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NCT04481243 Clinical Trial

A Study to Evaluate Pneumococcal Polysaccharide Vaccine Effectiveness in Children With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:
Vaccine Effectiveness and Seroconversion to 23 Valent Pneumococcal Polysaccharide Vaccination in Children With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04481243
Other study ID # 20-004356
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 30, 2021
Est. completion date January 20, 2023

Study information
Verified date October 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 29
Est. completion date January 20, 2023
Est. primary completion date January 20, 2023
Accepts healthy volunteers No
Gender All
Age group 3 Years to 18 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• Pneumovax 23- pneumococcal polysaccharide
PPSV23 is a vaccine to help protect against serious infection due to the Streptococcus pneumoniae bacteria. One dose administered intramuscularly or subcutaneously.
Procedure:
• Blood draw
6 ml blood draw at baseline and 6 months post immunization

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Immunoglobulin G (IgG) Antibodies Serological response. Blood draw for assessment of pneumococcal specific titer IgG. Measured as mcg/mL 6 months post vaccination
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