Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12622000506796
Ethics application status
Approved
Date submitted
17/03/2022
Date registered
30/03/2022
Date last updated
31/10/2022
Date data sharing statement initially provided
30/03/2022
Date results information initially provided
31/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Long-term outcomes of myocarditis and pericarditis after Pfizer COVID-19 vaccination
Scientific title
Long-term outcomes of myocarditis and pericarditis after Pfizer-BioNTech (Comirnaty) COVID-19 vaccination in children and adults
Secondary ID [1] 306712 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocarditis 325683 0
Pericarditis 325684 0
COVID-19 vaccine 325685 0
Condition category
Condition code
Cardiovascular 323034 323034 0 0
Other cardiovascular diseases
Public Health 323130 323130 0 0
Other public health

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Myocarditis and pericarditis have been recognised by Medsafe and international regulators as a rare side effect of vaccination with mRNA COVID-19 vaccines, such as the Pfizer vaccine (Comirnaty). More information is needed to understand the long-term outcomes (>3 months) in people who experience myocarditis and/or pericarditis following vaccination with the Pfizer vaccine.

The study will be delivered as a survey to consumers and their healthcare provider.
1) The consumer survey will collect data on participant demographics, diagnosis, health and functional status, medicines, and medical history.
2) The healthcare provider survey will include questions on diagnosis and aetiology, tests and investigations, clinical management, and medical history.
The consumer survey will be a one-off survey of approximately 30 minutes, these will be delivered primarily through phone interviews conducted by experienced nurse interviewers through a health survey company. The option of face to face interviews will also be available (COVID-19 restrictions permitting) if the participant prefers. Participants will be given the opportunity to provide the name and contact details for their healthcare provider (General Practitioner/Nurse Practitioner or Practice Nurse and/or specialist) and to consent for us to contact them for the purposes of a survey. The healthcare provider survey will be predominantly online, however the option for this to be done by other mechanism will also be available.
Participants should have received a diagnosis of myocarditis and/or pericarditis any dose of their Pfizer COVID-19 vaccine between 20 February 2021 and 28 February 2022. People will be contacted to participate between March 2022 and July 2022.
Intervention code [1] 323157 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330794 0
Current health – symptom type and duration, overall health
We have a questionnaire specific for this study which has been based on survey questions being used by the CDC in a similar study.
Questions on general health and mental health from a recent New Zealand Health Survey and COVID-19 Health and Wellbeing Survey may also be included to allow for comparison with the general population of New Zealand.
Timepoint [1] 330794 0
Once at a minimum of 3 months after clinical diagnosis
Primary outcome [2] 330795 0
Physical functioning – current level of physical activity
We have a questionnaire specific for this study which has been based on survey questions being used by the CDC in a similar study.
Questions on general health and mental health from a recent New Zealand Health Survey and COVID-19 Health and Wellbeing Survey may also be included to allow for comparison with the general population of New Zealand.
Timepoint [2] 330795 0
Once at a minimum of 3 months after clinical diagnosis
Primary outcome [3] 330796 0
Mental health
We have a questionnaire specific for this study which has been based on survey questions being used by the CDC in a similar study.
Questions on general health and mental health from a recent New Zealand Health Survey and COVID-19 Health and Wellbeing Survey may also be included to allow for comparison with the general population of New Zealand.
Timepoint [3] 330796 0
Once at a minimum of 3 months after clinical diagnosis
Secondary outcome [1] 407596 0
Hospitalisations – number of hospital admissions, length of stay, level of care required.
This data will be collected using a questionnaire specific for this study which has been based on survey questions being used by the CDC in a similar study.
In addition where consent from the participant is provided, we will access the primary healthcare record (where available) and also linkage to the National Minimum Dataset (hospitalisations).
Timepoint [1] 407596 0
Once at a minimum of 3 months after clinical diagnosis
Secondary outcome [2] 407597 0
Cardiac health – overall recovery, exercise restrictions, medications, cardiac test results (troponin, ECG, echocardiogram, cardiac MRI, other).
This data will be collected using a questionnaire specific for this study which has been based on survey questions being used by the CDC in a similar study.
In addition where consent from the participant is provided, we will access the primary healthcare record (where available).
Timepoint [2] 407597 0
Once at a minimum of 3 months after clinical diagnosis
Secondary outcome [3] 407598 0
Aetiology – COVID-19 test results, past medical history, suspected cause
This data will be collected using a questionnaire specific for this study which has been based on survey questions being used by the CDC in a similar study.
In addition where consent from the participant is provided, we will access the primary healthcare record (where available) and also linkage to COVID-19 testing history.
Timepoint [3] 407598 0
Once at a minimum of 3 months after clinical diagnosis

