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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01365494
First received: May 30, 2011
Last updated: December 6, 2011
Last verified: December 2011
History of Changes
  Purpose

This study is planned to establish the non-inferiority of Rabipur administered as simulated post exposure Zagreb regimen as compared to Essen regimen, in healthy Indian adult subjects.


Condition Intervention Phase
Rabies
 Biological: Purified Chick Embryo Cell Inactivated Rabies Vaccine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Rabies
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Rabies virus neutralizing antibody (RVNA) geometric mean concentrations (GMC's) compared between the study groups at day 14 using the rapid fluorescent focus inhibition test (RFFIT). [ Time Frame: 14 days after 1st vaccination ] [ Designated as safety issue: No ]

    Safety Endpoints:

    AEs will be collected for 7 days following vaccination or until time of next vaccination (whichever occurs sooner).

    Medically attended AEs and SAEs will be collected from the time the subject signs the informed consent until he/she stops study participation (day 42).



Secondary Outcome Measures:
  • Secondary Immunogenicity Endpoint: Percentage of subjects with RVNA concentrations ≥ 0.5 IU/mL at days 7, 14 and 42. RVNA GMC's at day 7 and day 42. [ Time Frame: 42 days after 1st vaccination ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: June 2011
Study Completion Date: November 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A
Group A: Rabipur® 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)
 Biological: Purified Chick Embryo Cell Inactivated Rabies Vaccine
Two group (group A and Group B) Group A and B will receive Rabipur® vaccine intramuscularly according to either Zagreb or Essen schedules.
Active Comparator: Group B
Group B: Rabipur® 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)
 Biological: Purified Chick Embryo Cell Inactivated Rabies Vaccine
Two group (group A and Group B) Group A and B will receive Rabipur® vaccine intramuscularly according to either Zagreb or Essen schedules.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Males and females of age ≥ 18 years.
  2. Individuals who have 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 immunization.
  3. History of allergy to egg protein.
  4. Known hypersensitivity to neomycin, 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365494

Locations
India
Kempagowda Institute of Medical Sciences Hospital
Bangalore, KA, India, 560070
Mandya Institute of Medical Sciences
Mandya, KA, India, 571401
Padmasree Dr. Dnyandeo Yashwanthrao Patil Hospital
Pune, MS, India, 411018
Sponsors and Collaborators
Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01365494     History of Changes
Other Study ID Numbers: V49_25
Study First Received: May 30, 2011
Last Updated: December 6, 2011
Health Authority: India: Ministry of Health

Keywords provided by Novartis:
Rabies
rabies vaccines
post-exposure prophylaxis

Additional relevant MeSH terms:
Rabies
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on June 17, 2013