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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-03-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Pneumococcal Vaccine Adverse Reaction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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PCV13 recipients (children)

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

10 or 13-valent pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

a four-dose series that is indicated for use at 2, 4, 6, and 12 to 15 months of age.

PPSV23 recipients (elderly adults)

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.

23-valent pneumococcal polysaccharide vaccine

Intervention Type BIOLOGICAL

Single 0.5-mL dose administered intramuscularly or subcutaneously only.

Influenza vaccine recipients (elderly adults)

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.

Influenza vaccine

Intervention Type BIOLOGICAL

One dose of trivalent influenza vaccine in flu seasons.

Interventions

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10 or 13-valent pneumococcal conjugate vaccine

a four-dose series that is indicated for use at 2, 4, 6, and 12 to 15 months of age.

Intervention Type BIOLOGICAL

23-valent pneumococcal polysaccharide vaccine

Single 0.5-mL dose administered intramuscularly or subcutaneously only.

Intervention Type BIOLOGICAL

Influenza vaccine

One dose of trivalent influenza vaccine in flu seasons.

Intervention Type BIOLOGICAL

Other Intervention Names

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Prevnar 13 Synflorix Prodiax-23

Eligibility Criteria

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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.