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Br J Clin Pharmacol. 2001 Mar;51(3):271-6.

Sudden unexpected death in infants under 3 months of age and vaccination status- -a case-control study.

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Department of Clinical Pharmacology and Regional Drug Monitoring Center University Hospital of Tours, France. Unité Inserm U 149 Cochin Port Royal University Hospital, Paris, France.



To determine whether DTPP+Hib vaccination (diphtheria, tetanus, pertussis, poliomyelitis +/- haemophilus) increased the risk of sudden unexpected death (SUD) in children under 3 months of age.


We conducted a multicentre case-control study in the 28 French 'SIDS Centers'. Case selection was based on death labelled sudden infant death syndrome (SIDS) of an infant aged between 30 and 90 days. Three living controls were selected, matched for sex, gestational age and born immediately after the victim in the same maternity unit.


We identified 114 cases of SUD aged between 30 and 90 days and 341 live controls matched for age and sex and born in the same maternity unit as the case. DTPP+/-Hib immunization did not increase the risk of SUD (OR 1.08) (95% CI 0.49, 2.36) in children under 3 months of age when adjusted for sleeping position, illness in the week before death, maternal tobacco consumption, birth weight, type of mattress, breastfeeding and sex. However, low birth-weight (6.53 [2.29, 18.9]), multiple birth (5.1 [1.76, 15.13]), no breastfeeding (1.77 [1.1, 2.85]), prone sleeping position (9.8 [5, 8, 18, 9]), soft mattress (3.26 [1.69, 6.29]), recent illness (3.44 [1.84, 6.41]) and parental smoking (1.74 [1.2, 2.96]) were confirmed as risk factors in early SIDS.


DTPP+/-Hib immunization is not a risk factor for early SUD. In this population, we found the same risk factors as described for SIDS.

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