Pneumococcal vaccine schedules (PVS) study: a cluster-randomised, non-inferiority trial of an alternative versus standard schedule for pneumococcal conjugate vaccination—statistical analysis plan

Table 1 Analysis framework for populations/cohorts, observations/follow-up, and outcome measures

Endpoint Designation	Population/cohort	Observation/follow-up	Endpoint	Effect measure
Primary	^aResident children and clinical pneumonia	Continuous surveillance	^bVT carriage	Prevalence ratio
Secondary	^cEnrolled children	^dIntention-to-treat	Radiological pneumonia	Incidence ratio
Secondary	All resident population	Cross-sectional	^eVT carriage	Prevalence ratio
Tertiary	^aResident children and clinical pneumonia	Continuous surveillance	^fNVT and ^gSpn carriage	Prevalence ratio
	Age 6–12 weeks no PCV	Cross-sectional	^hVT carriage	Prevalence ratio
	^cEnrolled children and clinical pneumonia	^dIntention-to-treat	VT, NVT, and ^gSpn carriage	Prevalence ratio
	ⁱEnrolled children received intervention and clinical pneumonia	^§§Per-protocol	VT, NVT, and ^gSpn carriage	Prevalence ratio
	Resident children	Continuous surveillance	VT, NVT, and ^gSpn IPD	Incidence ratio
	“	“	Radiological pneumonia	“
	“	“	Clinical pneumonia	“
	“	“	Clinical pneumonia and VT carriage	“
	“	“	Hypoxic pneumonia	“
	“	“	Hospitalisation	“
	“	“	Mortality	“
	Enrolled children	^dIntention-to-treat	VT, NVT, and ^gSpn IPD	“
	“	“	Clinical pneumonia	“
	“	“	Clinical pneumonia and VT carriage	“
	“	“	Hypoxic pneumonia	“
	“	“	Hospitalisation	“
	“	“	Mortality
	Enrolled children received intervention	^jPer-protocol	Radiological pneumonia	“
	“	“	VT, NVT, and Spn IPD	“
	“	“	Clinical pneumonia	“
	“	“	Clinical pneumonia and VT carriage	“
	“	“	Hypoxic pneumonia	“
	“	“	Hospitalisation	“
	“	“	Mortality	“

^aPopulation-based population aged 2–260 weeks. ^bPrimary endpoint specified in year 4 and also calculated as tertiary endpoints in years 1, 2, and 3. ^cCohort enrolled to receive interventions. ^dEvents counted from enrolment to end of follow-up. ^eSecondary endpoint specified in year 4 and also calculated as a tertiary endpoint in year 3 (all ages and age-stratified). ^fCalculated in years 1, 2, 3, and 4. ^gSpn = all pneumococcal carriage. ^hIn year 4. ⁱCohort enrolled and received interventions PP. ^jEvents counted from 14 days post-PCV1 to end of follow-up

ISSN: 1745-6215