@article {Kentfetalneonatal-2017-314152, author = {Alison Kent and Kazim Beebeejaun and Serena Braccio and Seilesh Kadambari and Paul Clarke and Paul T Heath and Shamez Ladhani}, editor = {, and , and Riordan, Andrew and Toldi, Gergely and Schwarz, Karin and Foo, Aiwyne and Kumar, Arun and Douthwaite, Amy and Vasu, Vimal and Clark, Susan and Dubus, Magali and Niedermaier, Sophie and Watts, Timothy and Harrison, Catherine and Ali, Sakina and Harizaj, Helen and Pattnayak, Santosh and Jayachandran, Saravanan and Smith, Janet and Yong, Kenneith and Cheadle, Wendy and Mcdevitt, Katharine and Ostrzewska, Anna and Anthony, Mark and Khemka, Priti and Scorrer, Tim J and Clargo, Hazel and Matthes, Jean and Kennea, Nigel and Davies, Hannah and Fedee, Joanne and Kitching, Rebecca and Green, Emma and Westwood, Leigh and Jackson, Christina and Huddleston, Victoria and Leith, Wynne and Stilwell, Philippa}, title = {Safety of meningococcal group B vaccination in hospitalised premature infants}, elocation-id = {fetalneonatal-2017-314152}, year = {2018}, doi = {10.1136/archdischild-2017-314152}, publisher = {BMJ Publishing Group}, abstract = {Objectives To assess the risk of significant adverse events in premature infants receiving the novel 4-component group B meningococcal vaccine (4CMenB) with their routine immunisations at 2 months of age.Participants, design and setting In December 2015, Public Health England requested neonatal units across England to voluntarily participate in a national audit; 19 units agreed to participate. Anonymised questionnaires were completed for infants receiving 4CMenB alongside their routine immunisations. For comparison, a historical cohort of premature infants receiving their primary immunisations without 4CMenB or paracetamol prophylaxis was used.Main outcome measures Paracetamol use; temperature, cardiovascular, respiratory and neurological status before and after vaccination; and management and investigations postvaccination, including serum C reactive protein levels, infection screens and antibiotic use.Results Complete questionnaires were returned for 133 premature infants (\<35 weeks{\textquoteright} gestation) who received their first dose of 4CMenB at 8 weeks of age, including 108 who received prophylactic paracetamol according to national recommendations. Overall, 7\% (8/108) of infants receiving 4CMenB with paracetamol had fever (\>38{\textdegree}C) after vaccination compared with 20\% (5/25) of those receiving 4CMenB without paracetamol (P=0.06) and none of those in the historical cohort. There were no significant differences between cohorts in the proportion of infants with apnoea, bradycardia, desaturation and receiving respiratory support after vaccination.Conclusions 4CMenB does not increase the risk of serious adverse events in hospitalised premature infants. This audit supports the current national recommendations to offer 4CMenB with other routine vaccinations and prophylactic paracetamol to premature infants at their chronological age.}, issn = {1359-2998}, URL = {https://fn.bmj.com/content/early/2018/04/10/archdischild-2017-314152}, eprint = {https://fn.bmj.com/content/early/2018/04/10/archdischild-2017-314152.full.pdf}, journal = {Archives of Disease in Childhood - Fetal and Neonatal Edition} }