Eligibility
Key inclusion criteria
1) Adults and children 12 years of age or older with a clinical diagnosis of myocarditis and/or pericarditis (includes myopericarditis), after any dose of the Pfizer vaccine, and their healthcare providers.
2) A report of myocarditis and/or pericarditis has been submitted to the Centre for Adverse Reactions Monitoring (CARM) by the person themselves, or by someone on their behalf (such as a healthcare professional or family member).
3) Participants will not be required to meet specific diagnostic criteria, such as the CDC criteria, to be eligible.
4) Myocarditis and/or pericarditis diagnosed up to and including 28 February 2022, and at least 3 months prior to the survey (minimum of 3 months post-diagnosis).
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Children <12 years of age.
2) People who have not received a clinical diagnosis of myocarditis and/or pericarditis. This includes self-diagnosis, or where a diagnosis of myocarditis or pericarditis was considered as part of the differential diagnosis but was not given as a final diagnosis.
3) Myocarditis and/or pericarditis diagnosed after 28 February 2022, and/or less than 3 months ago by the end of the specified recruitment period.
4) People who experienced myocarditis and/or pericarditis after a third or subsequent dose of the Pfizer vaccine.
5) People who did not receive the Pfizer vaccine prior to being diagnosed with myocarditis or pericarditis.
6) People who experienced myocarditis and/or pericarditis after vaccination with another COVID-19 vaccine (for example, the AstraZeneca vaccine).
7) People who have not provided sufficient contact information in CARM report to be able to make initial contact.
8) Circumstances that interfere with the participant’s ability to give informed consent (including a diminished understanding or comprehension of English and an interpreter unavailable).

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
A descriptive analysis of quantitative survey data will be performed. A narrative summary of any additional information collected during the survey may be conducted. Data linkage will be performed with other relevant health data and data collected from surveys.

Outcomes will be analysed separately based on diagnosis (myocarditis and/or pericarditis). Subgrouping may also be performed based on the CDC criteria (met/not met) and/or Brighton Criteria (level 1-3/level 4-5), age, and gender, if sufficient information is collected. Sensitivity analysis may be conducted based on time to onset of symptoms/diagnosis (< or > 30 days). Most cases of myocarditis and/or pericarditis after vaccination occur within the first 7 days.

Cases where an alternative aetiology (other than the COVID-19 vaccine) was confirmed or highly suspected will be excluded from the analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/03/2022
Actual
30/03/2022
Date of last participant enrolment
Anticipated
14/07/2022
Actual
31/08/2022
Date of last data collection
Anticipated
29/07/2022
Actual
10/10/2022
Sample size
Target
400
Accrual to date
Final
323
Recruitment outside Australia
Country [1] 24671 0
New Zealand
State/province [1] 24671 0

Funding & Sponsors
Funding source category [1] 311039 0
Government body
Name [1] 311039 0
Ministry of Health
Country [1] 311039 0
New Zealand
Primary sponsor type
Government body
Name
Medsafe
Address
133 Molesworth Street
Thorndon
Wellington
6011
Country
New Zealand
Secondary sponsor category [1] 312368 0
None
Name [1] 312368 0
Address [1] 312368 0
Country [1] 312368 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310587 0
Covid-19 ESOP Health and Disability Ethics Committee
Ethics committee address [1] 310587 0
Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
Thorndon
Wellington
Ethics committee country [1] 310587 0
New Zealand
Date submitted for ethics approval [1] 310587 0
11/02/2022
Approval date [1] 310587 0
18/02/2022
Ethics approval number [1] 310587 0
2022 FULL 11589
Ethics committee name [2] 310588 0
Northern B Health and Disability Ethics Committee
Ethics committee address [2] 310588 0
Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
Thorndon
Wellington
Ethics committee country [2] 310588 0
New Zealand
Date submitted for ethics approval [2] 310588 0
24/02/2022
Approval date [2] 310588 0
04/03/2022
Ethics approval number [2] 310588 0
2022 AM 11589

Summary
Brief summary
Myocarditis and pericarditis have been recognised by Medsafe and international regulators as a rare side effect of vaccination with mRNA COVID-19 vaccines, such as the Pfizer vaccine (Comirnaty). More information is needed to understand the long-term outcomes in people who experience myocarditis and/or pericarditis following vaccination with the Pfizer vaccine.

To address this gap in important knowledge, a survey of consumers who are reported to have experienced myocarditis and/or pericarditis after Pfizer vaccination and their healthcare providers will be undertaken. Information gained through this survey will help us to better understand the safety profile of the Pfizer vaccine, and to inform future recommendations on the use of this vaccine in New Zealand.

This project will be conducted by Medsafe, in collaboration with the National Immunisation Programme, and CARM, part of the NZPhvC based at the University of Otago. This study will be an extension of normal pharmacovigilance activities.
Trial website
https://www.health.govt.nz/myocarditisstudy
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118178 0
Dr Tim Hanlon
Address 118178 0
Ministry of Health
133 Molesworth Street
Thorndon
Wellington
6011
Country 118178 0
New Zealand
Phone 118178 0
+64 04 819 6800
Fax 118178 0
Email 118178 0
C19myostudy@health.govt.nz
Contact person for public queries
Name 118179 0
Dr Tim Hanlon
Address 118179 0
Ministry of Health
133 Molesworth Street
Thorndon
Wellington
6011
Country 118179 0
New Zealand
Phone 118179 0
+64 04 819 6800
Fax 118179 0
Email 118179 0
C19myostudy@health.govt.nz
Contact person for scientific queries
Name 118180 0
Dr Tim Hanlon
Address 118180 0
Ministry of Health
133 Molesworth Street
Thorndon
Wellington
6011
Country 118180 0
New Zealand
Phone 118180 0
+64 04 819 6800
Fax 118180 0
Email 118180 0
C19myostudy@health.govt.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data available in the public domain will be anonymized and grouped.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15454Informed consent form  C19myostudy@health.govt.nz



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.