Analysis on AEFI Surveillance Data for Live Attenuated Varicella Vaccine

NCT ID: NCT02983656

Last Updated: 2018-01-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 394 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-08-31

Brief Summary

The purpose of this study is to observe the occurrence of adverse events of live attenuated varicella vaccine.

Conditions

Varicocele

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Interventions

live attenuated varicella vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changchun Keygen Biological Products Co., Ltd.

OTHER

Sponsor Role: collaborator

Zhejiang Provincial Center for Disease Control and Prevention

OTHER_GOV

Sponsor Role: lead

Responsible Party

Qian Li

Deputy chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qian Li, Bachelor

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Provincial Center for Disease Control and Prevention

Other Identifiers

ZJCDC20161121

Identifier Type: -

Identifier Source: org_study_id