PainNCT05157191
Safety of Pediatric COVID-19 Vaccination
An observational study of Pain and Injection Site Reaction, run by Duke University at 5 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 5 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Injection Site Reaction, Adverse Drug Event
- What is being tested?
- Observational
- Type of treatment
- Vaccines
- How many people
- 299 participants
- Where
- 5 sitesUnited States
- Study dates
- 6 Apr 2022to 27 Oct 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 5 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 320 healthy male or female ≥ 5 years to < 16 years of age
Who may be able to join
- Children ≥ 5 years to < 16 years of age
- Receiving first dose or a booster dose of a U.S authorized or approved and recommended COVID-19 vaccine per standard of care
- Parent/legal authorized representative (LAR) willing to provide written informed consent per local IRB requirements
- Participant willing to provide assent per local IRB requirements
- Intention of being available for entire study period and complete all relevant study procedures, including follow-up phone calls
- English or Spanish literate.
Who cannot join
- Current or planned participation in any clinical trial with an investigational product during the study period.*
- Per protocol, co-enrollment in observational or behavioral intervention studies are permitted at any time. An investigational product or behavioral intervention permitted at any time. An investigational product may be permitted for therapy of an illness condition that occurs during the study period (e.g., COVID-19 illness)
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Centers for Disease Control and Prevention
Atlanta, Georgia, 30333
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Duke University
Durham, North Carolina, 27710
Columbia University
New York, New York, 10027
Kaiser Permanente Northern California
Oakland, California, 94612
About this study
Official title: A Prospective Observational Study to Evaluate the Safety of COVID-19 Vaccination in Children and Adolescents
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.
Read more
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.
- Conditions
- Pain, Injection Site Reaction, Adverse Drug Event
- Being tested
- Observational
- Keywords
- COVID-19 vaccine, fever following vaccination, pain following vaccination
- Medical subject headings
- Pain, Injection Site Reaction, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observational
| Study group | Role | What they receive |
|---|---|---|
| mRNA COVID-19 vaccine | Children and adolescents (ages ≥ 5 to < 16) who receive mRNA COVID-19 vaccine per standard of care Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 29 days post-vaccination
Secondary outcomes (12)
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
Measured: Up to 7 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 29 days post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start6 Apr 2022
- Primary completion25 May 2023
- Study completion27 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Kaiser Permanente, Columbia University, Children's Hospital Medical Center, Cincinnati
- Responsible party
- Sponsor
- Investigators
- Michael J Smith, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157191
- Sponsor's protocol ID
- Pro00110056
- Status last verified
- Oct 2024
- First submitted
- 10 Dec 2021
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study to Evaluate the Safety of COVID-19 Vaccination in Children and Adolescents
- ClinicalTrials.gov ID
- NCT05157191
- Acronym / sponsor ID
- Pro00110056
- Conditions
- Pain, Injection Site Reaction, Adverse Drug Event
- Keywords
- COVID-19 vaccine, fever following vaccination, pain following vaccination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Kaiser Permanente, Columbia University, Children's Hospital Medical Center, Cincinnati
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 27 Oct 2023 (actual)
- First posted
- 14 Dec 2021 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mRNA COVID-19 vaccine | – | Other: ObservationalChildren and adolescents (ages ≥ 5 to < 16) who receive mRNA COVID-19 vaccine per standard of care |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 320 healthy male or female ≥ 5 years to < 16 years of age
Key inclusion criteria (6 listed)
- Children ≥ 5 years to < 16 years of age
- Receiving first dose or a booster dose of a U.S authorized or approved and recommended COVID-19 vaccine per standard of care
- Parent/legal authorized representative (LAR) willing to provide written informed consent per local IRB requirements
- Participant willing to provide assent per local IRB requirements
- Intention of being available for entire study period and complete all relevant study procedures, including follow-up phone calls
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalObservational | Other | mRNA COVID-19 vaccine |
Primary outcome
Number of participants with defined local or systemic reactogenicity events after each dose of COVID-19 vaccine
Time frame: Up to 7 days post-vaccination
Tables summarizing each solicited local and systemic reactogenicity event by maximum classification (none, mild, moderate, and severe), as well as by moderate or severe
Number of participants with at least one severe (Grade 3) solicited local or systemic reactogenicity event after each dose of COVID-19 vaccine
Time frame: Up to 7 days post-vaccination
Tables summarizing each severe (Grade 3) solicited local and systemic reactogenicity event
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
Time frame: Up to 7 days post-vaccination
Tables summarizing each moderate-to-severe (Grade 2-3) solicited local and systemic reactogenicity event
Number of participants with an unsolicited adverse events after each dose of COVID-19 vaccine
Time frame: Up to 7 days post-vaccination
The number and percent and descriptions of unsolicited adverse events observed
Number of participants with an adverse event of special interest
Time frame: Up to 29 days post-vaccination
The number and percent of individuals with an adverse event of special interest after dose 2 of COVID-19 vaccine
The number and percent of participants with at least one serious adverse event after dose 2 of COVID-19 vaccine
Time frame: Up to 29 days post-vaccination
The number and percent of serious adverse events observed and description of each event
12 secondary outcomes
Number of participants with defined local or systemic reactogenicity events after receiving other routinely recommended vaccines with each dose of COVID-19 vaccine
Time frame: Up to 7 days post-vaccination
Number of participants with defined local or systemic reactogenicity events after receiving each dose of COVID-19 vaccine without other vaccines
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 29 days post-vaccination
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 1 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Michael J Smith, MD principal investigator
Duke University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Injection Site Reaction, run by Duke University at 5 sites 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 6 inclusion and 4 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 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 participants with defined local or systemic reactogenicity events after each dose of COVID-19 vaccine (time frame: Up to 7 days post-vaccination). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2026.