OPTimising IMmunisation Using Mixed schedules (OPTIMUM): comparing allergic outcomes in infants following pertussis vaccination dataset

Abstract

OPTIMUM is an investigator-initiated phase IV, two-stage, multisite, parallel, double-blind, adaptive, randomised controlled trial of a single dose of DTwP given at the age of 6 to <12 weeks, followed by DTaP at 4 and 6 months, versus three aP doses only, for the prevention of IgE-mediated food allergy. The primary objective of the study is to assess the allergy protective benefits of the addition of DTwP into the infant schedule. The study population will be up to 1500 Australian infants recruited at 6-10 weeks of age and randomised to receive either a combined Diphtheria-Tetanus-whole cell Pertussis, Hepatitis B, and Haemophilus influenzae type B vaccine (DTwP) OR a combined Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type B vaccine (DTaP) as their first vaccine dose at 6- <12 weeks of age as part of the infant vaccine schedule. The dataset includes demographics, birth history, vaccine history, allergic outcomes to 18 months, including SPT and food challenge data at 12 months of age. The file type is .CSV