Back to resultsA Study to Evaluate Pneumococcal Polysaccharide Vaccine Effectiveness in Children With Type 1 Diabetes
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pneumovax 23- pneumococcal polysaccharide
Sponsored by
About this trial
This is an interventional prevention trial for Type 1 Diabetes
Eligibility Criteria
Inclusion Criteria:
- Children ages 3-18 years old.
- Clinical diagnosis of Type 1 diabetes.
Exclusion Criteria:
- Newly diagnosed with Type 1 diabetes with in 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.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Children will receive Pneumovax 23 vaccination.
Outcomes
Primary Outcome Measures
IgG Response
serological response
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04481243
Brief Title
A Study to Evaluate Pneumococcal Polysaccharide Vaccine Effectiveness in Children With Type 1 Diabetes
Official Title
Vaccine Effectiveness and Seroconversion to 23 Valent Pneumococcal Polysaccharide Vaccination in Children With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 30, 2021 (Actual)
Primary Completion Date
January 20, 2023 (Actual)
Study Completion Date
January 20, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if children with type 1 diabetes have adequate immune response to PPSV23 vaccination and to assess factors affecting immune response.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Will study immunological response to vaccination
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Children will receive Pneumovax 23 vaccination.
Intervention Type
Biological
Intervention Name(s)
Pneumovax 23- pneumococcal polysaccharide
Intervention Description
Children will receive Pneumovax 23 vaccination. Vaccine response as assessed by Global IgG will be drawn 4-6 months after immunization.
Primary Outcome Measure Information:
Title
IgG Response
Description
serological response
Time Frame
4-6 months post vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children ages 3-18 years old.
Clinical diagnosis of Type 1 diabetes.
Exclusion Criteria:
Newly diagnosed with Type 1 diabetes with in 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Creo, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study to Evaluate Pneumococcal Polysaccharide Vaccine Effectiveness in Children With Type 1 Diabetes
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