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CompletedNCT02983656Updated Jan 11, 2018

Analysis on AEFI Surveillance Data for Live Attenuated Varicella Vaccine

An observational study in Varicocele, sponsored by Zhejiang Provincial Center for Disease Control and Prevention. Completed. Open to participants aged 1 Year to 15 Years. Per ClinicalTrials.gov, last updated 2018-01-11.

Sponsored by Zhejiang Provincial Center for Disease Control and Prevention · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
394
Ages
1 Year to 15 Years
Sex
All
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Study summary

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

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Conditions studied

  • Varicocele

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Keywords

  • Vaccine Safety
03

In context

Varicocele

53 studies on the registry are indexed under Varicocele; 15 are open to participants now.

This study's enrollment of 394 is above the median of 119 across 17 observational studies indexed under Varicocele.

Browse Varicocele studies →

Lead sponsor

Zhejiang Provincial Center for Disease Control and Prevention is the lead sponsor of 13 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participant preventive inoculation of varicella vaccine in 2014-2015

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
394 participants (actual)
Patient registry
No

Interventions

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What researchers measure

Primary outcomes

  1. incidence of adverse reactions

    Time frame: 1 year after the first and second doses

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02983656
Lead sponsor
Zhejiang Provincial Center for Disease Control and Prevention
Collaborators
Changchun Keygen Biological Products Co., Ltd.
Responsible party
Qian Li (Deputy chief physician, Zhejiang Provincial Center for Disease Control and Prevention) — Principal investigator
First posted
Dec 6, 2016
Start date
Nov 2016
Primary completion
Aug 31, 2017
Completion
Aug 31, 2017
Last update
Jan 11, 2018

Study contacts

Qian Li, Bachelor
principal investigator · Zhejiang Provincial Center for Disease Control and Prevention

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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