FIGURE 1. Flowchart of PnCRM7 clinical trial participants, primary efficacy cohort, and sub-populations used for efficacy analyses. Clinical trial participants n = 8292 Randomized by community *Exclusion criteria n = 3816 Eligible for primary efficacy analysis n = 4476 End-of-study chart review participants n = 944 Systematically selected Subject was not identifiable or was not randomized n = 33 **Subject was not part of primary efficacy cohort n = 55 Eligible for analysis n = 856 Did not receive third dose before 365 days of age + Did not receive booster between 365 and 480 days of age + Less than 60 days between end of primary series and booster n = 46 First 3 primary doses were not with vaccine subject was randomized to receive n = 6 First 3 primary doses and booster were not with vaccine subject was randomized to receive n = 7 Per-protocol subgroup n = 803 Primary Efficacy subgroup n = 856 PnCRM7 n=424 MnCC n=432 Primary Efficacy , correct vaccine n=850 PnCRM7 n=421 MnCC n=429 PnCRM7 n=394 MnCC n=409 *To be eligible for the end-of-study chart review, subjects had to be no more than seven months of age at first dose of vaccine, had to receive all three primary doses by one year of age, and had to have had at least 30 days between receiving each of the three primary doses. **In order to be part of the primary efficacy cohort, subjects had to have had their first vaccine dose between 42 and 180 days of age.