Status:
UNKNOWN
Non Inferiority Trial of Locally Manufactured Rabies Vaccine 'Rabix-VC' in Bangladesh
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh
Conditions:
Non Inferiority Trial
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
Rabies is a viral infectious disease of mammals including humans. Early symptoms of rabies include fever and tingling at the site of exposure, followed by one or more symptoms such as fear of water, v...
Detailed Description
This will be a randomized, controlled, double-blind, parallel design, comparative, non-inferiority study on a total of 440 healthy adult participants (18-75 years of age). Participants who will be eli...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT04715867
Start Date
January 1 2021
End Date
December 31 2022
Last Update
March 29 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Icddrb
Dhaka, Bangladesh