Post-marketing Safety Evaluation of Pneumococcal Vaccines Among Children and Elderly Adults.
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|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
|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|
|Study Type :||Observational|
|Estimated Enrollment :||1000000 participants|
|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|
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.
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.
- Relative risk of adverse events [ Time Frame: 2014-2018 ]
- 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.
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
|Contact: Ha-Lim Jeon, MSemail@example.com|
|Korea, Republic of|
|Suwon, Gyeonggi-do, Korea, Republic of, 16419|
|Principal Investigator:||Ju-Young Shin, PhD||Sungkyunkwan University|