Single Center, Open Label, Follow up Study in Subjects Who Previously Received Rabies Vaccine as Simulated Post-Exposure Regimen
Terminated
- Conditions
- Rabies
- Registration Number
- NCT01067079
- Lead Sponsor
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 200
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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