1. 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 =
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 =
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 =
- Incomplete number of doses n =
- Incorrect treatment at any visit n =
- Vaccinated per protocol n =
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)