Study concept and design: Sukumaran, McCarthy, McNeil, Naleway, Hambidge, DeStefano, Orenstein, Omer.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Sukumaran.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Sukumaran, McCarthy, Lugg, Li, Weintraub.
Obtained funding: Sukumaran, Klein, Jackson, DeStefano, Orenstein.
Administrative, technical, or material support: McCarthy, McNeil, Naleway, Hambidge, Lugg, King, Orenstein, Omer.
Study supervision: McNeil, Klein, Hambidge, Weintraub, DeStefano, Orenstein, Omer.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Sukumaran reports receiving research support from the National Institutes of Health. Dr Naleway reports receiving research support from GlaxoSmithKline and Pfizer. Dr Klein reports receiving research support from GlaxoSmithKline, Sanofi Pasteur, Merck, Pfizer, Nuron Biotech, MedImmune, Novartis, and Protein Science. The Vaccine Safety Datalink Project is funded by the Centers for Disease Control and Prevention.
Funding/Support: This work was supported by the Centers for Disease Control and Prevention and grant T32AI074492 from the National Institute of Allergy and Infectious Diseases (Dr Sukumaran).
Role of the Funder/Sponsor: The funders of this study had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation or review of the manuscript; and decision to submit the manuscript for publication. The manuscript was approved by the Centers for Disease Control and Prevention clearance process.
Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official policy or position of the Centers for Disease Control and Prevention, the National Institute of Allergy and Infectious Diseases, or the National Institutes of Health.
Additional Contributions: We thank Paige W. Lewis, MSPH, from the Centers for Disease Control and Prevention for her assistance with the statistical analysis. Ms Lewis did not receive compensation for her contribution.