| Autor: |
Mair, Stuart, Fiquet, Anne, Meghlaoui, Gilles, Thomas, Stephane, Ledesma, Emilio |
| Zdroj: |
Human Vaccines; September 2009, Vol. 5 Issue: 9 p608-613, 6p |
| Abstrakt: |
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 ≥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®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. |
| Databáze: |
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