Korean J Pediatr Infect Dis.  2013 Dec;20(3):139-146.

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

Affiliations
  • 1Department of Pediatrics, Busan Paik Hospital, Inje University College of Medicne, Busan, Korea. pedsin@inje.ac.kr
  • 2Department of Pediatrics, Ajou University Hospital, Suwon, Korea.
  • 3Department of Pediatrics, Fatima Hospital, Changwon, KN, Korea.
  • 4Department of Pediatrics, Chonnam National University Medical School, Kwangju, Korea.
  • 5Department of Pediatrics, Cheil General Hospital and Women's Health Care Center, Kwandong University College of Medicine, Seoul, Korea.
  • 6Department of Pediatrics, Daegu Fatima Hospital, Daegu, Korea.
  • 7GlaxoSmithKline Pharmaceuticals India Ltd., India.
  • 8GlaxoSmithKline Vaccines, Belgium.

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(TM) 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(TM) was well-tolerated in healthy subjects when administered according to the prescribing information as part of routine clinical practice.

Keyword

Poliomyelitis; Inactivated polio vaccine; Safety; Reactogenicity; Korea
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