Canadian COVID-19 Vaccine Registry for Pregnant & Lactating Individuals (COVERED): An Evaluation of Safety, Effectiveness & Acceptability
The COVID-19 Vaccine Registry for Pregnant and Lactating Individuals (COVERED) study is a national registry of unvaccinated and vaccinated pregnant and lactating individuals. Pregnant and lactating individuals are followed to determine data on safety of any of the vaccine types and their efficacity to protect against COVID-19.
Primary objectives are :
* To assess the safety of COVID-19 vaccines in pregnant and lactating individuals.
* To describe the effectiveness of COVID-19 vaccines in pregnant and lactating individuals.
* To examine attitudes towards COVID-19 vaccination among pregnant and lactating individuals.
The objectives of the COVERED sub-study (Immune Sub-Study) are :
* To examine the immunogenicity of COVID-19 vaccines within a subset of pregnant individuals and their infants.
* To measure IgG and IgA antibody levels in breastmilk samples provided by pregnant individuals.
Overview
- Acronym
- COVERED
- Website
- COVERED
- Investigators
-
- Contacts
-
General Design
- Study design
- Cohort
- Start - End Year
- 2021 - 2023
- General Information on Follow Up (profile, frequency)
-
* After baseline, pregnant and lactating Individuals participating in the COVERED main study are followed every two months. * Pregnant and lactating Individuals participating in the Immune Sub-Study are followed at delivery, 4 to 6 weeks after delivery and before and after COVID-19 vaccine doses. * Infants participating in the COVERED main study are followed 6 and 12 months after birth. * Infants participating in the Immune Sub-Study are followed at delivery and 4 to 6 weeks after delivery.
- Recruitment Target
-
- Individuals
- Number of Participants
- 7,340
- Number of Participants with Biological Samples
- 101
- Supplementary information about number of participants
-
Pregnant and lactating individuals : 59 participants with biological samples. Infants: 42 participants with biological samples.
- Supplementary Information
-
Data collected from individuals who do not receive COVID-19 vaccines will act as an internal comparison group. Self-identified gender will be capture through our online demographics questionnaire to examine differences by gender.
Access
Availability of data and biosamples
| Possible Access to Data | |
| Possible Access to Biosamples | |
| Other |
|
- On the study website : https://covered.med.ubc.ca
Timeline
Populations
COVERED - Pregnant and lactating individuals
The population is composed of individuals aged 19 and older living in Canada who have been pregnant or lactating during the COVID-19 pandemic.
Selection Criteria
- Gender
-
Women only
- Minimum age
-
19
- Countries
-
- Canada
- Canadian Provinces
-
- Alberta
- British Columbia
- Manitoba
- New Brunswick
- Newfoundland and Labrador
- Northwest Territories
- Nova Scotia
- Nunavut
- Ontario
- Prince Edward Island
- Quebec
- Saskatchewan
- Yukon
- Other Criteria
- Inclusion : * Pregnancy will or has concluded after March 1, 2020 Inclusion criteria Immune Sub-Study ; * Able to communicate in english * Scheduled to or have been vaccinated with a COVID-19 vaccination * Registered to deliver at BC Women’s Hospital * Living in British Columbia
Sources of Recruitment
- General Population
-
- Volunteer enrolment
- Selected sample
- Supplementary Information
-
Participants were recuited through the study website, social media and traditional media campaign and through dissemination of recruitment materials by health care providers. Immune Sub-Study participants were recruited through the baseline survey in the COVERED vaccine registry when eligible.
Sample Size
- Number of Participants
- 7,340
- Number of Participants with Biological Samples
- 59
- Supplementary information about number of participants
-
59 participants from the main study are recruited to participate in the Immune Sub-Study.
Data Collection Events
COVERED - Infants
The population is composed of children of pregnant and lactating individuals aged 19 years and older living in Canada.
Selection Criteria
- Minimum age
-
0
- Maximum age
-
1
- Countries
-
- Canada
- Canadian Provinces
-
- Alberta
- British Columbia
- Manitoba
- New Brunswick
- Newfoundland and Labrador
- Northwest Territories
- Nova Scotia
- Nunavut
- Ontario
- Prince Edward Island
- Quebec
- Saskatchewan
- Yukon
Sources of Recruitment
- Specific Population
-
- Other specific population : Children of participating mothers.
Sample Size
- Number of Participants
- 42
- Number of Participants with Biological Samples
- 42
- Supplementary information about number of participants
-
42 samples from the infant of the pregnant women enrolled in the Immune Sub-Study are collected.
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | COVERED - Infants - Immune sub-study - Delivery |
|
|
2021 (July) | 2023 (December) |
| 1 | COVERED - Infants - Immune sub-study - 4 to 6 weeks post delivery |
|
|
2021 (July) | 2023 (December) |
| 2 | COVERED - Infants - 6 months after delivery |
|
2021 (July) | 2023 (December) | |
| 3 | COVERED - Infants - 12 months after delivery |
|
2021 (July) | 2023 (December) |
Participating Studies
| Acronym | Name | Study design | Countries |
|---|
Harmonization Initiatives Included
| Acronym | Name |
|---|
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: 2023-04-19T14:32:23.998