Post-marketing Safety Evaluation of 10 or 13-valent Pneumococcal Conjugate Vaccine in Children and 23-valent Pneumococcal Polysaccharide Vaccine in Elderly Adults.
| Registry | NCT04551248 |
|---|---|
| Status | Unknown |
| Study type | Observational |
| Enrollment | 1000000 (Estimated) |
| Sponsor | Sungkyunkwan University (Other); collaborators: Government-wide R&D Fund project for infectious disease research |
| Conditions | Pneumococcal Vaccine Adverse Reaction |
| Interventions | 10 or 13-valent pneumococcal conjugate vaccine, 23-valent pneumococcal polysaccharide vaccine, Influenza vaccine (Biological) |
| Dates | start 2021-08-01 (estimated), primary completion 2022-03-31 (estimated), completion 2022-03-31 (estimated), first posted 2020-09-16, last updated 2020-09-16 |
| Locations | 1 site in South Korea |
Related Papers Related Patents Related Grants Related Experts
All trials for Pneumococcal Vaccine Adverse Reaction All trials of 10 or 13-valent pneumococcal conjugate vaccine All trials of 23-valent pneumococcal polysaccharide vaccine
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.
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| PCV13 recipients (children) | Biological: 10 or 13-valent pneumococcal conjugate vaccine | Children < 5 years who had received PCV10 or PCV13 from May, 2014 to December, 2018 under the national childhood immunization program in South Korea. | |
| PPSV23 recipients (elderly adults) | Biological: 23-valent pneumococcal polysaccharide vaccine | 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. | |
| Influenza vaccine recipients (elderly adults) | Biological: Influenza vaccine | 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. |
Sex: All, accepts healthy volunteers
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Sungkyunkwan University | Suwon, Gyeonggi-do | South Korea |