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Incidences of vaccine-preventable Haemophilus influenzae type b pneumonia and meningitis in Indonesian children: hamlet-randomised vaccine-probe trial. Comment

Identifieur interne : 004548 ( PascalFrancis/Checkpoint ); précédent : 004547; suivant : 004549

Incidences of vaccine-preventable Haemophilus influenzae type b pneumonia and meningitis in Indonesian children: hamlet-randomised vaccine-probe trial. Comment

Auteurs : Bradford D. Gessner [France] ; Agustinus Sutanto [Indonésie] ; Mary Linehan [États-Unis] ; I. Gusti Gede Djelantik [Indonésie] ; Tracy Fletcher [États-Unis] ; I. Komang Gerudug [Indonésie] ; INGERANI [Indonésie] ; David Mercer [États-Unis] ; Vanda Moniaga [États-Unis] ; Lawrence H. Moulton [États-Unis] ; Kim Mulholland [Australie] ; Carib Nelson [États-Unis] ; Soewignjo Soemohardjo [Indonésie] ; Mark Steinhoff [États-Unis] ; Anton Widjaya [États-Unis] ; Philippe Stoeckel [France] ; James Maynard [États-Unis] ; Soemarjati Arjoso [Indonésie] ; Ana Lucia S. Sgambatti De Andrade [France] ; Celina M. Turchi Martelli [France]

Source :

RBID : Pascal:05-0068634

Descripteurs français

English descriptors

Abstract

Background Most studies of Haemophilus influenzae type b (Hib) disease in Asia have found low rates, and few Asian countries use Hib vaccine in routine immunisation programmes. Whether Hib disease truly is rare or whether many cases remain undetected is unclear. Methods To estimate incidences of vaccine-preventable Hib pneumonia and meningitis among children younger than 2 years in Lombok, Indonesia, during 1998-2002, we undertook a hamlet-randomised, controlled, double-blind vaccine-probe study (818 hamlets). Children were immunised (WHO schedule) with diphtheria, tetanus, pertussis (DTP) or DTP-PRP-T (Hib conjugate) vaccine. Vaccine-preventable disease incidences were calculated as the difference in rates of clinical outcomes between DTP and DTP-PRP-T groups. Analyses included all children who received at least one vaccine dose. Findings We enrolled 55 073 children: 28 147 were assigned DTP-PRP-T and 26 926 DTP. The proportion of pneumonia outcomes prevented by vaccine ranged from less than 0 to 4.8%. Calculated incidences of vaccine-preventable Hib disease (per 105 child-years of observation) for outcome categories were: substantial alveolar consolidation or effusion, less than zero (-43 [95% CI -185 to 98]); all severe pneumonia, 264 (95% CI less than zero to 629); all clinical pneumonia, 1561 (270 to 2853); confirmed Hib meningitis, 16 (1.4 to 31); meningitis with cerebrospinal-fluid findings consistent with a bacterial aetiology, 67 (22 to 112); and admission for suspected meningitis or presenting to a clinic with convulsions, 158 (42 to 273). Interpretation Hib vaccine did not prevent the great majority of pneumonia cases, including those with alveolar consolidation. These results do not support a major role for Hib vaccine in overall pneumonia-prevention programmes. Nevertheless, the study identified high incidences of Hib meningitis and pneumonia; inclusion of Hib vaccine in routine infant immunisation programmes in Asia deserves consideration.


