Procedures | Recruitment and prescreening | Visit 1 (6 to<12 weeks) | 6 and 9 months phone or electronic contact | 12 months phone or electronic contact | Visit 2 (12 to<15 months) | Oral food challenge (≥12 to<18 months) | 15 months phone or electronic contact | 18 months phone or electronic contact | Visit 3 (18 to<19 months) | Visit 4 (21- 35 days after visit 3) |
Study information and permission to contact | X | |||||||||
Informed consent | X | X | ||||||||
Eligibility assessment | X | X | X | X | X | |||||
Demographics | X | |||||||||
Medical history | X | X | ||||||||
Randomisation | X | |||||||||
Pre vaccination assessment | X | X(*) | X | |||||||
Administration of the IMP (wP) or comparator (aP) | X | |||||||||
National immunisation programme (NIP) vaccines | X | X(†) | X | |||||||
Skin prick test | X | |||||||||
Food exposure and atopic dermatitis questionnaire | X | X | X | X | ||||||
Oral food challenge (if applicable) | X | |||||||||
Administration of the catch-up vaccine (DTaP-IPV) | X | |||||||||
Blood collection (if applicable) | X | X | ||||||||
Assessment of elimination criteria | X | X | X | X |
*Only if NIP vaccines are given at the study site.
†On parental request. NIP vaccines can be given by a local immunisation provider.
DTaP, diptheria, tetanus, acellular pertussis; IPV, inactivated poliovirus vaccine; wP, whole-cell pertussis.