AzTrials
AzTrials

Covid-19 VaccineNCT05288231

Cardiac Manifestation in Adolescent After Pfizer COVID-19 Injection in Thailand

An observational study of Covid-19 Vaccine, run by Mahidol University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 and pericarditis. For the cardiovascular system, 4863 adverse events (AEs) were reported from the Pfizer vaccine. Read more about this study

Who is it for?
Ages 13 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Covid-19 Vaccine
What is being tested?
Diagnostic of ECG
How many people
314 participants
Where
1 siteThailand
Study dates
3 Nov 2021to 15 Mar 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: Student age 13-18 who received 1st dose of pfizer COVID-19 vaccine from 1. Kong thabbok upatham changkol kho so tho bo school 2. Wachirathamsatit school

Who may be able to join

  • Age 13-18 years old
  • Both males and females
  • Received 1st dose Pfizer COVID-19 vaccine injection

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Faculty of Tropical Medicine

    Bangkok, 10400

Other trials in Thailand

About this study

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 and pericarditis. For the cardiovascular system, 4863 adverse events (AEs) were reported from the Pfizer vaccine. Common findings observed with vaccines under study were tachycardia(16.41%), flushing (12.17%), hypertension (5.82%), hypotension (3.6%), and increased heart rate (9.03%). In this study we characterized, classified, evaluate the dynamic of cardiac function and ECG abnormality after the Pfizer vaccine injection.

This is a prospective cohort study. All participants aged 13-18 years old and above who visited the second dose Pfizer covid-19 vaccine injection to determine cardiac manifestation.

Read more

Methods for analyzing research data The data will be collected from students enrollment at Kong thabbok upatham changkol kho so tho bo school and Wachirathamsatit school. The participant's history, physical exam, and laboratory data will be reviewed and data will be extracted based on the case record form (CRF). All data will be stored securely and analyzed using the SPSS® Statistics Version 23 developed by IBM®. Data entry will be carried out using coding and verification. Quantitative data will be expressed as mean with standard deviation (SD) or median (IQR) and qualitative data will be presented as a number of observations with percentage (%). Descriptive statistics will be used to summarize the baseline values and demographic data.

All p-values will be derived using the 2-tailed testing, and statistical significance will be set at 0.05 probability. All the categorical variables will be analyzed using the chi-square (x2) or Fisher's exact test whichever is appropriate. Normality of the distribution will be tested for the continuous variable using the Kolmogorov- Smirnov test. All the variables with normal distributions will be compared using the independent t-test and will be reported as mean ± standard deviation (SD). The variables that do not pass the normality test will be compared by means of the Mann-Whitney U test and will be reported as the median and interquartile range (IQR).

Read the 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 (optional if have cardiac manifestation) after 2nd dose of Pfizer COVID-19 vaccine) 2.1. Cardiac biomarker (Troponin-T, CK-MB) 2.2. Echocardiography 2.3. ECG (Electrocardiography)

After getting approval from the Ethics Committee and before the start of the trial, the study team informed the interesting participants about the study by invitation letter with ZOOM or line meeting. Informed consent printed to the parents who interested in this project and bring to the team investigator before enrollment. A contact address and phone number will be provided for the interesting participants to call for more information about the study.

Being tested
Diagnostic of ECG
Keywords
pfizer-BioNTech Covid-19 vaccine, adult, Thailand, myocarditis, cardiac manifestation, Covid-19 vaccine
Medical subject headings
Myocarditis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diagnostic of ECGDiagnostic test

    Also called Diagnostic of cardiac enzyme, Diagnostic of echocardiography

    All participants who enrolled in the study will be performed ECG, cardiac enzyme and echocardiography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number and percentage of participant with cardiac manifestation after Pfizer COVID-19 vaccine injection at baseline

    cardiac manifestation defined as sinus tachycardia, hypertension at baseline

    Measured: Day 0

  2. Number and percentage of participant with cardiac manifestation after Pfizer COVID-19 vaccine injection at day 3

    cardiac manifestation defined as sinus tachycardia, hypertension at day 3

    Measured: Day 3

  3. Number and percentage of participant with cardiac manifestation after Pfizer COVID-19 vaccine injection at day 7

    cardiac manifestation defined as sinus tachycardia, hypertension at day 7

    Measured: Day 7

Secondary outcomes (9)

  1. Number and percentage of participant with Myocarditis after Pfizer COVID-19 vaccine injection at baseline

    frequency (%) of participant with myocarditis at baseline

    Measured: Day 0

  2. Number and percentage of participant with Myocarditis after Pfizer COVID-19 vaccine injection at day 3

    frequency (%) of participant with myocarditis at day 3

    Measured: Day 3

  3. Number and percentage of participant with Myocarditis after Pfizer COVID-19 vaccine injection at day 7

    frequency (%) of participant with myocarditis at day 7

    Measured: Day 7

  4. Number and percentage of participant with pericarditis after Pfizer COVID-19 vaccine injection at baseline

    frequency (%) of participant with pericarditis at baseline

    Measured: Day 0

  5. Number and percentage of participant with pericarditis after Pfizer COVID-19 vaccine injection at day 3

    frequency (%) of participant with pericarditis at day 3

    Measured: Day 3

  6. Number and percentage of participant with pericarditis after Pfizer COVID-19 vaccine injection at day 7

    frequency (%) of participant with pericarditis at day 7

    Measured: Day 7

  7. Number and percentage of participant abnormal cardiac biomarker after Pfizer COVID-19 vaccine injection at baseline

    frequency (%) of participant with abnormal cardiac biomarker (Troponin and CKMB) at baseline

    Measured: Day 0

  8. Number and percentage of participant abnormal cardiac biomarker after Pfizer COVID-19 vaccine injection at day 3

    frequency (%) of participant with abnormal cardiac biomarker (Troponin and CKMB) at day 3

    Measured: Day 3

  9. Number and percentage of participant abnormal cardiac biomarker after Pfizer COVID-19 vaccine injection at day 7

    frequency (%) of participant with abnormal cardiac biomarker (Troponin and CKMB) at day 7

    Measured: Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2022
  2. Study start3 Nov 2021
  3. Primary completion29 Nov 2021
  4. Study completion15 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
314 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05288231
Sponsor's protocol ID
Cardiac and pfiizer
Status last verified
May 2022
First submitted
17 Mar 2022
Last updated
2 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data or leftover specimens will be shared for future study ONLY subjects who consent allow using their specimens. Sharing will be done without specimen identification.

Publications

  • Mansanguan S, Charunwatthana P, Piyaphanee W, Dechkhajorn W, Poolcharoen A, Mansanguan C. Cardiovascular Manifestation of the BNT162b2 mRNA COVID-19 Vaccine in Adolescents. Trop Med Infect Dis. 2022 Aug 19;7(8):196. doi: 10.3390/tropicalmed7080196.

    PubMed 36006288

Questions about this trial

What is this clinical trial studying?

An observational study of Covid-19 Vaccine, run by Mahidol University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number and percentage of participant with cardiac manifestation after Pfizer COVID-19 vaccine injection at baseline (time frame: Day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05288231, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.

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