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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-30

Study Completion Date

2023-01-20

Brief Summary

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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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Detailed Description

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Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Will study immunological response to vaccination

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Pneumovax 23

Type 1 Diabetes subjects will receive Pneumovax 23-pneumococcal polysaccharide (PPSV23)

Group Type EXPERIMENTAL

Pneumovax 23- pneumococcal polysaccharide

Intervention Type BIOLOGICAL

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

Blood draw

Intervention Type PROCEDURE

6 ml blood draw at baseline and 6 months post immunization

Interventions

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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.

Intervention Type BIOLOGICAL

Blood draw

6 ml blood draw at baseline and 6 months post immunization

Intervention Type PROCEDURE

Other Intervention Names

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PPSV23

Eligibility Criteria

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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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No