Presenter of 1 Presentation
O064 - IMMUNOGENICITY AND SAFETY OF A 10-VALENT PNEUMOCOCCAL CONJUGATE VACCINE (PCV) ADMINISTERED AS A 2+1 SCHEDULE TO HEALTHY INFANTS IN THE GAMBIA (ID 859)
Abstract
Background
SIIPL-PCV (Pneumosil®) is a new, low-cost, WHO prequalified 10-valent PCV manufactured by the Serum Institute of India Pvt. Ltd. This study was designed to describe how SIIPL-PCV compares to the other two WHO prequalified PCVs: 10-valent pneumococcal polysaccharide protein D-conjugate vaccine (PHiD-CV [Synflorix™], GlaxoSmithKline); and the 13-valent PCV (PCV13 [Prevenar 13®], Pfizer), when given as a 2+1 schedule.
Methods
Vaccines were administered in a 1:1:1 ratio to 660 infants at 6 and 14 weeks of age with the booster at 9 months. The primary immunogenicity objective, measured four weeks after the booster, was to compare the serotype-specific immunoglobulin G geometric mean concentrations (GMCs) generated by SIIPL-PCV with those generated by PHiD-CV and PCV13.
Results
For SIIPL-PCV compared to PHiD-CV, GMC ratios for the shared serotypes ranged from 0.64 (95% CI 0.52 to 0.79) for serotype 19F to 2.91 (95% CI 2.47 to 3.44) for serotype 1. For SIIPL-PCV compared to PCV13, GMC ratios ranged from 0.72 (95% CI 0.60 to 0.87) for serotype 19A to 1.44 (95% CI 1.23 to 1.69) for serotype 1. Sixteen (7.3%) infants experienced a mild or moderate systemic rash following vaccination with SIIPL-PCV compared to seven (3.2%) and six (2.7%) following PHiD-CV and PCV13, respectively. No other notable differences in solicited adverse event rates occurred.
Conclusions
SIIPL-PCV generates robust immune responses following administration to infants according to a 2+1 schedule. The serotype-specific immune responses are of the same order as those generated by PHiD-CV and PCV13 for which effectiveness data are available.