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NCT04481243

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

Completed Phase 4 Results posted Last updated 8 November 2023
What this trial tests

Phase 4 trial testing Pneumovax 23- pneumococcal polysaccharide in Type 1 Diabetes in 29 participants. Completed in 20 January 2023.

Timeline
30 April 2021
Primary endpoint
20 January 2023
20 January 2023

Quick facts

Lead sponsorMayo Clinic
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeprevention
Enrollment29
Start date30 April 2021
Primary completion20 January 2023
Estimated completion20 January 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Mayo Clinic

Who can join

Adults 3 to 18, any sex, with Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Immunoglobulin G (IgG) Antibodies Primary · 6 months post vaccination

Serological response. Blood draw for assessment of pneumococcal specific titer IgG. Measured as mcg/mL

GroupValue95% CI
Pneumovax 23270.0203.3 – 270.1

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Type 1 Diabetes

Currently open trials in the same condition.

Other Mayo Clinic trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04481243.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing