Safety monitoring of ROTAVAC vaccine and etiological investigation of intussusception in India: study protocol

BMC Public Health
Samarasimha ReddyIndian Intussusception Surveillance Network

Abstract

ROTAVAC, an indigenous rotavirus vaccine, was introduced in the universal immunization program of India in four states in 2016 and expanded to five more states in 2017. The clinical trial on efficacy of ROTAVAC did not detect an increased risk of intussusception, but the trial was not large enough to detect a small risk. This protocol paper describes the establishment and implementation of a surveillance system to monitor the safety of rotavirus vaccine and investigate the potential infectious etiologies of intussusception. This is a multi-centric hospital-based active surveillance being conducted at 28 hospitals in nine states of India. Data gathered from surveillance will be used to assess the risk of intussusception after ROTAVAC administration and to determine the infectious etiologies of intussusception. For safety assessment of ROTAVAC vaccine, children aged less than two years with intussusception admitted at the sentinel hospitals are enrolled into surveillance, a case report form completed, and a copy of the vaccination card obtained. The risk of intussusception following rotavirus vaccination will be assessed using a self-controlled case-series design. The investigation for potential infectious etiologies of intussusc...Continue Reading

References

Nov 1, 1985·American Journal of Epidemiology·P BruzziC Schairer
Feb 1, 1994·Human Pathology·E A Montgomery, E J Popek
Feb 1, 1993·Journal of Clinical Pathology·H J PorterP J Berry
Apr 1, 2000·Trends in Biochemical Sciences·H Kamminga
Feb 24, 2001·The New England Journal of Medicine·T V MurphyUNKNOWN Rotavirus Intussusception Investigation Team
Oct 3, 2006·The Journal of Pediatrics·Julie E BinesUNKNOWN Intussusception Study Group
Dec 27, 2007·The Canadian Journal of Infectious Diseases = Journal Canadien Des Maladies Infectieuses·G Delage
May 24, 2008·Biostatistics·C Paddy FarringtonMounia N Hocine
Jun 20, 2008·Statistical Methods in Medical Research·Heather J WhitakerC Paddy Farrington
Jul 16, 2011·International Journal of Infectious Diseases : IJID : Official Publication of the International Society for Infectious Diseases·Satoshi OkimotoMasao Kobayashi
Nov 28, 2012·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·William C BlackwelderMyron M Levine
Nov 24, 2012·Journal of Clinical Microbiology·Jie LiuEric R Houpt
Jan 16, 2014·The New England Journal of Medicine·W Katherine YihMichael Nguyen
Jan 16, 2014·The New England Journal of Medicine·Eric S WeintraubFrank DeStefano
Nov 23, 2015·American Journal of Preventive Medicine·Umesh D ParasharJacqueline E Tate
Apr 10, 2016·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Jacqueline E TateUNKNOWN World Health Organization–Coordinated Global Rotavirus Surveillance Network
Sep 14, 2016·BMJ : British Medical Journal·Irene PetersenHeather Whitaker
Apr 27, 2017·Clinical Microbiology and Infection : the Official Publication of the European Society of Clinical Microbiology and Infectious Diseases·K MuhsenD Cohen

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Citations

Jul 16, 2019·Current Opinion in Infectious Diseases·Rachel M BurkeUmesh D Parashar
Nov 12, 2020·The New England Journal of Medicine·Samarasimha N ReddyGagandeep Kang
Feb 20, 2021·Human Vaccines & Immunotherapeutics·Volker VetterPriya Pereira
Dec 24, 2021·Expert Review of Vaccines·Xiaolu NieSiyan Zhan

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