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Epileptic Seizure in Epilepsy Patients After SARS-CoV-2 Vaccination

NCT05341713 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 240

Last updated 2022-04-22

No results posted yet for this study

Summary

Background and Objectives: Seizure attack is one of adverse effects of vaccination in epileptic patients, the risk of which after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) inoculation was elucidated in the present study.

Methods: A self-controlled case series study was designed to examine the association between vaccination and epileptic seizure. A total of 240 epilepsy patients were included who were vaccinated with inactive SARS-CoV-2 vaccines (Sinovac Life Sciences and Lanzhou Institute of Biological Products) and admitted to outpatient clinics from July 2021 to December 2021. Poisson analysis was performed to estimate the relative incidence rate of epileptic seizure in risk periods (day 1-7, 8-21 and 1-21 after first-dose vaccination) compared to basal level in control period.

Conditions

  • Epileptic Seizures Related to Drugs
  • SARS-CoV-2 Acute Respiratory Disease
  • Vaccine Adverse Reaction

Interventions

BIOLOGICAL

inactive SARS-Cov-2 vaccine

We included epilepsy patients who were vaccinated with inactive SARS-CoV-2 vaccines

Sponsors & Collaborators

  • Xijing Hospital

    lead OTHER

Principal Investigators

  • Gengyao Hu, doctor · Air Force Military Medical University, China

  • Ze Chen, master · Air Force Military Medical University, China

  • Kejian Wu, doctor · Air Force Military Medical University, China

  • Yuanhang Pan, master · Air Force Military Medical University, China

  • Xia Li, master · Xian Children's Hospital

  • Junxiang Bao, doctor · Air Force Military Medical University, China

  • Yonghong Liu, doctor · Air Force Military Medical University, China

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2022-04-01
Completion
2022-04-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05341713 on ClinicalTrials.gov