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Abstract：
OBJECTIVE: To assess the efficacy and safety of MF59-adjuvanted pandemic influenza A/H1N1 vaccine in children.
METHODS: A systematic review of the literature was performed after searching the MedLine and Embase electronic databases, and manual search in specialties journals, with MeSH terms and and free terms. Inclusion criteria were clinical trials with children vaccinated with MF59-adjuvanted influenza A/H1N1 vaccine, compared with other vaccines doses with/without MF59-adjuvanted. The immunogenicity and safety of the vaccine was recorded. The quality of the studies included was assessed by CASPe checklist.
RESULTS: Four clinical trials with moderate quality were selected. The local and systemic adverse effects were rare and mild, with no differences between groups. Seroconversion and seroprotection levels were higher with MF59-adjuvanted vaccines. Antibody titres were also higher with the adjuvant vaccines.
CONCLUSIONS: The adjuvant vaccine has a good efficacy and safety profile. The adverse effects that may occur are common and appear similarly in both vaccination groups.
METHODS: A systematic review of the literature was performed after searching the MedLine and Embase electronic databases, and manual search in specialties journals, with MeSH terms and and free terms. Inclusion criteria were clinical trials with children vaccinated with MF59-adjuvanted influenza A/H1N1 vaccine, compared with other vaccines doses with/without MF59-adjuvanted. The immunogenicity and safety of the vaccine was recorded. The quality of the studies included was assessed by CASPe checklist.
RESULTS: Four clinical trials with moderate quality were selected. The local and systemic adverse effects were rare and mild, with no differences between groups. Seroconversion and seroprotection levels were higher with MF59-adjuvanted vaccines. Antibody titres were also higher with the adjuvant vaccines.
CONCLUSIONS: The adjuvant vaccine has a good efficacy and safety profile. The adverse effects that may occur are common and appear similarly in both vaccination groups.
摘要：
目的：评估MF59佐剂化大流行性流感A/H1N1疫苗在儿童中的有效性和安全性。
方法：在搜索MedLine和Embase电子数据库后，对文献进行了系统回顾，在专业期刊上手动搜索，具有MeSH条款和免费条款。纳入标准是儿童接种MF59佐剂流感A/H1N1疫苗的临床试验，与含或不含MF59佐剂的其他疫苗剂量相比。记录疫苗的免疫原性和安全性。纳入研究的质量通过CASPe核对表进行评估。
结果：选择了四个中等质量的临床试验。局部和全身不良反应罕见且轻微，组间没有差异。MF59佐剂化疫苗的血清转化和血清保护水平较高。佐剂疫苗的抗体滴度也较高。
结论：佐剂疫苗具有良好的疗效和安全性。可能发生的不良反应是常见的，并且在两个疫苗接种组中相似。
方法：在搜索MedLine和Embase电子数据库后，对文献进行了系统回顾，在专业期刊上手动搜索，具有MeSH条款和免费条款。纳入标准是儿童接种MF59佐剂流感A/H1N1疫苗的临床试验，与含或不含MF59佐剂的其他疫苗剂量相比。记录疫苗的免疫原性和安全性。纳入研究的质量通过CASPe核对表进行评估。
结果：选择了四个中等质量的临床试验。局部和全身不良反应罕见且轻微，组间没有差异。MF59佐剂化疫苗的血清转化和血清保护水平较高。佐剂疫苗的抗体滴度也较高。
结论：佐剂疫苗具有良好的疗效和安全性。可能发生的不良反应是常见的，并且在两个疫苗接种组中相似。
