The intervention procedure
| Primary series | Booster dose | ||||||
|---|---|---|---|---|---|---|---|
| Interventions | 3 months | 4 months | 5 months | 30 days postdose | 12–15 months | 30 days postdose | 6 months postdose |
| Informed consent | X | ||||||
| Eligibility screen | X | ||||||
| Randomisation | X | ||||||
| Temperature | X | X | X | X | |||
| Blood draw | X | X | X | X | |||
| Vaccination | X | X | X | X | |||
| Safety observations* | |||||||
| Immediate reaction | ◎ | ◎ | ◎ | ◎ | |||
| Local reactions and systemic events | ▲ | ▲ | ▲ | ▲ | |||
| Adverse events | ◆ | ◆ | ◆ | ◆ | |||
| Serious adverse events | ★ | ★ | ★ | ★ | ★ | ★ | ★ |
*Safety observations occur after vaccination for a planned period.
◎Immediate reaction will be observed for 30 min after vaccination.
▲Local reactions and systemic events will be actively collected for 8 days after vaccination.
◆Other adverse events will be recorded by parents/legally responsible representative(s) for 30 days after vaccination.
★Serious adverse events will be self-reported by parents/legally responsible representative(s) from the first visit until the 6 months after the last dose.