Safety of Simultaneous mRNA COVID-19 Vaccine With Other Childhood Vaccines in Young Children (NCT06038617) | Clinical Trial Compass
CompletedPhase 4
Safety of Simultaneous mRNA COVID-19 Vaccine With Other Childhood Vaccines in Young Children
United States347 participantsStarted 2023-10-30
Plain-language summary
This is a prospective, randomized, open-label clinical trial to evaluate the safety of COVID-19 vaccination and other routine childhood vaccines given simultaneously at Visit 1, as compared to sequential vaccination of COVID-19 vaccine and other vaccines at separate visits (Visits 1 and 2).
Parent(s) or legal authorized representative(s) (LAR) will assess fever and other solicited systemic adverse events on the day of vaccination (Day 1) and the next 6 days (through Day 7) following Visit 1 and Visit 2 using either a web-based data collection system or a paper memory aid. Serious adverse events and adverse events of special interest will be captured during the entire study period. Parental/LAR perceptions about their child's vaccine schedule will be assessed on Day 7 following Visit 2.
Who can participate
Age range
6 Months – 4 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Child 6 months through \<5 years of age at time of enrollment.
* Child is due to receive mRNA COVID-19 vaccine and at least one other routinely recommended non-live vaccine per CDC or ACIP recommendations.
* Parental/LAR intention of child receiving mRNA COVID-19 vaccine and at least one recommended non-live vaccine.
* The parent/LAR must be willing and capable of providing permission for their child to participate through the written informed consent process.
* The parent/LAR must be available for follow-up and must at minimum have telephone access.
* The parent/LAR must agree to sign a medical release for the child so that study personnel may obtain medical information about the child's health (if needed).
* The parent/LAR must be willing to delay COVID-19 vaccination for their child for up to 3 weeks.
* The parent/LAR must be able to read English or Spanish.
Exclusion Criteria:
* History of any seizure (including febrile seizure) or first degree relative (biologic parent or biologic sibling including half-sibling) with a history of febrile seizure.
* Contraindication to mRNA COVID-19 vaccine: A history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a component of the COVID-19 vaccine or a known diagnosed allergy to a component of COVID-19 vaccine.
* A history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a component of a vaccine administered on the day of study enrollment.
* For childre…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Fever Following Vaccination