Abstract: The research seeks to assess the safety profile of ROTAVAC®, a rotavirus vaccine, utilizing an observational prospective methodology. The findings are likely to contribute valuable insights to the field of vaccine safety. Rotavirus vaccination (ROTAVAC®) was incorporated into the Universal Immunisation Program (UIP) of Punjab, India, in 2019. This research constitutes a single-centre observational prospective study conducted in a Government Civil Hospital in Punjab, India.
Methods:
This study comprises two endpoints: primary, to detect and investigate the adverse events (AE) arising subsequent to ROTAVAC® vaccine administration to infants; and secondary, to generate awareness and facilitate the reporting of adverse events following immunisation (AEFI) by Health Care Practitioners (HCPs).
Results:
In this study, 47% of the subjects receiving ROTAVAC® vaccine experienced AEFIs. Most of the AEFIs were consistent with the established safety profile of ROTAVAC® vaccine. No statistically significant difference was observed between the various demographics and AEFI incidence. All 30 HCPs interviewed demonstrated limited knowledge regarding AEFI reporting and had infrequently reported any AEFI. The mean score prior to the provision of health education was 4.07±1.17, and the score following education increased to 7.27±1.05, indicating a statistically significant difference (W=465.000, p<0.005).
Conclusion:
The ROTAVAC® vaccine demonstrated safety in Punjab, India, following its recent implementation. No novel clinically significant safety concerns with medical implications were identified for ROTAVAC®. Furthermore, this investigation underscores the significance of conducting knowledge dissemination sessions for healthcare professionals (HCPs) at immunisation clinics to enhance adverse event detection and reporting.
Keywords: Rotavirus, ROTAVAC®, adverse events, adverse events following immunisation, safety profile.
Title: Safety Profile of ROTAVAC: An Observational Prospective Study
Author: Malook Vir Singh, Sue Ann Costa Clemens, Puneet Vir Singh
International Journal of Healthcare Sciences
ISSN 2348-5728 (Online)
Vol. 9, Issue 1, April 2021 - September 2021
Page No: 152-158
Research Publish Journals
Website: www.researchpublish.com
Published Date: 07-September-2021
Amendment Date: 28-October-2024
