Colombo C, Argiolas L, La Vecchia C, Negri E, Meloni G, Meloni T
Department of Pediatrics and Neonatology, University of Sassari, Viale San Petro 12, 07100 Sassari, Italy.
Rev Epidemiol Sante Publique. 2001 Apr;49(2):157-62.
Studies of influenza vaccination in healthy children have not definitely answered the question of their efficacy.
We have carried out a randomized trial in a well selected population of healthy preschool children in Sardinia, Italy. During October 1995, 344 children aged 1 to 6 years, were randomly assigned to receive influenza vaccine (n=177) or no treatment (n=167). Two doses of a trivalent subvirion vaccine, containing 15mg of highly purified surface antigens from the component strains A/Johannesburg/33/94-like, A/Singapore/6/86-like and B/ Beijing/184/ 93-like were administered. Follow-up data were collected from December 1, 1995 through April 30, 1996.
Seroconversion was documented in 17 out of 17 children. No specific systemic symptoms or severe local reactions were observed after vaccination. Influenza-like episodes, defined by the presence of fever and cough or sore throat that lasted at least 72 hours, occurred in 63 (37.7%) of unvaccinated children and in 22 (12.4%) of vaccinated ones. The corresponding reduction in disease incidence was 67% (95% CI: 0.59-0.74). Three episodes of otitis were observed among children in the control group versus zero among vaccinated children (p=0.07). Mean duration of day care center absenteism was significantly reduced by vaccination (2.3 days in unvaccinated and 0.5 day in vaccinated children, p<0.001)
Influenza vaccine is safe and effective in healthy preschool children. However the favourable implications of vaccination on disease rate in subsequent years have to be evaluated.
关于健康儿童流感疫苗接种效果的研究尚未明确回答该问题。
我们在意大利撒丁岛精心挑选的健康学龄前儿童群体中开展了一项随机试验。1995年10月，344名1至6岁儿童被随机分配接受流感疫苗接种（n = 177）或不接受治疗（n = 167）。接种了两剂三价亚病毒颗粒疫苗，该疫苗含有来自A/约翰内斯堡/33/94样、A/新加坡/6/86样和B/北京/184/93样毒株的15毫克高度纯化表面抗原。随访数据收集时间为1995年12月1日至1996年4月30日。
177名接种疫苗的儿童中有17名出现血清转化。接种疫苗后未观察到特定的全身症状或严重局部反应。未接种疫苗的儿童中有63名（37.7%）出现了流感样发作，表现为发热、咳嗽或喉咙痛持续至少72小时，而接种疫苗的儿童中有22名（12.4%）出现此类情况。疾病发病率相应降低了67%（95%可信区间：0.59 - 0.74）。对照组儿童中有3例中耳炎发作，而接种疫苗儿童中未观察到（p = 0.07）。接种疫苗显著缩短了日托中心缺勤的平均时长（未接种疫苗儿童为2.3天，接种疫苗儿童为0.5天，p < 0.001）
流感疫苗在健康学龄前儿童中安全有效。然而，接种疫苗对后续年份疾病发生率的有利影响有待评估。
