Ease Of Access To Covid VaccineNCT05537103
Adolescents Seeking COVID Vaccination (Teen COVID Vax)
An observational study of Ease Of Access To Covid Vaccine, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Background: Information is limited on the experience of children aged 15 to 17 who have or have not been vaccinated against COVID-19. Research has assessed attitudes toward COVID-19 vaccination among adults and parents of teenagers. Few surveys have explored attitudes among teens themselves. Read more about this study
- Who is it for?
- Ages 15 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Ease Of Access To Covid Vaccine
- How many people
- 454 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2022to 12 Jul 2023
- 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 15 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: We are collecting data from 15-17 year olds from US general population. Qualtrics will be retained to have access to sample.
Who may be able to join
- age 15-17, and
- living in urban, suburban or rural community
- Participants will only include subjects recruited by Qualtrics from their national panel of available respondents, who have agreed to be contacted by Qualtrics with opportunities to participate in surveys.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Adolescents Seeking COVID Vaccination
Background:
Information is limited on the experience of children aged 15 to 17 who have or have not been vaccinated against COVID-19. Research has assessed attitudes toward COVID-19 vaccination among adults and parents of teenagers. Few surveys have explored attitudes among teens themselves.
Read more
Objective:
This anonymous cross-sectional survey of a national sample US teens to find out about their experiences and attitudes on getting vaccinated for COVID-19. This study will be conducted in collaboration with a national firm (Qualtrics) responsible for the recruitment and data collection.
Eligibility:
People aged 15 to 17 years. Participants will come from urban, suburban, and rural areas in the United States. Factors such as race and gender will match US averages.
Participants will only include subjects recruited by Qualtrics from their national panel of available respondents, who have agreed to be contacted by Qualtrics with opportunities to participate in surveys.
Design:
Participants will be contacted by email. The email will include a link to the survey. The emails will be sent only to people who agreed to be contacted about taking surveys.
Participants will complete the survey online. It should take only 10 minutes.
Questions will include the following:
Have participants been vaccinated against COVID-19? Are they in the process of getting vaccinated?
Do they want to be vaccinated?
Have they had trouble getting vaccinated? If so, what kind of barriers did they face?
What reasons have they considered for and against getting vaccinated?
What have their personal experiences been with COVID-19?
What is their primary source of information about COVID-19?
Other questions will ask about:
Household size.
Employment of people in the household.
How many people in the house have been vaccinated.
The primary language spoken at home.
The natural history survey will be anonymous. Participants will not be asked to give their names....
Read the detailed description
The project will survey a representative sample of US adolescents age 15-17 and English speaking. This age group has been selected because they are likely to currently be High School students and are eligible for vaccination under the current Emergency Use Authorization (EUA) for and approval of the Pfizer-BioNTech COVID vaccine. The Pfizer-BioNTech vaccine received an EUA for those 16 and over in December of 2020, and was approved for this age group in August of 2021. Pfizer received an EUA for those 12 to 15 in May of 2021.
We are targeting a total of 460 responses which will give us a sufficient sample size to have a target power of 0.901 and 0.05 alpha to test our primary hypothesis that adolescents in rural settings are more likely to have encountered barriers in their pursuit of COVID vaccination. The respondents will be a convenience sample recruited from the Qualtrics panel, with demographic characteristic quotas (race/ethnicity, gender etc..) to approximate the most recent US census. The inclusion criteria are: age 15-17, and living in urban, suburban or rural community
- Conditions
- Ease Of Access To Covid Vaccine
- Keywords
- Survey, Teens, Choices, Natural History
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | 15-17 year olds from US general population |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Barriers Encountered
We will be asking 15-17 year olds if they encountered barriers when accessing COVID vaccination. Our primary outcome will be the number and types of barriers encountered.
Measured: Once
Secondary outcomes (1)
Reasons for and against vaccination
We will be asking 15-17 year olds about the reasons they considered for and against vaccination. Our primary outcome will be the number of reasons and ratio of for and against.
Measured: Once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start26 Sep 2022
- Primary completion24 Apr 2023
- Study completion12 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ease Of Access To Covid VaccineStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 454 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Holly A Taylor, Ph.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537103
- Sponsor's protocol ID
- 10000982
- Other IDs
- 000982-CC
- Status last verified
- Jan 2025
- First submitted
- 9 Sep 2022
- Last updated
- 10 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The survey will be anonymous.
Publications
Middleman AB, Klein J, Quinn J. Vaccine Hesitancy in the Time of COVID-19: Attitudes and Intentions of Teens and Parents Regarding the COVID-19 Vaccine. Vaccines (Basel). 2021 Dec 21;10(1):4. doi: 10.3390/vaccines10010004.
PubMed 35062665Scherer AM, Gedlinske AM, Parker AM, Gidengil CA, Askelson NM, Petersen CA, Woodworth KR, Lindley MC. Acceptability of Adolescent COVID-19 Vaccination Among Adolescents and Parents of Adolescents - United States, April 15-23, 2021. MMWR Morb Mortal Wkly Rep. 2021 Jul 16;70(28):997-1003. doi: 10.15585/mmwr.mm7028e1.
