| Trial ID: | L0729 |
| Source ID: | NCT06252051
|
| Associated Drug: |
Trivalent Influenza Vaccine
|
| Title: |
Effectiveness of Trivalent Influenza Vaccine (TIV) in Type 2 Diabetes Mellitus (T2DM) Patients With and Without Complications of Chronic Kidney Disease (CKD)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Influenza|Vaccine Reaction|Diabetes Mellitus|Chronic Kidney Diseases
|
| Interventions: |
DRUG: Trivalent Influenza Vaccine
|
| Outcome Measures: |
Primary: ILI Morbidity, Determined by the time from treatment to 6 months after, 6 months|Immunogenicity, Determine the changes in titers over time using the hemagglutination (HA) method at the 1st, 3rd, and 6th months after vaccination., 6 months | Secondary: Inflammatory interleukin measurements, Inflammatory analysis will be performed in the 1st, 3rd, and 6th months., 6 months
|
| Sponsor/Collaborators: |
Sponsor: Universitas Padjadjaran | Collaborators: Biofarma|Universiti Sains Malaysia
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
76
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
|
| Start Date: |
2021-01-05
|
| Completion Date: |
2022-08-31
|
| Results First Posted: |
|
| Last Update Posted: |
2024-02-09
|
| Locations: |
AMC Hospital, Bandung, West Java, Indonesia
|
| URL: |
https://clinicaltrials.gov/show/NCT06252051
|
