Pneumococcal Vaccine Adverse ReactionNCT04551248
Post-marketing Safety Evaluation of Pneumococcal Vaccines Among Children and Elderly Adults.
An observational study of Pneumococcal Vaccine Adverse Reaction, run by Sungkyunkwan University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Vaccine Adverse Reaction
- What is being tested?
- 10 or 13-valent pneumococcal conjugate vaccine, 23-valent pneumococcal polysaccharide vaccine and Influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 1,000,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2021to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Persons who experienced outcomes of interest within 1 year before the date of vaccination.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Pneumococcal Vaccine Adverse Reaction
- Being tested
- 10 or 13-valent pneumococcal conjugate vaccine, 23-valent pneumococcal polysaccharide vaccine, Influenza vaccine
- Keywords
- Pneumococcal conjugate vaccine, Pneumococcal polysaccharide vaccine, Adverse events following immunisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 or 13-valent pneumococcal conjugate vaccineBiological
Also called Prevnar 13, Synflorix
a four-dose series that is indicated for use at 2, 4, 6, and 12 to 15 months of age.
23-valent pneumococcal polysaccharide vaccineBiological
Also called Prodiax-23
Single 0.5-mL dose administered intramuscularly or subcutaneously only.
Influenza vaccineBiological
One dose of trivalent influenza vaccine in flu seasons.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Biological: Influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2014-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start1 Aug 2021 (estimated)
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pneumococcal Vaccine Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sungkyunkwan University
- Sponsor type
- University, hospital or other
- Collaborators
- Government-wide R&D Fund project for infectious disease research
- Responsible party
- Principal investigator, Ju-Young Shin, Sungkyunkwan University
- Investigators
- Ju-Young Shin, PhD, Principal investigator, Sungkyunkwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04551248
- Sponsor's protocol ID
- SKKU-2020-PneV
- Status last verified
- Sep 2020
- First submitted
- 9 Sep 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29977960Tseng 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.
PubMed 23579258Baker 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.
PubMed 31265459Miller 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.
PubMed 27087150Haber 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.
PubMed 27836437Trinh 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.
PubMed 28202210
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04551248
- Acronym / sponsor ID
- SKKU-2020-PneV
- Conditions
- Pneumococcal Vaccine Adverse Reaction
- Keywords
- Pneumococcal conjugate vaccine, Pneumococcal polysaccharide vaccine, Adverse events following immunisation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000,000 participants (estimated)
- Lead sponsor
- Sungkyunkwan UniversityUniversity, hospital or other
- Collaborators
- Government-wide R&D Fund project for infectious disease research
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PCV13 recipients (children) | – | Biological: 10 or 13-valent pneumococcal conjugate vaccineChildren < 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 vaccinePersons 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 vaccinePersons 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Persons who experienced outcomes of interest within 1 year before the date of vaccination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10 or 13-valent pneumococcal conjugate vaccineAlso: Prevnar 13, Synflorixa four-dose series that is indicated for use at 2, 4, 6, and 12 to 15 months of age. | Biological | PCV13 recipients (children) |
| 23-valent pneumococcal polysaccharide vaccineAlso: Prodiax-23Single 0.5-mL dose administered intramuscularly or subcutaneously only. | Biological | PPSV23 recipients (elderly adults) |
| Influenza vaccineOne dose of trivalent influenza vaccine in flu seasons. | Biological | Influenza vaccine recipients (elderly adults) |
Primary outcome
Relative risk of adverse events
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Background: PubMed 29977960Tseng 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.
- Background: PubMed 23579258Tseng 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.
- Background: PubMed 31265459Baker 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.
- Background: PubMed 27087150Miller 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.
- Background: PubMed 27836437Haber 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.
- Background: PubMed 28202210Trinh 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ju-Young Shin, PhD principal investigator
Sungkyunkwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumococcal Vaccine Adverse Reaction, run by Sungkyunkwan University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ha-Lim Jeon, MS (+82-31-299-4377, hrjeon@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative risk of adverse events (time frame: 2014-2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04551248, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.