Immunogenicity and Safety of Rabies Vaccine, Administered With Two Different Simulated Post Exposure Schedules

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Disease Information

Descriptive Information
Brief Title † Immunogenicity and Safety of Rabies Vaccine, Administered With Two Different Simulated Post Exposure Schedules
Official Title † A Phase IV, Multi-center, Randomized, Open-label Study of PCECV (Rabipur®) Comparing the Immunogenicity and Safety of Two Different Simulated Post Exposure Schedules (Zagreb 2-1-1 Versus Essen Regimen 1-1-1-1-1) in Healthy Indian Subjects
Brief Summary This study was planned to establish the non-inferiority of Rabipur administered as simulated post exposure Zagreb schedule as compared to Essen schedule, in healthy Indian adult subjects.
Detailed Description
Study Phase Phase 4
Study Type † Interventional
Study Design † Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary Outcome Measure † Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Each of the Zagreb and Essen Groups on Study Day 14
Secondary Outcome Measure † Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Zagreb and Essen Groups at Days 7, 14 and 42
Condition † Rabies
Intervention † BiologicalPurified Chick Embryo Cell Inactivated Rabies Vaccine
Study Arms / Comparison Groups Group A-Zagreb Purified Chick Embryo Cell Inactivated Rabies Vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21) Group B-Essen Purified Chick Embryo Cell Inactivated Rabies Vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14, and 28)
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Biological
Estimated Enrollment † 250
Start Date † July 2011
Completion Date November 2011
Primary Completion Date November 2011
Eligibility Criteria † Inclusion Criteria: 1. Males and females of age ≥ 18 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. History of allergy to egg protein. 4. Known hypersensitivity to neomycin, tetracycline, amphotericin-B or any other vaccine component. 5. 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. 6. Body temperature ≥38.0°C (≥ 100.4°F) within 3 days of study vaccination. 7. Treatment with an anti-malarial drug, up to two months prior to the study. 8. Individuals who received any other vaccines within 28 days prior to enrollment. 9. Subjects who have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks. 10. Any planned surgery during the study period. 11. Subjects who have cancer disorders excluding nonmelanotic skin cancer.
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers Accepts Healthy Volunteers
Contacts ††
Location Countries † India
Administrative Information
NCT ID † NCT01365494
Organization ID V49_25
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Novartis Vaccines
Collaborators ††
Investigators † Study Director: Novartis Vaccines and Diagnostics, Novartis
Information Provided By
Verification Date April 2014
First Received Date † May 30, 2011
Last Updated Date April 3, 2014
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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