Health Condition 1: null- Patients with Potential Rabies Exposure of Category II and Category III
Conditions
Interventions
Intervention1: SIIL Purified Vero Rabies Vaccine: 1 ml intramuscularly in the deltoid muscle on day 0, 3, 7, 14 and 28
Intervention2: SIIL Purified Vero Rabies Vaccine: 0.1 ml intradermal injection on
Sponsors
Serum Institute of India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients aged more than or equal to 5 years. 2.WHO Category II and III exposure(s) by a suspected rabid animal 3.Written informed consent by subjects (more than or equal to 18 years) / parents or legal guardian of subjects (5 - 17 years). 4.Written informed assent by subjects aged 13 - 17 years 5.Free of obvious health problems as established by medical history and clinical examination. 6.A woman of child bearing potential must agree not to become pregnant and a man must agree not to father a child, until the completion of the study period by using appropriate contraceptive methods.
Exclusion criteria
Exclusion criteria: 1.Previous receipt of rabies immune globulin and /or rabies vaccine. 2.Chronic administration of immunosuppressants or other immune-modifying agents within six months prior to administration of study medications. 3.Acute febrile illness or acute infectious disease. 4.Acute or chronic, clinically significant abnormality which in the opinion of the investigator might interfere with the study objectives. 5.Major congenital defects or serious chronic illness. 6.History of thrombocytopenia or known bleeding disorders. 7.History of a previous severe allergic reaction. 8.Pregnant and lactating women. 9.Receipt of other investigational study agent within previous 30 days or planned during the course of this study. 10.Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer participating in the study or making it unlikely the subject could complete the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Noninferiority of GMC Ratio Patients with each category II and III Exposure: Ratio of GMC of serum RVNATimepoint: Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| GMC of serum RVNA in subjects of all groupsTimepoint: Days 7, 14, 28, and 42;Incidence of solicited local and systemic reactions through day 42Timepoint: Day 42;Incidence of unsolicited adverse events and SAEs throughout the study period.Timepoint: Day 56;Percentage of subjects with RFFIT titres equal to or more than 0.5 IU/mlTimepoint: Day 7, 14, 28, and 42 | — |
Countries
India
Contacts
Public ContactDr Prasad Kulkarni
Serum Institute of India Ltd. Pune (India)
Outcome results
None listed