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

Sungkyunkwan University

Status: Unknown

Conditions: Pneumococcal Vaccine Adverse Reaction

Treatments: Biological: Influenza vaccine; Biological: 10 or 13-valent pneumococcal conjugate vaccine; Biological: 23-valent pneumococcal polysaccharide vaccine

Study type: Observational

Funder types: Other

Identifiers

NCT04551248

SKKU-2020-PneV

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,000,000 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,000,000 participants in 3 patient groups

PCV13 recipients (children)

Description:

Children \< 5 years who had received PCV10 or PCV13 from May, 2014 to December, 2018 under the national childhood immunization program in South Korea.

Treatment:

Biological: 10 or 13-valent pneumococcal conjugate vaccine

PPSV23 recipients (elderly adults)

Description:

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.

Treatment:

Biological: 23-valent pneumococcal polysaccharide vaccine

Influenza vaccine recipients (elderly adults)

Description:

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.

Treatment:

Biological: Influenza vaccine