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Clinical Trial
. 2011 Apr 5;29(16):2947-55.
doi: 10.1016/j.vaccine.2011.02.002. Epub 2011 Feb 16.

Phase 3 trial evaluating the immunogenicity, safety, and tolerability of manufacturing scale 13-valent pneumococcal conjugate vaccine

Janusz Gadzinowski  1 , Piotr Albrecht, Barbara Hasiec, Ryszard Konior, Jerzy Dziduch, Anita Witor, Tracey Mellelieu, Susan P Tansey, Thomas Jones, Denise Sarkozy, Emilio A Emini, William C Gruber, Daniel A Scott
Affiliations
Clinical Trial

Phase 3 trial evaluating the immunogenicity, safety, and tolerability of manufacturing scale 13-valent pneumococcal conjugate vaccine

Janusz Gadzinowski et al. Vaccine. .

Abstract

13-valent pneumococcal conjugate vaccine (PCV13) includes polysaccharide conjugates from six pneumococcal serotypes in addition to those in the licensed 7-valent vaccine, thereby offering expanded protection against pneumococcal disease. The phase 3 trial reported here was conducted per a regulatory requirement to evaluate the immunogenicity, safety, and tolerability of two lots of the final PCV13 formulation that differed with respect to production scale but not the manufacturing process. The anti-pneumococcal polysaccharide immunogenicity and safety/tolerability were found to be similar between the two PCV13 vaccine lots.

Trial registration: ClinicalTrials.gov NCT00464945.

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