NCT04551248

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

8 months

First QC Date

September 9, 2020

Last Update Submit

September 9, 2020

Conditions

Pneumococcal Vaccine Adverse Reaction

Keywords

Pneumococcal conjugate vaccinePneumococcal polysaccharide vaccineAdverse events following immunisation

Outcome Measures

Primary Outcomes (1)

  • Relative risk of adverse events

    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

Study Arms (3)

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

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

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

Interventions

10 or 13-valent pneumococcal conjugate vaccineBIOLOGICAL

a four-dose series that is indicated for use at 2, 4, 6, and 12 to 15 months of age.

Also known as: Prevnar 13, Synflorix
PCV13 recipients (children)
23-valent pneumococcal polysaccharide vaccineBIOLOGICAL

Single 0.5-mL dose administered intramuscularly or subcutaneously only.

Also known as: Prodiax-23
PPSV23 recipients (elderly adults)
Influenza vaccineBIOLOGICAL

One dose of trivalent influenza vaccine in flu seasons.

Influenza vaccine recipients (elderly adults)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • Persons who experienced outcomes of interest within 1 year before the date of vaccination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sungkyunkwan University

Suwon, Gyeonggi-do, 16419, South Korea

Location

Related Publications (6)

  • 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.

    PMID: 29977960BACKGROUND

  • 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.

    PMID: 23579258BACKGROUND

  • 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.

    PMID: 31265459BACKGROUND

  • 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.

    PMID: 27087150BACKGROUND

  • 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.

    PMID: 27836437BACKGROUND

  • 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.

    PMID: 28202210BACKGROUND

MeSH Terms

Interventions

13-valent pneumococcal vaccinePHiD-CV vaccine23-valent pneumococcal capsular polysaccharide vaccineInfluenza Vaccines

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Ju-Young Shin, PhD

    Sungkyunkwan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ha-Lim Jeon, MS

CONTACT

+82-31-299-4377hrjeon@skku.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 9, 2020

First Posted

September 16, 2020

Study Start

August 1, 2021

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

September 16, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)