Date

2021-03-30

Protocol

Protocol changed

Item Changed

Inclusion criteria

Previous Version

1.Is aged 4 to 16 years, inclusive, at the time of randomization., 2.Is in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the Investigator., 3.The participant and/or the participant’s parent/guardian signs and dates an assent/written informed consent form where applicable, and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements., 4.Can comply with trial procedures and are available for the duration of follow-up

Next Version

Subject eligibility is determined according to the following criteria: 1. The subject is aged 4 to 16 years, inclusive, at the time of randomization., 2. Individuals who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the Investigator., 3. The subject and/or the subject’s parent/guardian signs and dates an assent/written informed consent form where applicable, and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements (Appendix C)., 4. Individuals who can comply with trial procedures and are available for the duration of follow-up. Subject eligibility for enrollment in the booster phase of the trial is determined according to the following criteria: 1 The subject is included in the PPS of the trial., 2 The subject was aged 4 to 11 years at the time of randomization in the trial (Day 1 [Month 0])., 3 The subject and/or the subject’s parent/guardian signs and dates an assent/written informed consent form where applicable, and any required privacy authorization prior to the initiation of any trial procedures for the booster phase of the trial, after the nature of the booster phase of the trial has been explained according to local regulatory requirements (Appendix C)., 4 Individuals who can comply with trial procedures for the booster phase and are available for the duration of follow-up post-booster vaccination.