Safety study of live, oral human rotavirus vaccine: A cohort study in United States health insurance plans

References

• Rotavirus Vaccines. WHO position paper: January 2013 – Recommendations. Wkly Epidemiol Rec. 88:49–64. PMID:23424730.
   PubMedGoogle Scholar
• Parashar UD, Glass RI. Rotavirus vaccines – early success, remaining questions. N Engl J Med. 2009;360:1063–1065. PMID:19279338.
   PubMed Web of Science ®Google Scholar
• Vesikari T, Matson DO, Dennehy P, Van Damme P, Santosham M, Rodriguez Z, et al. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med. 2006;354(1):23–33. doi:10.1056/NEJMoa052664. PMID:16394299.
   PubMed Web of Science ®Google Scholar
• Ruiz-Palacios GM, Perez-Schael I, Velazquez FR, Abate H, Breuer T, Clemens SC, Cheuvart B, Espinoza F, Gillard P, Innis BL, et al. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med. 2006;354(1):11–22. doi:10.1056/NEJMoa052434. PMID:16394298.
   PubMed Web of Science ®Google Scholar
• Buyse H, Vinals C, Karkada N, Han HH. The human rotavirus vaccine Rotarix in infants: an integrated analysis of safety and reactogenicity. Hum Vaccin Immunother. 2014;10(1):19–24. doi:10.4161/hv.26476. PMID:24047799.
   PubMed Web of Science ®Google Scholar
• Tate JE, Haynes A, Payne DC, Cortese MM, Lopman BA, Patel MM, Parashar UD. Trends in national rotavirus activity before and after introduction of rotavirus vaccine into the national immunization program in the United States, 2000 to 2012. Pediatr Infect Dis J. 2013;32(7):741–4. doi:10.1097/INF.0b013e31828d639c.
   PubMed Web of Science ®Google Scholar
• Aliabadi N, Tate JE, Haynes AK, Parashar UD. Sustained decrease in laboratory detection of rotavirus after implementation of routine vaccination-United States, 2000–2014. MMWR Morb Mortal Wkly Rep. 2015;64(13):337–42. PMID:25856253.
   PubMed Web of Science ®Google Scholar
• Leshem E, Tate JE, Steiner CA, Curns AT, Lopman BA, Parashar UD. Acute gastroenteritis hospitalizations among US children following implementation of the rotavirus vaccine. JAMA. 2015;313(22):2282–4. doi:10.1001/jama.2015.5571. PMID:26057291.
   PubMed Web of Science ®Google Scholar
• Shah MP, Tate JE, Steiner CA, Parashar UD. Decline in Emergency Department Visits for Acute Gastroenteritis Among Children in 10 US States After Implementation of Rotavirus Vaccination, 2003 to 2013. Pediatr Infect Dis J. 2016;35(7):782–6. doi:10.1097/INF.0000000000001175.
   PubMed Web of Science ®Google Scholar
• Delage G. Rotavirus vaccine withdrawal in the United States; the role of postmarketing surveillance. Can J Infect Dis. 2000;11:10–12. doi:10.1155/2000/414396. PMID:18159257.
   PubMedGoogle Scholar
• Murphy TV, Gargiullo PM, Massoudi MS, Nelson DB, Jumaan AO, Okoro CA, Zanardi LR, Setia S, Fair E, LeBaron CW, et al. Intussusception among infants given an oral rotavirus vaccine. N Engl J Med. 2001;344(8):564–72. doi:10.1056/NEJM200102223440804. PMID:11207352.
   PubMed Web of Science ®Google Scholar
• Stringer MD, Pablot SM, Brereton RJ. Paediatric intussusception. Br J Surg. 1992;79(9):867–76. doi:10.1002/bjs.1800790906. PMID:1422744.
   PubMed Web of Science ®Google Scholar
• DiFiore JW. Intussusception. Semin Pediatr Surg. 1999;8(4):214–20. doi:10.1016/S1055-8586(99)70029-6. PMID:10573432.
   PubMedGoogle Scholar
• Roeyen G, Jansen M, Hubens G, Vaneerdeweg W, Eyskens E. Intussusception in infants: an emergency in diagnosis and treatment. Eur J Emerg Med. 1999;6(1):73–76. PMID:10340739.
   PubMedGoogle Scholar
• Tate JE, Simonsen L, Viboud C, Steiner C, Patel MM, Curns AT, Parashar UD. Trends in intussusception hospitalizations among US infants, 1993–2004: implications for monitoring the safety of the new rotavirus vaccination program. Pediatrics. 2008;121(5):e1125–1132. doi:10.1542/peds.2007-1590. PMID:18450856.
