Pneumococcal Vaccine Adverse Reaction Clinical Trial
Official title:
Post-marketing Safety Evaluation of 10 or 13-valent Pneumococcal Conjugate Vaccine in Children and 23-valent Pneumococcal Polysaccharide Vaccine in Elderly Adults.
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.
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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Sungkyunkwan University | Suwon | Gyeonggi-do |
Lead Sponsor | Collaborator |
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Sungkyunkwan University | Government-wide R&D Fund project for infectious disease research |
Korea, Republic of,
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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
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 |