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Pneumococcal conjugate vaccines for preventing otitis media

  • Review
  • Intervention




Acute otitis media (AOM) is a very common early infancy and childhood disease. The marginal benefits of antibiotics on AOM, the increasing problem of bacterial resistance to antibiotics, and the huge estimated direct and indirect annual costs associated with otitis media (OM) have prompted a search for effective vaccines to prevent AOM.


To assess the effect of pneumococcal conjugate vaccines (PCVs) in preventing AOM in children up to 12 years of age.

Search methods

We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2007, issue 2), which contains the Cochrane Acute Respiratory Infections Group's Specialised Register; MEDLINE (January 1995 to November 2007); and EMBASE (January 1995 to November 2007).

Selection criteria

Randomised controlled trials of PCVs to prevent AOM in children aged 12 years or younger, with a follow up of at least six months after vaccination.

Data collection and analysis

Three review authors independently assessed trial quality and two review authors extracted data.

Main results

We included seven trials on 7- to 11-valent PCV (with different carrier proteins). There was large heterogeneity regarding study population, type of conjugate vaccine, and outcome measures between trials, therefore, results were not pooled. The only currently licensed 7-valent PCV Prevenar® with CRM197 as carrier protein (CRM197-PCV7) administered during infancy was in two studies associated with a 6% (95% confidence interval (CI) -4% to 16%) and 7% (95% CI 4% to 9%) relative reduction in risk of AOM episodes. Another 7-valent PCV with the outer membrane protein complex of Neisseria meningitidis (N. meningitidis) serogroup B as carrier protein, administered in infancy, did not reduce overall AOM episodes, while an 11-valent PCV with Haemophilus influenzae (H. influenzae) protein D as carrier protein was associated with a relative reduction in risk of AOM episodes of 34% (95% CI 21% to 44%). 9-valent PCV (with CRM197 carrier protein) administered in healthy toddlers was associated with a 17% (95% CI -2% to 33%) relative reduction in risk of OM episodes. CRM197-PCV7 followed by 23-valent pneumococcal polysaccharide vaccination administered after infancy in older children with a history of AOM showed no beneficial effect on further AOM episodes.

Authors' conclusions

Based on current evidence of the effectiveness of PCVs for the prevention of AOM, the currently licensed 7-valent PCV administered during infancy has marginal beneficial effects. Discrete reductions of 6% to 7% may mean substantial reductions from a public health perspective. Administering PCV7 in older children with a history of AOM appears to have no benefit in preventing further episodes.



關於接種肺炎雙球菌疫苗(pneumococcal conjugate vaccines)預防中耳炎(otitis media)

急性中耳炎(acute otitis media)是嬰幼兒早期常見的疾病.抗生素對急性中耳炎的治療效果有限,細菌對抗生素的抗藥性問題日益嚴重,以及每年與中耳炎相關所估計的龐大直接和間接成本在在都引起了對於尋找能夠有效預防急性中耳炎的疫苗的投注.




我們搜尋了the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2007, issue 2)(其中包含了the Cochrane Acute Respiratory Infections Group's Specialised Register), MEDLINE (January 1995 to November 2007),和EMBASE (January 1995 to November 2007)3個資料庫.


有關於肺炎雙球菌疫苗預防小於12歲孩童急性中耳炎的隨機對照試驗(randomised controlled trials),這些試驗在孩童接種後至少追蹤6個月.




我們總共收錄了7個關於7價到11價的肺炎雙球菌疫苗(7to 11valent PCV)[使用不同的載體蛋白(carrier proteins)].由於試驗之間的研究族群,所使用的疫苗種類,以及結果的測量方式存在著很大的差異,所以最後試驗結果最終並未被匯集在一起(pooled).目前唯一准許在嬰兒接種的7價肺炎雙球菌疫苗PrevenarR (CRM197PCV7)(使用CRM197為載體蛋白]在兩項研究中分別可以相對減少6%[95% conference interval(CI) −4% to 16%]和7%(95% CI 4% to 9%)發生急性中耳炎的風險.另一在嬰兒期接種的7價肺炎雙球菌疫苗使用的是血清B型(serogroup B)腦膜炎奈瑟氏菌(Neisseria meningitidis)的外膜蛋白複合物為載體蛋白,並無法降低整體急性中耳炎的發生,而使用流感嗜血桿菌(Haemophilus influenza)蛋白D(protein D)為載體蛋白的11價肺炎雙球菌疫苗則可以相對減少34%(95% CI 21% to 44%)急性中耳炎發生的風險.接種在健康幼兒的9價肺炎雙球菌疫苗(使用CRM197為載體蛋白)可以相對減少17%(95% CI −2% to 33%)中耳炎發生的風險.年齡較大且曾經罹患急性中耳炎的的兒童在嬰兒期之後先接種CRM197PCV7再接種23價肺炎雙球菌多醣疫苗(pneumococcal polysaccharide vaccination)則無法預防再次急性中耳炎的發生.





此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。


急性中耳炎是中耳的感染且是一種兒童最常見的疾病.感染肺炎雙球菌(一種細菌)是一常見的原因. 的急性中耳炎.接種肺炎雙球菌疫苗旨在使年幼兒童對肺炎雙球菌的感染產生免疫力.本篇對7個臨床試驗總共46885參與兒童的評論是要評估肺炎雙球菌疫苗預防急性中耳炎的效力.目前唯一准許在嬰兒接種的7價的肺炎雙球菌疫苗能減少6%至7%急性中耳炎的發生.這意味著對於個人只有輕微減少急性中耳炎的發生,但是對對急性中耳炎的醫療照護負擔而言卻可能有重大影響.曾經罹患急性中耳炎的的兒童在嬰兒期之後接種7價的肺炎雙球菌疫苗則似乎沒有好處.

Plain language summary

Pneumococcal conjugate vaccines for preventing otitis media

Acute otitis media (AOM) is the infection of the middle ear and is one of the most common diseases in childhood. Infection with pneumococci (a type of bacterium) is a frequent cause of AOM. Pneumococcal conjugate vaccines (PCVs) aim to immunise young children against pneumococcal infections. This review of seven trials with 46,885 participating children aimed to assess the effects of PCV in preventing AOM. The only currently licensed 7-valent PCV given in infancy reduced the occurrence of AOM episodes by 6% to 7%. This means only a marginal decrease in AOM episodes for the individual, but this may have a substantial impact on the healthcare burden of AOM. Children with a history of AOM do not seem to benefit from 7-valent PCV when immunised at an older age (outside infancy).