   PubMed Web of Science ®Google Scholar
• Selvaraj G, Kirkwood C, Bines J, Buttery J. Molecular epidemiology of adenovirus isolates from patients diagnosed with intussusception in Melbourne, Australia. J Clin Microbiol. 2006;44(9):3371–3. doi:10.1128/JCM.01289-06. PMID:16954276.
   PubMed Web of Science ®Google Scholar
• Centers for Disease Control and Prevention (CDC). Postmarketing monitoring of intussusception after Rotateq vaccination-United States, February 1, 2006 – February 15, 2007. MMWR Morb Mortal Wkly Rep. 2007;56:218–22. PMID:17363890.
   PubMedGoogle Scholar
• Belongia EA, Irving SA, Shui IM, Kulldorff M, Lewis E, Yin R, Lieu TA, Weintraub E, Yih WK, Li R, et al. Real-time surveillance to assess risk of intussusception and other adverse events after pentavalent, bovine-derived rotavirus vaccine. Pediatr Infect Dis J. 2010;29(1):1–5. doi:10.1097/INF.0b013e3181af8605. PMID:19907356.
   PubMed Web of Science ®Google Scholar
• Loughlin J, Mast TC, Doherty MC, Wang FT, Wong J, Seeger JD. Postmarketing evaluation of the short-term safety of the pentavalent rotavirus vaccine. Pediatr Infect Dis J. 2012;31(3):292–6. doi:10.1097/INF.0b013e3182421390. PMID:22173146.
   PubMed Web of Science ®Google Scholar
• Shui IM, Baggs J, Patel M, Parashar UD, Rett M, Belongia EA, Hambidge SJ, Glanz JM, Klein NP, Weintraub E. Risk of intussusception following administration of a pentavalent rotavirus vaccine in US infants. JAMA. 2012;307(6):598–604. doi:10.1001/jama.2012.97. PMID:22318281.
   PubMed Web of Science ®Google Scholar
• National Death Index. Available at: https://www.cdc.gov/nchs/ndi/index.htm. Accessed 02 June 2017.
   Google Scholar
• Kulldorff M, and Information Management Services Inc. SatScan™ v9.4: software for the spatial and space-time scan statistics. Available at: http://www.satscan.org. Accessed 14 March 2017..
   Google Scholar
• Kulldorff M. A spatial scan statistic. Commun Statist – Theory Meth. 1997;26:1481–96. doi:10.1080/03610929708831995.
   Web of Science ®Google Scholar
• Yih WK, Lieu TA, Kulldorff M, Martin D, McMahill-Walraven CN, Platt R, Selvam N, Selvan M, Lee GM, Nguyen M. Intussusception risk after rotavirus vaccination in U.S. infants. N Engl J Med. 2014;370(6):503–12. doi:10.1056/NEJMoa1303164.
   PubMed Web of Science ®Google Scholar
• Haber P, Patel M, Pan Y, Baggs J, Haber M, Museru O, Yue X, Lewis P, Destefano F, Parashar UD. Intussusception after rotavirus vaccines reported to US VAERS, 2006–2012. Pediatrics. 2013;131(6):1042–9. doi:10.1542/peds.2012-2554. PMID:23669521.
   PubMed Web of Science ®Google Scholar
• Weintraub ES, Baggs J, Duffy J, Vellozzi C, Belongia EA, Irving S, Klein NP, Glanz JM, Jacobsen SJ, Naleway A, et al. Risk of intussusception after monovalent rotavirus vaccination. N Engl J Med. 2014;370(6):513–9. doi:10.1056/NEJMoa1311738. PMID:24422678.
   PubMed Web of Science ®Google Scholar
• Yen C, Tate JE, Steiner CA, Cortese MM, Patel MM, Parashar UD. Trends in intussusception hospitalizations among US infants before and after implementation of the rotavirus vaccination program, 2000–2009. J Infect Dis. 2012;206(1):41–48. doi:10.1093/infdis/jis314. PMID:22539812.
   PubMed Web of Science ®Google Scholar
• Rosillon D, Buyse H, Friedland LR, Ng SP, Velazquez FR, Breuer T. Risk of Intussusception After Rotavirus Vaccination: Meta-analysis of Postlicensure Studies. Pediatr Infect Dis J. 2015;34(7):763–8. doi:10.1097/INF.0000000000000715. PMID:26069948.
