References
- ROTARIX (Rotavirus Vaccine, Live, Oral) oral suspension https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM133539.pdf
- RotaTeq (Rotavirus Vaccine, Live, Oral, Pentavalent) http://www.merck.com/product/usa/pi_circulars/r/rotateq/rotateq_pi.pdf
- Parashar UD, Alexander JP, Glass RI. Prevention of rotavirus gastroenteritis among infants and children. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2006;55(RR-12):1−13.
- Cortese MM, Parashar UD. Prevention of rotavirus gastroenteritis among infants and children: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2009;58(RR-2):1−25.
- Recommended immunization schedule for children and adolescents aged 18 years or younger. United States, 2018 https://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf
- Hoffman V, Abu-Elyazeed R, Enger C, Esposito DB, Doherty MC, Quinlan SC, Skerry K, Holick CN, Basile P, Friedland LR, et al. Safety study of live, oral human rotavirus vaccine: A cohort study in United States health insurance plans. Hum Vaccin Immunother. 2018; Mar 13:1–9. doi: 10.1080/21645515.2018.
- Updated recommendation from the Advisory Committee on Immunization Practices (ACIP) for use of 7-valent pneumococcal conjugate vaccine (PCV7) in children aged 24–59 months who are not completely vaccinated. Centers for Disease Control and Prevention (CDC). MMWR Morb Mortal Wkly Rep. 2008;57:343−4.
- Licensure of a 13-valent pneumococcal conjugate vaccine (PCV13) and recommendations for use among children — Advisory Committee on Immunization Practices (ACIP), 2010. MMWR Morb Mortal Wkly Rep. 2010;59;258−61.
- Shimabukuro TT, Nguyen M, Martin D, DeStefano F. Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS). Vaccine. 2015;33:4398−405. doi:10.1016/j.vaccine.2015.07.035.
- Medical Dictionary for Regulatory Activities. Support Documentation. http://www.meddra.org/how-to-use/support-documentation; Accessed May 20, 2018
- U.S. Food & Drug Administration. CFR – Code of Federal Regulations. 21 CFR §600.80. Revised April 1, 2017. Available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=600.80