Home » Trials » SLCTR/2022/008
Heterologous covid-19 vaccine intervention effect on reactogenicity
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SLCTR Registration Number
SLCTR/2022/008
Date of Registration
The date of last modification
Apr 05, 2022
Scientific Title of Trial
Heterologous covid-19 vaccine intervention effect on reactogenicity
Public Title of Trial
Short term vaccine reactions due to mixing and matching of COVID-19 vaccines
Disease or Health Condition(s) Studied
Reactogenicity of vaccine
Scientific Acronym
COVID-19
Public Acronym
COVID-19
Brief title
COVID-19 vaccines reactogenicity
Universal Trial Number
U1111-12747639
Any other number(s) assigned to the trial and issuing authority
ERC / ID /194; ERC, Army medical college, Pakistan
What is the research question being addressed?
What is the frequency of short term reaction to vaccines in patients receiving heterologous COVID-19 vaccine compared to homologous vaccine?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded : Participants, Healthcare providers
Control
Standard therapy/practice
Assignment
Single
Purpose
Health services research
Study Phase
Phase 4
Intervention(s) planned
Study setting: Public sector medical college Rawalpindi. Intervention of Ad5-nCoV and mRNA-1273 vaccine is planned . Name of vaccine administered: Ad5-nCoV and mRNA-1273 vaccine. Strength and volume: 0.5 ml of Ad5-nCoV and 0.25 ml of mRNA-1273 Route of administration: Intramuscular. Intervention is planned by Public sector medical college.
It is a controlled study with absence of active control group. Participants history of vaccine reactogencity with homologous first booster dose will be compared with reactogenicity of heterologous second vaccine booster intervention.
Homologous first booster dose reactogenicity of BBIBP-CorV will be control group in this study. Intervention of Ad5-nCoV and mRNA-1273 vaccine will be planned and they both will serves as intervention group.
College medical facility is well equipped with every health care facility possible and is capable to cope up with mild to severe reactions. The participants will be given symptomatic relief for milder vaccine reactions. Severe vaccine reactions will be dealt with recommended medical guidelines.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Number of participants with anaphylactic reactions ( 3 to 4 hour post vaccine) |
[ 3 to 4 hour post vaccine ] |
|
2.
Number of participants with fever Number of participants with myalgia Number of participants with pain and redness at injection site Number of participants feeling cold Number of participants with dizziness Number of participants with paresthesia in arm Number of participants with lightheadedness (participants of point 2 to 8 will report back if they experience any of these symptoms or need any health service) |
[ 2- Participants of point 2 to 8 will report back if they experience any of these symptoms or need any health service) within first 7 days of giving vaccine ] |
|
3.
Number of participants with no reaction experienced or observed at all (after 7 days) they will all report back after 7 days to tell |
[ No reaction experienced or observed at all after 7 days of vaccination ] |
|
4.
Number of participants with dyspnea (till 3 to 4 hour) |
[ Till 3 to 4 hours post vaccination ] |
|
5.
Number of participants with tachycardia (24 hours ) |
[ Till 24 hours post ] |
Secondary outcome(s)
|
1.
None |
[] |
Target number/sample size
448
Countries of recruitment
Pakistan
Anticipated start date
2022-04-05
Anticipated end date
2022-04-20
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
University and Government of Pakistan
Regulatory approvals
Pending
Status
Approved
Date of Approval
2022-02-28
Approval number
ERC / ID /194
Details of Ethics Review Committee
| Name: | Ethical Review Committee of Army Medical College, Pakistan |
| Institutional Address: | Army Medical College, Abid Majeed Road, Rawalpindi cantt |
| Telephone: | 051-5516755 |
| Email: | erc@amc.numspak.edu.pk |
Contact person for Scientific Queries/Principal Investigator
Ms. Wajeha Najeeb
Student
Army Medical College Rawalpindi, Pakistan
+923330335060
+923330335060
wajehaamc@gmail.com
Contact Person for Public Queries
Prof. Palvasha Waheed
Professor of Biochemistry
Army Medical College Rawalpindi, Pakistan
+923005143242
+923330335060
p_waheed@hotmail.com
Primary study sponsor/organization
Public Sector Medical College, Rawalpindi
Rawalpindi, Pakistan
Abid Majeed, Rawalpindi cantt
03005143242
p_waheed@hotmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
Individual participants will not be available only de-identified data which will include tables text and graph will be shared. Statistical analysis plan will also be available. Data will be shared beginning from 3 months and ending 5 years following article publication. Data will be available for anyone who wishes to access data, for any purpose. Data will be available indefinitely at provided link to proposed IPD database
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
