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’ 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°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.
- 4cmenb vaccine
- infant, premature
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Contributors PTH, PC, SB and SL developed the audit. AK and SL performed the analysis and drafted the manuscript. SB coordinated the audit. KB developed and maintained the database. All authors contributed data for analysis and reviewed and agreed final manuscript.
Funding This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests SL and PTH have conducted studies on behalf of St George’s, University of London, funded by vaccine manufacturers but do not receive any personal payments or travel support.
Patient consent Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement No relevant unpublished data.
Collaborators National Neonatal Audit Network: Alder Hey Children’s NHS Foundation Trust: Andrew Riordan (Andrew.Riordan@alderhey.nhs.uk); Birmingham Women’s Hospital NHS Foundation Trust: Gergely Toldi (Gergely.Toldi@bwnft.nhs.uk); Calderdale and Huddersfield NHS Foundation Trust: Karin Schwarz (Karin.Schwarz@cht.nhs.uk); Chesterfield Royal Hospital NHS Foundation Trust: Aiwyne Foo (firstname.lastname@example.org); Croydon University Hospital: Arun Kumar (email@example.com) and Amy Douthwaite (firstname.lastname@example.org); East Kent Hospitals University NHS Trust: Vimal Vasu (email@example.com), Susan Clark (firstname.lastname@example.org) and Dr Magali Dubus (email@example.com); Guy’s and St Thomas’ NHS Foundation Trust: Sophie Niedermaier (Sophie.Niedermaier@gstt.nhs.uk) and Timothy Watts (Timothy.Watts@gstt.nhs.uk); Leeds Teaching Hospitals NHS Trust: Catherine Harrison (firstname.lastname@example.org); Luton and Dunstable University Hospital NHS Foundation Trust: Sakina Ali (Sakina.Ali@ldh.nhs.uk); Medway NHS Foundation Trust: Helen Harizaj (email@example.com) and Santosh Pattnayak (Santosh.Pattnayak@medway.nhs.uk); Mid Cheshire Hospitals NHS Foundation Trust: Saravanan Jayachandran (Saravanan.Jayachandran@mcht.nhs.uk) and Janet Smith (firstname.lastname@example.org); Norfolk and Norwich University Hospitals NHS Foundation Trust: Kenneith Yong (email@example.com); North Tees and Hartlepool NHS Foundation Trust: Wendy Cheadle (Wendy.Cheadle@nth.nhs.uk; firstname.lastname@example.org); North West Anglia NHS Foundation Trust: Katharine McDevitt (Katharine.McDevitt@pbh-tr.nhs.uk) and Anna Ostrzewska (Anna.Ostrzewska@pbh-tr.nhs.uk); Oxford University Hospitals NHS Foundation Trust: Mark Anthony (Anthony.Mark@ouh.nhs.uk) and Priti Khemka (email@example.com); Portsmouth Hospitals NHS Trust: Tim J Scorrer (firstname.lastname@example.org); Sheffield Teaching Hospitals NHS Foundation Trust: Hazel Clargo (Hazel.Clargo@sth.nhs.uk); Singleton Hospital, Swansea: Dr Jean Matthes (Jean.Matthes@wales.nhs.uk); St George’s University Hospitals NHS Foundation Trust: Nigel Kennea (Nigel.Kennea@stgeorges.nhs.uk) and Hannah Davies (email@example.com); University Hospitals of Morecambe Bay NHS Foundation Trust: Joanne Fedee (Joanne.Fedee@mbht.nhs.uk), Carol Burt (Carol.Burt@mbht.nhs.uk), Alison Hemsley (Alison.Helmsley@mbht.nhs.uk), Rebecca Kitching (Rebecca.Kitching@mbht.nhs.uk), Emma Green (Emma.Green@mbht.nhs.uk), Leigh Westwood (Leigh.Westwood@mbht.nhs.uk), Christina Jackson (Christina.Jackson@mbht.nhs.uk) and Victoria Huddleston (Victoria.Huddleston@mbht.nhs.uk); and Whittington Hospital NHS Trust: Wynne Leith (firstname.lastname@example.org) and Philippa Stilwell (email@example.com).