| CTRI Number |
CTRI/2021/08/035885 [Registered on: 24/08/2021] Trial Registered Prospectively |
| Last Modified On: |
20/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Perception of COVID-19 vaccines among adults in Tamil Nadu: a survey |
|
Scientific Title of Study
|
Perception of COVID-19 vaccines among adults in Tamil Nadu: a survey |
| Trial Acronym |
COVID-19 VACCINE SURVEY |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Melvin George |
| Designation |
Associate Professor |
| Affiliation |
SRM MCH and RC |
| Address |
Room No: 381, DEPARTMENT OF CLINICAL PHARMACOLOGY, SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER, KATTANKULATHUR, CHENNAI
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9894133697 |
| Fax |
|
| Email |
melvingeorge2003@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Melvin George |
| Designation |
Associate Professor |
| Affiliation |
SRM MCH and RC |
| Address |
Room No: 381, DEPARTMENT OF CLINICAL PHARMACOLOGY, SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER, KATTANKULATHUR, CHENNAI
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9894133697 |
| Fax |
|
| Email |
melvingeorge2003@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
R BILLY GRAHAM |
| Designation |
PHARM-D INTERN |
| Affiliation |
SRM MCH and RC |
| Address |
Room No: 381, DEPARTMENT OF CLINICAL PHARMACOLOGY, SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER, KATTANKULATHUR, CHENNAI
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9940267520 |
| Fax |
|
| Email |
billygraham29899@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
|
|
Primary Sponsor
|
| Name |
SRM University |
| Address |
SRM Medical Hospital and Research Centre, Kattankulathur 603203 |
| Type of Sponsor |
Other [Self Funding] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SRM UNIVERSITY |
SRM Medical Hospital and Research Centre, Kattankulathur 603203 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Melvin George |
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
Room No 381, DEPARTMENT OF CLINICAL PHARMACOLOGY,SRM MCH AND RC, KATTANKULATHUR, CHENNAI
Kancheepuram
TAMIL NADU |
9894133697
melvingeorge2003@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Instituional Ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Both Vaccinated and Non vaccinated Adults are involved in the study |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18 to 80 years of either gender
2. Both vaccinated and non-vaccinated adults
3. Adults with or without history of COVID-19 infection.
4. Participants resident of Tamil Nadu for at lest 2 years. |
|
| ExclusionCriteria |
| Details |
1. Those are not willing to participate in the study
2. Below 18 age participants
3. Participants who are from other states of India. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Proportion of adults with hesitancy towards COVID-19 vaccines.
• Evaluation of factors contributing towards vaccine hesitancy among the adult’s in Tamil Nadu.
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Description of information seeking behavior among adults living in Tamil Nadu towards COVID-19 vaccines.
• Description of trends in vaccine hesitancy among different districts in Tamil Nadu |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
30/08/2021 |
| 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="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
The results will be analyzed and published in a peer-reviewed journal. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will be initiated after obtaining the ethical approval. The Queries regarding the COVID-19 vaccination survey has been created using Google form. The survey consists of sections with Informed consent followed by 40 questions based on general opinion about COVID-19 vaccine and reasons for hesitancy in taking vaccinations will be recorded. The overall data will be collected and analysed by using appropriate statistical tool. |