title: Phase 3 trial evaluating the immunogenicity, safety, and tolerability of manufacturing scale 13-valent pneumococcal conjugate 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.
authors.affiliation: Department of Neonatology, Poznań University of Medical Sciences, Polna 33, 60-535 Poznań, Poland. jgadzin@gpsk.am.poznan.pl
authors.forename: Janusz
authors.initials: J
authors.lastname: Gadzinowski
authors.forename: Piotr
authors.initials: P
authors.lastname: Albrecht
authors.forename: Barbara
authors.initials: B
authors.lastname: Hasiec
authors.forename: Ryszard
authors.initials: R
authors.lastname: Konior
authors.forename: Jerzy
authors.initials: J
authors.lastname: Dziduch
authors.forename: Anita
authors.initials: A
authors.lastname: Witor
authors.forename: Tracey
authors.initials: T
authors.lastname: Mellelieu
authors.forename: Susan P
authors.initials: SP
authors.lastname: Tansey
authors.forename: Thomas
authors.initials: T
authors.lastname: Jones
authors.forename: Denise
authors.initials: D
authors.lastname: Sarkozy
authors.forename: Emilio A
authors.initials: EA
authors.lastname: Emini
authors.forename: William C
authors.initials: WC
authors.lastname: Gruber
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Scott
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D004311:Double-Blind Method; D005062:European Union; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D007223:Infant; D008297:Male; D011008:Pneumococcal Infections / Q000517:prevention & control*; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology* / Q000592:standards*; D011044:Poland; D011135:Polysaccharides, Bacterial / Q000276:immunology; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology / Q000592:standards
chemical_list: C538862:13-valent pneumococcal vaccine; D000907:Antibodies, Bacterial; D007074:Immunoglobulin G; D022242:Pneumococcal Vaccines; D011135:Polysaccharides, Bacterial; D018074:Vaccines, Conjugate