Trials / Unknown
UnknownNCT04551248
Post-marketing Safety Evaluation of Pneumococcal Vaccines Among Children and Elderly Adults.
Post-marketing Safety Evaluation of 10 or 13-valent Pneumococcal Conjugate Vaccine in Children and 23-valent Pneumococcal Polysaccharide Vaccine in Elderly Adults.
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,000,000 (estimated)
- Sponsor
- Sungkyunkwan University · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| BIOLOGICAL | 23-valent pneumococcal polysaccharide vaccine | Single 0.5-mL dose administered intramuscularly or subcutaneously only. |
| BIOLOGICAL | Influenza vaccine | One dose of trivalent influenza vaccine in flu seasons. |
Timeline
- Start date
- 2021-08-01
- Primary completion
- 2022-03-31
- Completion
- 2022-03-31
- First posted
- 2020-09-16
- Last updated
- 2020-09-16
Locations
1 site across 1 country: South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04551248. Inclusion in this directory is not an endorsement.