Table 2 Definition of protocol deviations
Reason for protocol deviation | |
|---|---|
Enrolment of ineligible participant | See Sect. 4.2 Eligibility |
Non-adherence to vaccine schedule | |
Incorrect dose given | 1st dose—age < 6 weeks |
Standard schedule—received > 3 doses | |
Standard schedule—3rd dose age > 22 weeks | |
Alternative schedule—2nd dose age < 40 weeks | |
Alternative schedule—received > 2 doses | |
Withdrawn, received alternative schedule | Withdrawn—2nd dose age ≥ 36 weeks |
Non-adherence to endpoint timeline | |
Blood | Collection > 35 days from specified date |
NP specimen | < 14 days between consecutive specimens |
Collection at 16 or 17 months of age (standard schedule) | |
Collection > 6 months after booster administration and < 18 months of age (alternative schedule) | |
18-month specimen collection > 20 months of age | |
28-month specimen collection > 30 months of age | |