Post-marketing surveillance study to assess the safety and tolerability of an Inactivated Poliomyelitis Vaccine in Indian children.

Abstract:

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.

journal_name

Hum Vaccin Immunother

authors

Sharma H,Dhere R,Parekh S,Shewale S

doi

10.1080/21645515.2017.1356960

subject

Has Abstract

pub_date

2017-11-02 00:00:00

pages

2538-2542

issue

11

eissn

2164-5515

issn

2164-554X

journal_volume

13

pub_type

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