Pregnancy RelatedVCCOVIDNCT04694664
COVID-19 Vaccine Confidence Among Pregnant Women and Mothers
An observational study of Pregnancy Related and Mothers, run by Pregistry at 1 site in United States.
Trial summary
The purpose of this study is to assess the level of vaccine confidence and influencers among pregnant women and mothers of school-aged children during the COVID-19 pandemic. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Mothers
- How many people
- 18,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 1 Dec 2020
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women or women who have at least one child younger than 18 years of age.
Who may be able to join
- Pregnant women or women who have at least one child younger than 18 years of age. Able to give electronic informed consent
Who cannot join
- <18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vaccine Confidence Among Pregnant Women and Mothers During the COVID-19 Pandemic
The purpose of this study is to assess the level of vaccine confidence and influencers among pregnant women and mothers of school-aged children during the COVID-19 pandemic.
Read the detailed description
The WHO has listed "vaccine hesitancy" as one of the top threats to global health.
The COVID-19 pandemic has triggered the need to vaccinate worldwide as soon as a safe and efficacious vaccine becomes available. However preliminary data show that, on average, only 50% to 66% of US adults would be willing to receive COVID-19 vaccination when it becomes available, a percentage lower than what is required for herd immunity to control the pandemic. Furthermore, there is a pressing need to vaccinate children to reopen schools and keeping them safe, as well as to immunize pregnant women through vaccination programs since they constitute a vulnerable population. Vaccine confidence among pregnant women and mothers of school-aged children during the period of COVID-19 pandemic is unknown, leading to an important gap of knowledge that may hinder the upcoming global COVID-19 vaccination scale-up effort. It is therefore of critical importance to assess the level of vaccine confidence and influencers among pregnant women and mothers of school-aged children during the COVID-19 pandemic.
The international nature of the proposed survey will allow the evaluation of vaccine confidence and its influencers among pregnant women and mothers of school-aged children on a global level. Therefore, social and geographic characteristics from different countries and cultures will be available for comparison. The resulting knowledge will be relevant to a large percentage of the world's population. Any country in the world can participate.
- Conditions
- Pregnancy Related, Mothers
- Being tested
- This is an online survey with no intervention.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is an online survey with no intervention.Other
As this is an online survey about health and wellbeing, there is no intervention.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Women | Pregnant women who are 18 years of age or older. Receives: Other: This is an online survey with no intervention. | |
| Post-partum women | Women who have at least one child younger than 18 years of age. Receives: Other: This is an online survey with no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of acceptance of a COVID-19 vaccine
This outcome will evaluate the hesitancy or acceptance to a COVID-19 vaccine
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Oct 2020
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cross-sectional
- Enrolment
- 18,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pregistry
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Harvard School of Public Health (HSPH)
- Responsible party
- Sponsor
- Investigators
- Julia Wu, SD, MS, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694664
- Sponsor's protocol ID
- 0003
- Acronym
- VCCOVID
- Status last verified
- Jan 2021
- First submitted
- 1 Nov 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccine Confidence Among Pregnant Women and Mothers During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04694664
- Acronym / sponsor ID
- VCCOVID / 0003
- Conditions
- Pregnancy Related, Mothers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18,000 participants (actual)
- Lead sponsor
- PregistryIndustry (pharma, biotech, devices)
- Collaborators
- Harvard School of Public Health (HSPH)
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the level of vaccine confidence and influencers among pregnant women and mothers of school-aged children during the COVID-19 pandemic.
Detailed description
The WHO has listed "vaccine hesitancy" as one of the top threats to global health.
The COVID-19 pandemic has triggered the need to vaccinate worldwide as soon as a safe and efficacious vaccine becomes available. However preliminary data show that, on average, only 50% to 66% of US adults would be willing to receive COVID-19 vaccination when it becomes available, a percentage lower than what is required for herd immunity to control the pandemic. Furthermore, there is a pressing need to vaccinate children to reopen schools and keeping them safe, as well as to immunize pregnant women through vaccination programs since they constitute a vulnerable population. Vaccine confidence among pregnant women and mothers of school-aged children during the period of COVID-19 pandemic is unknown, leading to an important gap of knowledge that may hinder the upcoming global COVID-19 vaccination scale-up effort. It is therefore of critical importance to assess the level of vaccine confidence and influencers among pregnant women and mothers of school-aged children during the COVID-19 pandemic.
The international nature of the proposed survey will allow the evaluation of vaccine confidence and its influencers among pregnant women and mothers of school-aged children on a global level. Therefore, social and geographic characteristics from different countries and cultures will be available for comparison. The resulting knowledge will be relevant to a large percentage of the world's population. Any country in the world can participate.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women | – | Other: This is an online survey with no intervention.Pregnant women who are 18 years of age or older. |
| Post-partum women | – | Other: This is an online survey with no intervention.Women who have at least one child younger than 18 years of age. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women or women who have at least one child younger than 18 years of age.
Key inclusion criteria (1 listed)
- Pregnant women or women who have at least one child younger than 18 years of age. Able to give electronic informed consent
Key exclusion criteria (1 listed)
- <18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is an online survey with no intervention.As this is an online survey about health and wellbeing, there is no intervention. | Other | Post-partum women, Pregnant Women |
Primary outcome
Percentage of acceptance of a COVID-19 vaccine
Time frame: up to 2 months
This outcome will evaluate the hesitancy or acceptance to a COVID-19 vaccine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Wu, SD, MS principal investigator
Harvard School of Public Health (HSPH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Mothers, run by Pregistry at 1 site in United States.
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 1 inclusion and 1 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 5 Jan 2021. 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 United States. 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?
Percentage of acceptance of a COVID-19 vaccine (time frame: up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2021.