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

NCT ID: NCT01067079

Last Updated: 2011-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-01-31

Brief Summary

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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

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Conditions

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Rabies

Keywords

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Rabies vaccine Long-term Immunogenicity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Arm 1

No vaccine administered; subjects only have blood sampling for immunogenicity

Intervention Type OTHER

No vaccine administered; subjects only have blood sampling for

Interventions

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No vaccine administered; subjects only have blood sampling for immunogenicity

No vaccine administered; subjects only have blood sampling for

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Jizhou County, Hebei, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 25483635 (View on PubMed)

Other Identifiers

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M49P8E1

Identifier Type: -

Identifier Source: org_study_id