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

Launched by SANOFI PASTEUR, A SANOFI COMPANY · Oct 14, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new rabies vaccine called Purified Vero Rabies Vaccine - Serum Free (VRVg-2) to see how it compares to two existing vaccines, Verorab and Imovax. The goal is to determine if VRVg-2 is just as effective in helping people build immunity to the rabies virus after receiving a series of three shots, especially in children and adults who have not been vaccinated against rabies before. Participants will be monitored to check if their body produces enough protective antibodies against rabies after these vaccinations.

To be eligible for this study, individuals need to be at least one year old and able to attend all scheduled visits. They must also have signed consent forms, and certain health conditions or previous vaccinations may prevent them from participating. Throughout the trial, participants can expect to receive vaccinations, blood tests to check their immune response, and regular follow-ups to ensure their safety. The trial is currently active but not recruiting new participants, and it aims to gather important information about the safety and effectiveness of the new vaccine.

Gender

ALL

Eligibility criteria

• 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 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 less than \[\<\]18 years) are able to attend all scheduled visits and to comply with all study procedures.
• Exclusion Criteria:
• • 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.
• • 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 (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
• • 1. Chronic illness may include, but is not limited to, neurological, cardiopulmonary, gastrointestinal, renal, genitourinary, metabolic, hematologic, auto-immune, or psychiatric disorders or infection