Study period | |||||||
---|---|---|---|---|---|---|---|
Enrolment | Allocation | Postallocation | |||||
Study visit number | 1 | 1 | 2 | 3 | 4 | 5 | |
Age (months) | 1 | 1 | 2 | 4 | 6 | 7 | |
Allocation | x | ||||||
Eligibility screen | x | x | |||||
Informed consent | x | x | |||||
Interventions | |||||||
Group 1 PHiD-CV10 | x | x | x | ||||
Group 2 PCV13 | x | x | x | ||||
Group 3 PHiD-CV10 PCV13 | x | x | x | ||||
x | |||||||
Assessments | |||||||
Risk factors | |||||||
Fixed, eg, sex, birth weight, gestational age, maternal education | x | ||||||
Not fixed, eg, household occupancy, smoke exposure, breastfeeding | x | x | |||||
Ear assessment | |||||||
Tympanometry | x | x | x | x | x | ||
Otoscopy | x | x | x | ||||
Nasopharyngeal swab | x | x | x | x | |||
Blood draw (heel prick or venepuncture) | x* | x* | x | ||||
General health (skin, chest, nose, temp, weight, length) | x | x | x | x | x |
*Blood draw occurs at either 2 or 4 months of age (decided by a random process).