Risk of intussusception following administration of a pentavalent rotavirus vaccine in US infants

JAMA

Volumn 307, Issue 6, 2012, Pages 598-604

  Shui, Irene M ^a,b   Baggs, James ^c   Patel, Manish ^c   Parashar, Umesh D ^c   Rett, Melisa ^b   Belongia, Edward A ^d   Hambidge, Simon J ^e   Glanz, Jason M ^e   Klein, Nicola P ^f   Weintraub, Eric ^c  

^a HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

^c CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^d MARSHFIELD CLINIC   (United States)

^e Global Health and Health Disparities   (United States)

^f KAISER PERMANENTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ROTAVIRUS VACCINE;

ARTICLE; ATTRIBUTABLE RISK; COHORT ANALYSIS; DRUG SAFETY; EMERGENCY WARD; FOLLOW UP; HUMAN; INFANT; INTUSSUSCEPTION; MEDICAL RECORD; PRIORITY JOURNAL; PROSPECTIVE STUDY; RISK FACTOR; STANDARDIZED INCIDENCE RATIO; UNITED STATES;

EID: 84856805737     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2012.97     Document Type: Article

References (32)

1. Murphy TV, Smith PJ, Gargiullo PM, Schwartz B. The first rotavirus vaccine and intussusception: epidemiological studies and policy decisions. J Infect Dis. 2003;187(8):1309-1313. (Pubitemid 36438971)
2. Murphy TV, Gargiullo PM,Massoudi MS, et al Rotavirus Intussusception Investigation Team. Intussusception among infants given an oral rotavirus vaccine. N Engl J Med. 2001;344(8):564-572. (Pubitemid 32167870)
3. Kramarz P, France EK, Destefano F, et al. Population-based study of rotavirus vaccination and intussusception. Pediatr Infect Dis J. 2001;20(4): 410-416. (Pubitemid 32294750)
4. Parashar UD, Alexander JP, Glass RI; Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention (CDC). 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.
5. CorteseMM,Parashar UD; Centers for Disease Control and Prevention (CDC). 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.
6. Vesikari T, Matson DO, Dennehy P, et al Rotavirus Efficacy and Safety Trial (REST) Study Team. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med. 2006; 354(1):23-33. (Pubitemid 43048948)
7. Ruiz-Palacios GM, Pérez-Schael I, Velázquez FR, et al Human Rotavirus Vaccine Study Group. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med. 2006;354 (1):11-22. (Pubitemid 43048947)
8. Belongia EA, Irving SA, Shui IM, et al Vaccine Safety Datalink Investigation Group. 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.
9. Buttery JP, Danchin MH, Lee KJ, et al PAEDS/APSU Study Group. Intussusception following rotavirus vaccine administration: post-marketing surveillance in the National Immunization Program in Australia. Vaccine. 2011;29(16):3061-3066.
10. Patel MM, López-Collada VR, Bulhões MM, et al. Intussusception risk and health benefits of rotavirus vaccination in Mexico and Brazil. N Engl JMed. 2011; 364(24):2283-2292.
11. Baggs J, Gee J, Lewis E, et al. The Vaccine Safety Datalink: amodel for monitoring immunization safety. Pediatrics. 2011;127(127)(suppl 1):S45-S53.
12. Bines JE, Kohl KS, Forster J, et al Brighton Collaboration Intussusception Working Group. Acute intussusception in infants and children as an adverse event following immunization: case definition and guidelines of data collection, analysis, and presentation. Vaccine. 2004;22(5-6):569-574. (Pubitemid 38114883)
13. Tate JE, Panozzo CA, Payne DC, et al. Decline and change in seasonality of US rotavirus activity after the introduction of rotavirus vaccine. Pediatrics. 2009; 124(2):465-471.
14. Tate JE, Mutuc JD, Panozzo CA, et al. Sustained decline in rotavirus detections in the United States following the introduction of rotavirus vaccine in 2006. Pediatr Infect Dis J. 2011;30(1)(suppl):S30-S34.
15. Tate JE, Cortese MM, Payne DC, et al. Uptake, impact, and effectiveness of rotavirus vaccination in the United States: review of the first 3 years of postlicensure data. Pediatr Infect Dis J. 2011;30(1)(suppl): S56-S60.
16. Curns AT, Steiner CA, Barrett M, Hunter K, Wilson E, Parashar UD. Reduction in acute gastroenteritis hospitalizations among US children after introduction of rotavirus vaccine: analysis of hospital discharge data from 18 US states. J Infect Dis. 2010;201(11):1617-1624.
17. Centers for Disease Control and Prevention (CDC). Rotavirus vaccination coverage among infants aged 5 months-immunization information system sentinel sites, United States, June 2006-June 2009.MMWR Morb Mortal Wkly Rep. 2010;59(17):521-524.
18. Justice F, Carlin J, Bines J. Changing epidemiology of intussusception in Australia. J Paediatr Child Health. 2005;41(9-10):475-478. (Pubitemid 43951228)
19. Bines JE, Patel M, Parashar U. Assessment of postlicensure safety of rotavirus vaccines, with emphasis on intussusception. J Infect Dis. 2009;200(suppl 1): S282-S290.
20. Johnson B, Gargiullo P, Murphy TV, Parashar UD, Patel MM. Sociodemographic and dietary risk factors for natural infant intussusception in the United States. J Pediatr Gastroenterol Nutr. 2010;51(4): 458-463.
21. Patel M, Shane AL, Parashar UD, Jiang B, Gentsch JR, Glass RI. Oral rotavirus vaccines: how well will they work where they are needed most? J Infect Dis. 2009; 200(suppl 1):S39-S48.
22. Steele AD, De Vos B, Tumbo J, et al. Coadministration study in South African infants of a live-attenuated oral human rotavirus vaccine (RIX4414) and poliovirus vaccines. Vaccine. 2010;28(39):6542-6548.
23. Moon SS, Wang Y, Shane AL, et al. Inhibitory effect of breast milk on infectivity of live oral rotavirus vaccines. Pediatr Infect Dis J. 2010;29(10):919-923.
24. Lieu TA, Kulldorff M, Davis RL, et al; for the Vaccine Safety Datalink Rapid Cycle Analysis Team. Real-time vaccine safety surveillance for the early detection of adverse events. Med Care. 2007;45(10) (suppl 2):S89-S95.
25. Simonsen L, Morens D, Elixhauser A, Gerber M, Van Raden M, Blackwelder W. Effect of rotavirus vaccination programme on trends in admission of infants to hospital for intussusception. Lancet. 2001; 358(9289):1224-1229. (Pubitemid 33010847)
26. Macias M, Lopez P, Velazquez FR, Vergara RF, Salmeron J. The Rotavirus vaccine RIX 4414 (Rotarix) is not associated with intussusception in one year old infants [abstract]. Presented at: the 45th ICAAC Annual Meeting; December 16-19; Washington, DC. Poster G-841.
27. Greenberg HB. Rotavirus vaccination and intussusception-act two. N Engl J Med. 2011; 364(24):2354-2355.
28. Mullooly J, Drew L, DeStefano F, et al. Quality ofHMOvaccination databases used to monitor childhood vaccine safety. Vaccine Safety DataLink Team. Am J Epidemiol. 1999;149(2):186-194. (Pubitemid 29039522)
29. Chang EJ, Zangwill KM, Lee H, Ward JI. Lack of association between rotavirus infection and intussusception: implications for use of attenuated rotavirus vaccines. Pediatr Infect Dis J. 2002;21(2):97-102. (Pubitemid 34150605)
30. Shui IM, Shi P, Dutta-Linn MM, et al Vaccine Safety Datalink Research Team. Predictive value of seizure ICD-9 codes for vaccine safety research. Vaccine. 2009;27(39):5307-5312.
31. Mullooly JP, Donahue JG, DeStefano F, Baggs J, Eriksen E; VSD Data Quality Working Group. Predictive value of ICD-9-CM codes used in vaccine safety research. Methods Inf Med. 2008;47(4):328-335.
32. Cortese M. Estimates of benefits and potential risks of rotavirus vaccination in the United States. Presented at the Advisory Committee on Immunization Practices Meeting; Atlanta, GA, USA; October 28, 2010.