   PubMed Web of Science ®Google Scholar
• Escolano S, Hill C, Tubert-Bitter P. Intussusception risk after RotaTeq vaccination: evaluation from worldwide spontaneous reporting data using a self-controlled case series approach. Vaccine. 2015;33(8):1017–20. doi:10.1016/j.vaccine.2015.01.005. PMID:25596460.
   PubMed Web of Science ®Google Scholar
• Yung CF, Chan SP, Soh S, Tan A, Thoon KC. Intussusception and Monovalent Rotavirus Vaccination in Singapore: Self-Controlled Case Series and Risk-Benefit Study. J Pediatr. 2015;167(1):163–8. doi:10.1016/j.jpeds.2015.03.038. PMID:25882872.
   PubMed Web of Science ®Google Scholar
• Pardo-Seco J, Cebey-Lopez M, Martinon-Torres N, Salas A, Gomez-Rial J, Rodriguez-Tenreiro C, Martinón-Sánchez JM, Martinón-Torres F. Impact of Rotavirus Vaccination on Childhood Hospitalization for Seizures. Pediatr Infect Dis J. 2015;34(7):769–73. doi:10.1097/INF.0000000000000723. PMID:25923425.
   PubMed Web of Science ®Google Scholar
• Payne DC, Baggs J, Zerr DM, Klein NP, Yih K, Glanz J, Curns AT, Weintraub E, Parashar UD. Protective association between rotavirus vaccination and childhood seizures in the year following vaccination in US children. Clin Infect Dis. 2014;58(2):173–7. doi:10.1093/cid/cit671. PMID:24265355.
   PubMed Web of Science ®Google Scholar
• Pringle KD, Burke RM, Steiner CA, Parashar UD, Tate JE. Trends in rate of seizure-associated hospitalizations among children <5 years old before and after rotavirus vaccine introduction in the United Sates, 2000–2013. J Infect Dis. 2018;217(4):581–8. doi:10.1093/infdis/jix589. PMID:29325147.
   PubMed Web of Science ®Google Scholar
• Zerr DM, Blume HK, Berg AT, Del Beccaro MA, Gospe SM, Jr., Allpress AL, Christakis DA. Nonfebrile illness seizures: a unique seizure category? Epilepsia. 2005;46(6):952–5. doi:10.1111/j.1528-1167.2005.65204.x. PMID:15946338.
   PubMed Web of Science ®Google Scholar
• DiFazio MP, Braun L, Freedman S, Hickey P. Rotavirus-induced seizures in childhood. J Child Neurol. 2007;22(12):1367–70. doi:10.1177/0883073807307083. PMID:18174553.
   PubMed Web of Science ®Google Scholar
• Lloyd MB, Lloyd JC, Gesteland PH, Bale JF, Jr. Rotavirus gastroenteritis and seizures in young children. Pediatr Neurol. 2010;42(6):404–8. doi:10.1016/j.pediatrneurol.2010.03.002. PMID:20472191.
   PubMed Web of Science ®Google Scholar
• Martin ET, Kerin T, Christakis DA, Blume HK, Gospe SM, Jr., Vinje J, Bowen MD, Gentsch J, Zerr DM. Redefining outcome of first seizures by acute illness. Pediatrics. 2010;126(6):e1477–1484. doi:10.1542/peds.2010-1138. PMID:21098153.
   PubMed Web of Science ®Google Scholar
• Duffy J, Weintraub E, Hambidge SJ, Jackson LA, Kharbanda EO, Klein NP, Lee GM, Marcy SM, Nakasato CC, Naleway A, et al. Febrile Seizure Risk After Vaccination in Children 6 to 23 Months. Pediatrics. 2016;138(1):e1–10. doi:10.1542/peds.2016-0320.
   Web of Science ®Google Scholar
• Dore DD, Turnbull BR, Seeger JD. Vaccine discontinuation and switching following regulatory interventions in response to rotavirus vaccine contamination with porcine circovirus DNA fragments. Pharmacoepidemiol Drug Saf. 2012;21(4):415–9. doi:10.1002/pds.3217. PMID:22290786.
   PubMed Web of Science ®Google Scholar
• Hoffman V, Everage NJ, Quinlan SC, Skerry K, Esposito D, Praet N, Rosillon D, Holick CN, Dore DD. Validation of current procedural terminology codes for rotavirus vaccination among infants in two commercially insured US populations. Pharmacoepidemiol Drug Saf. 2016;25(12):1465–9. doi:10.1002/pds.4085. PMID:27623759.
   PubMed Web of Science ®Google Scholar