Analysis on AEFI Surveillance Data for Live Attenuated Varicella Vaccine

Varicocele Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02983656
• Other study ID #: ZJCDC20161121
• Status: Completed
• Phase: N/A
• First received: December 1, 2016
• Last updated: January 10, 2018
• Start date: November 2016
• Est. completion date: August 31, 2017

Study information

• Verified date: January 2018
• Source: Zhejiang Provincial Center for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 394
• Est. completion date: August 31, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Varicocele

Intervention

Biological:
• live attenuated varicella vaccine

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Zhejiang Provincial Center for Disease Control and Prevention	Changchun Keygen Biological Products Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of adverse reactions		1 year after the first and second doses