Immunogenicity of a single standard dose versus a double standard dose of inactivated trivalent influenza vaccine in patients on peritoneal dialysis: Open labelled Randomized control trial

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20220526003

Enrollment

125

Registered

2022-05-26

Start date

2022-07-04

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Single standard dose of trivalent inactivated influenza vaccine, 15 mcg/strain, Intramuscular,Double standard dose of trivalent inactivated influenza vaccine, 30 mcg/strain , Intramuscular

Active Comparator Biological/Vaccine,Active Comparator Biological/Vaccine

Single standard dose,Double standard dose

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. End stage kidney disease patients on peritoneal dialysis more than one month with a total weekly kt/v of at least 1.7 2. Life expectancy more than 1 year 3. No history of kidney transplantation

Exclusion criteria

Exclusion criteria: 1. Receiving any vaccine 2 weeks before enrollment 2. Receiving influenza vaccine 6 months before enrollment 3. Egg allergy, influenza vaccine allergy 4. influenza-like symptoms in the previous 3 days 5. thrombocytopenia 6. recieved immunosuppression or having immunocompromised status 7. active cancer with treatment 8. underwent organ transplantation 9. history of Guillain-Barre syndrome or family history of Guillain-Barre syndrome

Design outcomes

Primary

Measure	Time frame
Immunogenicity Baseline, 1 Mo, 6 Mo, 12 Months Hemagglutination inhibition assay, activation and/or exhaustion T cell markers, T cell subpopulation	—

Secondary

Measure	Time frame
Vaccine efficacy within 12 months after end of intervention incidence of influenza,Safety day 3 and day 7 after additional dose of vaccine Solicited and unsolicited adverse events	—

Countries

Thailand

Contacts

Public ContactSarinya Boongird

Ramathibodi Hospital, Mahidol University

sarinya.bon@mahidol.ac.th022011400

Outcome results