Analysis on AEFI Surveillance Data for Live Attenuated Varicella Vaccine

January 10, 2018 updated by: Qian Li, Zhejiang Provincial Center for Disease Control and Prevention
The purpose of this study is to observe the occurrence of adverse events of live attenuated varicella vaccine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

394

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participant preventive inoculation of varicella vaccine in 2014-2015

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of adverse reactions
Time Frame: 1 year after the first and second doses
1 year after the first and second doses

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Provincial Center for Disease Control and Prevention

Collaborators

Changchun Keygen Biological Products Co., Ltd.

Investigators

  • Principal Investigator: Qian Li, Bachelor, Zhejiang Provincial Center for Disease Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

August 31, 2017

Study Completion (Actual)

August 31, 2017

Study Registration Dates

First Submitted

December 1, 2016

First Submitted That Met QC Criteria

December 1, 2016

First Posted (Estimate)

December 6, 2016

Study Record Updates

Last Update Posted (Actual)

January 11, 2018

Last Update Submitted That Met QC Criteria

January 10, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZJCDC20161121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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