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Pascal:05-0068634

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<title xml:lang="en" level="a">Incidences of vaccine-preventable Haemophilus influenzae type b pneumonia and meningitis in Indonesian children: hamlet-randomised vaccine-probe trial. Comment</title>
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<name sortKey="Sgambatti De Andrade, Ana Lucia S" sort="Sgambatti De Andrade, Ana Lucia S" uniqKey="Sgambatti De Andrade A" first="Ana Lucia S." last="Sgambatti De Andrade">Ana Lucia S. Sgambatti De Andrade</name>
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<name sortKey="Turchi Martelli, Celina M" sort="Turchi Martelli, Celina M" uniqKey="Turchi Martelli C" first="Celina M." last="Turchi Martelli">Celina M. Turchi Martelli</name>
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<series>
<title level="j" type="main">Lancet : (British edition)</title>
<title level="j" type="abbreviated">Lancet : (Br. ed.)</title>
<idno type="ISSN">0140-6736</idno>
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<date when="2005">2005</date>
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<title level="j" type="main">Lancet : (British edition)</title>
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<term>Child</term>
<term>Clinical trial</term>
<term>Epidemiology</term>
<term>Haemophilus influenzae</term>
<term>Immunoprophylaxis</term>
<term>Incidence</term>
<term>Indonesia</term>
<term>Medicine</term>
<term>Meningitis</term>
<term>Pneumonia</term>
<term>Prevention</term>
<term>Probe</term>
<term>Vaccine</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Immunoprophylaxie</term>
<term>Incidence</term>
<term>Epidémiologie</term>
<term>Pneumonie</term>
<term>Prévention</term>
<term>Vaccin</term>
<term>Méningite</term>
<term>Haemophilus influenzae</term>
<term>Indonésie</term>
<term>Enfant</term>
<term>Essai clinique</term>
<term>Sonde</term>
<term>Médecine</term>
</keywords>
<keywords scheme="Wicri" type="geographic" xml:lang="fr">
<term>Indonésie</term>
</keywords>
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<term>Vaccin</term>
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<front>
<div type="abstract" xml:lang="en">Background Most studies of Haemophilus influenzae type b (Hib) disease in Asia have found low rates, and few Asian countries use Hib vaccine in routine immunisation programmes. Whether Hib disease truly is rare or whether many cases remain undetected is unclear. Methods To estimate incidences of vaccine-preventable Hib pneumonia and meningitis among children younger than 2 years in Lombok, Indonesia, during 1998-2002, we undertook a hamlet-randomised, controlled, double-blind vaccine-probe study (818 hamlets). Children were immunised (WHO schedule) with diphtheria, tetanus, pertussis (DTP) or DTP-PRP-T (Hib conjugate) vaccine. Vaccine-preventable disease incidences were calculated as the difference in rates of clinical outcomes between DTP and DTP-PRP-T groups. Analyses included all children who received at least one vaccine dose. Findings We enrolled 55 073 children: 28 147 were assigned DTP-PRP-T and 26 926 DTP. The proportion of pneumonia outcomes prevented by vaccine ranged from less than 0 to 4.8%. Calculated incidences of vaccine-preventable Hib disease (per 10
<sup>5</sup>
child-years of observation) for outcome categories were: substantial alveolar consolidation or effusion, less than zero (-43 [95% CI -185 to 98]); all severe pneumonia, 264 (95% CI less than zero to 629); all clinical pneumonia, 1561 (270 to 2853); confirmed Hib meningitis, 16 (1.4 to 31); meningitis with cerebrospinal-fluid findings consistent with a bacterial aetiology, 67 (22 to 112); and admission for suspected meningitis or presenting to a clinic with convulsions, 158 (42 to 273). Interpretation Hib vaccine did not prevent the great majority of pneumonia cases, including those with alveolar consolidation. These results do not support a major role for Hib vaccine in overall pneumonia-prevention programmes. Nevertheless, the study identified high incidences of Hib meningitis and pneumonia; inclusion of Hib vaccine in routine infant immunisation programmes in Asia deserves consideration.</div>
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<s1>Department of International Health, Bloomberg School of Public Health, Johns Hopkins University</s1>
