Health Condition 1: Z291- Encounter for prophylactic immunotherapy
Conditions
Interventions
Intervention1: TwinRab(Combination two Monoclonal Antibodies): We are checking the safety of these Two monoclonal Antibodies and there are no comparator agents in the study
Intervention2: TwinRab: Dos
Sponsors
Zydus Lifesciences Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients who fall under WHO Category III exposure(s) by a suspected rabid animal 2.Subjects (=18 years), who are able to provide written informed consent and willing to comply with the study procedure, will be invited to participate in the study. 3.Subjects (=2 years), whose parents/guardians are willing to provide an Assent form along with Legally Authorized Representative (LAR) form and willing to comply with the study procedure, will be invited to participate in the study.
Exclusion criteria
Exclusion criteria: 1.Subjects who will be previously a receipt of complete PEP or pre-exposure prophylaxis with modern rabies vaccine. 2.Subjects with Acute or chronic, clinically significant pulmonary, endocrine, autoimmune, psychiatric, cardiovascular, hepatic, or renal functional abnormality, as determined by medical history and physical examination, which in the opinion of the investigator might interfere with the study objectives. 3.Subject with major congenital defects or serious chronic illness. 4.Subject with a history of thrombocytopenia or known bleeding disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point of this study is to evaluate all Adverse events (AEs) through 7 days after the last dose of the POST EXPOSURE PROPHYLAXIS(PEP)regimenTimepoint: 7 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| The Secondary end point of this study is to evaluate all Adverse events (AEs) at the end of 35 days after the last dose of the PEP regimenTimepoint: 35 DAYS | — |
Countries
India
Contacts
Public ContactDr Trayambak Dutta
Zydus Vaxxicare
Outcome results
None listed