Table 1 Schedule of enrolment, interventions, and assessments

allocation

Study visit number

1

1

2

3

4

5

Age (months)

1

1

2

4

6

7

Eligibility screen

x

Informed consent signed

x

Randomisation

x

 Prevenar13 (_PPP)

_

P

P

P

 Synflorix (_SSS)

_

S

S

S

 COMBO (SSSP)

S

S

S

P

 Rotarix^R

x

x

 Infanrix^R Hexa

x

x

x

 Risk factor data and interviews

 Fixed e.g. sex, birthweight, gestational age, maternal education

x

 Not fixed e.g. household occupancy, smoke exposure, breastfeeding

x

x

 Blood draw (heel, finger prick, or venepuncture)

x*

x*

x

 Ear assessment

 Tympanometry

x

x

x

x

x

 Video otoscopy

x

x

x

 Nasopharyngeal swab

x§

x

x

x

x

 General health (skin, chest, nose, temp, weight, length) and medical record review

x

x

x

x

x