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

Bradford D. Gessner, Agustinus Sutanto, Mary Linehan, I. Gusti Gede Djelantik, Tracy Fletcher, I. Komang Gerudug, Ingerani, David Mercer, Vanda Moniaga, Lawrence Hale Moulton, Prof Kim Mulholland, Carib Nelson, Soewignjo Soemohardjo, Prof Mark Steinhoff, Anton Widjaya, Philippe Stoeckel, James Maynard, Soemarjati Arjoso

Research output: Contribution to journalArticle

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 10 5 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.

Original languageEnglish (US)
Pages (from-to)43-52
Number of pages10
JournalThe Lancet
Volume365
Issue number9453
DOIs
StatePublished - Jan 1 2005

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Haemophilus influenzae type b
Meningitis
Pneumonia
Vaccines
Diphtheria
Whooping Cough
Tetanus
Haemophilus Vaccines
Incidence
Immunization Programs
Conjugate Vaccines
Indonesia
Cerebrospinal Fluid
Appointments and Schedules
Seizures
Observation

ASJC Scopus subject areas

  • Medicine(all)

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Gessner, B. D., Sutanto, A., Linehan, M., Djelantik, I. G. G., Fletcher, T., Gerudug, I. K., ... Arjoso, S. (2005). Incidences of vaccine-preventable Haemophilus influenzae type b pneumonia and meningitis in Indonesian children: Hamlet-randomised vaccine-probe trial. The Lancet, 365(9453), 43-52. https://doi.org/10.1016/S0140-6736(04)17664-2

Incidences of vaccine-preventable Haemophilus influenzae type b pneumonia and meningitis in Indonesian children : Hamlet-randomised vaccine-probe trial. / Gessner, Bradford D.; Sutanto, Agustinus; Linehan, Mary; Djelantik, I. Gusti Gede; Fletcher, Tracy; Gerudug, I. Komang; Ingerani; Mercer, David; Moniaga, Vanda; Moulton, Lawrence Hale; Mulholland, Prof Kim; Nelson, Carib; Soemohardjo, Soewignjo; Steinhoff, Prof Mark; Widjaya, Anton; Stoeckel, Philippe; Maynard, James; Arjoso, Soemarjati.

In: The Lancet, Vol. 365, No. 9453, 01.01.2005, p. 43-52.

Research output: Contribution to journalArticle

Gessner, BD, Sutanto, A, Linehan, M, Djelantik, IGG, Fletcher, T, Gerudug, IK, Ingerani, Mercer, D, Moniaga, V, Moulton, LH, Mulholland, PK, Nelson, C, Soemohardjo, S, Steinhoff, PM, Widjaya, A, Stoeckel, P, Maynard, J & Arjoso, S 2005, 'Incidences of vaccine-preventable Haemophilus influenzae type b pneumonia and meningitis in Indonesian children: Hamlet-randomised vaccine-probe trial', The Lancet, vol. 365, no. 9453, pp. 43-52. https://doi.org/10.1016/S0140-6736(04)17664-2
Gessner, Bradford D. ; Sutanto, Agustinus ; Linehan, Mary ; Djelantik, I. Gusti Gede ; Fletcher, Tracy ; Gerudug, I. Komang ; Ingerani ; Mercer, David ; Moniaga, Vanda ; Moulton, Lawrence Hale ; Mulholland, Prof Kim ; Nelson, Carib ; Soemohardjo, Soewignjo ; Steinhoff, Prof Mark ; Widjaya, Anton ; Stoeckel, Philippe ; Maynard, James ; Arjoso, Soemarjati. / Incidences of vaccine-preventable Haemophilus influenzae type b pneumonia and meningitis in Indonesian children : Hamlet-randomised vaccine-probe trial. In: The Lancet. 2005 ; Vol. 365, No. 9453. pp. 43-52.
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T1 - Incidences of vaccine-preventable Haemophilus influenzae type b pneumonia and meningitis in Indonesian children

T2 - Hamlet-randomised vaccine-probe trial

AU - Gessner, Bradford D.

AU - Sutanto, Agustinus

AU - Linehan, Mary

AU - Djelantik, I. Gusti Gede

AU - Fletcher, Tracy

AU - Gerudug, I. Komang

AU - Ingerani,

AU - Mercer, David

AU - Moniaga, Vanda

AU - Moulton, Lawrence Hale

AU - Mulholland, Prof Kim

AU - Nelson, Carib

AU - Soemohardjo, Soewignjo

AU - Steinhoff, Prof Mark

AU - Widjaya, Anton

AU - Stoeckel, Philippe

AU - Maynard, James

AU - Arjoso, Soemarjati

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N2 - 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 5 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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