Trial Outcomes & Findings for A Study to Evaluate Pneumococcal Polysaccharide Vaccine Effectiveness in Children With Type 1 Diabetes (NCT NCT04481243)

Last Updated: 2023-11-08

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

29 participants

Primary outcome timeframe

6 months post vaccination

Results posted on

2023-11-08

Participant milestones
Measure	Pneumovax 23 Type 1 Diabetes subjects received Pneumovax 23-pneumococcal polysaccharide (PPSV23) 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. Blood draw: 6 ml blood draw at baseline and 6 months post immunization
Overall Study STARTED	29
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	4

Reasons for withdrawal
Measure	Pneumovax 23 Type 1 Diabetes subjects received Pneumovax 23-pneumococcal polysaccharide (PPSV23) 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. Blood draw: 6 ml blood draw at baseline and 6 months post immunization
Overall Study Withdrawal by Subject	4

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

Baseline characteristics by cohort
Measure	Pneumovax 23 n=29 Participants Type 1 Diabetes subjects received Pneumovax 23-pneumococcal polysaccharide (PPSV23) 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. Blood draw: 6 ml blood draw at baseline and 6 months post immunization
Age, Continuous	11.6 years STANDARD_DEVIATION 3.3 • n=5 Participants
Sex/Gender, Customized Male	17 Participants n=5 Participants
Sex/Gender, Customized Female	11 Participants n=5 Participants
Sex/Gender, Customized Unknown	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants

Timeframe: 6 months post vaccination

Population: Three subjects withdrew prior to the 6 months post vaccination blood draw and one subject withdrew prior to receiving the vaccine.

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

Outcome measures
Measure	Pneumovax 23 n=25 Participants Type 1 Diabetes subjects received Pneumovax 23-pneumococcal polysaccharide (PPSV23) 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. Blood draw: 6 ml blood draw at baseline and 6 months post immunization
Immunoglobulin G (IgG) Antibodies	270.0 mcg/mL Interval 203.3 to 270.1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Mayo Clinic

Phone: 507-284-3300