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

Fever Clinical Trial

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.

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06038617
Study type Interventional
Source Duke University
Contact Michael J Smith, MD
Phone 919-684-6335
Email michael.j.smith@duke.edu
Status Recruiting
Phase Phase 4
Start date October 30, 2023
Completion date December 2024
View Details
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