Not Available
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