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

Mayo Clinic

Status and phase: Completed; Phase 4

Conditions: Type 1 Diabetes

Treatments: Procedure: Blood draw; Biological: Pneumovax 23- pneumococcal polysaccharide

Study type: Interventional

Funder types: Other

Identifiers

NCT04481243

20-004356

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

29 participants in 1 patient group

Pneumovax 23

Experimental group

Description:

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

Treatment:

Biological: Pneumovax 23- pneumococcal polysaccharide

Procedure: Blood draw