Last reviewed · How we verify

NCT06252051

Effectiveness of Trivalent Influenza Vaccine (TIV) in Type 2 Diabetes Mellitus (T2DM) Patients With and Without Complications of Chronic Kidney Disease (CKD)

Completed Phase 4 Last updated 9 February 2024
What this trial tests

Phase 4 trial testing Trivalent Influenza Vaccine in Influenza in 76 participants. Completed in 31 August 2022.

Timeline
5 January 2021
Primary endpoint
31 March 2022
31 August 2022

Quick facts

Lead sponsorUniversitas Padjadjaran
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeprevention
Enrollment76
Start date5 January 2021
Primary completion31 March 2022
Estimated completion31 August 2022
Sites1 location across Indonesia

Drugs / interventions tested

Conditions studied

Sponsor

Universitas Padjadjaran — full company profile →

Who can join

Adults 40 to 49, any sex, with Influenza or Vaccine Reaction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study assesses the effectiveness of the seasonal flu vaccine in individuals with Type 2 Diabetes Mellitus (T2DM) with and without Chronic Kidney Disease (CKD), as well as in healthy individuals. Additionally, the study investigates the dynamics of cytokines, specifically IL-2 and IL-6, in the three groups following influenza vaccination. The findings from these studies will contribute to our understanding of the safety and efficacy of the influenza vaccine in T2DM and T2DM-CKD, shedding light on inflammation changes and informing future research on mitigation strategies.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Immunogenicity, Safety, and Efficacy of Influenza Vaccine in T2DM and T2DM with Chronic Kidney Disease.
    Heryaman H, Juli C, Nazir A, Syamsunarno MRAA, et al · · 2024 · cited 1× · PMID 38543861 · DOI 10.3390/vaccines12030227

Verify or expand the search:

Other trials of Trivalent Influenza Vaccine

Trials testing the same drug.

Other recruiting trials for Influenza

Currently open trials in the same condition.

Other Universitas Padjadjaran 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/NCT06252051.

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