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

NCT06038617 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 347

Last updated 2026-05-13

Study results available
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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.

Conditions

  • Fever After Vaccination
  • Fever
  • Seizures Fever

Interventions

BIOLOGICAL

mRNA COVID-19 Vaccine

ACIP Recommended Vaccine

BIOLOGICAL

Routine Childhood Vaccinations

ACIP Recommended Vaccines

Sponsors & Collaborators

Principal Investigators

  • Michael J Smith, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
4 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-30
Primary Completion
2025-04-24
Completion
2025-07-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06038617 on ClinicalTrials.gov