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Clinical Trial Summary

The purpose of this observational study is to examine the risk of adverse events following vaccination with 10 or 13-valent pneumococcal conjugate vaccine (PCV10 or PCV13) among infants or children age <59 months and 23-valent pneumococcal polysaccharide vaccine (PPSV23) among adults age 65 years and older.


Clinical Trial Description

The purpose of this observational study is to examine 1) the risk of adverse events (AEs) following vaccination with 10 or 13-valent pneumococcal conjugate vaccine (PCV10 or PCV13) among infants or children age <59 months using a self-controlled risk interval design and 2) the risk of AEs following vaccination with 23-valent pneumococcal polysaccharide vaccine (PPSV23) among adults age 65 years and older compared with influenza vaccine recipients using a cohort design. We will use the national health insurance database from the National Health Insurance Service (NHIS) linked with the national immunization program registry data from the Korea Centers for Diseases Control & Prevention (KCDC). ;


Study Design


Related Conditions & MeSH terms

  • Pneumococcal Vaccine Adverse Reaction

NCT number NCT04551248
Study type Observational
Source Sungkyunkwan University
Contact Ha-Lim Jeon, MS
Phone +82-31-299-4377
Email hrjeon@skku.edu
Status Not yet recruiting
Phase
Start date August 1, 2021
Completion date March 31, 2022