Type 1 DiabetesPhase 4NCT04481243
A Study to Evaluate Pneumococcal Polysaccharide Vaccine Effectiveness in Children With Type 1 Diabetes
A Phase 4 study testing Pneumovax 23- pneumococcal polysaccharide and Blood draw in people with Type 1 Diabetes, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Pneumovax 23- pneumococcal polysaccharide and Blood draw
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2021to 20 Jan 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children ages 3-18 years old.
- Clinical diagnosis of Type 1 diabetes.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Vaccine Effectiveness and Seroconversion to 23 Valent Pneumococcal Polysaccharide Vaccination in Children With Type 1 Diabetes
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.
- Conditions
- Type 1 Diabetes
- Being tested
- Pneumovax 23- pneumococcal polysaccharide, Blood draw
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumovax 23- pneumococcal polysaccharideBiological
Also called PPSV23
PPSV23 is a vaccine to help protect against serious infection due to the Streptococcus pneumoniae bacteria. One dose administered intramuscularly or subcutaneously.
Blood drawProcedure or surgery
6 ml blood draw at baseline and 6 months post immunization
| Study group | Role | What they receive |
|---|---|---|
| Pneumovax 23 | Experimental | Type 1 Diabetes subjects will receive Pneumovax 23-pneumococcal polysaccharide (PPSV23) Receives: Biological: Pneumovax 23- pneumococcal polysaccharide; Procedure: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunoglobulin G (IgG) Antibodies
Serological response. Blood draw for assessment of pneumococcal specific titer IgG. Measured as mcg/mL
Measured: 6 months post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start30 Apr 2021
- Primary completion20 Jan 2023
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Will study immunological response to vaccination
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana L. Creo, Mayo Clinic
- Investigators
- Ana Creo, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481243
- Sponsor's protocol ID
- 20-004356
- Status last verified
- Oct 2023
- First submitted
- 20 Jul 2020
- Last updated
- 8 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ender E, Joshi A, Snyder M, Kumar S, Hentz R, Creo A. Seroconversion following PPSV23 vaccination in children with type 1 diabetes mellitus. Vaccine. 2025 Jan 25;45:126592. doi: 10.1016/j.vaccine.2024.126592. Epub 2024 Dec 11.
PubMed 39667114
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccine Effectiveness and Seroconversion to 23 Valent Pneumococcal Polysaccharide Vaccination in Children With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04481243
- Acronym / sponsor ID
- 20-004356
- Conditions
- Type 1 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 22 Jul 2020 (actual)
- Results
- Posted 8 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Will study immunological response to vaccination
| Arm | Type | Receives |
|---|---|---|
| Pneumovax 23 | Experimental | Biological: Pneumovax 23- pneumococcal polysaccharide, Procedure: Blood drawType 1 Diabetes subjects will receive Pneumovax 23-pneumococcal polysaccharide (PPSV23) |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children ages 3-18 years old.
- Clinical diagnosis of Type 1 diabetes.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pneumovax 23- pneumococcal polysaccharideAlso: PPSV23PPSV23 is a vaccine to help protect against serious infection due to the Streptococcus pneumoniae bacteria. One dose administered intramuscularly or subcutaneously. | Biological | Pneumovax 23 |
| Blood draw6 ml blood draw at baseline and 6 months post immunization | Procedure or surgery | Pneumovax 23 |
Primary outcome
Immunoglobulin G (IgG) Antibodies
Time frame: 6 months post vaccination
Serological response. Blood draw for assessment of pneumococcal specific titer IgG. Measured as mcg/mL
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39667114Ender E, Joshi A, Snyder M, Kumar S, Hentz R, Creo A. Seroconversion following PPSV23 vaccination in children with type 1 diabetes mellitus. Vaccine. 2025 Jan 25;45:126592. doi: 10.1016/j.vaccine.2024.126592. Epub 2024 Dec 11.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Creo, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pneumovax 23- pneumococcal polysaccharide and Blood draw in people with Type 1 Diabetes, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunoglobulin G (IgG) Antibodies (time frame: 6 months post vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04481243, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.