TY - JOUR
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, Prof Lawrence H.
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
N1 - Funding Information:
This study was supported by the Office of Health and Nutrition, US Agency for International Development, under the terms of Cooperative Agreement number HRN-A-00-95-00025-01 with Program for Appropriate Technology in Health and support from the programme's Children's Vaccine Program; Aventis Pasteur, France (a pharmaceutical company involved in the manufacture of vaccines) and the Mérieux Foundation, France. The opinions expressed herein are those of the authors and do not necessarily reflect the views of USAID, the Mérieux Foundation, or Aventis Pasteur.
Funding Information:
This study was funded in part by Aventis Pasteur, a producer of the Hib conjugate vaccine used in the study. PS was employed by Aventis Pasteur during study implementation and owned stock in the company. BDG, EKM, and PS have conducted other studies funded or supported through vaccine donations by Aventis Pasteur and have received travel grants from Aventis Pasteur. MS has received honoraria from Aventis Pasteur.
PY - 2005/1/1
Y1 - 2005/1/1
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 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.
AB - 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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U2 - 10.1016/S0140-6736(04)17664-2
DO - 10.1016/S0140-6736(04)17664-2
M3 - Article
C2 - 15643700
AN - SCOPUS:19944427882
SN - 0140-6736
VL - 365
SP - 43
EP - 52
JO - Lancet
JF - Lancet
IS - 9453
ER -