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<s1>Departamento de Saúde Coletiva, Universidade Federal de Goiás. S Universitário</s1>
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<s0>Background Most studies of Haemophilus influenzae type b (Hib) disease in Asia have found low rates, and few Asian countries use Hib vaccine in routine immunisation programmes. Whether Hib disease truly is rare or whether many cases remain undetected is unclear. Methods To estimate incidences of vaccine-preventable Hib pneumonia and meningitis among children younger than 2 years in Lombok, Indonesia, during 1998-2002, we undertook a hamlet-randomised, controlled, double-blind vaccine-probe study (818 hamlets). Children were immunised (WHO schedule) with diphtheria, tetanus, pertussis (DTP) or DTP-PRP-T (Hib conjugate) vaccine. Vaccine-preventable disease incidences were calculated as the difference in rates of clinical outcomes between DTP and DTP-PRP-T groups. Analyses included all children who received at least one vaccine dose. Findings We enrolled 55 073 children: 28 147 were assigned DTP-PRP-T and 26 926 DTP. The proportion of pneumonia outcomes prevented by vaccine ranged from less than 0 to 4.8%. Calculated incidences of vaccine-preventable Hib disease (per 10
<sup>5</sup>
child-years of observation) for outcome categories were: substantial alveolar consolidation or effusion, less than zero (-43 [95% CI -185 to 98]); all severe pneumonia, 264 (95% CI less than zero to 629); all clinical pneumonia, 1561 (270 to 2853); confirmed Hib meningitis, 16 (1.4 to 31); meningitis with cerebrospinal-fluid findings consistent with a bacterial aetiology, 67 (22 to 112); and admission for suspected meningitis or presenting to a clinic with convulsions, 158 (42 to 273). Interpretation Hib vaccine did not prevent the great majority of pneumonia cases, including those with alveolar consolidation. These results do not support a major role for Hib vaccine in overall pneumonia-prevention programmes. Nevertheless, the study identified high incidences of Hib meningitis and pneumonia; inclusion of Hib vaccine in routine infant immunisation programmes in Asia deserves consideration.</s0>
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<s2>NS</s2>
<s5>08</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG">
<s0>Haemophilus influenzae</s0>
<s2>NS</s2>
<s5>08</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA">
<s0>Haemophilus influenzae</s0>
<s2>NS</s2>
<s5>08</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE">
<s0>Indonésie</s0>
<s2>NG</s2>
<s5>09</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG">
<s0>Indonesia</s0>
<s2>NG</s2>
<s5>09</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA">
<s0>Indonesia</s0>
<s2>NG</s2>
<s5>09</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE">
<s0>Enfant</s0>
<s5>11</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG">
<s0>Child</s0>
<s5>11</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA">
<s0>Niño</s0>
<s5>11</s5>
</fC03>
<fC03 i1="11" i2="X" l="FRE">
<s0>Essai clinique</s0>
<s5>12</s5>
</fC03>
<fC03 i1="11" i2="X" l="ENG">
<s0>Clinical trial</s0>
<s5>12</s5>
</fC03>
<fC03 i1="11" i2="X" l="SPA">
<s0>Ensayo clínico</s0>
<s5>12</s5>
</fC03>
<fC03 i1="12" i2="X" l="FRE">
<s0>Sonde</s0>
<s5>17</s5>
</fC03>
<fC03 i1="12" i2="X" l="ENG">
<s0>Probe</s0>
<s5>17</s5>
</fC03>
<fC03 i1="12" i2="X" l="SPA">
<s0>Sonda</s0>
<s5>17</s5>
</fC03>
<fC03 i1="13" i2="X" l="FRE">
<s0>Médecine</s0>
<s5>18</s5>
</fC03>
<fC03 i1="13" i2="X" l="ENG">
<s0>Medicine</s0>
<s5>18</s5>
</fC03>
<fC03 i1="13" i2="X" l="SPA">
<s0>Medicina</s0>
<s5>18</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE">
<s0>Pasteurellaceae</s0>
<s2>NS</s2>
</fC07>
<fC07 i1="01" i2="X" l="ENG">
<s0>Pasteurellaceae</s0>
<s2>NS</s2>
</fC07>
<fC07 i1="01" i2="X" l="SPA">
<s0>Pasteurellaceae</s0>
<s2>NS</s2>
</fC07>
<fC07 i1="02" i2="X" l="FRE">
<s0>Bactérie</s0>
</fC07>
<fC07 i1="02" i2="X" l="ENG">
<s0>Bacteria</s0>
</fC07>
<fC07 i1="02" i2="X" l="SPA">
<s0>Bacteria</s0>
</fC07>
<fC07 i1="03" i2="X" l="FRE">
<s0>Asie</s0>
<s2>NG</s2>
</fC07>
<fC07 i1="03" i2="X" l="ENG">
<s0>Asia</s0>
<s2>NG</s2>
</fC07>
<fC07 i1="03" i2="X" l="SPA">
<s0>Asia</s0>
<s2>NG</s2>
</fC07>
<fC07 i1="04" i2="X" l="FRE">
<s0>Homme</s0>
</fC07>
<fC07 i1="04" i2="X" l="ENG">
<s0>Human</s0>
</fC07>
<fC07 i1="04" i2="X" l="SPA">
<s0>Hombre</s0>
</fC07>
<fC07 i1="05" i2="X" l="FRE">
<s0>Appareil respiratoire pathologie</s0>
<s5>37</s5>
</fC07>
<fC07 i1="05" i2="X" l="ENG">
