Text Size

Single Center, Open Label, Follow up Study in Subjects Who Previously Received Rabies Vaccine as Simulated Post-Exposure Regimen

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01067079
First received: February 9, 2010
Last updated: December 27, 2011
Last verified: December 2011
History of Changes
  Purpose

This study will evaluate the immunogenicity of rabies vaccine at 13 months, 3 year and 5 years after initial vaccination, administered in two different post-exposure vaccination schedules


Condition Intervention Phase
Rabies
 Other: No vaccine administered; subjects only have blood sampling for immunogenicity
 Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Phase III, Single Center, Open Label, Follow-up Immunogenicity Study in Subjects Who Previously Received Post-exposure Rabies Vaccine According to the Essen or 2:1:1 (Zagreb) Schedule

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) responses 13months, 3 years and 5 years after completion of initial vaccination series as evaluated by percentage of subjects with RVNA greater than or equal to 0.5 IU/mL [ Time Frame: 13 months, 3 years and 5 years after initial vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rabies virus neutralizing antibody(RVNA) responses 13months, 3 years and 5 years after completion of initial vaccination series as evaluated by geometric mean concentration [ Time Frame: 13months, 3 years and 5years after initial vaccination ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: January 2010
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Arm 1 Other: No vaccine administered; subjects only have blood sampling for immunogenicity
No vaccine administered; subjects only have blood sampling for

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects who received complete vaccine series in accordance to the designated vaccination schedule in the previous M49P8 study

Criteria

Inclusion Criteria:

  • Male and Female subjects who received complete vaccine series in accordance to the designated vaccination schedule in the previous M49P8 study

Exclusion Criteria:

  • Any disease condition, that in the opinion of investigator may interfere with subjects ability to participate in the study.
  • Receipt of additional doses of rabies vaccine after completion of initial vaccine series.
  • For additional entry criteria please refer to protocol.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01067079

Locations
China, Hebei
Jizhou County, Hebei, China, 053200
Sponsors and Collaborators
Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01067079     History of Changes
Other Study ID Numbers: M49P8E1
Study First Received: February 9, 2010
Last Updated: December 27, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Novartis:
Rabies vaccine
Long-term Immunogenicity

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

ClinicalTrials.gov processed this record on May 19, 2013