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

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ClinicalTrials.gov Identifier: NCT01365494
Recruitment Status : Completed
First Posted : June 3, 2011
Results First Posted : May 5, 2014
Last Update Posted : May 5, 2014
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Tracking Information
First Submitted Date  ICMJE May 30, 2011
First Posted Date  ICMJE June 3, 2011
Results First Submitted Date  ICMJE January 28, 2014
Results First Posted Date  ICMJE May 5, 2014
Last Update Posted Date May 5, 2014
Study Start Date  ICMJE July 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2014)
Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Each of the Zagreb and Essen Groups on Study Day 14 [ Time Frame: On Day 0 and Day 14 ]
Immunogenicity was measured as the geometric mean concentrations (GMCs) of rabies virus neutralizing antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and on study day 14 as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule
Original Primary Outcome Measures  ICMJE
 (submitted: June 1, 2011)
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 ]
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).
Change History Complete list of historical versions of study NCT01365494 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2014)
  • Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Zagreb and Essen Groups at Days 7, 14 and 42 [ Time Frame: Study day 7, 14 and 42 ]
    Immunogenicity was measured as the percentage of subjects who achieved anti-RVNA titer ≥0.5 IU/mL, at days 0, 7, 14 and 42 as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
  • Ratio of GMCs in Study Groups (Zagreb/Essen Schedules) on Days 7 and 42 as Measured by RVNA Geometric Mean Concentrations [ Time Frame: Day 0, Day 7, Day 14 and Day 42 ]
    Immunogenicity was measured as the ratio of GMCs of RVNA titer , evaluated using the rapid fluorescent focus inhibition test, on Days 7 and 42 as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedules
  • Percentages of Subjects Reporting Adverse Events (AEs) [ Time Frame: All reported SAEs and medically attended AEs or AEs that resulted in the premature withdrawal of subjects were collected up to 42 days after first vaccination. Adverse events were collected throughout the study period ]
    Adverse events (AEs) were collected for 7 days following administration of each study vaccination or until time of next vaccination (whichever occurred sooner). All reported SAEs and medically attended AEs or AEs that resulted in the premature withdrawal of subjects during the study were collected throughout the study period and all AEs were unsolicited.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2011)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunogenicity and Safety of Rabies Vaccine, Administered With Two Different Simulated Post Exposure Schedules
Official Title  ICMJE 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Rabies
Intervention  ICMJE Biological: Purified Chick Embryo Cell Inactivated Rabies Vaccine
Two group (Zagreb and Essen) will receive Rabipur vaccine IM according to either Zagreb or Essen schedules.
Study Arms  ICMJE
  • Active Comparator: 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)
    Intervention: Biological: Purified Chick Embryo Cell Inactivated Rabies Vaccine
  • Active Comparator: 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)
    Intervention: Biological: Purified Chick Embryo Cell Inactivated Rabies Vaccine
Publications * Mahendra BJ, Narayana DA, Agarkhedkar S, Ravish HS, Harish BR, Agarkhedkar S, Madhusudana SN, Belludi A, Ahmed K, Jonnalagedda R, Vakil H, Bhusal C, Arora AK. Comparative study on the immunogenicity and safety of a purified chick embryo cell rabies vaccine (PCECV) administered according to two different simulated post exposure intramuscular regimens (Zagreb versus Essen). Hum Vaccin Immunother. 2015;11(2):428-34. doi: 10.4161/21645515.2014.995059.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 1, 2011)
250
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01365494
Other Study ID Numbers  ICMJE V49_25
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Vaccines )
Study Sponsor  ICMJE Novartis Vaccines
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Vaccines and Diagnostics Novartis
PRS Account Novartis
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP