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Safety of Simultaneous mRNA COVID-19 Vaccine With Other Childhood Vaccines in Young Children
Sponsor: Duke University
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.
Official title: A Prospective, Randomized, Open-label Clinical Trial to Assess the Safety of Simultaneous Vaccination With mRNA COVID-19 Vaccine and Other Vaccines in Young Children Aged 6 Months to <5 Years.
Key Details
Gender
All
Age Range
6 Months - 4 Years
Study Type
INTERVENTIONAL
Enrollment
347
Start Date
2023-10-30
Completion Date
2025-07-25
Last Updated
2026-05-13
Healthy Volunteers
Yes
Interventions
mRNA COVID-19 Vaccine
ACIP Recommended Vaccine
Routine Childhood Vaccinations
ACIP Recommended Vaccines
Locations (5)
Kaiser Permanente Northern California
Oakland, California, United States
Centers for Disease Control and Prevention
Atlanta, Georgia, United States
Columbia University
New York, New York, United States
Duke University
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States