PMID- 27494163
OWN - NLM
STAT- MEDLINE
DCOM- 20171002
LR  - 20181113
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 12
IP  - 10
DP  - 2016 Oct 2
TI  - Post-marketing safety surveillance conducted in Korea (2008-2013) following the 
      introduction of the rotavirus vaccine, RIX4414 (Rotarix).
PG  - 2590-2594
LID - 10.1080/21645515.2016.1189046 [doi]
AB  - PURPOSE: According to regulations from the Ministry of Food and Drug Safety in 
      Korea, additional safety information on the use of Rotarix vaccine (RIX4414; 
      GSK, Belgium) in >/=3000 evaluable Korean infants was required following vaccine 
      registration. In order to comply with these regulations, we conducted a 6-year 
      open, non-comparative, multicenter post-marketing surveillance (NCT00750893). 
      METHODS: During this time, the original lyophilized vaccine formulation of 
      RIX4414 was replaced by a liquid formulation. Healthy infants aged >/=6 weeks were 
      enrolled and given 2 doses of the RIX4414 vaccine, separated by an interval of 
      >/=4 weeks. The overall incidence of adverse events (AEs) (expected and unexpected) 
      was then assessed for up to 30 days along with the incidence of serious adverse 
      events (SAEs). Adverse drug reactions (ADRs: any AE whose causality to the drug 
      could not be ruled out) were identified. RESULTS: A total of 3040 children (mean 
      age: 9.55 weeks) were analyzed. One or more expected AE was experienced by 30.5% 
      infants and 8.6% had an ADR. The most commonly seen expected AE was irritability 
      (14.0%). One or more unexpected AE was seen in 32.5% infants and 3.1% experienced 
      an ADR. The most commonly seen unexpected AE was upper respiratory tract 
      infection (8.7%). Of 34 SAEs recorded in 24 subjects, none were related to 
      vaccination. CONCLUSIONS: We conclude that this 6-year surveillance showed both 
      formulations of RIX4414 to have acceptable safety profiles when administered to 
      Korean infants according to local prescribing recommendations and current 
      clinical practice.
FAU - Shin, Son Moon
AU  - Shin SM
AD  - a Dankook University College of Medicine , Seoul , Korea.
FAU - Kim, Chun Soo
AU  - Kim CS
AD  - b Keimyung University School of Medicine , Daegu , Korea.
FAU - Karkada, Naveen
AU  - Karkada N
AD  - c GSK Pharmaceuticals , Bangalore , India.
FAU - Liu, Aixue
AU  - Liu A
AD  - d Merck , North Wales , PA , USA.
FAU - Jayadeva, Girish
AU  - Jayadeva G
AD  - c GSK Pharmaceuticals , Bangalore , India.
FAU - Han, Htay Htay
AU  - Han HH
AD  - e GSK Vaccines , King of Prussia , PA , USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT00750893
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20160805
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (RIX4414 vaccine)
RN  - 0 (Rotavirus Vaccines)
RN  - 0 (Vaccines, Attenuated)
SB  - IM
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology/pathology
MH  - Female
MH  - Humans
MH  - Incidence
MH  - Infant
MH  - Korea
MH  - Male
MH  - *Product Surveillance, Postmarketing
MH  - Rotavirus Infections/*prevention & control
MH  - Rotavirus Vaccines/*administration & dosage/*adverse effects
MH  - Vaccines, Attenuated/administration & dosage/adverse effects
PMC - PMC5084987
OTO - NOTNLM
OT  - Korea
OT  - gastroenteritis
OT  - post-marketing surveillance
OT  - rotavirus
OT  - safety
EDAT- 2016/08/06 06:00
MHDA- 2017/10/03 06:00
PMCR- 2016/08/05
CRDT- 2016/08/06 06:00
PHST- 2016/08/06 06:00 [pubmed]
PHST- 2017/10/03 06:00 [medline]
PHST- 2016/08/06 06:00 [entrez]
PHST- 2016/08/05 00:00 [pmc-release]
AID - 1189046 [pii]
AID - 10.1080/21645515.2016.1189046 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2016 Oct 2;12(10):2590-2594. doi: 
      10.1080/21645515.2016.1189046. Epub 2016 Aug 5.