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How effectively influenza vaccine offers protection in children with nephrotic syndrome

Immunogenicity of influenza vaccination in children with idiopathic nephrotic syndrome - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094874
Enrollment
80
Registered
2025-09-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: N04- Nephrotic syndrome

Interventions

Intervention1: Influenza vaccination: Influenza vaccination with inactivated split virion quadrivalent vaccine, preferably Northern hemisphere IIV4 with longer expiry date or vaccine advocated by NIV,

Sponsors

JIPMER Intramural Research fundIMRF
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 1-18 years, diagnosed with Idiopathic nephrotic syndrome attending pediatric nephrology clinic

Exclusion criteria

Exclusion criteria: Children who have low eGFR less than 60mL/min/1.73m2 at enrollment Children with known severe allergy to vaccine components or to previous doses of inactivated influenza vaccine (IIV)

Design outcomes

Primary

MeasureTime frame
To estimate the immunogenicity of influenza vaccination as measured by proportion of vaccinated participants achieving seroprotection; Hemagglutinin Inhibition Antibody (HAI) titre more than or equal to 1:40 at 30 days, 6 months, and 1-year postvaccination.Timepoint: Proportion of vaccinated participants achieving seroprotection; Hemagglutinin Inhibition Antibody (HAI) titre more than or equal to 1:40 at 30 days, 6 months, and 1-year postvaccination.—

Secondary

MeasureTime frame
To determine the change (from the baseline) in HAI (GMT) antibody titres when assessed at 30 days, 6 months, & 1-year post-vaccination. To compare the seroprotection rates & HAI antibody titres among different clinical phenotypes of pediatric nephrotic syndrome (e.g., infrequently relapsing nephrotic syndrome, frequently relapsing nephrotic syndrome, steroid dependent nephrotic syndrome, & steroid resistant nephrotic syn-drome). INS relapse rate in the year following vaccination (efficacy measure) To determine the proportion of children who develop lower respiratory illness due to influenza virus in the year follow-ing vaccination Timepoint: baseline, 30 days, 6 months, 1 year—

Countries

India

Contacts

Public ContactDr Bobbity Deepthi

JIPMER Puducherry

deepu.reddy222@gmail.com9999236415

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026