PMID- 26867395
OWN - NLM
STAT- MEDLINE
DCOM- 20160421
LR  - 20181202
IS  - 0125-1562 (Print)
IS  - 0125-1562 (Linking)
VI  - 46
IP  - 4
DP  - 2015 Jul
TI  - SAFETY OF A CRM197-CONJUGATED HAEMOPHILUS INFLUENZAE TYPE B VACCINE IN KOREAN 
      CHILDREN.
PG  - 743-52
AB  - Haemophilus influenzae type b (Hib) is a major cause of meningitis and pneumonia 
      with high morbidity and mortality rates in young children. The introduction of 
      effective and well-tolerated conjugate Hib vaccines, has nearly eradicated this 
      disease in many countries. We investigated the safety of the Hib PRP-CRM197 
      vaccine in a multi-center post-marketing surveillance (PMS) study. Korean 
      children (N = 764) aged 1-33 months were enrolled when receiving a routine 
      primary immunization or a booster vaccine with Hib PRP-CRM197 and solicited and 
      unsolicited adverse events (AEs) were recorded using a diary card for 7 and 28 
      days after each vaccination, respectively. In this study, AEs were reported by 
      66% of subjects but were generally mild, with 42% of subjects reporting solicited 
      AEs and 46% reporting unsolicited AEs. Among the unsolicited AEs, 98% were 
      determined to be unrelated to the study vaccine. The studied Hib PRP-CRM197 
      vaccine was well tolerated by the study group and found to have a similar safety 
      profile to that reported in other clinical studies. This vaccine is suitable for 
      routine immunization against Hib disease among Korean children. AEs due to this 
      vaccine will continue to be monitored.
FAU - Song, Hyoyoung
AU  - Song H
FAU - Bock, Hans
AU  - Bock H
FAU - Guadagno, Alana
AU  - Guadagno A
FAU - Costantini, Marco
AU  - Costantini M
FAU - Baehner, Frank
AU  - Baehner F
FAU - Kim, Yeon Ho
AU  - Kim YH
FAU - Ahn, Seung In
AU  - Ahn SI
FAU - Son, Ki Hyuk
AU  - Son KH
FAU - Yim, Dong-Seok
AU  - Yim DS
LA  - eng
PT  - Clinical Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - Thailand
TA  - Southeast Asian J Trop Med Public Health
JT  - The Southeast Asian journal of tropical medicine and public health
JID - 0266303
RN  - 0 (Antigens, Bacterial)
RN  - 0 (Bacterial Proteins)
RN  - 0 (Diphtheria Toxoid)
RN  - 0 (Haemophilus Vaccines)
RN  - 0 (Haemophilus influenzae type b polysaccharide vaccine)
RN  - 0 (Haemophilus influenzae type b-polysaccharide vaccine-diphtheria toxoid 
      conjugate)
RN  - 08VC9WC084 (CRM197 (non-toxic variant of diphtheria toxin))
SB  - IM
MH  - Antigens, Bacterial/immunology
MH  - Bacterial Capsules
MH  - Bacterial Proteins/adverse effects
MH  - Child, Preschool
MH  - Diphtheria/*prevention & control
MH  - Diphtheria Toxoid/*adverse effects
MH  - Erythema/*chemically induced
MH  - Female
MH  - Haemophilus Infections/*prevention & control
MH  - Haemophilus Vaccines/*adverse effects
MH  - Haemophilus influenzae type b/immunology
MH  - Humans
MH  - Immunization, Secondary
MH  - Infant
MH  - Infant, Newborn
MH  - Irritable Mood
MH  - Male
MH  - Pain/*chemically induced
MH  - Product Surveillance, Postmarketing
MH  - Republic of Korea
EDAT- 2016/02/13 06:00
MHDA- 2016/04/22 06:00
CRDT- 2016/02/13 06:00
PHST- 2016/02/13 06:00 [entrez]
PHST- 2016/02/13 06:00 [pubmed]
PHST- 2016/04/22 06:00 [medline]
PST - ppublish
SO  - Southeast Asian J Trop Med Public Health. 2015 Jul;46(4):743-52.