Takeda’s Quadrivalent Vaccine TAK-361S Enters Into Phase II Trials in Japan

Takeda Pharma announced today that it has initiated Phase II clinical trials of the quadrivalent vaccine TAK-361S in Japan.

AsianScientist (Nov. 16, 2011) – Takeda Pharmaceutical Company Limited announced today that it has initiated Phase II clinical trials of the quadrivalent vaccine TAK-361S in Japan.

TAK-361S is a combination of the combined diphtheria, tetanus, and acellular pertussis vaccine (trivalent vaccine) that has already been marketed by Takeda, and the inactivated poliovirus vaccine derived from Sabin strain (“Sabin-IPV”).

Polio, or acute poliomyelitis, is a viral infectious disease which is commonly referred to as infantile paralysis due to its high prevalence among children.

In Japan, although live polio vaccine derived from attenuated Sabin-strain poliovirus has been used in periodic regular immunization, vaccine-associated paralytic poliomyelitis (VAPP) is found to develop in one of several million vaccine recipients, and hence there has been an increasing call for the development of an inactivated polio vaccine that does not induce VAPP.

Sabin-IPV is an inactivated poliovirus vaccine derived from attenuated strains, and its safety and efficacy are expected to be comparable to the inactivated polio vaccines derived from virulent strains, which are commonly used outside Japan.

In addition, the inactivation production process of Sabin-IPV offers better safety than that of the virulent strain-derived inactivated one.

Based on such profiles, the WHO recommends the earlier development of Sabin-IPV. Meanwhile, the development of combination vaccines without increasing the number of injections is important as a basic strategy for pediatric prophylactic vaccines.

“In order to fulfill our social responsibility as a pharmaceutical company that has been committed to the steady supply of pediatric vaccines over the past 60 years, Takeda will accelerate the development of quadrivalent vaccine TAK-361S containing the inactivated poliovirus vaccine,” said Masato Iwasaki, Corporate Officer and Senior VP of the Strategic Product Planning Department of Takeda.

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Source: Takeda Pharmaceutical Co. Ltd.
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