“Last year, Pittsburghers rolled up their sleeves and volunteered to participate in our local Moderna vaccine adult trials, helping to make this vaccine available to the public in record time,” said Judy Martin, M.D., professor of pediatrics at the University of Pittsburgh School of Medicine
and member of Pitt’s Center for Vaccine Research
. “We are excited to now have the opportunity to invite our children to volunteer as well.”
The trial is a Phase 2/3 study of the mRNA-1273 vaccine, which is the Moderna COVID-19 vaccine that the U.S. Food & Drug Administration
in December granted an emergency use authorization for people age 18 and older. An estimated 132 million doses of the vaccine have been administered to date. This trial evaluates the safety, tolerability, reactogenicity and efficacy of the vaccine.
In Part 1, participants may receive one of two dose levels (50 micrograms or 100 micrograms); and participants six months to 2 years of age may receive one of three dose levels (25 micrograms, 50 micrograms or 100 micrograms). Each child will receive a second “booster” dose 28 days later.
In Part 2, an interim analysis will determine which dose will be used in comparison to a placebo. Children will be given either two doses of vaccine 28 days apart or two doses of placebo (saline) 28 days apart in a 3:1 ratio (every 4 children, 3 will receive vaccine and 1 will receive placebo). The children, their parents and their pediatricians will not know whether they received vaccine or placebo.
Participants receive 12 months of follow-up after the second vaccination to determine its effectiveness in protecting against COVID-19.