Single Center, Open Label, Follow up Study in Subjects Who Previously Received Rabies Vaccine as Simulated Post-Exposure Regimen
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
1 other identifier
observational
200
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 9, 2010
CompletedFirst Posted
Study publicly available on registry
February 11, 2010
CompletedDecember 30, 2011
December 1, 2011
Same day
February 9, 2010
December 27, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
13 months, 3 years and 5 years after initial vaccination
Secondary Outcomes (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
13months, 3 years and 5years after initial vaccination
Study Arms (1)
Arm 1
Interventions
No vaccine administered; subjects only have blood sampling for
Eligibility Criteria
Subjects who received complete vaccine series in accordance to the designated vaccination schedule in the previous M49P8 study
You may qualify if:
- Male and Female subjects who received complete vaccine series in accordance to the designated vaccination schedule in the previous M49P8 study
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Jizhou County, Hebei, 053200, China
Related Publications (1)
Ma J, Wang H, Li J, Chang L, Xie Y, Liu Z, Zhao Y, Malerczyk C. A randomized open-labeled study to demonstrate the non-inferiority of purified chick-embryo cell rabies vaccine administered in the Zagreb regimen (2-1-1) compared with the Essen regimen in Chinese adults. Hum Vaccin Immunother. 2014;10(10):2805-12. doi: 10.4161/21645515.2014.972773.
PMID: 25483635DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2010
First Posted
February 11, 2010
Study Start
January 1, 2010
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
December 30, 2011
Record last verified: 2011-12