NCT06038617

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

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 344 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 6 Months – 4 Years
• Healthy volunteers: Accepted

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).

Detailed description

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.

Conditions

• Fever After Vaccination
• Fever
• Seizures Fever

Interventions

Type	Name	Description
BIOLOGICAL	mRNA COVID-19 Vaccine	ACIP Recommended Vaccine
BIOLOGICAL	Routine Childhood Vaccinations	ACIP Recommended Vaccines

Timeline

• Start date: 2023-10-30
• Primary completion: 2025-04-24
• Completion: 2025-07-25
• First posted: 2023-09-15
• Last updated: 2025-09-09

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study