| CTRI Number |
CTRI/2025/09/094874 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Other |
|
Public Title of Study
|
How effectively influenza vaccine offers protection in children with nephrotic syndrome |
|
Scientific Title of Study
|
Immunogenicity of influenza vaccination in children with idiopathic nephrotic syndrome |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anupama Vinayan |
| Designation |
Junior resident |
| Affiliation |
JIPMER Puducherry |
| Address |
Junior resident, Department of paediatrics, 2nd floor, Women and child block, JIPMER, Dhanwantari Nagar, Puducherry-605006, India
Jawaharlal institute of postgraduate medical education and research, Dhanwantari Nagar, Puducherry-605006, India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
6235944432 |
| Fax |
|
| Email |
vinayan.anupama@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bobbity Deepthi |
| Designation |
Associate Professor |
| Affiliation |
JIPMER Puducherry |
| Address |
Department of paediatrics, 2nd floor, Women and child block, JIPMER, Dhanwantari Nagar, Puducherry-605006, India
Jawaharlal institute of postgraduate medical education and research, Dhanwantari Nagar, Puducherry-605006, India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9999236415 |
| Fax |
|
| Email |
deepu.reddy222@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bobbity Deepthi |
| Designation |
Associate Professor |
| Affiliation |
JIPMER Puducherry |
| Address |
Department of paediatrics, 2nd floor, Women and child block, JIPMER, Dhanwantari Nagar, Puducherry-605006, India
Jawaharlal institute of postgraduate medical education and research, Dhanwantari Nagar, Puducherry-605006, India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9999236415 |
| Fax |
|
| Email |
deepu.reddy222@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JIPMER Intramural Research fundIMRF |
| Address |
Jawaharlal institute of post graduate medical education and research, Jipmer campus road, Gorimedu, Dhanvantari nagar, Puducherry, India, 605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anupama Vinayan |
JIPMER |
Paediatric nephrology clinic,Department of paediatrics, Ist floor Women and child hospital, Jawaharlal institute of post graduate medical education and research, Puducherry, 605006
Pondicherry
PONDICHERRY |
6235944432
vinayan.anupama@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER Institutional ethics committee- Interventional studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N04||Nephrotic syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Influenza vaccination |
Influenza vaccination with inactivated split virion quadrivalent vaccine, preferably Northern hemisphere IIV4 with longer expiry date or vaccine advocated by NIV, Pune for current year |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 1-18 years, diagnosed with Idiopathic nephrotic syndrome attending pediatric nephrology clinic |
|
| ExclusionCriteria |
| Details |
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)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
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 Outcome
|
| Outcome |
TimePoints |
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
|
baseline, 30 days, 6 months, 1 year |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present study shall be conducted at the pediatric nephrology clinic, of a tertiary care centre hospital, JIPMER, Puducherry from June 2025 to June 2027 after obtaining prior approval from the Institutional Ethics Committee. The study will be carried out in accordance with the World Medical Association (WMA) Declaration of Helsinki ethical principles for medical research involving human subjects. Written informed consent shall be obtained from the parents prior to enrolment for the study. This study will be a prospective study in which children and adolescents with idiopathic nephrotic syndrome fulfilling the inclusion criteria shall be enrolled. Children and Adolescents aged 1-18 years with idiopathic nephrotic syndrome (INS) satisfying the inclusion and exclusion criteria (attending the Pediatric nephrology clinic) shall be recruited for this study. The enrolled participants shall receive the intervention Northern hemisphere quadrivalent Inactivated Influenza vaccine (IIV4) with longer expiry date, composition of vaccine as per Government of India guidelines for the season. The vaccine available in the prefilled syringe, 0.5 ml will be given as deep intramuscular injection in deltoid. For children aged below 8 years, 2 doses 4-weeks apart are recommended if they are receiving the IIV for the first time, while older children shall receive a single dose of vaccine. The vaccine shall be administered by the unblinded study staff.To measure the immunogenicity of vaccine, the change in the level of Hemagglutinin Inhibition Antibody (HAI) titres will be measured and expressed in Geometric Mean Titres (GMT). HAI assay will be standardized with 8HA units/50ml of all four standard vaccine antigens individually. The standard vaccine antigens will be procured from Influenza resource centre, National Institute for Biological Standards and Control (NIBSC) UK. Serum sample will be diluted two-fold in 96 well plated followed by addition of standard antigen to each well. Finally, 1% turkey RBC will be added to determine the HAI titre for each sample. The mean change in GMT titres at day 30, 6 months, and 1 year, shall be compared with baseline GMT in all study participants. The seroconversion is defined as HAI titres > 1:40, the level which gives 50% protection against lab confirmed influenza in vaccine recipients. The proportion of participants achieving and maintaining seroconversion at day 30, 6 months, and 1 year, will be compared.
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