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COMPLETED
NCT06038617
PHASE4

Safety of Simultaneous mRNA COVID-19 Vaccine With Other Childhood Vaccines in Young Children

Sponsor: Duke University

View on ClinicalTrials.gov

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

BIOLOGICAL

mRNA COVID-19 Vaccine

ACIP Recommended Vaccine

BIOLOGICAL

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