A Study to Evaluate Pneumococcal Polysaccharide Vaccine Effectiveness in Children with Type 1 Diabetes
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 20-004356
NCT ID: NCT04481243
About this study
Diabetics are at risk for invasive pneumococcal infections and are more likely to have severe outcomes with infection compared to the general population. The pneumococcal (PPSV23) vaccination is recommended for all people with type 1 diabetes, but whether the vaccine is beneficial for this population has not been established. The purpose of this study is to determine if children with type 1 diabetes have adequate immune response to the PPSV23 vaccination and to assess factors affecting immune response through a pre and post vaccination blood sample.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Children ages 3-18 years old.
- Clinical diagnosis of Type 1 diabetes.
Exclusion Criteria:
- Newly diagnosed with Type 1 diabetes within the past month of study date.
- Contraindications to receiving 23 valent pneumococcal vaccines.
- Other conditions associated with compromised immunity and vaccine response.
- Primary or Secondary Immune deficiency.
- Previous receipt of PPSV-23 vaccination.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Ana Creo, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available