Purified Vero Rabies Vaccine-Serum Free Compared to Human Diploid Cell Vaccine in a Pre-exposure Prophylaxis Regimen

Sanofi

Status and phase

Completed

Phase 2

Conditions

Rabies

Treatments

Biological: Purified Vero Rabies Vaccine Serum Free (VRVg)

Biological: Imovax® Rabies: Human Diploid Cell Vaccine (HDCV),

Study type

Interventional

Funder types

Industry

Identifiers

NCT01930357

U1111-1127-7340 (Other Identifier)

VRV06

PHRR130822-000107 (Registry Identifier)

Details and patient eligibility

About

The aim of the study is to document immunogenicity and safety of VRVg in a pre-exposure regimen in healthy children and adolescents aged 2 to 17 years.

Primary Objectives:

To demonstrate that VRVg is non-inferior to Imovax® Rabies in terms of proportion of subjects achieving a rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 international units (IU)/mL at D42, i.e. 14 days after the last vaccination.
To describe if at least 99% of subjects achieve an RVNA titer ≥ 0.5 IU/mL at D42 with a lower bound of the 95% confidence interval (CI) of at least 97%, in the VRVg group.

Secondary Objectives:

To assess the clinical safety of each vaccine after each vaccine injection when administered in a pre-exposure schedule.
To describe the immune response induced by each vaccine 14 days after the last vaccination, i.e. at D42, and 6 months after the first vaccination
To describe the geometric mean titer ratio between the two vaccine groups at D42, i.e. 14 days after the last vaccination.

Full description

Participants will receive a total of three vaccinations, one each at Day 0, Day 7, and Day 28, respectively, and will be assessment for immune response to rabies vaccine before the first injection (baseline titer), at Day 42, and at Month 6.

Safety will be assessed in all participants up to 28 days after each injection. Serious adverse events and adverse events of special interest (AESIs) will be collected up to 6 months after the last injection.

Enrollment

342 patients

Sex

All

Ages

2 to 17 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Aged 2 to 17 years on the day of inclusion
Informed consent form has been signed and dated by the parent(s) (and subject, if applicable by local regulations), or another legally acceptable representative and by an independent witness, as applicable, and the assent form has been signed and dated by the subject (if applicable by the local Ethics Committee or country regulations)
Subject and parent/legally acceptable representative are able to attend all scheduled visits and to 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 pre-menarche, 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 the 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
Any previous vaccination against rabies (in pre- or post-exposure regimen) with either the trial vaccine or another vaccine
Bite by 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)
Self-reported seropositivity for Human Immunodeficiency Virus (HIV)
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
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 abuse or drug addiction
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 ≥ 38.0°C). 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., spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
History of Guillain-Barré syndrome.