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

NCT04481243 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2023-11-08

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Ana Creo, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2023-01-20
Completion
2023-01-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04481243 on ClinicalTrials.gov