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

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ClinicalTrials.gov Identifier: NCT01067079
Recruitment Status : Terminated
First Posted : February 11, 2010
Last Update Posted : December 30, 2011
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Brief Summary:
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 or disease Intervention/treatment
Rabies Other: No vaccine administered; subjects only have blood sampling for immunogenicity

Study Type : Observational
Actual Enrollment : 200 participants
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
Study Start Date : January 2010
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rabies
U.S. FDA Resources

Group/Cohort Intervention/treatment
Arm 1 Other: No vaccine administered; subjects only have blood sampling for immunogenicity
No vaccine administered; subjects only have blood sampling for



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01067079


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT01067079     History of Changes
Other Study ID Numbers: M49P8E1
First Posted: February 11, 2010    Key Record Dates
Last Update Posted: December 30, 2011
Last Verified: December 2011

Keywords provided by Novartis ( Novartis Vaccines ):
Rabies vaccine
Long-term Immunogenicity

Additional relevant MeSH terms:
Rabies
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs