Table 1

Schedule of enrolment, interventions, and assessments

Study period
EnrolmentAllocationPostallocation
Study visit number112345
Age (months)112467
 Allocationx
 Eligibility screenxx
 Informed consentxx
Interventions
 Group 1 PHiD-CV10xxx
 Group 2 PCV13xxx
 Group 3 PHiD-CV10
PCV13
 xxx 
x
Assessments
 Risk factors
  Fixed, eg, sex, birth weight, gestational age, maternal educationx
  Not fixed, eg, household occupancy, smoke exposure, breastfeedingxx
 Ear assessment
  Tympanometryxxxxx
  Otoscopyxxx
 Nasopharyngeal swabxxxx
 Blood draw (heel prick or venepuncture)x*x*x
 General health (skin, chest, nose, temp, weight, length)xxxxx
  • *Blood draw occurs at either 2 or 4 months of age (decided by a random process).