title: SAFETY OF A CRM197-CONJUGATED HAEMOPHILUS INFLUENZAE TYPE B VACCINE IN KOREAN CHILDREN.
abstract: 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.
authors: Hyoyoung
authors: H
authors: Song
authors: Hans
authors: H
authors: Bock
authors: Alana
authors: A
authors: Guadagno
authors: Marco
authors: M
authors: Costantini
authors: Frank
authors: F
authors: Baehner
authors: Yeon Ho
authors: YH
authors: Kim
authors: Seung In
authors: SI
authors: Ahn
authors: Ki Hyuk
authors: KH
authors: Son
authors: Dong-Seok
authors: DS
authors: Yim
mesh_terms: D000942:Antigens, Bacterial / Q000276:immunology; D016667:Bacterial Capsules; D001426:Bacterial Proteins / Q000009:adverse effects; D002675:Child, Preschool; D004165:Diphtheria / Q000517:prevention & control*; D004168:Diphtheria Toxoid / Q000009:adverse effects*; D004890:Erythema / Q000139:chemically induced*; D005260:Female; D006192:Haemophilus Infections / Q000517:prevention & control*; D018073:Haemophilus Vaccines / Q000009:adverse effects*; D019741:Haemophilus influenzae type b / Q000276:immunology; D006801:Humans; D007117:Immunization, Secondary; D007223:Infant; D007231:Infant, Newborn; D007508:Irritable Mood; D008297:Male; D010146:Pain / Q000139:chemically induced*; D011358:Product Surveillance, Postmarketing; D056910:Republic of Korea
chemical_list: D000942:Antigens, Bacterial; D001426:Bacterial Proteins; D004168:Diphtheria Toxoid; D018073:Haemophilus Vaccines; C044237:Haemophilus influenzae type b polysaccharide vaccine; C052180:Haemophilus influenzae type b-polysaccharide vaccine-diphtheria toxoid conjugate; C028581:CRM197 (non-toxic variant of diphtheria toxin)