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Response to BNT162b2 Vaccine in Adolescents With Type 1 Diabetes - Trial NCT05620251

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.

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NCT05620251
Completed
diagnostic test
Trial Details
ClinicalTrials.gov โ€ข NCT05620251
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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

Study Focus

type1diabetes

Blood test

Observational

diagnostic test

Sponsor & Location

Istanbul Medeniyet University

Istanbul, Turkey

Timeline & Enrollment

N/A

Sep 03, 2021

Jun 12, 2022

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 mellitus
Type 1 diabetes mellitus with unspecified complications
Type 1 diabetes mellitus with other specified complications
Type 1 diabetes mellitus without complications
Type 1 diabetes mellitus with multiple complications

Data Source

ClinicalTrials.gov

NCT05620251

Non-Device Trial