PHASE 1 STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF RABIES VACCINE,HUMAN I.P. PURIFIED INACTIVATED VERO CELL RABIES VACCINE-LYOPHILIZED(PVRV) OF M/S ZYDUS LIFESCIENCES LTD. (FORMERLY CADILA HEALTHCARE LTD.),INDIA IN HEALTHY, ADULT HUMAN SUBJECTS
- Registration Number
- CTRI/2022/07/044054
- Lead Sponsor
- Zydus Lifesciences Ltd Formerly Cadila Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method