CDSCO Panel approves Biological E's Phase IV clinical trial protocol to study PNEUBEVAX-14

New Delhi: The vaccine major Biological E has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase IV clinical trial of the Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed)(14-valent) [PCV-14].

This came after Biological E presented the amended Phase IV clinical trial protocol titled “A prospective multicentre Phase-IV study to evaluate the safety of Biological E’s 14-valent Pneumococcal Polysaccharide Conjugate Vaccine (PNEUBEVAX-14) when administered in 6-10-14 weeks dosing schedule to 6-8 week old healthy Indian infants.”

Biological E's 14-valent Pneumococcal Polysaccharide Conjugate Vaccine (PNEUBEVAX-14) is a prescription injection that helps prevent invasive pneumococcal disease in children.

At the recent SEC meeting for vaccine held on October 3, 2024, the expert panel reviewed the amended Phase IV clinical trial protocol titled “A prospective multicentre Phase-IV study to evaluate the safety of Biological E’s 14-valent Pneumococcal Polysaccharide Conjugate Vaccine (PNEUBEVAX-14) when administered in 6-10-14 weeks dosing schedule to 6-8 weeks old healthy Indian infants.”

After detailed deliberation, the committee recommended approval of the Phase IV clinical trial protocol as presented.

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