In contrast, pneumococcal polysaccharide vaccines have shown no effect on pneumococcal carriage [20], [21], [22], [23] and [24]. Most studies evaluating the impact of pneumococcal polysaccharide immunization in the absence of additional PCV-7 in infants or children have not shown any impact on pneumococcal disease or carriage [25], [26] and [27] Data from Fiji shows that the 7 serotypes included in PCV-7, plus the cross reactive serotype 6A, would potentially cover 63.3% of invasive pneumococcal disease (IPD) cases in children under 5 years [28]. This coverage would potentially increase to 83% if the PPV-23 was used, and would increase to 87% if the new 13-valent pneumococcal

click here conjugate vaccine produced by Wyeth Vaccines (which includes serotypes 1, 3, 5, 6A, 7F and 19A) was used, largely due to the inclusion of 6A which is not included in the PPV-23 [28]. The aim of this study was to find an optimal vaccination strategy suitable for resource poor countries in terms of serotype coverage, flexibility, and affordability. To address these issues, we undertook a Phase II vaccine trial in Fiji to document the safety, Selleck Staurosporine immunogenicity and impact on pneumococcal carriage of various pneumococcal vaccination regimens combining 1, 2, or 3 doses of PCV-7 in infancy. In order to broaden the serotype coverage, the additional benefit of a PPV-23 booster at 12 months of age was also assessed. Presented

are the geometric mean serotype-specific IgG antibody concentrations (GMC) prior to and 2 weeks following the 12 month PPV-23, and at 17 months of age. The study was these a single blind, open-label randomized Phase II vaccine trial undertaken in Suva, the capital of Fiji. Healthy infants aged between six and eight weeks were eligible for enrolment. Details of the selection criteria and the randomization procedure have been reported elsewhere [29] The study was conducted and monitored according to Good Clinical Practice. It was approved by the Fiji National Research Ethics Review Committee and the University of Melbourne Human Research Ethics Committee Infants were stratified by ethnicity and randomized into one of eight groups. The seven-valent CRM197 protein–polysaccharide conjugate vaccine containing polysaccharide antigen from pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F (Prevenar™, Wyeth Vaccines) was used. The vaccine contains 2 μg of each serotype, except serotype 6B which contains 4 μg. The three dose group received PCV-7 at 6, 10, and 14 weeks of age, the 2 dose group received PCV-7 at 6 and 14 weeks of age and the single dose group received PCV-7 at 14 weeks of age. Routine vaccines (Hiberix™ mixed with Tritanrix™–HepB™, GlaxoSmithKline) and oral polio were given with the primary series.