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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
| Kaiser Permanente | OTHER |
| Columbia University | OTHER |
| Children's Hospital Medical Center, Cincinnati |
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This is a prospective, observational study. During the study, children and adolescents (ages ≥ 5 to < 16) will be followed post administration of mRNA COVID-19 vaccines.
Injection site (local), systemic reaction, and unsolicited adverse event data will be assessed on vaccination day and during the 7 days following each vaccination using either identical web-based or paper diaries, depending on study participant preference.
At Duke University, Cincinnati's Children Hospital, and Kaiser Permanente Northern California, serum samples will be collected for optional assessment of antibody titers to COVID-19. Each participant who opts in will have baseline (within 3 days of vaccination) serologies obtained and immunogenicity assessment at 28 (+7) days after each dose.
All participants will be followed for 180 days after dose 2 for serious adverse events and adverse events of special interest.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRNA COVID-19 vaccine | Children and adolescents (ages ≥ 5 to < 16) who receive mRNA COVID-19 vaccine per standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational | Other | Observational |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with defined local or systemic reactogenicity events after each dose of COVID-19 vaccine | Tables summarizing each solicited local and systemic reactogenicity event by maximum classification (none, mild, moderate, and severe), as well as by moderate or severe | Up to 7 days post-vaccination |
| Number of participants with at least one severe (Grade 3) solicited local or systemic reactogenicity event after each dose of COVID-19 vaccine | Tables summarizing each severe (Grade 3) solicited local and systemic reactogenicity event | Up to 7 days post-vaccination |
| Number of participants with at least one moderate-to-severe (Grade 2-3) solicited local or systemic reactogenicity event after each dose of COVID-19 vaccine | Tables summarizing each moderate-to-severe (Grade 2-3) solicited local and systemic reactogenicity event | Up to 7 days post-vaccination |
| Number of participants with an unsolicited adverse events after each dose of COVID-19 vaccine | The number and percent and descriptions of unsolicited adverse events observed | Up to 7 days post-vaccination |
| Number of participants with an adverse event of special interest | The number and percent of individuals with an adverse event of special interest after dose 2 of COVID-19 vaccine | Up to 29 days post-vaccination |
| The number and percent of participants with at least one serious adverse event after dose 2 of COVID-19 vaccine | The number and percent of serious adverse events observed and description of each event |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with defined local or systemic reactogenicity events after receiving other routinely recommended vaccines with each dose of COVID-19 vaccine | Tables summarizing each solicited local and systemic reactogenicity event by maximum classification (none, mild, moderate, and severe), as well as by moderate or severe | Up to 7 days post-vaccination |
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Inclusion Criteria:
Exclusion Criteria:
Current or planned participation in any clinical trial with an investigational product during the study period.*
Any condition, which, in the opinion of the investigators, may pose a health risk to the subject or interfere with the evaluation of the study objectives.
Anyone who is a relative of any research study personnel or is an employee supervised by study staff.
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320 healthy male or female ≥ 5 years to < 16 years of age
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Smith, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Northern California | Oakland | California | 94612 | United States | ||
| Centers for Disease Control and Prevention |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 3, 2025 | Jun 29, 2026 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000075662 | Injection Site Reaction |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005119 | Extravasation of Diagnostic and Therapeutic Materials |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| OTHER |
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Serum
| Up to 29 days post-vaccination |
| Number of participants with defined local or systemic reactogenicity events after receiving each dose of COVID-19 vaccine without other vaccines | Tables summarizing each solicited local and systemic reactogenicity event by maximum classification (none, mild, moderate, and severe), as well as by moderate or severe | Up to 7 days post-vaccination |
| Number of participants with at least one severe (Grade 3) solicited local or systemic reactogenicity event after other routinely recommended vaccines with each dose of COVID-19 vaccine | Tables summarizing each moderate to severe (Grade 2-3) solicited local and systemic reactogenicity event | Up to 7 days post-vaccination |
| Number of participants with at least one severe (Grade 3) solicited local or systemic reactogenicity event after receiving COVID-19 vaccine without receiving other vaccines | Tables summarizing each severe (Grade 3) solicited local and systemic reactogenicity event | Up to 7 days post-vaccination |
| Number of participants with at least one moderate-to-severe (Grade 2-3) solicited local or systemic reactogenicity event after receiving other routinely recommended vaccines with each dose of COVID-19 vaccine | Tables summarizing each moderate-to-severe (Grade 2-3) solicited local and systemic reactogenicity event | Up to 7 days post-vaccination |
| Number of participants with at least one moderate-to-severe (Grade 2-3) solicited local or systemic reactogenicity event after receiving COVID-19 vaccine without receiving other vaccines | Tables summarizing each moderate-to-severe (Grade 2-3) solicited local and systemic reactogenicity event | Up to 7 days post-vaccination |
| Number of participants with an unsolicited adverse events after receiving other routinely recommended vaccines with each dose of COVID-19 vaccine | The number and percent and descriptions of unsolicited adverse events observed | Up to 7 days post-vaccination |
| Number of participants with an unsolicited adverse events after receiving other routinely recommended vaccines with each dose of COVID-19 vaccine without receiving other vaccines | The number and percent and descriptions of unsolicited adverse events observed | Up to 7 days post-vaccination |
| Number of participants with an adverse event of special interest who received other routinely recommended vaccines with each dose of COVID-19 vaccine | The number and percent of individuals who had at least one adverse event of special interest | Up to 29 days post-vaccination |
| Number of participants with an adverse event of special interest who received other routinely recommended vaccines with each dose of COVID-19 vaccine without receiving other vaccines | The number and percent of individuals who had at least one adverse event of special interest | Up to 29 days post-vaccination |
| The number and percent of participants with at least one serious adverse event who received other routinely recommended vaccines after dose 2 of COVID-19 vaccine | The number and percent of serious adverse events observed and description of each event | Up to 29 days post-vaccination |
| The number and percent of participants with at least one serious adverse event who received other routinely recommended vaccines after dose 2 of COVID-19 vaccine without receiving other vaccines | The number and percent of serious adverse events observed and description of each event | Up to 29 days post-vaccination |
| Atlanta |
| Georgia |
| 30333 |
| United States |
| Columbia University | New York | New York | 10027 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| D010335 | Pathologic Processes |
| D064419 | Chemically-Induced Disorders |