Table 4 Definition of protocol deviations

Reason for protocol deviation

 Enrolment of ineligible participant

Age >40 weeks on day of consent

Non-resident on day of consent

 Enrolment without consent

Enrolled without valid consent form

Non-adherence to vaccine schedule

 Incorrect dose given

  Standard schedule—received >3 doses

  Standard schedule—3rd dose age >40 weeks

  Alternative schedule—2nd dose age <40 weeks

  Alternative schedule—3rd dose age <40 weeks

 Ineligible and received alternative schedule

Non-resident—2nd dose age ≥36 weeks

 Withdrawn and received alternative schedule

Withdrawn—2nd dose age ≥36 weeks