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

September 9, 2020 updated by: Ju-Young Shin, Sungkyunkwan University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1000000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, Korea, Republic of, 16419
        • Sungkyunkwan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Persons (children aged under 59 months and elderly adults aged 65 years and older) who received pneumococcal vaccines under the national immunization program.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Biological: 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.
Other Names:
  • Prevnar 13
  • Synflorix
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.
Biological: 23-valent pneumococcal polysaccharide vaccine
Single 0.5-mL dose administered intramuscularly or subcutaneously only.
Other Names:
  • Prodiax-23
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.
Biological: Influenza vaccine
One dose of trivalent influenza vaccine in flu seasons.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative risk of adverse events
Time Frame: 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.
2014-2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sungkyunkwan University

Collaborators

Government-wide R&D Fund project for infectious disease research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2021

Primary Completion (Anticipated)

March 31, 2022

Study Completion (Anticipated)

March 31, 2022

Study Registration Dates

First Submitted

September 9, 2020

First Submitted That Met QC Criteria

September 9, 2020

First Posted (Actual)

September 16, 2020

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 9, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SKKU-2020-PneV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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