Biological E Gets CDSCO Panel Nod for Continued Safety study of 14-valent pneumococcal polysaccharide conjugate vaccine
New Delhi: The drug major Biological E has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDCSO) to conduct the Phase IV clinical study of the 14-valent pneumococcal polysaccharide conjugate vaccine (Adsorbed).This came after Biological E presented the Phase IV clinical trial protocol titled “A Phase IV...
New Delhi: The drug major Biological E has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDCSO) to conduct the Phase IV clinical study of the 14-valent pneumococcal polysaccharide conjugate vaccine (Adsorbed).
Pneumococcal polysaccharide vaccine can prevent pneumococcal disease. Pneumococcal disease refers to any illness caused by pneumococcal bacteria. These bacteria can cause many types of illnesses, including pneumonia, which is an infection of the lungs.
Biological E’s PCV14 contains 14 serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F). Biological E’s PCV14 contains the largest number of serotypes in India and offers expanded protection against two new serotypes 22F and 33F. These new serotypes have been reported recently to be causing infections.
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