| CTRI Number |
CTRI/2025/12/098836 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
01/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Longitudinal |
| Study Design |
Other |
|
Public Title of Study
|
Studying the Immune Systems Reaction to the Flu Shot in healthcare workers |
|
Scientific Title of Study
|
Characterization of immune response post influenza vaccination among health care workers |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anup Jayaram |
| Designation |
Lecturer |
| Affiliation |
Manipal Institute of Virology, Manipal Academy of Higher Education |
| Address |
Room No. 108
Manipal Institute of Virology, Manipal Academy of Higher Education, Manipal, Karnataka - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9482406560 |
| Fax |
08202922719 |
| Email |
anup.jayaram@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Anup Jayaram |
| Designation |
Lecturer |
| Affiliation |
Manipal Institute of Virology, Manipal Academy of Higher Education |
| Address |
Room No. 108
Manipal Institute of Virology, Manipal Academy of Higher Education, Manipal, Karnataka - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9482406560 |
| Fax |
08202922719 |
| Email |
anup.jayaram@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Anup Jayaram |
| Designation |
Lecturer |
| Affiliation |
Manipal Institute of Virology, Manipal Academy of Higher Education |
| Address |
Room No. 108
Manipal Institute of Virology, Manipal Academy of Higher Education, Manipal, Karnataka - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9482406560 |
| Fax |
08202922719 |
| Email |
anup.jayaram@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Institute of Virology, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Karnataka, India - 576104 |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Madhav Nagar, Manipal, Karnataka - 576104 |
| Type of Sponsor |
Research institution |
|
|
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 Chiranjay Mukhopadhyay |
Manipal Institute of Virology |
Room No. 107, Madhav Nagar, Manipal, Karnataka - 576104
Udupi
KARNATAKA |
9845513057
08202922719
chiranjay.m@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ICD-10-CM |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Consented individual
Individuals who are willing to provide pre and post vaccination blood sample as per schedule |
|
| ExclusionCriteria |
| Details |
Participants who have recently diagnosed with Influenza virus infection (within 3 months)
Participants who have received medication/ therapy recently (last six months)
Participants that have refused or withdrawn from study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will provide insights in to evidence-based improvement of immunization protocol in high-risk clinical settings. |
12 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
14/12/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Influenza vaccination is essential for healthcare workers, a priority risk group due to their high exposure and vital role in healthcare delivery. By specifically evaluating vaccine-induced immunity within this group, the study will provide valuable insights into determinants of immune protection, help identify potential gaps in vaccine effectiveness, and contribute to strengthening vaccination strategies and public health preparedness in India. Host factors such as age, prior exposure, vaccination history, co-morbidities, and occupational risk influence immune responses following vaccination. This study will assess how host factors such as age, prior exposure, vaccination history, co-morbidities, and occupational risk influence vaccine-induced immunity, thereby identifying potential gaps in protection and supporting stronger vaccination strategies and public health preparedness in India.
|