Both WHO and IAP encourage using combination vaccines, wherever feasible. The phase III trial rep... more Both WHO and IAP encourage using combination vaccines, wherever feasible. The phase III trial reported here was conducted to assess and compare the immunogenicity, tolerability and safety of two quadravalent vaccines, Quadrovax(®) (new vaccine), and TETRAct-Hib(®) (available in the market) in a multicentre study, in India. In all, 361 infants aged 6-8 weeks were enrolled, out of which 339 completed the study. The vaccination was done at 6-10-14 weeks following EPI/WHO recommended immunization schedule. Blood samples were collected prior to the administration of first dose and one month after the third dose. Postvaccination, geometric mean titres for each component did not differ significantly between the single dose vial and multi dose vial subgroups and among the two study groups. Adverse events observed were within the range quoted in literature. Quadrovax(®) vaccine manufactured by SIIL was found to be safe, immunogenic and non-inferior to the comparator vaccine. The quadravalent vaccine is best recommended in the second year of life when children receive their booster dose at 15-18 months. It can be given to infants during primary immunization series at 6, 10 and 14 weeks of age when Hepatitis B vaccine is given in a separate arm or to infants at 10 weeks who receive the Hepatitis B vaccine separately following the 0, 6 and 14 weeks or 0, 1 and 6 months schedule.
<p>An HA1 fragment, H1pHA9, defined by stable breakpoints was designed <i>in silico&l... more <p>An HA1 fragment, H1pHA9, defined by stable breakpoints was designed <i>in silico</i>. (A) Shown in stereoview is the cartoon representation of H1N1 A/California/04/2009 HA trimer (PDB ID: 3LZG). Residues 65–286 comprising H1pHA9 (colored grey) have been mapped onto a monomer (orange) of the crystal structure of H1N1 A/California/04/2009 HA. The rest of the molecule is colored green. The mutations introduced in H1pHA9 are colored red. The receptor binding site residues are colored yellow. (B) The mutated residues (red) in H1pHA9 do not contribute to any of the antigenic sites or the receptor binding site (yellow) on HA. The figures were generated in PyMOL (The PyMOL Molecular Graphics System, version 1.2r2, DeLano Scientific, LLC).</p
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, Jan 15, 2015
In 2002, the Meningitis Vaccine Project (MVP) chose the Serum Institute of India, Ltd (SIIL), as ... more In 2002, the Meningitis Vaccine Project (MVP) chose the Serum Institute of India, Ltd (SIIL), as its manufacturing partner to establish a product development partnership (PDP) with the Meningitis Vaccine Project (MVP). MVP was a collaboration between PATH and the World Health Organization (WHO) to develop meningococcal conjugate vaccines for sub-Saharan Africa. From the outset, SIIL recognized that a partnership with MVP carried some risk but also offered important opportunities for accessing new conjugate vaccine technology and know-how. Over 3 years, SIIL successfully accepted technology transfer for the group A meningococcal polysaccharide from SynCo Bio Partners and a conjugation method from the US Food and Drug Administration. SIIL successfully scaled up production of a group A meningococcal conjugate vaccine that used SIIL tetanus toxoid as the carrier protein. Phase 1 studies began in India in 2005, followed by phase 2/3 studies in Africa and India. A regulatory dossier was s...
Both WHO and IAP encourage using combination vaccines, wherever feasible. The phase III trial rep... more Both WHO and IAP encourage using combination vaccines, wherever feasible. The phase III trial reported here was conducted to assess and compare the immunogenicity, tolerability and safety of two quadravalent vaccines, Quadrovax(®) (new vaccine), and TETRAct-Hib(®) (available in the market) in a multicentre study, in India. In all, 361 infants aged 6-8 weeks were enrolled, out of which 339 completed the study. The vaccination was done at 6-10-14 weeks following EPI/WHO recommended immunization schedule. Blood samples were collected prior to the administration of first dose and one month after the third dose. Postvaccination, geometric mean titres for each component did not differ significantly between the single dose vial and multi dose vial subgroups and among the two study groups. Adverse events observed were within the range quoted in literature. Quadrovax(®) vaccine manufactured by SIIL was found to be safe, immunogenic and non-inferior to the comparator vaccine. The quadravalent vaccine is best recommended in the second year of life when children receive their booster dose at 15-18 months. It can be given to infants during primary immunization series at 6, 10 and 14 weeks of age when Hepatitis B vaccine is given in a separate arm or to infants at 10 weeks who receive the Hepatitis B vaccine separately following the 0, 6 and 14 weeks or 0, 1 and 6 months schedule.
<p>An HA1 fragment, H1pHA9, defined by stable breakpoints was designed <i>in silico&l... more <p>An HA1 fragment, H1pHA9, defined by stable breakpoints was designed <i>in silico</i>. (A) Shown in stereoview is the cartoon representation of H1N1 A/California/04/2009 HA trimer (PDB ID: 3LZG). Residues 65–286 comprising H1pHA9 (colored grey) have been mapped onto a monomer (orange) of the crystal structure of H1N1 A/California/04/2009 HA. The rest of the molecule is colored green. The mutations introduced in H1pHA9 are colored red. The receptor binding site residues are colored yellow. (B) The mutated residues (red) in H1pHA9 do not contribute to any of the antigenic sites or the receptor binding site (yellow) on HA. The figures were generated in PyMOL (The PyMOL Molecular Graphics System, version 1.2r2, DeLano Scientific, LLC).</p
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, Jan 15, 2015
In 2002, the Meningitis Vaccine Project (MVP) chose the Serum Institute of India, Ltd (SIIL), as ... more In 2002, the Meningitis Vaccine Project (MVP) chose the Serum Institute of India, Ltd (SIIL), as its manufacturing partner to establish a product development partnership (PDP) with the Meningitis Vaccine Project (MVP). MVP was a collaboration between PATH and the World Health Organization (WHO) to develop meningococcal conjugate vaccines for sub-Saharan Africa. From the outset, SIIL recognized that a partnership with MVP carried some risk but also offered important opportunities for accessing new conjugate vaccine technology and know-how. Over 3 years, SIIL successfully accepted technology transfer for the group A meningococcal polysaccharide from SynCo Bio Partners and a conjugation method from the US Food and Drug Administration. SIIL successfully scaled up production of a group A meningococcal conjugate vaccine that used SIIL tetanus toxoid as the carrier protein. Phase 1 studies began in India in 2005, followed by phase 2/3 studies in Africa and India. A regulatory dossier was s...
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