- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04481243
A Study to Evaluate Pneumococcal Polysaccharide Vaccine Effectiveness in Children With Type 1 Diabetes
October 18, 2023 updated by: Ana L. Creo, Mayo Clinic
Vaccine Effectiveness and Seroconversion to 23 Valent Pneumococcal Polysaccharide Vaccination in Children With Type 1 Diabetes
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pneumovax 23
Type 1 Diabetes subjects will receive Pneumovax 23-pneumococcal polysaccharide (PPSV23)
|
PPSV23 is a vaccine to help protect against serious infection due to the Streptococcus pneumoniae bacteria.
One dose administered intramuscularly or subcutaneously.
Other Names:
6 ml blood draw at baseline and 6 months post immunization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunoglobulin G (IgG) Antibodies
Time Frame: 6 months post vaccination
|
Serological response.
Blood draw for assessment of pneumococcal specific titer IgG.
Measured as mcg/mL
|
6 months post vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ana Creo, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 30, 2021
Primary Completion (Actual)
January 20, 2023
Study Completion (Actual)
January 20, 2023
Study Registration Dates
First Submitted
July 20, 2020
First Submitted That Met QC Criteria
July 20, 2020
First Posted (Actual)
July 22, 2020
Study Record Updates
Last Update Posted (Estimated)
November 8, 2023
Last Update Submitted That Met QC Criteria
October 18, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-004356
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 1 Diabetes
-
Poznan University of Medical SciencesUnknownDiabetes Mellitus Type 1 | Remission of Type 1 Diabetes | Chronic Complications of DiabetesPoland
-
Eledon PharmaceuticalsWithdrawnBrittle Type 1 Diabetes MellitusUnited States
-
National Institute of Allergy and Infectious Diseases...PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)CompletedType 1 Diabetes Mellitus | T1DM | T1D | New-onset Type 1 Diabetes MellitusUnited States, Australia
-
Hoffmann-La RocheCompletedType 2 Diabetes, Type 1 DiabetesAustria, United Kingdom
-
Shanghai Changzheng HospitalRecruitingBrittle Type 1 Diabetes MellitusChina
-
Capillary Biomedical, Inc.TerminatedType 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Type I | Diabetes Mellitus, Insulin-Dependent, 1 | IDDMAustria
-
Capillary Biomedical, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Insulin-Dependent, 1Australia
-
AstraZenecaCompletedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
NYU Langone HealthNational Heart, Lung, and Blood Institute (NHLBI)Recruiting
-
Rabin Medical CenterDreaMed DiabetesTerminated
Clinical Trials on Pneumovax 23- pneumococcal polysaccharide
-
Cedars-Sinai Medical CenterCompletedCrohn Disease | Ulcerative Colitis | Inflammatory Bowel DiseaseUnited States
-
Seema BhatRecruitingChronic Lymphocytic Leukemia | Small Lymphocytic LymphomaUnited States
-
University of UtahNational Cancer Institute (NCI)RecruitingChronic Lymphocytic Leukemia | Small Lymphocytic LymphomaUnited States
-
US Department of Veterans AffairsAlbert Einstein College of Medicine; Montefiore Medical CenterCompletedHIV InfectionsUnited States
-
Rohit DivekarCompleted
-
PATHCompleted
-
University of FloridaCompleted
-
VA Office of Research and DevelopmentTerminatedAging | Renal TransplantationUnited States
-
University of MinnesotaNational Heart, Lung, and Blood Institute (NHLBI)CompletedPulmonary Disease, Chronic ObstructiveUnited States
-
Medical University of South CarolinaCompletedAging | HIV LipodystrophyUnited States