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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04551248
Recruitment Status : Unknown
Verified September 2020 by Ju-Young Shin, Sungkyunkwan University.
Recruitment status was:  Not yet recruiting
First Posted : September 16, 2020
Last Update Posted : September 16, 2020
Sponsor:
Collaborator:
Government-wide R&D Fund project for infectious disease research
Information provided by (Responsible Party):
Ju-Young Shin, 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.

Condition or disease Intervention/treatment
Pneumococcal Vaccine Adverse Reaction Biological: 10 or 13-valent pneumococcal conjugate vaccine Biological: 23-valent pneumococcal polysaccharide vaccine Biological: Influenza vaccine

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).

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Study Type : Observational
Estimated Enrollment : 1000000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Post-marketing Safety Evaluation of 10 or 13-valent Pneumococcal Conjugate Vaccine in Children and 23-valent Pneumococcal Polysaccharide Vaccine in Elderly Adults.
Estimated Study Start Date : August 1, 2021
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Shot Vaccines

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 Name: 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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04551248


Contacts
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Contact: Ha-Lim Jeon, MS +82-31-299-4377 hrjeon@skku.edu

Locations
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Korea, Republic of
Sungkyunkwan University
Suwon, Gyeonggi-do, Korea, Republic of, 16419
Sponsors and Collaborators
Sungkyunkwan University
Government-wide R&D Fund project for infectious disease research
Investigators
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Principal Investigator: Ju-Young Shin, PhD Sungkyunkwan University
Publications:

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Responsible Party: Ju-Young Shin, Associate Professor, Sungkyunkwan University
ClinicalTrials.gov Identifier: NCT04551248    
Other Study ID Numbers: SKKU-2020-PneV
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Ju-Young Shin, Sungkyunkwan University:
Pneumococcal conjugate vaccine
Pneumococcal polysaccharide vaccine
Adverse events following immunisation
Additional relevant MeSH terms:
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Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs