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NCT05620251

Response to BNT162b2 Vaccine in Adolescents With Type 1 Diabetes

Immunogenicity of SARS-CoV-2 BNT162b2 Vaccine in Adolescents With Type 1 Diabetes: A Prospective Observational Study
Istanbul Medeniyet University·ClinicalTrials.gov·diagnostic testCompleted
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Study focus
Disease/Condition
type1diabetes
Drug/Device/Intervention
Blood test
Study type
Observational
Intervention type
diagnostic test
Sponsor & location
Primary sponsor
Istanbul Medeniyet University
Location
Istanbul, Turkey
Timeline & enrollment
Phase
N/A
Start date
Sep 03, 2021
End date
Jun 12, 2022
Enrollment
121 participants
Primary outcome

humoral immune response after first vaccine dose,humoral immune response after second vaccine dose

Summary

Adolescents with type 1 diabetes may be at increased risk for severe coronavirus disease-2019
 (COVID-19) and are therefore prioritized for access to severe acute respiratory syndrome
 coronavirus 2 (SARS-CoV-2) vaccination. The pivotal trial that assessed the efficacy of the
 BNT162b2 vaccine among adolescents demonstrated 100% protection against SARS-CoV-2 infection
 after a two-dose regimen. However, the research did not include adolescents with type 1
 diabetes. In this study, the investigators aimed to assess the humoral immune response of
 infection-naive adolescents with type 1 diabetes following vaccination with the BNT162b2
 vaccine in comparison to that of infection-naive healthy controls and the factors associated
 with that response.

ICD-10 classifications
Type 1 diabetes mellitusType 1 diabetes mellitus with unspecified complicationsType 1 diabetes mellitus with other specified complicationsType 1 diabetes mellitus without complicationsType 1 diabetes mellitus with multiple complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05620251
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05620251 through Pure Global AI's free database. This phase not specified trial is sponsored by Istanbul Medeniyet University and is currently Completed. The study focuses on type1diabetes. Target enrollment is 121 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.