作者
Katherine L O'Brien, Lawrence H Moulton, Raymond Reid, Robert Weatherholtz, Jane Oski, Laura Brown, Gaurav Kumar, Alan Parkinson, Diana Hu, Jill Hackell, Ih Chang, Robert Kohberger, George Siber, Mathuram Santosham
发表日期
2003/8/2
期刊
The Lancet
卷号
362
期号
9381
页码范围
355-361
出版商
Elsevier
简介
Background
Streptococcus pneumoniae is the main cause of invasive bacterial disease in children aged younger than 2 years. Navajo and White Mountain Apache children have some of the highest rates of invasive pneumococcal disease documented in the world. We aimed to assess the safety and efficacy of a seven-valent polysaccharide protein conjugate pneumococcal vaccine (PnCRM7) against such disease.
Methods
In a group-randomised study, we gave this vaccine to children younger than 2 years from the Navajo and White Mountain Apache Indian reservations; meningococcal type C conjugate vaccine (MnCC) served as the control vaccine. Vaccine schedules were determined by age at enrolment. We recorded episodes of invasive pneumococcal disease and serotyped isolates. Analyses were by intention to treat and per protocol.
Findings
8292 children enrolled in the trial. In the per protocol analysis of …
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