Increase sample size for immunogenicity analysis for booster dose: CDSCO Panel Tells Biological E on PCV-14 Vaccine
New Delhi: Reviewing the amended Phase IV clinical trial protocol of Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) (14-valent) [PCV-14] presented by the vaccine major Biological E, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined the firm to revise the protocol for increasing sample size for immunogenicity analysis for booster dose.
This came after the vaccine major Biological E presented the amended Phase IV clinical trial protocol of the study titled “A prospective multicentre Phase- IV study to evaluate the safety of Biological E's 14 -valent pneumococcal polysaccharide conjugate vaccine when administered in 6-10-14 weeks dosing schedule to 6-8 weeks old healthy Indian infants."
Pneumococcal conjugate 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.
BE-PCV14 (Pneumococcal Conjugate Vaccine14 valent) is a whitish suspension in which the mineral carriers tend to settle down slowly.
The vaccine contains Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F. These polysaccharides are conjugated using CRM197.BE-PCV14 is indicated for active immunization against invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in children from 6 weeks of age.
At the recent SEC meeting for vaccines held on July 31, 2024, the expert panel reviewed the amended Phase IV clinical trial protocol of Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) (14-valent) [PCV-14].
After detailed deliberation, the committee recommended revising the protocol to increase the sample size for immunogenicity analysis for a booster dose.
Accordingly, the expert panel suggested that the firm should submit a revised protocol for further deliberation.
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