<s0>Respiratory disease</s0>
<s5>37</s5>
</fC07>
<fC07 i1="05" i2="X" l="SPA">
<s0>Aparato respiratorio patología</s0>
<s5>37</s5>
</fC07>
<fC07 i1="06" i2="X" l="FRE">
<s0>Poumon pathologie</s0>
<s5>38</s5>
</fC07>
<fC07 i1="06" i2="X" l="ENG">
<s0>Lung disease</s0>
<s5>38</s5>
</fC07>
<fC07 i1="06" i2="X" l="SPA">
<s0>Pulmón patología</s0>
<s5>38</s5>
</fC07>
<fC07 i1="07" i2="X" l="FRE">
<s0>Système nerveux central pathologie</s0>
<s5>39</s5>
</fC07>
<fC07 i1="07" i2="X" l="ENG">
<s0>Central nervous system disease</s0>
<s5>39</s5>
</fC07>
<fC07 i1="07" i2="X" l="SPA">
<s0>Sistema nervosio central patología</s0>
<s5>39</s5>
</fC07>
<fC07 i1="08" i2="X" l="FRE">
<s0>Système nerveux pathologie</s0>
<s5>40</s5>
</fC07>
<fC07 i1="08" i2="X" l="ENG">
<s0>Nervous system diseases</s0>
<s5>40</s5>
</fC07>
<fC07 i1="08" i2="X" l="SPA">
<s0>Sistema nervioso patología</s0>
<s5>40</s5>
</fC07>
<fN21>
<s1>038</s1>
</fN21>
<fN44 i1="01">
<s1>OTO</s1>
</fN44>
<fN82>
<s1>OTO</s1>
</fN82>
</pA>
</standard>
</inist>
<affiliations>
<list>
<country>
<li>Australie</li>
<li>France</li>
<li>Indonésie</li>
<li>États-Unis</li>
</country>
<region>
<li>Victoria (État)</li>
<li>Île-de-France</li>
</region>
<settlement>
<li>Melbourne</li>
<li>Paris</li>
</settlement>
<orgName>
<li>Université de Melbourne</li>
</orgName>
</list>
<tree>
<country name="France">
<region name="Île-de-France">
<name sortKey="Gessner, Bradford D" sort="Gessner, Bradford D" uniqKey="Gessner B" first="Bradford D." last="Gessner">Bradford D. Gessner</name>
</region>
<name sortKey="Sgambatti De Andrade, Ana Lucia S" sort="Sgambatti De Andrade, Ana Lucia S" uniqKey="Sgambatti De Andrade A" first="Ana Lucia S." last="Sgambatti De Andrade">Ana Lucia S. Sgambatti De Andrade</name>
<name sortKey="Stoeckel, Philippe" sort="Stoeckel, Philippe" uniqKey="Stoeckel P" first="Philippe" last="Stoeckel">Philippe Stoeckel</name>
<name sortKey="Turchi Martelli, Celina M" sort="Turchi Martelli, Celina M" uniqKey="Turchi Martelli C" first="Celina M." last="Turchi Martelli">Celina M. Turchi Martelli</name>
</country>
<country name="Indonésie">
<noRegion>
<name sortKey="Sutanto, Agustinus" sort="Sutanto, Agustinus" uniqKey="Sutanto A" first="Agustinus" last="Sutanto">Agustinus Sutanto</name>
</noRegion>
<name sortKey="Arjoso, Soemarjati" sort="Arjoso, Soemarjati" uniqKey="Arjoso S" first="Soemarjati" last="Arjoso">Soemarjati Arjoso</name>
<name sortKey="Gede Djelantik, I Gusti" sort="Gede Djelantik, I Gusti" uniqKey="Gede Djelantik I" first="I. Gusti" last="Gede Djelantik">I. Gusti Gede Djelantik</name>
<name sortKey="Gerudug, I Komang" sort="Gerudug, I Komang" uniqKey="Gerudug I" first="I. Komang" last="Gerudug">I. Komang Gerudug</name>
<name sortKey="Ingerani" sort="Ingerani" uniqKey="Ingerani" last="Ingerani">INGERANI</name>
<name sortKey="Soemohardjo, Soewignjo" sort="Soemohardjo, Soewignjo" uniqKey="Soemohardjo S" first="Soewignjo" last="Soemohardjo">Soewignjo Soemohardjo</name>
</country>
<country name="États-Unis">
<noRegion>
<name sortKey="Linehan, Mary" sort="Linehan, Mary" uniqKey="Linehan M" first="Mary" last="Linehan">Mary Linehan</name>
</noRegion>
<name sortKey="Fletcher, Tracy" sort="Fletcher, Tracy" uniqKey="Fletcher T" first="Tracy" last="Fletcher">Tracy Fletcher</name>
<name sortKey="Maynard, James" sort="Maynard, James" uniqKey="Maynard J" first="James" last="Maynard">James Maynard</name>
<name sortKey="Mercer, David" sort="Mercer, David" uniqKey="Mercer D" first="David" last="Mercer">David Mercer</name>
<name sortKey="Moniaga, Vanda" sort="Moniaga, Vanda" uniqKey="Moniaga V" first="Vanda" last="Moniaga">Vanda Moniaga</name>
<name sortKey="Moulton, Lawrence H" sort="Moulton, Lawrence H" uniqKey="Moulton L" first="Lawrence H." last="Moulton">Lawrence H. Moulton</name>
<name sortKey="Nelson, Carib" sort="Nelson, Carib" uniqKey="Nelson C" first="Carib" last="Nelson">Carib Nelson</name>
<name sortKey="Steinhoff, Mark" sort="Steinhoff, Mark" uniqKey="Steinhoff M" first="Mark" last="Steinhoff">Mark Steinhoff</name>
<name sortKey="Widjaya, Anton" sort="Widjaya, Anton" uniqKey="Widjaya A" first="Anton" last="Widjaya">Anton Widjaya</name>
</country>
<country name="Australie">
<region name="Victoria (État)">
<name sortKey="Mulholland, Kim" sort="Mulholland, Kim" uniqKey="Mulholland K" first="Kim" last="Mulholland">Kim Mulholland</name>
</region>
</country>
</tree>
</affiliations>
</record>

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