The trials are being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).
‘The Phase 2/3 two-part and randomized study will evaluate the safety, tolerability, reactogenicity and effectiveness of two doses of mRNA-1273 in children.
’
“We are pleased to begin this Phase 2/3 study of mRNA-1273 in healthy children in the US and Canada and we thank NIAID and BARDA for their collaboration,” Stephane Bancel, Chief Executive Officer of Moderna, said in a statement.
“We are encouraged by the primary analysis of the Phase 3 COVE study of mRNA-1273 in adults ages 18 and above and this paediatric study will help us assess the potential safety and immunogenicity of our Covid-19 vaccine candidate in this important younger age population,” Bancel added.
In Part 1, each participant ages two years to less than 12 years may receive one of two dose levels (50 microgrammes or 100 microgrammes). Also in Part 1, each participant ages six months to less than 2 years may receive one of three dose levels (25 microgrammes, 50 microgrammes and 100 microgrammes).
An interim analysis will be conducted to determine which dose will be used in Part 2, the placebo-controlled expansion portion of the study. Participants will be followed through 12 months after the second vaccination, the company said.
Vaccine effectiveness will either be inferred through achieving a correlate of protection, if established, or through immunobridging to the young adult (ages 18-25) population, it added.
Source: IANS
