Close
Close

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

Access Programs

Disease Information

Descriptive Information
Brief Title † Single Center, Open Label, Follow up Study in Subjects Who Previously Received Rabies Vaccine as Simulated Post-Exposure Regimen
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
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
Detailed Description
Study Phase Phase 3
Study Type † Observational
Study Design † Observational Model: Cohort, Time Perspective: Retrospective
Primary Outcome Measure † 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
Secondary Outcome Measure † Rabies virus neutralizing antibody(RVNA) responses 13months, 3 years and 5 years after completion of initial vaccination series as evaluated by geometric mean concentration
Condition † Rabies
Intervention † OtherNo vaccine administered; subjects only have blood sampling for immunogenicity
Study Arms / Comparison Groups Arm 1
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Other
Estimated Enrollment † 200
Start Date † January 2010
Completion Date January 2010
Primary Completion Date January 2010
Eligibility 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.
Gender Both
Ages N/A - N/A
Accepts Healthy Volunteers Accepts Healthy Volunteers
Contacts ††
Location Countries † China
Administrative Information
NCT ID † NCT01067079
Organization ID M49P8E1
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Novartis Vaccines
Collaborators ††
Investigators † : ,
Information Provided By
Verification Date December 2011
First Received Date † February 9, 2010
Last Updated Date December 27, 2011
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
Find a Clinical Trial
Related Videos
by Abidemi Uruejoma
193 views
Free Newsletter