University of Wisconsin: UW Selected As Site For Moderna COVID-19 Vaccine Pediatric Clinical Trial

The study will take place at American Family Children’s Hospital in Madison, and enrollment for a limited number of children between the ages of 6 months and 11 years begins Aug. 13. Enrollment at the Madison site is very limited and determined strictly by age and medical eligibility as defined by Moderna.

The Moderna vaccine is administered in two doses, four weeks apart. Participants are grouped in three age categories: 6 months to less than 2 years old; 2 years old to less than 6 years old; and 6 years old to less than 12 years old. Researchers are looking to enroll approximately 4,000 children in each group, spread over 75 to 100 study sites in the United States and Canada.

Participation in the trial lasts 14 months with at least four follow up appointments during that time. To participate in the clinical trial, children will be screened via medical examination and medical record review to ensure they are in good health. All participants must be at least 6 months to less than 12 years old at the time of the initial screening visit. This is a placebo-controlled trial, meaning participants will either get the vaccine or the placebo. Participants will not know which one they get.

If a potential participant has a chronic disease, like asthma or diabetes, the disease must be under stable control when the screening occurs. Participant must not have had COVID-19 or been exposed to someone with COVID-19 within the two weeks prior to receiving the first dose of vaccine.

“Getting children vaccinated will help protect everyone and get us closer to mitigating this pandemic,” said William Hartman, MD, PhD, co-principal investigator of the KidCOVE Study at UW. “This vaccine is identical to the one given to adults today, but this trial will help us determine the correct dosage for kids.”

To date, more than 4 million children have contracted COVID-19 and more than 300 have died. Though children’s survival rates are higher than those for adults, it is clear this virus can still harm children and that they can pass COVID-19 to other people, including elders and other vulnerable members of the community who are at higher risk of severe disease, Hartman said.

“UW has participated in some of the most important studies to treat and prevent this disease, which protects the people of Wisconsin and beyond,” he said. “Testing and understanding the safety and efficacy of these treatments and vaccinations has global impact and is one of the best contributions we can make to help end this pandemic.”

James Conway, MD, professor of pediatrics at the UW School of Medicine and Public Health and UW Health pediatric infectious disease physician and medical director of the UW Health immunization program, is a co-principal investigator on this study.

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