Pneumococcal Vaccine Adverse Reaction
Conditions
Keywords
Pneumococcal conjugate vaccine, Pneumococcal polysaccharide vaccine, Adverse events following immunisation
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.
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).
Interventions
BIOLOGICAL10 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.
Single 0.5-mL dose administered intramuscularly or subcutaneously only.
BIOLOGICALInfluenza vaccine
One dose of trivalent influenza vaccine in flu seasons.
Sponsors
Government-wide R&D Fund project for infectious disease research
Sungkyunkwan University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative risk of adverse events | 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. |
Countries
South Korea
Contacts
Primary ContactHa-Lim Jeon, MS
Outcome results
None listed