Adolescents Seeking COVID Vaccination (Teen COVID Vax)

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.

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....

Study Overview

• Status: Completed
• Conditions: Ease Of Access To Covid Vaccine

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 Type: Observational
• Enrollment (Actual): 454

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

We are collecting data from 15-17 year olds from US general population. Qualtrics will be retained to have access to sample.

Description

• INCLUSION CRITERIA:
• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1; 15-17 year olds from US general population

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Once

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Once

Collaborators and Investigators

• Sponsor: National Institutes of Health Clinical Center (CC)
• Investigators: Principal Investigator: Holly A Taylor, Ph.D., National Institutes of Health Clinical Center (CC)

Publications and helpful links

General 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.
• Scherer 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2022
• Primary Completion (Actual): April 24, 2023
• Study Completion (Actual): July 12, 2023

Study Registration Dates

• First Submitted: September 9, 2022
• First Submitted That Met QC Criteria: September 12, 2022
• First Posted (Actual): September 13, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: July 12, 2023

More Information

Terms related to this study

• Keywords: Teens; Natural History; Survey; Choices
• Other Study ID Numbers: 10000982; 000982-CC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: .The survey will be anonymous.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No