Association between type 1 diabetes and Haemophilus influenzae type b vaccination: birth cohort study.

OBJECTIVES To determine the effect of Haemophilus influenzae type b vaccination and its timing on the risk of type 1 diabetes in Finnish children. DESIGN Cumulative incidence and relative risk of type 1 diabetes was compared among three birth cohorts of Finnish children: those born during the 24 months before the H influenzae type b vaccination trial, those in the trial cohort who were vaccinated at 3 months of age and later with a booster vaccine, and those in the trial cohort who were vaccinated at 24 months of age only. The probability of type 1 diabetes was estimated using regression analysis assuming that there were no losses to 10 year follow up and no competing risks. SETTING Finland (total population 5 million and annual birth rate 1.3%). SUBJECTS 128 936 children born from 1 October 1983 to 1 September 1985, and 116 352 children born from 1 October 1985 to 31 August 1987. MAIN OUTCOME MEASURES Probability of type 1 diabetes among children vaccinated with H influenzae type b and non-vaccinated children. RESULTS No statistically significant difference was found at any time during the 10 year follow up in the risk of type 1 diabetes between the children born before the vaccination period and those vaccinated at the age of 24 months only (relative risk 1.01). The difference in the risk between the cohort vaccinated first at the age of 3 months and the cohort vaccinated at the age of 24 months only was not statistically significant either (1.06). CONCLUSION It is unlikely that H influenzae type b vaccination or its timing cause type 1 diabetes in children.