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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014