Study concept and design: Ramsay, Slack, Ladhani.
Acquisition of data: Collins, Ramsay, Slack, Flynn, Litt, Ladhani.
Analysis and interpretation of data: Collins, Ramsay, Slack, Campbell, Ladhani.
Drafting of the manuscript: Collins, Slack, Campbell, Ladhani.
Critical revision of the manuscript for important intellectual content: Ramsay, Slack, Flynn, Litt, Ladhani.
Statistical analysis: Collins, Ladhani.
Administrative, technical, and material support: All authors.
Study supervision: Ramsay, Slack, Campbell, Ladhani.
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Mss Collins and Campbell and Drs Ramsay and Ladhani reported providing vaccine manufacturers with postmarketing surveillance reports, which the companies are required to submit to the UK licensing authority in compliance with their risk management strategy. In accordance with Public Health England policy, a cost recovery charge is made for these reports payable to the Immunisation Department. Public Health England has received payment from GlaxoSmithKline, Baxter, sanofi-pasteur MSD, and Novartis for lectures given by Drs Slack and Ladhani and has received grants from GlaxoSmithKline in payment for research performed by the authors. Dr Slack reported receiving travel reimbursement from GlaxoSmithKline and Pfizer. Dr Litt reported receiving a research grant from GlaxoSmithKline. No other disclosures were reported.
Additional Contributions: We thank Tracey Leech and Julie Brough (both with Immunisation Department, Public Health England) for their assistance with the clinical follow-up of cases and data entry. We are grateful to the clinicians who took the time to complete the surveillance questionnaires and provide additional information when requested. Mss Leech and Brough were compensated as part of their salaries.