Novavax, Inc. (Nasdaq: NVAX), a biotechnology company, announced on Thursday that it has commenced its Phase 2b/3 Hummingbird global clinical trial to assess the safety, effectiveness (immunogenicity), and efficacy of two doses of the Novavax COVID-19 vaccine (NVX-CoV2373) in younger children aged six months through 11 years, followed by a booster at six months after the primary vaccination series.

The trial is to evaluate the vaccine in infants, toddlers, and children up to 11 years old. It is an age de-escalation trial and age groups will be tested sequentially. The trial has started dosing participants in the six to 11-year-old age group. It will also have sentinel cohorts in each age group and cohort progression and age-de-escalation will occur after safety review.

The trial is aiming to enrol 3,600 participants in the US, Mexico, Colombia, Argentina, Spain, UK, South Africa, Philippines, and Brazil. Initial results are likely to be revealed in the first quarter of 2023.