title: Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine manufactured with and without polysorbate 80 given to healthy infants at 2, 3, 4 and 12 months of age.
abstract: BACKGROUND
  Polysorbate 80 (P80), a nonionic detergent used to solubilize proteins, is used in both oral and injectable medications including vaccines. Development studies with 13-valent pneumococcal conjugate vaccine (PCV13) showed that adding P80 resulted in a more robust manufacturing process. Before adding P80 to the formulation of PCV13, we investigated the immunogenicity and safety of PCV13 with and without P80.
  
  
  METHODS
  Phase 3, parallel-group, randomized, active-controlled, double-blind multicenter trial was conducted at 15 sites in Poland. Healthy infants were randomized (1:1) to receive PCV13+P80 or PCV13 without P80 given at ages 2, 3, 4 and 12 months concomitantly with DTaP-IPV-Hib at 2, 3 and 4 months; hepatitis B at 2 months and measles, mumps, and rubella at 12 months. Serotype-specific antipneumococcal immune responses were evaluated using antipolysaccharide capsular immunoglobulin (Ig)G responses and opsonophagocytic activity (OPA) assay. Safety data were also collected.
  
  
  RESULTS
  The 2 treatment groups were demographically similar. Following the infant immunization series, anticapsular IgG antibody geometric mean concentrations and OPA geometric mean titers for each serotype were within 2-fold between the 2 groups. Formal noninferiority criteria for comparison of proportion of responders (subjects with IgG titers ≥0.35 μg/mL) were met for 11 of the 13 serotypes. Overall population responses were highly similar. Anticapsular IgG responses were also within 2-fold following the toddler dose. Safety profiles were similar between the 2 groups.
  
  
  CONCLUSIONS
  Addition of P80 to PCV13 did not adversely affect PCV13 immunogenicity or safety when compared with vaccine formulated without P80.
authors.affiliation: From the *Department of Neonatology, Poznań University of Medical Sciences, Poznan, Poland; †Pfizer Vaccine Research, Maidenhead, United Kingdom; ‡Department of Preventive Medicine, Poznań University of Medical Sciences, Poznan; §Physicians Practice Group Family Specialist Outpatient Clinic, Torun; ¶The Wl. Bieganski Provincial Specialist Hospital of Lodz, Lodz; ‖The St. Luis Provincial Specialist Children's Hospital, Cracow; **The Dr. Biziel University Hospital No. 2 of Bydgoszcz, Bydgoszcz; ††University Children's Hospital of Cracow, Cracow; ‡‡Vaccine Research, Pfizer Inc, Pearl River, NY; and §§Pfizer Vaccines Research, Pfizer Inc, Collegeville, PA.
authors.forename: Janusz
authors.initials: J
authors.lastname: Gadzinowski
authors.forename: Susan P
authors.initials: SP
authors.lastname: Tansey
authors.forename: Jacek
authors.initials: J
authors.lastname: Wysocki
authors.forename: Elzbieta
authors.initials: E
authors.lastname: Kopińska
authors.forename: Ewa
authors.initials: E
authors.lastname: Majda-Stanisławska
authors.forename: Hanna
authors.initials: H
authors.lastname: Czajka
authors.forename: Piotr
authors.initials: P
authors.lastname: Korbal
authors.forename: Jacek J
authors.initials: JJ
authors.lastname: Pietrzyk
authors.forename: Sherryl A
authors.initials: SA
authors.lastname: Baker
authors.forename: Peter C
authors.initials: PC
authors.lastname: Giardina
authors.forename: William C
authors.initials: WC
authors.lastname: Gruber
authors.forename: Emilio A
authors.initials: EA
authors.lastname: Emini
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Scott
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005079:Excipients / Q000008:administration & dosage*; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D007223:Infant; D008297:Male; D009895:Opsonin Proteins / Q000097:blood; D010587:Phagocytosis; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D011044:Poland; D011136:Polysorbates / Q000008:administration & dosage*; D013501:Surface-Active Agents / Q000008:administration & dosage*
chemical_list: C538862:13-valent pneumococcal vaccine; D000907:Antibodies, Bacterial; D005079:Excipients; D007074:Immunoglobulin G; D009895:Opsonin Proteins; D022242:Pneumococcal Vaccines; D011136:Polysorbates; D013501:Surface-Active Agents