Phase 4 N=29 Prevention

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

Type 1 Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT04481243 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2023

Primary outcome: Primary: Immunoglobulin G (IgG) Antibodies — 270.0 mcg/mL

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Pneumovax 23- pneumococcal polysaccharide (Biological); Blood draw (Procedure)
Age: Pediatric, Adult · 3+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Jan 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Immunoglobulin G (IgG) Antibodies	270.0	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04481243). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.