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Pneumococcal Conjugate Vaccine and Clinically Suspected Invasive Pneumococcal Disease. OBJECTIVE: Ten-valent pneumococcal conjugate vaccine (PCV10) was earlier shown to reduce clinically suspected, non-laboratory-confirmed invasive pneumococcal disease (IPD) in a cluster-randomized trial (the Finnish Invasive Pneumococcal disease trial). PCV10 was introduced into the Finnish national vaccination program in September 2010 using a 3-dose schedule. We evaluated the impact of PCV10 on clinically suspected IPD among vaccine-eligible children in a population-based nationwide study. METHODS: The target cohort eligible for vaccination program (children born June 2010-September 2013) was compared with 2 season- and age-matched (ages 3-42 months) reference cohorts before PCV10 introduction. The trial period (January 2009-August 2010) was excluded. Hospitals' inpatient and outpatient discharge notifications with International Classification of Diseases, 10th Revision, diagnoses compatible with IPD (A40.3/B95.3/G00.1/M00.1) and unspecified sepsis (A40.9/A41.9/A49.9/G00/G00.9/I30.1/M00/M00.9/B95.5) were collected from the national Care Register. Laboratory-confirmed IPD cases were excluded. Rates of register-based non-laboratory-confirmed IPD (or unspecified sepsis) before and after PCV10 implementation were calculated. RESULTS: The rate of register-based non-laboratory-confirmed IPD episodes was 32 in 100 000 person-years in the vaccine-eligible target cohort and 94 in the combined reference cohorts. Relative rate reduction was 66% (95% confidence interval: 59-73) and absolute rate reduction 62 in 100 000 person-years. For the more sensitive case definition of register-based non-laboratory-confirmed IPD or unspecified sepsis, the relative rate reduction was 34% (95% confidence interval 29-39), but the absolute reduction was as high as 122 in 100 000 person-years. CONCLUSIONS: This is the first report demonstrating nationwide PCV impact on clinically suspected IPD during routine vaccination program. The large absolute rate reductions observed have major implications for cost-effectiveness of PCVs.