Reactogenicity and tolerability of a non-adjuvanted 11-valent diphtheria-tetanus toxoid pneumococcal conjugate vaccine in Filipino children

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• 作者：Juanita Ugpo ; Marilla Lucero ; Gail Williams ; Marites Lechago ; Leilani Nillos ; Veronica Tallo ; Hanna Nohynek ; Arivac Consortium
• 关键词：Reactogenicity ; Pneumococcal conjugate vaccine ; Adverse events
• 刊名：Vaccine
• 出版年：2009
• 出版时间：5 May 2009
• 年：2009
• 卷：27
• 期：20
• 页码：2723-2729
• 全文大小：137 K

文摘

In a phase three randomized, double-blind, saline-placebo controlled study conducted in Bohol, Philippines, we assessed the reactogenicity of an 11-valent PCV (11PCV) when given simultaneously with EPI vaccines at 6, 10 and 14 weeks of age in a subset of 252 and 126 children who were followed-up by passive and active surveillance, respectively.

In passive surveillance (parents’ observation), redness was observed in 14.4 % vs. 11.8 % , swelling in 8 % vs. 3.9 % , induration in 13.6 % vs. 8.6 % , and pain in 54.4 % vs. 47.2 % of 11PCV and placebo infants, respectively, after the first dose of the vaccine. Redness at injection site was significantly more common with 11PCV than placebo infants after the third dose (13.6 % vs. 3.2 % , p = 0.005). Crying (53.6 % vs. 48 % ), irritability (48 % vs. 46.4 % ), and fever (22.4 % vs. 19.6 % ) were commonly observed in 11PCV and placebo infants, respectively, after the first dose. Loss of appetite was significantly more common among 11PCV (12 % ) than placebo (4.7 % ) infants but only after the first dose of the vaccine (P = 0.04). The number of reactions decreased in both groups with subsequent doses. The non-adjuvanted 11PCV vaccine was found to be well-tolerated among Filipino infants.