Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-28 @ 7:03 AM
Study NCT ID:
NCT05537103
Status:
COMPLETED
Last Update Posted:
2025-01-10
First Post:
2022-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adolescents Seeking COVID Vaccination (Teen COVID Vax)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 454}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-09', 'studyFirstSubmitDate': '2022-09-09', 'studyFirstSubmitQcDate': '2022-09-12', 'lastUpdatePostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Barriers Encountered', 'timeFrame': 'Once', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Reasons for and against vaccination', 'timeFrame': 'Once', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Survey', 'Teens', 'Choices', 'Natural History'], 'conditions': ['Ease Of Access To Covid Vaccine']}, 'referencesModule': {'references': [{'pmid': '35062665', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '34264908', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nInformation 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.\n\nObjective:\n\nThis 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.\n\nEligibility:\n\nPeople 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.\n\nParticipants 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.\n\nDesign:\n\nParticipants 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.\n\nParticipants will complete the survey online. It should take only 10 minutes.\n\nQuestions will include the following:\n\nHave participants been vaccinated against COVID-19? Are they in the process of getting vaccinated?\n\nDo they want to be vaccinated?\n\nHave they had trouble getting vaccinated? If so, what kind of barriers did they face?\n\nWhat reasons have they considered for and against getting vaccinated?\n\nWhat have their personal experiences been with COVID-19?\n\nWhat is their primary source of information about COVID-19?\n\nOther questions will ask about:\n\nHousehold size.\n\nEmployment of people in the household.\n\nHow many people in the house have been vaccinated.\n\nThe primary language spoken at home.\n\nThe natural history survey will be anonymous. Participants will not be asked to give their names....', 'detailedDescription': '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.\n\nWe 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We are collecting data from 15-17 year olds from US general population. Qualtrics will be retained to have access to sample.', 'healthyVolunteers': True, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n* age 15-17, and\n* living in urban, suburban or rural community\n* 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.'}, 'identificationModule': {'nctId': 'NCT05537103', 'briefTitle': 'Adolescents Seeking COVID Vaccination (Teen COVID Vax)', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Adolescents Seeking COVID Vaccination', 'orgStudyIdInfo': {'id': '10000982'}, 'secondaryIdInfos': [{'id': '000982-CC'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': '15-17 year olds from US general population'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Holly A Taylor, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institutes of Health Clinical Center (CC)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The survey will be anonymous.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institutes of Health Clinical Center (CC)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}