Active surveillance for COVID-19 vaccine safety and effectiveness among Canadian children: A Canadian Immunization Monitoring Program ACTive (IMPACT) Project
The objectives of this study are:
* To determine safety of COVID-19 vaccination among children 0-16 years of age assessed at an IMPACT centre by estimating:
a) Relative incidence of hospitalization for multisystem inflammatory syndrome in children (MIS-C) during various risk intervals between 0 and 90 days following COVID-19 vaccination versus the pre-vaccination period (>7 days pre-vaccination) and >91 days post-vaccination;
b) Relative incidence of Emergency Department (ED) visit or hospitalization for myocarditis/pericarditis during various risk intervals between 0 and 90 days following COVID-19 vaccination versus the pre-vaccination period (>7 days pre-vaccination) and >91 days post-vaccination;
c) Relative incidence of ED visit or hospitalization for febrile seizure during various risk intervals between days 0 and 14 following COVID-19 vaccination versus >7 days pre-vaccination and >21 days post-vaccination;
d) Relative risk of moderate, severe and critical COVID-19 leading to hospitalization by COVID-19 vaccination status.
* To evaluate trends in SARS-CoV-2 infection, COVID-19, and MIS-C among children 0-16 years of age requiring hospitalization at an IMPACT centre in the pre-vaccination period (April–December 2020), “adult only” vaccination period (January 2021 until June 2021 when vaccine programs start for ≤16 year olds), and paediatric vaccination period (July 2021 to December 2022).
Overview
- Acronym
- IMPACT
- Website
- IMPACT
- Investigators
-
General Design
- Study design
- Case only
- Start - End Year
- 2021 - 2022
- General Information on Follow Up (profile, frequency)
-
Nurse monitors will regularly screen ED visit lists, hospital admission lists and laboratory reports to capture specific data on cases meeting the various case definitions. Outcomes are captured at discharge and at to 3 months after discharge for patients with myocarditis/pericarditis and MIS-C.
- Recruitment Target
-
- Individuals
- Number of Participants
- No Limit
- Number of Participants with Biological Samples
- 325
- Supplementary information about number of participants
-
Number of participants will be dependent on patients presenting to the ED or hospitalized and meeting the criteria outlined in the various case definitions.
- Supplementary Information
-
This is an observational study of children ≤16 years of age presenting to the ED for febrile seizures, myocarditis/pericarditis or adverse events following immunization or hospitalized with SARS-CoV-2 infection, COVID-19, MIS-C, myocarditis/pericarditis, or febrile seizures at 13 tertiary care pediatric centers. Children will be eligible if they meet a case definition for one of the above conditions.
Access
Availability of data and biosamples
| Possible Access to Data | |
| Possible Access to Biosamples | |
| Other |
|
Supplementary Information
IMPACT will work with Canadian Paediatric Surveillance Program (CPSP) study leads to examine data on acute COVID-19 and MIS-C hospitalizations from April 2020-May 2021, prior to the start of the IMPACT surveillance activities.
Timeline
Population
IMPACT population
The population is composed of children 16 years old or younger presenting to the emergency department (ED) or hospitalized at an IMPACT centre for specific surveillance targets from April 1, 2020 to March 31, 2022, or 12 months after COVID-19 vaccination programs start for children; and have been diagnosed with an acute COVID-19, a multi-system inflammatory syndrome in children (MIS-C), a febrile seizure, myocarditis/pericarditis or a COVID-19 vaccine associated enhanced disease.
Selection Criteria
- Maximum age
-
16
- Countries
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- Canada
- Canadian Provinces
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- Alberta
- British Columbia
- Manitoba
- Newfoundland and Labrador
- Nova Scotia
- Ontario
- Quebec
- Saskatchewan
- Health Status
-
- Confirmed SARS-CoV-2 infection, acute COVID-19 or MIS-C, myocarditis/pericarditis
- Febrile seizure
- Vaccine associated enhanced disease
- Other Criteria
-
Inclusion:
- Child presenting to the ED or hospitalized at an IMPACT hospital with positive SARS-CoV-2-specific RT-PCR or equivalent molecular test, symptoms compatible with COVID-19, and no alternate diagnosis for their presentation
- Child who received ≥1 doses of any COVID-19 vaccine product, had laboratory-confirmed SARS-CoV-2 infection based on RT-PCR, and moderate, severe or critical COVID-19 based on the modified Dong criteria
Sources of Recruitment
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Cases of acute COVID-19, MIS-C, febrile seizure, myocarditis/pericarditis or COVID-19 vaccine associated enhanced disease were identified via ED and hospitalization surveillance.
For the retrospective case ascertainment, confirmed SARS-CoV-2 infection, acute COVID-19 and MIS-C cases and hospitalized at an IMPACT centre were reported to the Canadian Paediatric Surveillance Program (CPSP). To ensure complete case ascertainment, ICD-10 diagnostic code searches for MIS-C (from October 2020 when the ICD-10 code was released), Kawasaki Disease and toxic shock syndrome will be conducted to identify cases that meet criteria for MIS-C.
For the prospective case ascertainment, IMPACT nurse monitors will screen daily ED visit lists, hospital admission lists, and laboratory reports for cases of SARS-CoV-2 infection, COVID-19, MIS-C, febrile seizure, myocarditis/pericarditis, and adverse events following immunization.
IMPACT investigators will collaborate with rheumatologist co-Is and collaborators at each center to identify suspected MIS-C cases.
Sample Size
- Number of Participants
- No Limit
- Number of Participants with Biological Samples
- 325
- Supplementary information about number of participants
-
There will be as many participants as those who meet the eligibility criteria.
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | IMPACT - Surveillance |
|
2021 (August) | 2022 (December) |
Participating Studies
| Acronym | Name | Study design | Countries |
|---|
Harmonization Initiatives Included
| Acronym | Name |
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Datasets
| Name | Data Collection Events | Variables |
|---|
Areas of Information Collected
- Socio-demographic and economic characteristics
- Death
- Lifestyle and behaviours
- Physical measures and assessments
- Birth, pregnancy and reproductive health history
- Laboratory measures
- Perception of health, quality of life, development and functional limitations
- Cognition, personality and psychological measures and assessments
- Diseases
- Life events, life plans, beliefs and values
- Symptoms and signs
- Preschool, school and work life
- Medication and supplements
- Social environment and relationships
- Non-pharmacological interventions
- Physical environment
- Health and community care services utilization
- Administrative information
Variables Content Summary
Areas of Information Collected
No Areas of Information Collected
No Scales Collected
Areas of Information Collected per per Population and Data Collection Event
No Areas of Information Collected
No Scales Collected
Networks
| Acronym | Name | Harmonization Initiatives | Individual Studies |
|---|
Last Update: 2024-02-27T14:28:36.065