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OpenTrials
Completed

NCT Number: NCT02983656

Analysis on AEFI Surveillance Data for Live Attenuated Varicella Vaccine

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

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Key information

Conditions

Varicocele Cardiovascular Diseases Genital Diseases Genital Diseases, Male Male Urogenital Diseases Urogenital Diseases Vascular Diseases

Age range

1 year–15 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Live Attenuated Varicella Vaccine

Biological

Primary outcomes

  1. incidence of adverse reactions

    Time frame: 1 year after the first and second doses

Sponsors and collaborators

Lead sponsor

Zhejiang Provincial Center for Disease Control and Prevention

Other Gov

Collaborators

  • Changchun Keygen Biological Products Co., Ltd.

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 6, 2016
Registry last updated
Jan 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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