Schedule of events
| On-study period | Long-term follow-up | ||||||
| Procedures | Preconsent (birth to 5 months) | Screening/Baseline (day 1) | Follow-up visit 1 | Follow-up visit 2* | Surveillance visit 1 | 6 monthly surveillance visit | End of trial surveillance visit (36 months of age) |
| Visit window | +3 days | Days 14–21 | Days 28–55 | Days 28–55 | ±2 weeks | +2 weeks | |
| Study information and permission to contact | X (optional) | X | |||||
| Informed consent | X | ||||||
| Eligibility assessment | X | ||||||
| Vaccination history | X | ||||||
| Demographics | X | ||||||
| Randomisation allocation | X | ||||||
| Pre-vaccination assessment† | X | ||||||
| Study treatment administration (Rotarix or placebo) | X | ||||||
| Baseline anthropometric indices assessment‡ | X | ||||||
| Baseline serum blood sample | X | ||||||
| Telephone contact | X | ||||||
| Assess elimination criteria | X | ||||||
| Follow-up serum blood sample | X | ||||||
| Active SAE/Safety critical AE assessment | X | ||||||
| Passive SAE/Safety critical AE assessment § | X | X | X | ||||
*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.