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An increase in accident and emergency presentations for adverse events following immunisation after introduction of the group B meningococcal vaccine: an observational study
  1. Viveka Nainani1,2,3,
  2. Ushma Galal4,
  3. Jim Buttery2,3,5,6,
  4. Matthew D Snape1,7
  1. 1 Department of Paediatrics, University of Oxford, Oxford, UK
  2. 2 Department of Infection and Immunity, Monash Children’s Hospital, Clayton, Victoria, Australia
  3. 3 Department of Paediatrics, Monash University, Clayton, Victoria, Australia
  4. 4 Nuffield Department of Primary Care Health Sciences, Clinical Trials Unit, University of Oxford, Oxford, UK
  5. 5 SAFEVIC, Murdoch Childrens Research Institute, Melbourne, Victoria, Australia
  6. 6 Monash Immunisation, Monash Health, Clayton, Victoria, Australia
  7. 7 NIHR, Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford, UK
  1. Correspondence to Viveka Nainani, Oxford Vaccine Group, University of Oxford, Department of Paediatrics, Oxford OX3 7LJ, UK; vknai2{at}student.monash.edu

Footnotes

  • Contributors MDS conceived the study. VN wrote the initial draft as well as all subsequent drafts, which were all edited by UG, MS and JB.

  • Funding This project was internally funded. We have received support from the NIHR Oxford Biomedical Research Centre and a travel grant from Monash University Department of Paediatrics.

  • Competing interests MDS is currently, or has been, a principal investigator on clinical trials funded and/or sponsored by vaccine manufacturers including GlaxoSmithKline, Pfizer, Medimmune and Johnson and Johnson. MDS has also spoken at industry sponsored symposia and contributed to advisory boards. This work is undertaken on behalf of the University of Oxford. JB is an investigator on clinical vaccine trials or observational studies sponsored by vaccine manufacturers including Novavax, Pfizer and MedImmune. JB also serves on data safety monitoring committees for Sequiris. This work was undertaken on behalf of Monash Health.

  • Ethics approval Permission to conduct this study as a service evaluation was obtained through the OUH NHS trust, thus the study did not require approval from an NHS ethics committee. Low-risk ethical approval was granted by Monash University.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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Footnotes

  • Contributors MDS conceived the study. VN wrote the initial draft as well as all subsequent drafts, which were all edited by UG, MS and JB.

  • Funding This project was internally funded. We have received support from the NIHR Oxford Biomedical Research Centre and a travel grant from Monash University Department of Paediatrics.

  • Competing interests MDS is currently, or has been, a principal investigator on clinical trials funded and/or sponsored by vaccine manufacturers including GlaxoSmithKline, Pfizer, Medimmune and Johnson and Johnson. MDS has also spoken at industry sponsored symposia and contributed to advisory boards. This work is undertaken on behalf of the University of Oxford. JB is an investigator on clinical vaccine trials or observational studies sponsored by vaccine manufacturers including Novavax, Pfizer and MedImmune. JB also serves on data safety monitoring committees for Sequiris. This work was undertaken on behalf of Monash Health.

  • Ethics approval Permission to conduct this study as a service evaluation was obtained through the OUH NHS trust, thus the study did not require approval from an NHS ethics committee. Low-risk ethical approval was granted by Monash University.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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