Comparison of Purified Vero Rabies Vaccine, Serum Free With Human Diploid Cell Vaccine in Pre-exposure Use

The vaccination will be given in three injections, at Day 0, Day 7, and Day 28, respectively,
based on the Advisory Committee on Immunization Practice (ACIP) and the World Health
Organization (WHO) recommendations for pre-exposure regimen. A booster dose will be
administered 1 year after the first vaccine injection in a randomized subset of participants.

Safety will be assessed in all participants up to 28 days after vaccination, as applicable,
in terms of occurrence of adverse events (AEs), and serious adverse events (SAEs) and adverse
events of special interest (AESIs) up to Month 12.

Inclusion Criteria:

- Aged 18 to < 65 years on the day of inclusion

- Informed consent form has been signed and dated

- Able to attend all scheduled visits and comply with all trial procedures.

Exclusion Criteria:

- Subject is pregnant, or lactating, or of childbearing potential (to be considered of
non-childbearing potential, a female must be post-menopausal for at least 1 year,
surgically sterile, or using an effective method of contraception or abstinence from
at least 4 weeks prior to the first vaccination and until at least 4 weeks after last
vaccination)

- Participation at the time of study enrollment (or in the 4 weeks preceding the first
trial vaccination)or planned participation during the present trial period in another
clinical trial investigating a vaccine, drug, medical device, or medical procedure

- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned
receipt of any vaccine in the 4 weeks following any trial vaccination

- Previous vaccination against rabies (in pre- or post-exposure regimen) with either the
trial vaccine or another vaccine

- 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)

- Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or
Hepatitis C

- At high risk for rabies exposure during the trial

- Known systemic hypersensitivity to any of the vaccine components, or history of a
life-threatening reaction to a vaccine containing any of the same substances as the
vaccines used in the study

- Self-reported thrombocytopenia, contraindicating intra muscular (IM) vaccination

- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
contraindicating IM vaccination

- Deprived of freedom by an administrative or court order, or in an emergency setting,
or hospitalized involuntarily

- Current alcohol abuse or drug addiction that might interfere with the ability to
comply with trial procedures

- Chronic illness that, in the opinion of the investigator, is at a stage where it might
interfere with trial conduct or completion

- Moderate or severe acute illness/infection (according to investigator judgment) on the
day of vaccination or febrile illness (temperature ≥ 100.4°F). A prospective subject
should not be included in the study until the condition has resolved or the febrile
event has subsided

- 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

- History of Guillain-Barré Syndrome.