Ethics approval and consent to participate
The study protocol was approved by institutional review boards at each study site and was registered at ClinicalTrials.gov (NCT03183908); CDC relied on the Duke institutional review board
Consent for publication
Not applicable
Availability of data and materials
Individual deidentified participant data will not be shared.
Competing interests
KES also received support from the National Institute on Aging, Duke Pepper Older Americans Independence Center, NIA P30AG028716. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
EPS also received support from the National Center for Advancing Translational Sciences of the National Institutes of Health, under Award Number 5UL1TR001425-04. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
CL also received support from the Department of Medicine at Boston University School of Medicineand the National Center for Advancing Translational Sciences (1KL2TR001411), and the National Institute of Aging (1K23AG057813) of the National Institutes of Health.
EBW has received support from Pfizer and Moderna as an investigator for clinical trials and is an advisor to Vaxcyte.
Funding
This work was supported by the Centers for Disease Control and Prevention (Clinical Immunization Safety Assessment (CISA) Project Contract [200-2012-53663/0008 and 200-2012-53663/0015] to Duke University and Contract [200-2012-53709] to Boston University. The role of the funder included providing input on all aspects of the design and conduct of the study; analysis, preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Authors' contributions
KES, CKL,WR, HA, EDB, CAT, MP, TH, KRB and EBW made substantial contributions to the conception and design of the work; and the acquisition, analysis, and interpretation of data; All authors made substantial contributions to the interpretation of the data and have drafted the work or substantively revised it. All authors have approved the submitted version and have agreed both to be personally accountable for the author's own contributions and to ensure that questions related to the accuracy or integrity of any part of the work, even ones in which the author was not personally involved, are appropriately investigated, resolved, and the resolution documented in the literature. Dr. Schmader had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. WR and MP conducted and are responsible for the data analysis.
Acknowledgments
The authors acknowledge the contributions of the study participants and staff; from the CDC, Frank DeStefano, MD, MPH, Lisa Grohskopf, MD, MPH, Oidda Museru, MSN, MPH, Alicia Fry, MD, MPH, Tom Shimabukuro MD, MPH, MBA, Pedro Moro, MD, MPH, Devindra Sharma, MSN, MPH, Patricia Wodi, MD; from Duke, Sue Doyle, Kristen Gunnell, Joyce Gandee; from Boston Medical Center, Anisha Bhanot, Elizabeth Liu, Dayeun Lee, Jordan Detrick, and Maria Narvaez and the nurses and office staff at Boston Medical Center Geriatric Clinic; from Cincinnati Children’s Hospital and Medical Center, Nancy Black, Brittney Cassell, and Krista Doerflein.
KES also received support from the National Institute on Aging, Duke Pepper Older Americans Independence Center, NIA P30AG028716. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
EPS also received support from the National Center for Advancing Translational Sciences of the National Institutes of Health, under Award Number 5UL1TR001425-04. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
CL also received support from the Department of Medicine at Boston University School of Medicineand the National Center for Advancing Translational Sciences (1KL2TR001411), and the National Institute of Aging (1K23AG057813) of the National Institutes of Health.
EBW has received support from Pfizer and Moderna as an investigator for clinical trials and is an advisor to Vaxcyte.
DISCLAIMER
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.