RESUMEN
OBJECTIVE: To evaluate the incidence of adverse events following administration of an Inactivated poliomyelitis vaccine (IPV) manufactured by Serum Institute of India Pvt. Ltd., Pune, India. METHODS: A single 0.5 ml dose of the IPV was administered intramuscularly to children attending private clinics or out-patient department of hospitals for routine immunization across different cities in India. They were observed over a period of 30 d for local or systemic adverse events and rare case of anaphylaxis, if any. RESULTS: A total of 2210 children were enrolled of which 2120 children received the vaccine within primary immunization series and 90 children received booster dose. The common adverse events reported were pain, erythema, swelling and fever. No serious adverse event was reported during the study period. CONCLUSIONS: Poliomyelitis vaccine (Inactivated) manufactured by Serum Institute of India Pvt. Ltd., Pune can be safely administered to children following the Expanded Programme on Immunization or World Health Organization recommended immunization schedule.
Asunto(s)
Poliomielitis/prevención & control , Vacuna Antipolio de Virus Inactivados/efectos adversos , Vigilancia de Productos Comercializados , Vacunación/efectos adversos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/etnología , Femenino , Humanos , Programas de Inmunización , Esquemas de Inmunización , India/epidemiología , Lactante , Inyecciones Intramusculares , Masculino , Poliomielitis/epidemiología , Poliomielitis/etnología , Vacuna Antipolio de Virus Inactivados/administración & dosificación , Vacuna Antipolio de Virus Inactivados/inmunologíaRESUMEN
A study was conducted to test the sterility of 416 final lots of OPV produced by POLIOVAC, Vietnam from 1994 to 2003 in thioglycolate and soybean casein digest media under the standard operating procedure. The study results showed that all the tested lots (461/461 = 100%) had met the requirements for sterility