Novavax has commenced the Phase IIb/III Hummingbird clinical trial of its Covid-19 vaccine, NVX-CoV2373, in younger children of the age six months to 11 years.
The international trial will assess the safety, immunogenicity and efficacy of the primary vaccine regimen of two doses in these children and a booster shot administered following six months.
NVX-CoV2373 will be analysed in infants aged six to 23 months, toddlers aged two to five years and children of the age six to 11 years.
The age de-escalation trial will analyse various age groups on a sequential basis.
Subjects in the six to 11-year-old age group have started receiving vaccine doses.
Furthermore, the study will have sentinel cohorts in each age group and cohort progression, age-de-escalation will be carried out following safety assessment.
The company plans to enrol 3,600 participants in Mexico, US, Argentina, Spain, UK, Colombia, South Africa, Philippines and Brazil.
Initial data from the trial are anticipated in the first quarter of next year.
A protein-based vaccine, NVX-CoV2373 is made from the genetic sequence of the initial SARS-CoV-2 virus strain.
To boost the immune response and induce increased neutralising antibody levels, it is formulated with the company’s saponin-based Matrix-M adjuvant.
Novavax president and CEO Stanley Erck said: “We are excited to begin the Hummingbird trial to study Nuvaxovid’s efficacy in children as young as six months through age 11.
“With a successful trial, we may have the opportunity to offer our Covid-19 vaccine to all age groups aged six months and older for protection against this ongoing pandemic.”
In July this year, the company obtained expanded approval for provisional registration from the Australian Therapeutic Goods Agency (TGA) for NVX-CoV2373 in adolescents of the age 12 to 17 years.