Incidences of vaccine-preventable Haemophilus influenzae type b pneumonia and meningitis in Indonesian children: hamlet-randomised vaccine-probe trial. Comment
Identifieur interne : 00A586 ( Main/Exploration ); précédent : 00A585; suivant : 00A587Incidences 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 :
- Lancet : (British edition) [ 0140-6736 ] ; 2005.
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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.
Affiliations:
- Australie, France, Indonésie, États-Unis
- Victoria (État), Île-de-France
- Melbourne, Paris
- Université de Melbourne
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Comment</title><author><name sortKey="Gessner, Bradford D" sort="Gessner, Bradford D" uniqKey="Gessner B" first="Bradford D." last="Gessner">Bradford D. Gessner</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Association Pour l'Aide à la Médecine Préventive</s1><s2>Paris</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>16 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Sutanto, Agustinus" sort="Sutanto, Agustinus" uniqKey="Sutanto A" first="Agustinus" last="Sutanto">Agustinus Sutanto</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>West Nusa Tenggara Provincial Government</s1><s2>Lombok</s2><s3>IDN</s3><sZ>2 aut.</sZ><sZ>4 aut.</sZ><sZ>6 aut.</sZ><sZ>13 aut.</sZ></inist:fA14><country>Indonésie</country><wicri:noRegion>West Nusa Tenggara Provincial Government</wicri:noRegion></affiliation></author><author><name sortKey="Linehan, Mary" sort="Linehan, Mary" uniqKey="Linehan M" first="Mary" last="Linehan">Mary Linehan</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Program for Appropriate Technology in Health</s1><s2>Seattle, WA</s2><s3>USA</s3><sZ>3 aut.</sZ><sZ>5 aut.</sZ><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>12 aut.</sZ><sZ>15 aut.</sZ><sZ>17 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Program for Appropriate Technology in Health</wicri:noRegion></affiliation></author><author><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><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>West Nusa Tenggara Provincial Government</s1><s2>Lombok</s2><s3>IDN</s3><sZ>2 aut.</sZ><sZ>4 aut.</sZ><sZ>6 aut.</sZ><sZ>13 aut.</sZ></inist:fA14><country>Indonésie</country><wicri:noRegion>West Nusa Tenggara Provincial Government</wicri:noRegion></affiliation></author><author><name sortKey="Fletcher, Tracy" sort="Fletcher, Tracy" uniqKey="Fletcher T" first="Tracy" last="Fletcher">Tracy Fletcher</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Program for Appropriate Technology in Health</s1><s2>Seattle, WA</s2><s3>USA</s3><sZ>3 aut.</sZ><sZ>5 aut.</sZ><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>12 aut.</sZ><sZ>15 aut.</sZ><sZ>17 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Program for Appropriate Technology in Health</wicri:noRegion></affiliation></author><author><name sortKey="Gerudug, I Komang" sort="Gerudug, I Komang" uniqKey="Gerudug I" first="I. Komang" last="Gerudug">I. Komang Gerudug</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>West Nusa Tenggara Provincial Government</s1><s2>Lombok</s2><s3>IDN</s3><sZ>2 aut.</sZ><sZ>4 aut.</sZ><sZ>6 aut.</sZ><sZ>13 aut.</sZ></inist:fA14><country>Indonésie</country><wicri:noRegion>West Nusa Tenggara Provincial Government</wicri:noRegion></affiliation></author><author><name sortKey="Ingerani" sort="Ingerani" uniqKey="Ingerani" last="Ingerani">INGERANI</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Indonesian Ministry of Health</s1><s2>Jakarta</s2><s3>IDN</s3><sZ>7 aut.</sZ><sZ>18 aut.</sZ></inist:fA14><country>Indonésie</country><wicri:noRegion>Indonesian Ministry of Health</wicri:noRegion></affiliation></author><author><name sortKey="Mercer, David" sort="Mercer, David" uniqKey="Mercer D" first="David" last="Mercer">David Mercer</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Program for Appropriate Technology in Health</s1><s2>Seattle, WA</s2><s3>USA</s3><sZ>3 aut.</sZ><sZ>5 aut.</sZ><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>12 aut.</sZ><sZ>15 aut.</sZ><sZ>17 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Program for Appropriate Technology in Health</wicri:noRegion></affiliation></author><author><name sortKey="Moniaga, Vanda" sort="Moniaga, Vanda" uniqKey="Moniaga V" first="Vanda" last="Moniaga">Vanda Moniaga</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Program for Appropriate Technology in Health</s1><s2>Seattle, WA</s2><s3>USA</s3><sZ>3 aut.</sZ><sZ>5 aut.</sZ><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>12 aut.</sZ><sZ>15 aut.</sZ><sZ>17 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Program for Appropriate Technology in Health</wicri:noRegion></affiliation></author><author><name sortKey="Moulton, Lawrence H" sort="Moulton, Lawrence H" uniqKey="Moulton L" first="Lawrence H." last="Moulton">Lawrence H. Moulton</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Department of International Health, Bloomberg School of Public Health, Johns Hopkins University</s1><s2>Baltimore, MD</s2><s3>USA</s3><sZ>10 aut.