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| ID | Type | Description | Link |
|---|---|---|---|
| U01IP001093 | U.S. NIH Grant/Contract | View source |
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A single COVID-19 booster dose has been recommended in the United States for adolescents aged ≥12 years to enhance protection against SARS-CoV-2 infection. This study will assess the efficacy of a one-time reminder/recall for COVID-19 booster dose among eligible adolescents in a regional healthcare system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Reminder/recall |
|
| Usual Care | No Intervention | No Reminder/Recall |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reminder/Recall Sent Via Preferred Method of Communication | Behavioral | Parents of 12-17 year-old patients due for COVID-19 booster dose will receive a one-time vaccine reminder/recall via the parent's preferred method of communication (mailed letter, text message, email) |
| Measure | Description | Time Frame |
|---|---|---|
| COVID-19 Booster Dose | Number of patients that received a COVID-19 booster dose during follow-up based on electronic health data. Receipt of a COVID-19 booster dose within 90 days of randomization (yes/no) will be assessed using vaccination data available from the Marshfield Clinic Health System (MCHS) electronic health record, which includes vaccinations administered outside of MCHS through data exchanges with the Wisconsin Immunization Registry. Specifically patients will be classified as having received a COVID-19 booster dose if they have record of receipt of COVID-19 booster dose with a vaccination date during the 90-day follow-up period. | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huong McLean, PhD | Marshfield Clinic Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marshfield Clinic Health System | Marshfield | Wisconsin | 54449 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 29, 2022 | |
| Reset | Sep 27, 2023 | |
| Release | Nov 18, 2025 | |
| Reset | Dec 9, 2025 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 21, 2022 | Oct 6, 2022 | Prot_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 29, 2022 | Sep 27, 2023 | |||
| Nov 18, 2025 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Dec 9, 2025 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |