Jong Beom Sin; Moon Sung Park; Sang Hyuk Ma; Young Youn Choi; Son Moon Shin; Won Duck Kim; Sherine Kuriyakose; Liliana Ulianov; Karin Hardt

doi:10.14776/kjpid.2013.20.3.139

Journal List > Korean J Pediatr Infect Dis > v.20(3) > 1096038

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Sin, Park, Ma, Choi, Shin, Kim, Kuriyakose, Ulianov, and Hardt: Safety and Reactogenicity of the Inactivated Poliomyelitis Vaccine (Poliorix™) in Korea (2006-2012)

Original Article

Korean Journal of Pediatric Infectious Diseases 2013; 20(3): 139-146.

Published online: 26 December 2013

DOI: https://doi.org/10.14776/kjpid.2013.20.3.139

Safety and Reactogenicity of the Inactivated Poliomyelitis Vaccine (Poliorix™) in Korea (2006-2012)

Jong Beom Sin, M.D., Moon Sung Park, M.D.^*, Sang Hyuk Ma, M.D.^†, Young Youn Choi, M.D.^‡, Son Moon Shin, M.D.^∫, Won Duck Kim, M.D.^∥, Sherine Kuriyakose^¶, Liliana Ulianov^**, Karin Hardt^**

Department of Pediatrics, Busan Paik Hospital, Inje University College of Medicne, Busan, Korea.

^*Department of Pediatrics, Ajou University Hospital, Suwon, Korea.

^†Department of Pediatrics, Fatima Hospital, Changwon, KN, Korea.

^‡Department of Pediatrics, Chonnam National University Medical School, Kwangju, Korea.

^∫Department of Pediatrics, Cheil General Hospital and Women's Health Care Center, Kwandong University College of Medicine, Seoul, Korea.

^∥Department of Pediatrics, Daegu Fatima Hospital, Daegu, Korea.

^¶GlaxoSmithKline Pharmaceuticals India Ltd., India.

^**GlaxoSmithKline Vaccines, Belgium.

Correspondence: Jong Beom Sin, M.D. Department of Pediatrics, Busan Paik Hospital, Inje University College of Medicne, Busan, Korea. Tel: +82-51-890-6126, Fax: +82-51-895-7785, pedsin@inje.ac.kr

Received 12 June 2013 Revised 21 October 2013 Accepted 22 October 2013

Abstract

Objective

As per the requirement of Korean Food and Drug Administration, this post-marketing surveillance was conducted in Korea to evaluate the safety and reactogenicity of Poliorix™ following its introduction in 2006.

Methods

In this open, multicenter study, the vaccine was administered as per the current practice of Korean doctors and in reference to the guidebook by the Korean Pediatric Society and as indicated in the Korean label which was as follows - for primary vaccination three doses were given to infants at ages 2, 4 and 6 months whereas, for the booster dose a single dose was given to children aged 4-6 years. Safety data during this six year surveillance was collected using diary cards which were distributed to the parents to record adverse events.

Results

A total of 639 subjects were enrolled into the study. Of these, 617 subjects and 22 subjects received the vaccine as a primary and booster dose, respectively. At least one unsolicited symptom was reported in 11.4% (73/639) of the subjects during the 7-day follow-up period; upper respiratory tract infection (2.5%;16/639) was the most frequently reported unsolicited symptom. One subject reported at least one unsolicited symptom (gastroenteritis) of grade 3 intensity within the 31-day post-vaccination period. Approximately 1.7% (11/639) of subjects reported 13 serious adverse events (SAEs). All SAEs were resolved by the end of the study.

Conclusion

In Korea, primary and booster vaccination with Poliorix™ was well-tolerated in healthy subjects when administered according to the prescribing information as part of routine clinical practice.

Keywords: Poliomyelitis, Inactivated polio vaccine, Safety, Reactogenicity, Korea

Figures and Tables

Fig. 1

Study design.

Fig. 2

Occurrence of each solicited symptom during the 7-day follow-up period for each dose of Poliorix™ (A) local symptoms (B) general symptoms (total vaccinated cohort).

Table 1

Definition of Parameters for the Assessment of Safety and Reactogenicity

Table 2

Definition of Parameters for the Assessment of Safety and Reactogenicity: Solicited General AE

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