Efficacy and safety of seven-valent conjugate pneumococcal vaccine in American Indian children: Group randomised trial

Katherine L O'Brien, Lawrence Hale Moulton, Raymond Reid, Robert C Weatherholtz, Jane Oski, Laura B Brown, Gaurav Kumar, Alan Parkinson, Diana Hu, Jill Hackell, Ih Chang, Robert Kohberger, George Siber, Mathuram Santosham

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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 the primary efficacy group (children enrolled by 7 months of age) there were eight cases of vaccine serotype disease in the controls and two in the PnCRM7 group; in the intention-to-treat analysis we noted11 cases of vaccine serotype disease in the MnCC control group and two in the PnCRM7 group. After group randomisation had been controlled for, the per protocol primary efficacy of PnCRM7 was 76.8% (95% CI -9.4% to 95.1%) and the intention-to-treat total primary efficacy was 82.6% (21.4% to 96.1%). Interpretation: PnCRM7 vaccine prevents vaccine serotype invasive pneumococcal disease even in a high risk population. Other regions with similar disease burden should consider including this vaccine in the routine childhood vaccine schedule.

Original languageEnglish (US)
Pages (from-to)355-361
Number of pages7
JournalThe Lancet
Issue number9381
Publication statusPublished - Aug 2 2003


ASJC Scopus subject areas

  • Medicine(all)

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