Status:
COMPLETED
Cardiac Manifestation in Adolescent After Pfizer COVID-19 Injection in Thailand
Lead Sponsor:
Mahidol University
Conditions:
Covid-19 Vaccine
Eligibility:
All Genders
13-18 years
Brief Summary
Rationale Recently, a CDC advisory Committee on Immunization Practices identified a likely association between the 2 COVID-19 mRNA vaccines from Pfizer-BioNTech and Moderna and cases of myocarditis an...
Detailed Description
Data Collection Methods 1. Participants' demographics will be collected at baseline using case record form. 2. Laboratory tests include: at 3 clinical visits (Baseline, Day3, Day7 and Day 14 (optiona...
Eligibility Criteria
Inclusion
- Age 13-18 years old
- Both males and females
- Received 1st dose Pfizer COVID-19 vaccine injection
Exclusion
- Unable to obtain written informed consent from the participants or their legal representatives
- History of cardiomyopathy, tuberculous pericarditis, and constrictive pericarditis
- Severe allergic reaction to COVID-19 vaccine
Key Trial Info
Start Date :
November 3 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 15 2022
Estimated Enrollment :
314 Patients enrolled
Trial Details
Trial ID
NCT05288231
Start Date
November 3 2021
End Date
March 15 2022
Last Update
June 2 2022
Active Locations (1)
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1
Faculty of Tropical Medicine
Bangkok, Thailand, 10400