Analysis on AEFI Surveillance Data for Live Attenuated Varicella Vaccine

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02983656

Enrollment

394

Registered

2016-12-06

Start date

2016-11-30

Completion date

2017-08-31

Last updated

2018-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Varicocele

Keywords

Vaccine Safety

Brief summary

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

Interventions

BIOLOGICALlive attenuated varicella vaccine

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 15 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
incidence of adverse reactions	1 year after the first and second doses

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026