Li Rong-cheng, Li Feng-xiang, Li Yan-ping
Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention, Nanning 530028, Guangxi, China.
Zhongguo Yi Miao He Mian Yi. 2009 Jun;15(3):196-200.
To evaluate the safety and immunogenicity of the booster dose of 7 valent pneumococcal conjugate vaccine (PCV7) to the healthy Chinese toddlers who had received 3 primary doses.
Four hundred and eighty-eight Chinese toddlers received a booster dose of PCV7 at age of 12-15 months following a primary series of the vaccine given at ages 3, 4, 5 months separately with Diphtheria Tetanus Acellular Pertussis Combined Vaccine (DTaP) in Group 1 or concurrently with DTaP in Group 2. Following the booster dose immunization, each subject was followed up for 30 days to observe the safety of the vaccine. Blood samples were taken from a subset of subjects prior and post 30 days the booster dose immunization to evaluate immunogenicity.
A high proportion of subjects in Group 1 (89%) and Group 2 (91%) remained afebrile after the booster dose. Local reactions to the PCV7 booster dose were generally mild. For each serotype, the rise in GMC (post-/pre-vaccination) showed a statistically significant difference (P<0.0001) between both groups.
PCV7 administered as a booster dose is generally safe, well tolerate, and immunogenic in healthy Chinese toddlers.
评估7价肺炎球菌结合疫苗（PCV7）加强剂量对已接种3剂基础疫苗的健康中国幼儿的安全性和免疫原性。
488名中国幼儿在12至15月龄时接受PCV7加强剂量，其中第1组在3、4、5月龄时分别与白喉破伤风无细胞百日咳联合疫苗（DTaP）同时接种基础系列疫苗，第2组在3、4、5月龄时与DTaP同时接种基础系列疫苗。加强剂量免疫后，对每个受试者随访30天以观察疫苗的安全性。在加强剂量免疫前和免疫后30天从一部分受试者采集血样以评估免疫原性。
第1组（89%）和第2组（91%）中很大比例的受试者在加强剂量后仍无发热。PCV7加强剂量的局部反应一般较轻。对于每种血清型，两组之间GMC（接种后/接种前）的升高均显示出统计学显著差异（P<0.0001）。
作为加强剂量给予的PCV7在健康中国幼儿中总体上是安全的，耐受性良好且具有免疫原性。
