Immunogenicity and safety of PNEUMOVAX II manufactured by a new process in older adults.

In response to increased demand for the 23-valent pneumococcal vaccine PNEUMOVAX II, a new manufacturing process has been implemented that improves the consistency and increases the scale of production. This double-blind, randomized, clinical study compared the immunogenicity and safety profiles of the new-process PNEUMOVAX II (n = 111) formulated with all 23 new process polysaccharides to the former-process PNEUMOVAX II (n = 109) formulation in adults aged > or =50 years. The primary aim of the study was to compare the post-vaccination geometric mean of antibody titres (GMT) to pneumococcal serotypes 3 and 8 in recipients of new- and former-process PNEUMOVAX II. The post-vaccination GMTs for serotypes 3 and 8 elicited by the new-process PNEUMOVAX II [1.40 (95% confidence interval, 1.21-1.63) and 10.78 (95% CI, 9.10-12.77), respectively] were non-inferior to those elicited by the former-process PNEUMOVAX II [1.24 (95% CI, 1.07-1.43) and 9.72 (95% CI, 8.22-11.50), respectively]. Both PNEUMOVAX II formulations were well tolerated; there were no vaccine-related serious adverse events. A total of 74 (66.7%) subjects in the new-process group and 66 (60.6%) in the former-process group had at least one injection-site reaction or vaccine-related systemic event within 14 days following vaccination. There was a trend for higher incidence of two solicited injection-site reactions (erythmea and induration) and three solicited systemic events (asthenia, chills and body aches) with the new- versus former-process PNEUMOVAX II, but these were mainly of mild intensity and short duration. The new-process PNEUMOVAX(R II thus showed similar immunogenicity to the former-process vaccine for pneumococcal serotypes 3 and 8 and both vaccines were well tolerated in older subjects.