</sZ><sZ>14 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Baltimore, MD</wicri:noRegion></affiliation></author><author><name sortKey="Mulholland, Kim" sort="Mulholland, Kim" uniqKey="Mulholland K" first="Kim" last="Mulholland">Kim Mulholland</name><affiliation wicri:level="4"><inist:fA14 i1="06"><s1>University of Melbourne</s1><s2>Melbourne</s2><s3>AUS</s3><sZ>11 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region><settlement type="city">Melbourne</settlement></placeName><orgName type="university">Université de Melbourne</orgName></affiliation></author><author><name sortKey="Nelson, Carib" sort="Nelson, Carib" uniqKey="Nelson C" first="Carib" last="Nelson">Carib Nelson</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Program for Appropriate Technology in Health</s1><s2>Seattle, WA</s2><s3>USA</s3><sZ>3 aut.</sZ><sZ>5 aut.</sZ><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>12 aut.</sZ><sZ>15 aut.</sZ><sZ>17 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Program for Appropriate Technology in Health</wicri:noRegion></affiliation></author><author><name sortKey="Soemohardjo, Soewignjo" sort="Soemohardjo, Soewignjo" uniqKey="Soemohardjo S" first="Soewignjo" last="Soemohardjo">Soewignjo Soemohardjo</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>West Nusa Tenggara Provincial Government</s1><s2>Lombok</s2><s3>IDN</s3><sZ>2 aut.</sZ><sZ>4 aut.</sZ><sZ>6 aut.</sZ><sZ>13 aut.</sZ></inist:fA14><country>Indonésie</country><wicri:noRegion>West Nusa Tenggara Provincial Government</wicri:noRegion></affiliation></author><author><name sortKey="Steinhoff, Mark" sort="Steinhoff, Mark" uniqKey="Steinhoff M" first="Mark" last="Steinhoff">Mark Steinhoff</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Department of International Health, Bloomberg School of Public Health, Johns Hopkins University</s1><s2>Baltimore, MD</s2><s3>USA</s3><sZ>10 aut.</sZ><sZ>14 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Baltimore, MD</wicri:noRegion></affiliation></author><author><name sortKey="Widjaya, Anton" sort="Widjaya, Anton" uniqKey="Widjaya A" first="Anton" last="Widjaya">Anton Widjaya</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Program for Appropriate Technology in Health</s1><s2>Seattle, WA</s2><s3>USA</s3><sZ>3 aut.</sZ><sZ>5 aut.</sZ><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>12 aut.</sZ><sZ>15 aut.</sZ><sZ>17 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Program for Appropriate Technology in Health</wicri:noRegion></affiliation></author><author><name sortKey="Stoeckel, Philippe" sort="Stoeckel, Philippe" uniqKey="Stoeckel P" first="Philippe" last="Stoeckel">Philippe Stoeckel</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Association Pour l'Aide à la Médecine Préventive</s1><s2>Paris</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>16 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Maynard, James" sort="Maynard, James" uniqKey="Maynard J" first="James" last="Maynard">James Maynard</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Program for Appropriate Technology in Health</s1><s2>Seattle, WA</s2><s3>USA</s3><sZ>3 aut.</sZ><sZ>5 aut.</sZ><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>12 aut.</sZ><sZ>15 aut.</sZ><sZ>17 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Program for Appropriate Technology in Health</wicri:noRegion></affiliation></author><author><name sortKey="Arjoso, Soemarjati" sort="Arjoso, Soemarjati" uniqKey="Arjoso S" first="Soemarjati" last="Arjoso">Soemarjati Arjoso</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Indonesian Ministry of Health</s1><s2>Jakarta</s2><s3>IDN</s3><sZ>7 aut.</sZ><sZ>18 aut.</sZ></inist:fA14><country>Indonésie</country><wicri:noRegion>Indonesian Ministry of Health</wicri:noRegion></affiliation></author><author><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><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Departamento de Saúde Coletiva, Universidade Federal de Goiás. S Universitário</s1><s2>Goiânia, 74605-050</s2><s3>FRA</s3><sZ>19 aut.</sZ><sZ>20 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>74605-050</wicri:noRegion><wicri:noRegion>Universidade Federal de Goiás. S Universitário</wicri:noRegion><wicri:noRegion>Goiânia, 74605-050</wicri:noRegion></affiliation></author><author><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><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Departamento de Saúde Coletiva, Universidade Federal de Goiás. S Universitário</s1><s2>Goiânia, 74605-050</s2><s3>FRA</s3><sZ>19 aut.</sZ><sZ>20 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>74605-050</wicri:noRegion><wicri:noRegion>Universidade Federal de Goiás. S Universitário</wicri:noRegion><wicri:noRegion>Goiânia, 74605-050</wicri:noRegion></affiliation></author></analytic><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><imprint><date when="2005">2005</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Lancet : (British edition)</title><title level="j" type="abbreviated">Lancet : (Br. ed.)</title><idno type="ISSN">0140-6736</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><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><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Vaccin</term><term>Enfant</term><term>Médecine</term></keywords></textClass></profileDesc></teiHeader><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></front></TEI><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>Pour manipuler ce document sous Unix (Dilib)
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