SII gets CDSCO panel nod to study Pneumococcal Polysaccharide Conjugate Vaccine,Adsorbed,10-Valent
New Delhi: Serum Institute of India has got a go-ahead from the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) to conduct Post Market Surveillance or Phase IV clinical trial of Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) (10-Valent) to evaluate the Pneumococcal Nasopharyngeal carriage in the age group of 15 to 21months.
This came after the firm presented its proposal for grant of permission to conduct Phase IV clinical trial of Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) (10-Valent) to evaluate the Pneumococcal Nasopharyngeal carriage in the age group of 15 to 21 Months.
Pneumococcal Polysaccharide Conjugate Vaccine (10-valent, adsorbed)] is a sterile suspension of saccharides of the capsular antigens of Streptococcus pneumoniae serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F and 23F individually conjugated by using 1-cyano-4-dimethylamino pyridinium tetrafluoroborate chemistry (CDAP) to non-toxic diphtheria CRM197 protein.
The polysaccharides are chemically activated and then covalently linked to the protein carrier CRM197 to form the glycoconjugate. Individual conjugates are compounded and then polysorbate 20 and aluminium phosphate are added to formulate the vaccine.
At the SEC meeting for Vaccine the expert panel reviewed the proposal to grant permission to conduct Phase IV clinical trial of Polysaccharide Conjugate Vaccine (Adsorbed) (10-Valent) to evaluate Pneumococcal Nasopharyngeal carriage in the age group of 15 to 21 Months.
The committee noted that earlier this committee recommended the vaccine for additional indication for administration in 2+1 dose schedule (6 weeks, 14 weeks & 9 months)
After detailed deliberation, the committee recommended for grant of permission to conduct Phase IV clinical trial of Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) (10-Valent) subject to the approval of vaccine for administration in 2+1 dose schedule (6 weeks, 14 weeks & 9 months) by CDSCO.
Further, the expert panel directed that the firm is required to vaccinate the unvaccinated subject participants with the approved Pneumococcal vaccine after collection of swab sample.
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