Document Classification

Section Type: METHODS

Text: For this phase 3/4 cluster-randomised, double-blind trial, undertaken between Feb 18, 2009, and Dec 31, 2011, in municipal health-care centres and the Tampere University Vaccine Research Centre (Finland), we randomly assigned (2:2:1:1) 78 clusters into PHiD-CV10 three plus one, PHiD-CV10 two plus one, control three plus one, control two plus one groups (26:26:13:13 clusters) to give PHiD-CV10 in either three plus one or two plus one schedule (if enrolled before 7 months of age ; infant schedules), two plus one (if enrolled between 7 and 11 months ; catch-up schedules), and two doses at least 6 months apart (if enrolled between 12 and 18 months ; catch-up schedules).