PubMed 34264908
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescents Seeking COVID Vaccination
- ClinicalTrials.gov ID
- NCT05537103
- Acronym / sponsor ID
- 10000982
- Conditions
- Ease Of Access To Covid Vaccine
- Keywords
- Survey, Teens, Choices, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 454 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 24 Apr 2023 (actual)
- Study completion
- 12 Jul 2023 (actual)
- First posted
- 13 Sep 2022 (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.
Background:
Information is limited on the experience of children aged 15 to 17 who have or have not been vaccinated against COVID-19. Research has assessed attitudes toward COVID-19 vaccination among adults and parents of teenagers. Few surveys have explored attitudes among teens themselves.
Objective:
This anonymous cross-sectional survey of a national sample US teens to find out about their experiences and attitudes on getting vaccinated for COVID-19. This study will be conducted in collaboration with a national firm (Qualtrics) responsible for the recruitment and data collection.
Eligibility:
People aged 15 to 17 years. Participants will come from urban, suburban, and rural areas in the United States. Factors such as race and gender will match US averages.
Participants will only include subjects recruited by Qualtrics from their national panel of available respondents, who have agreed to be contacted by Qualtrics with opportunities to participate in surveys.
Design:
Participants will be contacted by email. The email will include a link to the survey. The emails will be sent only to people who agreed to be contacted about taking surveys.
Participants will complete the survey online. It should take only 10 minutes.
Questions will include the following:
Have participants been vaccinated against COVID-19? Are they in the process of getting vaccinated?
Do they want to be vaccinated?
Have they had trouble getting vaccinated? If so, what kind of barriers did they face?
What reasons have they considered for and against getting vaccinated?
What have their personal experiences been with COVID-19?
What is their primary source of information about COVID-19?
Other questions will ask about:
Household size.
Employment of people in the household.
How many people in the house have been vaccinated.
The primary language spoken at home.
The natural history survey will be anonymous. Participants will not be asked to give their names....
Detailed description
The project will survey a representative sample of US adolescents age 15-17 and English speaking. This age group has been selected because they are likely to currently be High School students and are eligible for vaccination under the current Emergency Use Authorization (EUA) for and approval of the Pfizer-BioNTech COVID vaccine. The Pfizer-BioNTech vaccine received an EUA for those 16 and over in December of 2020, and was approved for this age group in August of 2021. Pfizer received an EUA for those 12 to 15 in May of 2021.
We are targeting a total of 460 responses which will give us a sufficient sample size to have a target power of 0.901 and 0.05 alpha to test our primary hypothesis that adolescents in rural settings are more likely to have encountered barriers in their pursuit of COVID vaccination. The respondents will be a convenience sample recruited from the Qualtrics panel, with demographic characteristic quotas (race/ethnicity, gender etc..) to approximate the most recent US census. The inclusion criteria are: age 15-17, and living in urban, suburban or rural community
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –15-17 year olds from US general population |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- We are collecting data from 15-17 year olds from US general population. Qualtrics will be retained to have access to sample.
Key inclusion criteria (3 listed)
- age 15-17, and
- living in urban, suburban or rural community
- Participants will only include subjects recruited by Qualtrics from their national panel of available respondents, who have agreed to be contacted by Qualtrics with opportunities to participate in surveys.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Barriers Encountered
Time frame: Once
We will be asking 15-17 year olds if they encountered barriers when accessing COVID vaccination. Our primary outcome will be the number and types of barriers encountered.
1 secondary outcome
Reasons for and against vaccination
Time frame: Once
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 10 Jan 2025.
- Background: PubMed 35062665Middleman AB, Klein J, Quinn J. Vaccine Hesitancy in the Time of COVID-19: Attitudes and Intentions of Teens and Parents Regarding the COVID-19 Vaccine. Vaccines (Basel). 2021 Dec 21;10(1):4. doi: 10.3390/vaccines10010004.
- Background: PubMed 34264908Scherer AM, Gedlinske AM, Parker AM, Gidengil CA, Askelson NM, Petersen CA, Woodworth KR, Lindley MC. Acceptability of Adolescent COVID-19 Vaccination Among Adolescents and Parents of Adolescents - United States, April 15-23, 2021. MMWR Morb Mortal Wkly Rep. 2021 Jul 16;70(28):997-1003. doi: 10.15585/mmwr.mm7028e1.
- Individual participant dataSharing planned: No. The survey will be anonymous.
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.
Holly A Taylor, Ph.D. principal investigator
National Institutes of Health Clinical Center (CC)
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 Ease Of Access To Covid Vaccine, run by National Institutes of Health Clinical Center (CC) 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 3 inclusion and 0 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 10 Jan 2025. 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?
Number of Barriers Encountered (time frame: Once). 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 NCT05537103, which also lists 2 linked publications.
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 10 Jan 2025.