View clinical trials related to Rabies.
Filter by: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.
The aim of the study is to document the safety and immunogenicity of Purified Vero Rabies Vaccine (VRVg) when given in a simulated post-exposure regimen, i.e. with co-administration of human rabies immunoglobulins (Imovax® Rabies). 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 Day 14. - To demonstrate that the observed proportion of subjects achieving an RVNA titer ≥ 0.5 IU/mL at Day 14 is at least 99%, with a lower limit of the 95% confidence interval (CI) of at least 97%. Secondary Objectives: - To assess the clinical safety of each vaccine after each vaccine injection when administered in a simulated post-exposure schedule. - To describe the geometric mean titer ratio (GMTR) between the 2 vaccine groups at Day 14.
The objective of this study was to achieve the post-marketing protective effect research of Speeda® rabies vaccine for human use from Chengda Bio.
The objective of this study was to achieve the post-marketing safety and immunogenicity research of Speeda® rabies vaccine for human use from Chengda Bio
The aim of this study is to generate data on immunogenicity and safety of Purified Vero Rabies Vaccine - Serum Free (VRVg) in comparison with Imovax® Rabies in order to support the registration of VRVg in the USA. Primary Objectives: - To demonstrate that VRVg is non inferior to Imovax® Rabies in terms of proportion of subjects achieving an rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 IU/mL at Day 42. - To demonstrate that the observed proportion of subjects achieving an RVNA titer ≥ 0.5 IU/mL at Day 42 is at least 99%, with a 95% lower confidence limit of at least 97%. Secondary Objectives: - To assess the clinical safety of VRVg each vaccine after each vaccine injection when administered in a pre-exposure schedule. - To describe the immune response induced by each vaccine 21 days after two vaccinations (Day 28) in a randomized subset of subjects and 14 days after the last vaccination of the primary vaccination series. - To describe antibody persistence at 6 and 12 months after the first vaccination in all subjects, and at 18 and 24 months in a subset of subjects.
This study was designed to evaluate the safety and immunogenicity of two simulated postexposure rabies vaccination schedules (Zagreb 2-1-1 and Essen 1-1-1-1-1) in Chinese children and older adults.
Establish non-inferiority of the immune response and evaluate the safety and tolerability of Rabies and Japanese Encephalitis (JE) vaccines given concomitantly or alone and according to either of 2 schedules for preexposure prophylaxis.
Reduced 4-dose intramuscular rabies vaccination schedule was announced by US-ACIP and WHO to be one of the post-exposure prophylaxis regimens. However, concurrent usage of this regimen with rabies immunoglobulin have never been studied in the aspect that the immunity level would above the protective level required by WHO (0.5 IU/ml) for at least a year period. This study would access this subject.
The purpose of this study is to assess the 4-site "one-week" post-exposure prophylaxis (PEP) regimen as a possible alternative to the 2-site updated Thai Red Cross (TRC) PEP regimen. Primary objective: - To demonstrate that PEP using the new "one-week, 4-site" (4-4-4-0-0) intradermal (ID) vaccination regimen is non-inferior to PEP using the updated TRC (2-2-2-0-2) ID vaccination regimen. Secondary objectives: - Primary immunization: To describe the immune response in each group at Day 0, Day 14 and Day 90. - Antibody persistence: To describe rabies virus-neutralizing antibody persistence during the 5 years after completion of PEP in each group. - Booster vaccination: To describe the immune response induced by a single-visit 4-site intradermal booster vaccination in each group at Year 5. - Safety: To describe the safety profile of each group after the primary and booster vaccinations.
Dosage of rabies immune globulin was calculated from the victim's body weight, then the amount of rabies immune globulin would be injected as much as possible to all of the wounds. Increase dosage of rabies immune globulin was needed in situation of multiple severe bite-wounds especially among children whose had lower body weight than adults. Our study would be conducted in order to determine whether the increase dosage of rabies immune globulin would interfere with the protective antibody levels against rabies.