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

Study Overview
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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.

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).

Official Title
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Post-marketing Safety Evaluation of 10 or 13-valent Pneumococcal Conjugate Vaccine in Children and 23-valent Pneumococcal Polysaccharide Vaccine in Elderly Adults.

Conditions
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Pneumococcal Vaccine Adverse Reaction

Intervention / Treatment
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* Biological: 10 or 13-valent pneumococcal conjugate vaccine
* Biological: 23-valent pneumococcal polysaccharide vaccine
* Biological: Influenza vaccine


Participation Criteria
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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. Exclusion Criteria: Persons who experienced outcomes of interest within 1 year before the date of vaccination.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PCV13 recipients (children)<br>Children < 5 years who had received PCV10 or PCV13 from May, 2014 to December, 2018 under the national childhood immunization program in South Korea. | Biological: 10 or 13-valent pneumococcal conjugate vaccine<br>* a four-dose series that is indicated for use at 2, 4, 6, and 12 to 15 months of age.<br>* Other names: Synflorix;|
| PPSV23 recipients (elderly adults)<br>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. | Biological: 23-valent pneumococcal polysaccharide vaccine<br>* Single 0.5-mL dose administered intramuscularly or subcutaneously only.<br>* Other names: Prodiax-23;|
| Influenza vaccine recipients (elderly adults)<br>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. | Biological: Influenza vaccine<br>* One dose of trivalent influenza vaccine in flu seasons.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative risk of adverse events | 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. the ratio of probability of adverse events occuring in the PPSV23 group versus the influenza vaccine (a comparator) group in the cohort study design. | 2014-2018 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumococcal conjugate vaccine, Pneumococcal polysaccharide vaccine, Adverse events following immunisation