1. 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.