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Risk of Intussusception with Rotavirus Vaccine

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Abstract

Objective

To study the case series for intussusception associated with the vaccination of rotavirus vaccine in children.

Methods

The study of spontaneous adverse event monitoring such as intussusception due to rotavirus vaccine was carried out from the year 2011 through 2015. The individual case safety reports (ICSRs) of this event were collated, assessed and recorded as per the requirement of Suspected Adverse Drug Reactions Reporting form of Pharmacovigilance Programme of India (PvPI).

Results

In the present study, 10 ICSRs of intussussception due to rotavirus vaccine were reported to PvPI. Of which 3 ICSRs were found to be causal relationship with rotavirus vaccine, as evidenced by the adequate information provided in ICSRs.

Conclusions

Since intussusception, the emerging safety as one of the important safety concern, healthcare professionals are advised to monitor and report to the concerned authority for appropriate action.

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Acknowledgments

Adverse Drugs Monitoring Centers, Merck Pharmaceutical Limited & GlaxoSmithKline Limited.

Contributions

VK: Concept, definition of intellectual content and manuscript preparation; PT: Provided literature and edited the manuscript; VipK: Identified these cases at NCC-PvPI and processed them into national drug safety management system i.e., VigiFlow and communicated to WHO-Uppsala Monitoring Centre (International database i.e., VigiBase) & communicated this manuscript to Indian Journal of Pediatrics; MSR: Data analysis, data acquisition and communicated these cases to the Ministry for this concern; AT: Prepared the manuscript; GNS: Provided the intellectual content. VK will act as guarantor for the paper.

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Authors and Affiliations

  1. Indian Pharmacopoeia Commission, Ghaziabad, Agra, Uttar Pradesh, 201002, India

    Vivekanandan Kalaiselvan, Prasad Thota, Vipin Kumar, Madhvi Singh Rathore, Anusha Thota & Gyanendra Nath Singh

Authors
  1. Vivekanandan Kalaiselvan
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  2. Prasad Thota
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  3. Vipin Kumar
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  4. Madhvi Singh Rathore
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  5. Anusha Thota
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  6. Gyanendra Nath Singh
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Corresponding author

Correspondence to Vipin Kumar.

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Kalaiselvan, V., Thota, P., Kumar, V. et al. Risk of Intussusception with Rotavirus Vaccine. Indian J Pediatr 84, 97–100 (2017). https://doi.org/10.1007/s12098-016-2230-z

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  • DOI: https://doi.org/10.1007/s12098-016-2230-z

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