Effectiveness of maternal influenza immunization in mothers and infants
Effectiveness of maternal influenza immunization in mothers and infants
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DOI：
10.1056/nejmoa0708630
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发表时间：
2008-10-09
影响因子：
158.5
通讯作者：
Steinhoff, Mark C.
中科院分区：
文献类型：
--
作者：
Zaman, K.;Roy, Eliza;Steinhoff, Mark C.
背景：婴儿和孕妇患流感严重后果的风险增加。灭活流感疫苗推荐用于孕妇，但不允许用于6个月以下的婴儿。我们评估了孟加拉国怀孕期间接种灭活流感疫苗的临床效果。方法：在这项随机研究中，我们指定340名母亲接种灭活流感疫苗（流感疫苗组）或23价肺炎球菌多糖疫苗（对照组）。母亲们每周接受一次访谈，评估她们的疾病，直到出生后24周。对患有发热性呼吸道疾病的受试者进行临床评估，并对患病婴儿进行流感抗原检测。我们估计了发病率、发病率比和疫苗有效性。结果：从2004年8月至2005年12月对母亲和婴儿进行了观察。在接种流感疫苗的母亲的婴儿中，实验室确诊的流感病例少于对照组婴儿（分别为6例和16例），疫苗有效性为63%（95%置信区间[CI]， 5至85）。流感疫苗组有110名婴儿出现呼吸道疾病伴发热，对照组有153名婴儿出现呼吸道疾病伴发热，疫苗有效性为29% （95% CI, 7 - 46）。在母亲中，呼吸道疾病的发病率降低了36% （95% CI, 4 - 57）。结论：灭活流感疫苗可使6个月以下婴儿的确诊流感发病率降低63%，并可避免母亲和婴儿中约三分之一的发热性呼吸道疾病。产妇流感免疫接种是一项对母亲和婴儿都有实质性好处的战略。（ClinicalTrials.gov编号：NCT00142389）。
Background: Young infants and pregnant women are at increased risk for serious consequences of influenza infection. Inactivated influenza vaccine is recommended for pregnant women but is not licensed for infants younger than 6 months of age. We assessed the clinical effectiveness of inactivated influenza vaccine administered during pregnancy in Bangladesh.Methods: In this randomized study, we assigned 340 mothers to receive either inactivated influenza vaccine (influenza-vaccine group) or the 23-valent pneumococcal polysaccharide vaccine (control group). Mothers were interviewed weekly to assess illnesses until 24 weeks after birth. Subjects with febrile respiratory illness were assessed clinically, and ill infants were tested for influenza antigens. We estimated the incidence of illness, incidence rate ratios, and vaccine effectiveness.Results: Mothers and infants were observed from August 2004 through December 2005. Among infants of mothers who received influenza vaccine, there were fewer cases of laboratory-confirmed influenza than among infants in the control group (6 cases and 16 cases, respectively), with a vaccine effectiveness of 63% (95% confidence interval [CI], 5 to 85). Respiratory illness with fever occurred in 110 infants in the influenza-vaccine group and 153 infants in the control group, with a vaccine effectiveness of 29% (95% CI, 7 to 46). Among the mothers, there was a reduction in the rate of respiratory illness with fever of 36% (95% CI, 4 to 57).Conclusions: Inactivated influenza vaccine reduced proven influenza illness by 63% in infants up to 6 months of age and averted approximately a third of all febrile respiratory illnesses in mothers and young infants. Maternal influenza immunization is a strategy with substantial benefits for both mothers and infants. (ClinicalTrials.gov number, NCT00142389.).