| CTRI Number |
CTRI/2022/01/039372 [Registered on: 13/01/2022] Trial Registered Prospectively |
| Last Modified On: |
12/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Determination of COVID-19 Vaccine Acceptance and Side Effects |
|
Scientific Title of Study
|
Determination of COVID-19 Vaccine Acceptance and Encountered Side Effects among the Vaccinated People in Andhra Pradesh |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhupalam Pradeepkumar |
| Designation |
Principal Investigator |
| Affiliation |
Raghavendra Institute of Pharmaceutical Education and Research (RIPER)-Autonomous |
| Address |
Raghavendra Institute of Pharmaceutical Education and Research (RIPER) Autonomous
KR Palli Cross Chiyedu Post Anantapur 515721 KR Palli Cross Chiyedu Post Anantapur-515721
Anantapur
ANDHRA PRADESH
515721
India |
| Phone |
9985968504 |
| Fax |
|
| Email |
bhupalampradeep@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhupalam Pradeepkumar |
| Designation |
Principal Investigator |
| Affiliation |
Raghavendra Institute of Pharmaceutical Education and Research (RIPER)-Autonomous |
| Address |
Raghavendra Institute of Pharmaceutical Education and Research (RIPER) Autonomous
KR Palli Cross Chiyedu Post Anantapur 515721 KR Palli Cross Chiyedu Post Anantapur-515721
12-105, II Cross, Sainagar, Anantapur-515001, AP
Anantapur
ANDHRA PRADESH
515721
India |
| Phone |
9985968504 |
| Fax |
08554255646 |
| Email |
bhupalampradeep@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
B H Sai Dharani |
| Designation |
Project student |
| Affiliation |
Raghavendra Institute of Pharmaceutical Education and Research (RIPER)-Autonomous |
| Address |
Pharm D V Year
Raghavendra Institute of Pharmaceutical Education and Research (RIPER) Autonomous
KR Palli Cross Chiyedu Post Anantapur 515721 KR Palli Cross Chiyedu Post Anantapur-515721, AP, India
RIPER Hostel, Sharada Nagar, Anantapur-515002, AP, India
Anantapur
ANDHRA PRADESH
515721
India |
| Phone |
8639247166 |
| Fax |
08554255646 |
| Email |
saidharanictr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Raghavendra Institute of Pharmaceutical Education and Research RIPER Autonomous |
|
|
Primary Sponsor
|
| Name |
Raghavendra Institute of Pharmaceutical Education and Research RIPERAutonomous |
| Address |
Raghavendra Institute of Pharmaceutical Education and Research (RIPER) Autonomous
KR Palli Cross, Chiyedu Post, Anantapur-515721KR Palli Cross, Chiyedu Post, Anantapur-515721 |
| 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 |
| Bhupalam Pradeepkumar |
Raghavendra Institute of Pharmaceutical Education and Research RIPER Autonomous |
Room Number: 84,Department of Pharmacology, KR Palli Cross, Chiyedu Post, Anantapur-515721
Anantapur
ANDHRA PRADESH |
9985968504
bhupalampradeep@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RIPER IRB |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal health |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Population of age above 18 years of either sex and residents of Andhra Pradesh are included in the study. |
|
| ExclusionCriteria |
| Details |
Population with no internet facilities or androids and illiterates were excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
This study aids in determining potential barriers for accepting COVID-19 vaccine.
This information helps in changing the public perspective regarding COVID-19 vaccine and related side effects.
This survey will assist the government and policy makers to create awareness in public for better vaccine acceptancy rate.
This study will support in decreasing COVID-19 incidence rate in Andhra Pradesh. |
3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine side effects encountered in vaccinated people |
3 months |
|
|
Target Sample Size
|
Total Sample Size="357"
Sample Size from India="357"
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)
|
17/01/2022 |
| 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="3"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [bhupalampradeep@gmail.com].
- For how long will this data be available start date provided 16-02-2022 and end date provided 15-11-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
The study is planned to conduct after
getting approval from the Ethics committee (IRB, RIPER). Participants who met inclusion criteria will
be enrolled. A structured questionnaire comprising demographic information,
including gender, region, religion, parenteral income, educational
qualification, occupation, attitude towards vaccination, and barriers of vaccine
acceptance will be prepared. A Google form comprising of this questionnaire
will be prepared and the link will be sent to the study participants to seek
the response. All responses of the participants will be recorded and analyzed
to find statistical significance. |