COVID-19 Vaccine for Children: The KidCOVE Study – Phase II/III

A Study to Evaluate Safety and Effectiveness of mRNA-1273 COVID-19 Vaccine in Healthy Children Between 6 Months of Age and Less Than 12 Years of Age

Protocol Description

The primary purpose of this multi-center research program, called the KidCOVE Study, is to test the safety and effectiveness of the vaccine mRNA-1273 when given to healthy children. Researchers will evaluate different dose levels of the vaccine to determine the optimal amount and will examine the effectiveness of the vaccine when compared to a placebo.

Study Level: Phase II/III

Eligibility Criteria

Subject to certain exclusion criteria, this study is enrolling participants who are at least 6 months old and less than 12 years of age.
Males and Females: Ages 6 months through 11 years

Requirements

Participants in the study will be given 2 injections of mRNA-1273 or a placebo, with injections spaced 28 days apart. The research team will visit participants and their parent/guardians via telemedicine twice after each injection and then monthly after that to monitor for COVID-19 symptoms. Participants will be required to return to the study site up to 6 times, depending on their enrollment assignment.
Visits: Up to 8 in-person, plus telemedicine follow-up visits.
Duration: About 14 months

Status: Open to Enrollment

Source(s) of Support

ModernaTX

Primary Investigator

Judith Martin, MD

Contact Information

For more information about the study or enrollment, please contact:
The Pittsburgh Vaccine Trials Unit
412-692-7382