The placebo-controlled study will assess the safety and immunogenicity of doses of TAK-019 given 21 days apart.
The company plans to enrol 200 subjects aged 20 years and above who will receive a placebo or a 0.5ml dose of TAK-019 at both inoculations. They will be followed up for 12 months after administering the second dose.
Earlier this month, Takeda concluded enrollment in its Phase I/II study of Moderna’s Covid-19 vaccine candidate (TAK-919) in Japan.
The placebo-controlled study will analyse the safety and immunogenicity of two doses of TAK-919 administered 28 days apart. Each subject will be given either a placebo or a 0.5ml dose of TAK-919 at both vaccinations.
This trial concluded enrolment of 200 subjects aged 20 years and above and will be followed for 12 months after second vaccination.
Takeda Global Vaccine Business Unit president Rajeev Venkayya said: “Early in the pandemic, we made the decision to partner with other companies and leverage our substantial vaccine experience and capabilities to make Covid-19 vaccines available in Japan.
“We have been pleased to see the outstanding Phase III efficacy data from the Moderna and Novavax programmes and are excited to work with each company and the Government of Japan to help bring the pandemic to an end.”
Through collaborations with Novavax and Moderna, Takeda had promised to offer rapid and sustained access to Covid-19 vaccines in Japan.
As per the deal with Novavax, the company will transfer manufacturing technologies to Takeda and the latter will develop and market based on manufacturing capacity of over 250 million doses of TAK-019.
Takeda will import and distribute 50 million doses of TAK-919 as per its deal with Moderna and the Government of Japan’s Ministry of Health Labour and Welfare (MHLW).
Primary analysis results from the TAK-919 study and TAK-019 study are expected in the first half and second half of the year, respectively.
Last November, Takeda announced final positive results from the Phase III HELP Study OLE analysing Takhzyro.