A Study to Evaluate Pneumococcal Polysaccharide Vaccine Effectiveness 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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pneumovax 23- pneumococcal polysaccharide

Biological

PPSV23 is a vaccine to help protect against serious infection due to the Streptococcus pneumoniae bacteria. One dose administered intramuscularly or subcutaneously.

Other names: PPSV23

Blood draw

Procedure

6 ml blood draw at baseline and 6 months post immunization

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Jul 22, 2020
Registry last updated: Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed