Age dependence of the risk of intussusception following tetravalent rhesus-human reassortant rotavirus tetravalent vaccine: Is it beyond doubt?

American Journal of Epidemiology

Volumn 171, Issue 9, 2010, Pages 1046-1054

  Chen, Jie ^a   Heyse, Joseph F ^b   Heaton, Penny ^c   Kuter, Barbara J ^b  

^a ABBOTT LABORATORIES   (United States)

^b MERCK RESEARCH LABORATORIES   (United States)

^c Novartis Vaccines and Diagnostics Inc   (United States)

Author keywords

intussusception; odds ratio; rotavirus vaccines

Indexed keywords

ROTAVIRUS VACCINE; SIMIAN ROTAVIRUS VACCINE;

AGE; DATA SET; DIGESTIVE SYSTEM DISORDER; DISEASE INCIDENCE; HEALTH RISK; PUBLIC HEALTH; REGRESSION ANALYSIS; VACCINATION; VACCINE;

AGE DISTRIBUTION; ARTICLE; CASE CONTROL STUDY; CONTROLLED STUDY; DISEASE ASSOCIATION; DRUG EXPOSURE; HUMAN; INFANT; INTUSSUSCEPTION; MAJOR CLINICAL STUDY; RISK ASSESSMENT; ROTAVIRUS INFECTION; VACCINATION; AGE; COHORT ANALYSIS; DRUG ADMINISTRATION; HOSPITALIZATION; RISK; RISK FACTOR; STATISTICAL MODEL; UNITED STATES;

ROTAVIRUS;

AGE FACTORS; CASE-CONTROL STUDIES; COHORT STUDIES; DRUG ADMINISTRATION SCHEDULE; HOSPITALIZATION; HUMANS; INFANT; INTUSSUSCEPTION; LOGISTIC MODELS; ODDS RATIO; RISK FACTORS; ROTAVIRUS VACCINES; UNITED STATES;

EID: 77952317743     PISSN: 00029262     EISSN: 14766256     Source Type: Journal    
DOI: 10.1093/aje/kwq048     Document Type: Article

References (26)

1. Murphy TV, Gargiullo PM, Massoudi MS, et al. Intussusception among infants given an oral rotavirus vaccine. N Engl J Med. 2001;344(8):564-572.
2. Murphy TV, Smith PJ, Gargiullo PM, et al. The first rotavirus vaccine and intussusception: epidemiological studies and policy decisions. J Infect Dis. 2003;187(8):1309-1313.
3. Simonsen L, Viboud C, Elixhauser A, et al. More on Rota- Shield and intussusception: the role of age at the time of vaccination. J Infect Dis. 2005;192(suppl 1):S36-S43.
4. 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.
5. Murphy BR, Morens DM, Simonsen L, et al. Reappraisal of the association of intussusception with the licensed live rotavirus vaccine challenges initial conclusions. J Infect Dis. 2003; 187(8):1301-1308.
6. Rothman KJ, Young-Xu Y, Arellano F. Age dependence of the relation between reassortant rotavirus vaccine (RotaShield) and intussusceptions [letter]. J Infect Dis. 2006;193(6):898.
7. Simonsen L, Taylor RJ, Elixhauser A, et al. Reply to Rothman et al. [letter]. J Infect Dis. 2006;193(6):898-899.
8. Gargiullo PM, Murphy TV, Davis RL. Is there a safe age for vaccinating infants with tetravalent rhesus-human reassortant rotavirus vaccine? [letter]. J Infect Dis. 2006;194(12):1793-1794.
9. Rothman KJ, Arellano FM, Young-Xu Y, et al. Reply to Gargiullo et al. [letter]. J Infect Dis. 2006;194(12):1794-1795.
10. Global Advisory Committee on Vaccine Safety, World Health Organization. Effect of Age at Vaccination on Risk of Intussusception From RotaShield-Supplementary Analysis of CDC Case-Control Study. Geneva, Switzerland: World Health Organization; 2005.
11. Tai JH, Curns AT, Parashar UD, et al. Rotavirus vaccination and intussusception: can we decrease temporally associated background cases of intussusception by restricting the vaccination schedule? Pediatrics. 2006;118(2):e258-e264.
12. Rotavirus vaccine for the prevention of rotavirus gastroenteritis among children. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 1999;48(RR-2):1-20.
13. American Academy of Pediatrics. Prevention of rotavirus disease: guidelines for use of rotavirus vaccine. Pediatrics. 1998;102(6):1483-1491.
14. Bines J. Intussusception and rotavirus vaccines. Vaccine. 2006;24(18):3772-3776.
15. Rennels MB. The rotavirus vaccine story: a clinical investigators view. Pediatrics. 2000;106(1):123-125.
16. Zanardi LR, Haber P, Mootrey GT, et al. Intussusception among recipients of rotavirus vaccine: reports to the Vaccine Adverse Event Reporting System [electronic article]. Pediatrics. 2001;107(6):E97.
17. Pike MC, Hill AP, Smith PG. Bias and efficiency in logistic analyses of stratified case-control studies. Int J Epidemiol. 1980;9(1):89-95.
18. Kleinbaum DG. Logistic Regression-A Self Learning Text. Berlin, Germany: Springer-Verlag; 1994.
19. Greenland S. Dose-response and trend analysis in epidemiology: alternatives to categorical analysis. Epidemiology. 1995; 6(4):356-365.
20. Ruppert D,Wand MP, Carroll RJ. Semiparametric Regression. Cambridge, United Kingdom: Cambridge University Press; 2003.
21. World Health Organization. Rotavirus vaccines. Wkly Epidemiol Rec. 2007;82(32):285-295.
22. Tate JE, Simonsen L, Viboud C, et al. 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-e1132.
23. Ruiz-Palacios GM, Pérez-Schael I, Velázquez FR, et al. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med. 2006;354(1):11-22.
24. Vesikari T, Matson DO, Dennehy P, et al. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med. 2006;354(1):23-33.
25. World Health Organization. Global Advisory Committee on Vaccine Safety, report of meeting held 17-18 June 2009. Wkly Epidemiol Rec. 2009;84(32):325-332.
26. Patel MM, Clark AD, Glass RI, et al. Broadening the age restriction for initiating rotavirus vaccination in regions with high rotavirus mortality: benefits of mortality reduction versus risk of fatal intussusception. Vaccine. 2009; 27(22):2916-2922.