Non Inferiority Trial of Locally Manufactured Rabies Vaccine 'Rabix-VC' in Bangladesh
Non Inferiority Trial
About this trial
This is an interventional prevention trial for Non Inferiority Trial
Eligibility Criteria
Inclusion Criteria:
- 1. Males and females of age 18 years to 75 years. 2. Individuals who had given written consent. 3. Individuals in good health and available for all the visits scheduled in the study.
Exclusion Criteria:
1. Pregnancy or unwillingness to practice acceptable contraception. 2. A history of Rabies vaccination. 3. Known hypersensitivity to neomycin, tetracycline, amphotericin-B or any other vaccine component.
4. A significant acute or chronic infectious disease or use of antibiotics that may impact the subject's safety and /or immunogenicity in the Investigators opinion at the time of enrolment.
5. Body temperature ≥38.0°C (≥ 100.4°F) within 3 days of study vaccination. 6. Individuals who received any other vaccines within 28 days prior to enrolment.
7. Clinically Significant abnormalities in screening hematology and serum bio-chemistry, as determined by the study physician.
8. Subjects who have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks.
9. Any planned surgery during the study period. 10. Subjects who have cancer disorders excluding non-melatonin skin cancer.
Sites / Locations
- IcddrbRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Experimental
Active Comparator
Test Group for intramuscular route
Comparator group for intramuscular route
Test Group for Intradermal Route
Comparator Group for Intradermal Route
110 adult participant will get Ravix-VC
110 adult participant will get Rabipur
110 adult participant will get Ravix-VC
110 adult participant will get Rabipur