Table 1

Schedule of events

On-study periodLong-term follow-up
ProceduresPreconsent (birth to 5 months)Screening/Baseline (day 1)Follow-up
visit 1
visit 2*
Surveillance visit 16 monthly surveillance visitEnd of trial
surveillance visit (36
months of age)
Visit window+3 daysDays 14–21Days 28–55Days 28–55±2 weeks+2 weeks
Study information and permission to contactX (optional)X
Informed consentX
Eligibility assessmentX
Vaccination historyX
Randomisation allocationX
Pre-vaccination assessment†X
Study treatment administration (Rotarix or placebo)X
Baseline anthropometric indices assessment‡X
Baseline serum blood sampleX
Telephone contactX
Assess elimination criteriaX
Follow-up serum blood sampleX
Active SAE/Safety critical AE assessmentX
Passive SAE/Safety critical AE assessment §XXX
  • *Follow-up blood collection visit will cease if immunogenicity interim analysis results meet one of the stopping rules, at which point no further venous blood samples will be collected.

  • † Pre-vaccination assessments performed are assessment of temporary exclusion criteria.

  • ‡Anthropometric indices performed are mid-upper arm circumference and weight.

  • §From 28 days after Rotarix/placebo administration until 36 months, only intussusception and death will be recorded as SAEs regardless of causality.

  • SAE, serious adverse effect.