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Pediatr Infect Dis J. 2015 Feb;34(2):180-5. doi: 10.1097/INF.0000000000000511.

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.

Author information

1
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.

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00366548.

PMID:
25126854
DOI:
10.1097/INF.0000000000000511
[Indexed for MEDLINE]

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