Analysis on AEFI Surveillance Data for Live Attenuated Varicella Vaccine
Sponsor
Zhejiang Provincial Center for Disease Control and Prevention (Other)
Overall Status
Completed
CT.gov ID
NCT02983656
Collaborator
Changchun Keygen Biological Products Co., Ltd. (Other)
394
10
Study Details
Study Description
Brief Summary
The purpose of this study is to observe the occurrence of adverse events of live attenuated varicella vaccine.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
394 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Study Start Date
:
Nov 1, 2016
Actual Primary Completion Date
:
Aug 31, 2017
Actual Study Completion Date
:
Aug 31, 2017
Outcome Measures
Primary Outcome Measures
- incidence of adverse reactions [1 year after the first and second doses]
Eligibility Criteria
Criteria
Ages Eligible for Study:
1 Year
to 15 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
The registered permanent residence or resident place are local (reside more than 3 months);
-
Participant preventive inoculation of varicella vaccine in 2014-2015;
-
Adverse reactions occurred and should be reported in the AEFI monitoring system.
Exclusion Criteria:
-
Subjects with a known allergy to any ingredient of the vaccine, and with any allergy history to any vaccine;
-
Subjects with any acute diseases, severe chronic diseases, acute bout of chronic diseases, and catching cold and fever;
-
Subjects with uncontrolled seizures and other progressive neurological diseases, with a history of Guillain-Barré syndrome.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Zhejiang Provincial Center for Disease Control and Prevention
- Changchun Keygen Biological Products Co., Ltd.
Investigators
- Principal Investigator: Qian Li, Bachelor, Zhejiang Provincial Center for Disease Control and Prevention
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Qian Li,
Deputy chief physician,
Zhejiang Provincial Center for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT02983656
Other Study ID Numbers:
- ZJCDC20161121
First Posted:
Dec 6, 2016
Last Update Posted:
Jan 11, 2018
Last Verified:
Jan 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Qian Li,
Deputy chief physician,
Zhejiang Provincial Center for Disease Control and Prevention
Additional relevant MeSH terms: