Intended for healthcare professionals


The UK accelerated immunisation programme and sudden unexpected death in infancy: case-control study

BMJ 2001; 322 doi: (Published 07 April 2001) Cite this as: BMJ 2001;322:822
  1. Peter J Fleming, professor of infant health and developmental physiology (peter.fleming{at},
  2. Peter S Blair, medical statisticiana,
  3. Martin Ward Platt, consultant paediatricianb,
  4. John Tripp, consultant paediatricianc,
  5. Iain J Smith, senior lecturer in health researchd,
  6. Jean Golding, professor of paediatric and perinatal epidemiologya,
  7. the CESDI SUDI research group
  1. a Institute of Child Health, Royal Hospital for Children, Bristol BS2 8BJ
  2. b Newcastle Neonatal Service, Ward 35, Royal Victoria Infirmary, Newcastle upon Tyne NE1 4LP
  3. c Department of Child Health, Postgraduate Medical School, Royal Devon and Exeter Hospital, Exeter EX2 5DW
  4. d Nuffield Institute for Health Services, Leeds LS2 9PL
  1. Correspondence to: P Fleming
  • Accepted 16 January 2001


Objectives: To investigate whether the accelerated immunisation programme in the United Kingdom is associated, after adjustment for potential confounding, with the sudden infant death syndrome.

Design: Population based case-control study, February 1993 to March 1996. Parental interviews were conducted for each death and for four controls matched for age, locality, and time of sleep. Immunisation status was taken from records held by the parents.

Setting: Five regions in England with a combined population of over 17 million.

Subjects: Immunisation details were available for 93% (303/325) of infants whose deaths were attributed to the sudden infant death syndrome (SIDS); 90% (65/72) of infants with explained sudden deaths; and 95% (1515/1588) of controls.

Results: After all potential confounding factors were controlled for, immunisation uptake was strongly associated with a lower risk of SIDS (odds ratio 0.45 (95% confidence interval 0.24 to 0.85)). This difference became non-significant (0.67 (0.31 to 1.43)) after further adjustment for other factors specific to the infant's sleeping environment. Similar proportions of SIDS deaths and reference sleeps (corresponding to the time of day during which the index baby had died) among the controls occurred within 48 hours of the last vaccination (5% (7/149) v 5% (41/822)) and within two weeks (21% (31/149) v 27% (224/822)). No longer term temporal association with immunisation was found (P=0.78). Of the SIDS infants who died within two weeks of vaccination, 16% (5/31) had signs and symptoms of illness that suggested that medical contact was required, compared with 26% (16/61) of the non-immunised SIDS infants of similar age. The findings for the infants who died suddenly and unexpectedly but of explained causes mirrored those for SIDS infants.

Conclusions: Immunisation does not lead to sudden unexpected death in infancy, and the direction of the relation is towards protection rather than risk.

What is already known on this topic

What is already known on this topic Some studies have suggested a link between the sudden infant death syndrome and primary immunisation, but most have failed to show a link

Potential bias in the studies includes lack of a comparative control group with similar low immunisation uptake and misclassification of cause of death

What this study adds

What this study adds This study investigated explained sudden infant deaths as well as the sudden infant death syndrome and took into account potential bias

After confounding was controlled for, immunisation uptake was lowest among the infants who died, with no temporal relation or correlation with signs and symptoms of illness


  • Funding The study was supported by research grants from the National Advisory Body for Confidential Enquiry into Stillbirths and Deaths in Infancy, the Foundation for the Study of Infant Deaths, and the Babes in Arms charity.

  • Competing interests None declared.

  • Accepted 16 January 2001
View Full Text