Intussusception following rotavirus vaccine administration: Post-marketing surveillance in the National Immunization Program in Australia

被引：209

作者：

Buttery, J. P. ^{[1
,2
,3
,4
]}

Danchin, M. H. ^{[1
,2
,3
,5
]}

Lee, K. J. ^{[5
,6
]}

Carlin, J. B. ^{[5
,6
]}

McIntyre, P. B.

Elliott, E. J. ^{[7
,8
]}

Booy, R.

Bines, J. E. ^{[2
,5
,9
]}

机构：

[1] Murdoch Childrens Res Inst, SAEFVIC Child & Adolescent Immunisat, Parkville, Vic 3052, Australia

[2] Murdoch Childrens Res Inst, NHMRC CCRE Child & Adolescent Immunisat, Parkville, Vic 3052, Australia

[3] Royal Childrens Hosp Melbourne, Dept Gen Med, Melbourne, Vic, Australia

[4] Monash Univ, Monash Childrens Hosp, Dept Paediat, Infect Dis Unit, Melbourne, Vic 3004, Australia

[5] Univ Melbourne, Dept Paediat, Melbourne, Vic 3010, Australia

[6] Murdoch Childrens Res Inst, Clin Epidemiol & Biostat Unit, Murdoch, WA, Australia

[7] Univ Sydney, Sydney, NSW 2006, Australia

[8] Childrens Hosp Westmead, Australian Paediat Surveillance Unit, Sydney Med Sch, Discipline Paediat & Child Hlth, Sydney, NSW, Australia

[9] Royal Childrens Hosp, Dept Gastroenterol & Clin Nutr, Melbourne, Vic, Australia

来源：

VACCINE | 2011年 / 29卷 / 16期

基金：

英国医学研究理事会;

关键词：

Rotavirus vaccine; Intussusception; Post-marketing surveillance; RotaTeq (R); Rotarix (R); Immunization; UNITED-STATES; INFANTS; SAFETY; EFFICACY; CHILDREN;

D O I：

10.1016/j.vaccine.2011.01.088

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Introduction: In Australia, post-marketing surveillance for intussusception following vaccination commenced with funding of RotaTeq (R) and Rotarix (R) vaccines under the National Immunization Program (NIP) in July 2007. Methods: Two active surveillance mechanisms (hospital-based case ascertainment and monthly reports from paediatricians) identified intussusception cases between 1st July 2007 and 31st December 2008 in four states. Linkage to vaccination records identified cases occurring within 1-7 and 1-21 days of rotavirus vaccination. Expected cases within the post-vaccination windows were calculated by applying rates of intussusception from national hospitalisation data over 6 years (mid-2000 to mid-2006), by age and state, to numbers vaccinated (by dose) according to the Australian Childhood Immunization Register. Results: Combining exposure windows associated with all doses of rotavirus vaccine from 1 to 9 months of age, there was no evidence of an increased risk of intussusception following vaccination for either vaccine. However, in infants 1 to <3 months of age, there was suggestive evidence of excess intussusception cases 1-7 and 1-21 days following dose 1(1-7 days: RotaTeq (R) relative risk (RR) = 5.3, 95% confidence interval [Cl] 1.1,15.4; Rotarix (R) RR 3.5,95% Cl 0.7,10.1; 1-21 days: RotaTeq (R) RR 3.5,95% CI 1.3,7.6; Rotarix (R) RR 1.5, 95% CI 0.4, 3.9). There was no evidence that clinical outcome of intussusception occurring within 21 days of rotavirus vaccination differed from that in cases occurring later post-vaccination. Conclusion: Although we found no overall increase in intussusception following receipt of rotavirus vaccine, there was some evidence of an elevated risk following the first dose of both vaccines. Larger population-based studies using linked databases are required to provide more definitive evidence. (C) 2011 Elsevier Ltd. All rights reserved.

引用

页码：3061 / 3066

页数：6

共 29 条

[1]

*ABS, AUSTR BUR STAT AUSTR

[2]

*AIHW, INT NAT HOSP DAT DAT

[3]

[Anonymous], MMWR

[4]

BELONGIA EA, PEDIAT INFECT DIS J, V29, P1