A prospective study on safety and clinical efficacy of rabies biologicals in paediatric patients with category III animal exposure.

Purpose: Rabies remains a significant public health concern worldwide, particularly among paediatric populations who are vulnerable to animal exposures. This prospective study aimed to assess the safety and clinical efficacy of rabies biologicals in pediatric patients following category III animal exposures. Materials and Methods: A prospective study was undertaken enrolling 289 pediatric patients fulfilling eligibility criteria who presented with category III animal exposures at the anti-rabies clinic of Kempegowda Institute of Medical Sciences Hospital and Research Centre, Bangalore. All the subjects received rabies biologicals as per National Centre for Disease Control guidelines. The details pertaining to socio-demographic profile, biting animal, characteristics of wound, and details of post-exposure prophylaxis (PEP) provided were recorded. All the study subjects were followed up for immediate and delayed adverse events (AEs). Subsequently, all were followed up for 6 months to demonstrate the clinical efficacy of PEP. Results: The mean age of study subjects was 9.4 years, and most of them (43%) were going to school. Dog was the predominant biting animal (96.6%) with most bites being abrasions (45%), mainly on the lower limbs (42%). Single rabies monoclonal antibody was the most commonly administered passive immunization (67%), and purified Vero cell rabies vaccine was the predominant vaccine (65%). AEs following PEP were primarily local, predominantly pain (13.2%), and there were no systemic events. All the subjects were alive and healthy at the end of 6 months following PEP. Conclusion: This study contributes valuable insights into the safety and clinical efficacy of rabies biologicals in a pediatric cohort following category III animal exposures, supporting the continued use of these biologicals in pediatric patients.