Assessed for eligibility N = 15593 Figure 1. online only Trial profile Assessed for eligibility N = 15593 Eligible but not enrolled N = 993 Death before 6 weeks of age N = 154 Medical reasons N = 57 Non-user of health center N = 249 Refused N = 533 Not eligible N = 2406 Foreseen Migration N = 2292 Other * N = 114 Randomized N = 12194 Allocated to 11PCV n = 6098 - Received 1 dose 11PCV n = 6097 - Received 2 doses 11PCV n = 6054 - Received 3 doses 11PCV n = 6023 - Did not receive any dose n = 1 of 11PCV due to voluntary withdrawal Allocated to placebo n = 6096 - Received 1 dose placebo n = 6094 - Received 2 doses placebo n = 6052 - Received 3 doses placebo n = 6026 - Did not receive any dose of n = 2 placebo due to protocol violation Intent-to-treat Population n = 6097 Per Protocol Population n =6013 Excluded from analysis n = 84 -Incomplete number of doses n = 74 - Incorrect timing n = 4 - Incorrect treatment at any visit n = 3 -Vaccinated per protocol, n = 3 but exited during 14 days following the 3rd dose Intent-to-treat Population n = 6094 Per Protocol Population n = 6018 Excluded from analysis n = 76 - Incomplete number of doses n = 68 - Incorrect treatment at any visit n = 2 - Vaccinated per protocol n = 6 but exited during 14 days following the 3rd dose ** Other reasons for non-eligibility were: Already received DTP (N=22); Too old (11); Could not be identified (N=80);Ward of social service (1)