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NCT01067079 Clinical Trial

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

Rabies Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01067079
Other study ID # M49P8E1
Secondary ID
Status Terminated
Phase Phase 3
First received February 9, 2010
Last updated December 27, 2011
Start date January 2010
Est. completion date January 2010

Study information
Verified date December 2011
Source Novartis
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Terminated
Enrollment 200
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Other:
• No vaccine administered; subjects only have blood sampling for immunogenicity
No vaccine administered; subjects only have blood sampling for

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novartis Vaccines

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 13 months, 3 years and 5 years after initial vaccination No
Secondary Rabies virus neutralizing antibody(RVNA) responses 13months, 3 years and 5 years after completion of initial vaccination series as evaluated by geometric mean concentration 13months, 3 years and 5years after initial vaccination No
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