None listed
Conditions
Interventions
Intervention1: Rabies vaccine: Frequency:-Single dose of Vaccine
Part 1: Intramuscular injection 1mL
Part 2 : Intradermal injection 0.2 mL (0.1 ml in each arm)
Control Intervention1: Not Applicable:
Sponsors
Zydus Lifesciences Ltd Formerly Cadila Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and non-pregnant, non-lactating female subjects aged between 18 and 55 years (both inclusive). 2. Body weight > 50 kg for male and >45 kg for female and BMI within the range 18.5 - 30.0 kg/m2 (Both inclusive). 3. Ability to communicate effectively with study personnel. 4. Willingness to adhere to the protocol requirements. 5. Be able to give consent for participation in the trial. 6. Normal health as determined by personal medical/surgical history, physical examination, ECG and laboratory assessment data during screening (within the clinically acceptable range). 7.Male subjects and female subjects of childbearing potential must agree to use effective contraception during the study.
Exclusion criteria
Exclusion criteria: 1.History of anaphylaxis or serious reactions to any vaccines. 2. Allergic to sucrose, human albumin, maltose and dextran. 3. Subjects who are taking immunostimulant therapy (e.g. interferons) or immunosuppressant medications (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.). 4. Subjects who are known to be suffering from diseases which can affect immune competence e.g. diabetes, immunodeficiency disorders or known to be HIV positive. 5. Subjects who have received immunoglobulins parenterally during the preceding 3 months. 6. Subjects who have received any type of rabies vaccine in last one year. 7. Subjects who have received any vaccine in preceding one month of dosing and who are planning to take vaccine during study period. 8. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease, gynaecological or any other body system involvement which interferes with safety assessment as per investigator discretion. 9. History or presence of alcoholism or drug abuse within the past one-year. 10. History or presence of significant smoking (more than 10 cigarettes per day) 11. Blood pressure less than 100/60 (Systolic/diastolic) mm Hg or more than 140/90 (Systolic/diastolic) mm Hg. 12. Pulse less than 60/minute or more than 100/minute. 13.History of fever or any other infection in last 2 weeks of enrollment 14. Any clinically significant ECG abnormalities at screening. 15. Any clinically significant abnormal laboratory values during screening. 16. Subjects who have participated in clinical research studies within past 3 months. 17. A positive urine drugs of abuse test or positive alcohol test at check-in. 18. For female subjects, positive serum �²-hCG level or urine pregnancy test at the screening or check-in visit. 19. Female subjects with history of pregnancy or lactation in the past 3 months. 20. Female subjects with history of less than 1 year of menopause and not using adequate anti-fertility measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence, severity and relationship to rabies vaccineTimepoint: Day 0 to Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with clinically significant changes in laboratory safety tests (hematology, biochemistry and urinalysis),Timepoint: Day 0 to Day 28;Proportion of subjects with clinically significant changes in vital signs (systolic blood pressure, body temperature, diastolic blood pressure and pulse rate)Timepoint: Day 0 to Day 28 | — |
Countries
India
Contacts
Public ContactDr Gaurav Jansari MD Pharmacology
Zydus lifesciences Ltd (Formerly Cadila Healthcare Ltd.)
Outcome results
None listed