Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04551248
Other study ID # SKKU-2020-PneV
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 1, 2021
Est. completion date March 31, 2022

Study information

Verified date September 2020
Source Sungkyunkwan University
Contact Ha-Lim Jeon, MS
Phone +82-31-299-4377
Email hrjeon@skku.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1000000
Est. completion date March 31, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Pneumococcal Vaccine Adverse Reaction

Intervention

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.
23-valent pneumococcal polysaccharide vaccine
Single 0.5-mL dose administered intramuscularly or subcutaneously only.
Influenza vaccine
One dose of trivalent influenza vaccine in flu seasons.

Locations

Country Name City State
Korea, Republic of Sungkyunkwan University Suwon Gyeonggi-do

Sponsors (2)

Lead Sponsor Collaborator
Sungkyunkwan University Government-wide R&D Fund project for infectious disease research

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (6)

Baker MA, Baer B, Kulldorff M, Zichittella L, Reindel R, DeLuccia S, Lipowicz H, Freitas K, Jin R, Yih WK. Kawasaki disease and 13-valent pneumococcal conjugate vaccination among young children: A self-controlled risk interval and cohort study with null results. PLoS Med. 2019 Jul 2;16(7):e1002844. doi: 10.1371/journal.pmed.1002844. eCollection 2019 Jul. — View Citation

Haber P, Arana J, Pilishvili T, Lewis P, Moro PL, Cano M. Post-licensure surveillance of 13-valent pneumococcal conjugate vaccine (PCV13) in adults aged ?19years old in the United States, Vaccine Adverse Event Reporting System (VAERS), June 1, 2012-December 31, 2015. Vaccine. 2016 Dec 7;34(50):6330-6334. doi: 10.1016/j.vaccine.2016.10.052. Epub 2016 Nov 9. — View Citation

Miller ER, Moro PL, Cano M, Lewis P, Bryant-Genevier M, Shimabukuro TT. Post-licensure safety surveillance of 23-valent pneumococcal polysaccharide vaccine in the Vaccine Adverse Event Reporting System (VAERS), 1990-2013. Vaccine. 2016 May 27;34(25):2841-6. doi: 10.1016/j.vaccine.2016.04.021. Epub 2016 Apr 15. — View Citation

Trinh L, Macartney K, McIntyre P, Chiu C, Dey A, Menzies R. Investigating adverse events following immunisation with pneumococcal polysaccharide vaccine using electronic General Practice data. Vaccine. 2017 Mar 13;35(11):1524-1529. doi: 10.1016/j.vaccine.2017.01.063. Epub 2017 Feb 13. — View Citation

Tseng HF, Sy LS, Liu IL, Qian L, Marcy SM, Weintraub E, Yih K, Baxter R, Glanz JM, Donahue J, Naleway A, Nordin J, Jacobsen SJ. Postlicensure surveillance for pre-specified adverse events following the 13-valent pneumococcal conjugate vaccine in children. Vaccine. 2013 May 24;31(22):2578-83. doi: 10.1016/j.vaccine.2013.03.040. Epub 2013 Apr 8. — View Citation

Tseng HF, Sy LS, Qian L, Liu IA, Mercado C, Lewin B, Tartof SY, Nelson J, Jackson LA, Daley MF, Weintraub E, Klein NP, Belongia E, Liles EG, Jacobsen SJ. Pneumococcal Conjugate Vaccine Safety in Elderly Adults. Open Forum Infect Dis. 2018 May 2;5(6):ofy100. doi: 10.1093/ofid/ofy100. eCollection 2018 Jun. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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