Post-marketing Safety Evaluation of Pneumococcal Vaccines Among Children and Elderly Adults.

• Conditions: Pneumococcal Vaccine Adverse Reaction
• Interventions: Biological: Influenza vaccine; Biological: 23-valent pneumococcal polysaccharide vaccine; Biological: 10 or 13-valent pneumococcal conjugate vaccine

• Registration Number: NCT04551248
• Lead Sponsor: Sungkyunkwan University

Brief 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.

Detailed 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 Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-09
• Study First Submitted QC: 2020-09-09
• Last Update Submitted: 2020-09-09
• Study First Posted: 2020-09-16
• Last Update Posted: 2020-09-16
• Study Start: 2021-08-01
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000000

Inclusion Criteria

• Children < 5 years who had received PCV10 or PCV13 from May, 2014 to December, 2018.
• Persons 65 years or older who had received at least one dose of PPSV23 or influenza vaccine (as a comparator) between January, 2014 and December, 2018.

Exclusion Criteria

• Persons who experienced outcomes of interest within 1 year before the date of vaccination.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Influenza vaccine recipients (elderly adults)	Influenza vaccine	Persons 65 years or older who had received at least one dose of influenza vaccine (as comparator) between January, 2014 and December, 2018 under the national immunization program in South Korea.
PPSV23 recipients (elderly adults)	23-valent pneumococcal polysaccharide vaccine	Persons 65 years or older who had received at least one dose of PPSV23 between January, 2014 and December, 2018 under the national immunization program in South Korea.
PCV13 recipients (children)	10 or 13-valent pneumococcal conjugate vaccine	Children \< 5 years who had received PCV10 or PCV13 from May, 2014 to December, 2018 under the national childhood immunization program in South Korea.

Primary Outcome Measures

Name	Time	Method
Relative risk of adverse events	2014-2018	1. the ratio of probability of adverse events occuring in the risk periods after vaccination with PCV10 or PCV13 versus the control periods in the self-controlled risk interval study design.; 2. the ratio of probability of adverse events occuring in the PPSV23 group versus the influenza vaccine (a comparator) group in the cohort study design.

Trial Locations

Locations (1)

Sungkyunkwan University; 🇰🇷 Suwon, Gyeonggi-do, Korea, Republic of