| The general objective of the research is to find an effective primary prevention for a significant fraction of serious acute respiratory infections (ART), especially of severe ARI and related severe disease, in infants and children in developing countries. This can be achieved by studying the effectiveness of the 11-valet pneumococcal conjugate vaccine (11PCV) in preventing childhood pneumonia in the Philippines within a population-based randomised, placebo-controlled, blinded study . Other scientific questions, including transmission of pneumococci, will be addressed in nested studies and a specific household carriage study in Indonesia. The minimum sample size of 12 190 children to be enrolled within 3.5 years time is calculated on the basis of the primary hypothesis. An interim analysis is planned at end of 3rd year. The final results within 5 years will be directly and immediately applicable to countries in the South-East and East Asian region, and more widely to the large and growing number of developing countries with a moderate infant mortality rate of 40-60 / 1 000 live births. |