title: Prospective safety monitoring of Haemophilus influenzae type b and heptavalent pneumococcal conjugate vaccines in Kagoshima, Japan.
abstract: Haemophilus influenzae type b (Hib) conjugate vaccine (PRP-T) and heptavalent pneumococcal conjugate vaccine (PCV7) were introduced in Japan in December 2008 and February 2010, respectively. The concurrent administration of these vaccines is routinely performed worldwide. However, the safety of the simultaneous administration of these vaccines has not been fully evaluated in Japan, because it has rarely been performed thus far. We conducted a 2-year prospective, observational, multicenter study on PRP-T and PCV7 safety from February 2009 through January 2011 in 29 facilities located in Kagoshima Prefecture, Japan. Objective severe adverse events included anaphylactoid reaction, encephalitis/encephalopathy, neurological events, severe focal reactions, systemic eruption/urticaria, fever above 39℃ within 2 days after inoculation, and other complications requiring hospitalization. The incidences of these events for PRP-T and PCV7 administration were 0.68% (76/11,197) and 0.92% (28/3,049), respectively. No deaths or subsequent complications were reported during the course of the study. There was no significant difference in the incidence of severe adverse events between the single and co-administration groups for both vaccines: PRP-T, 0.55% (31/5,662) versus 0.81% (45/5,535; P = 0.11); PCV7, 0.88% (11/1,247) versus 0.94% (17/1,802; P = 0.86). These results suggest that the simultaneous administration of vaccines including PRP-T and/or PCV7 does not increase the incidence of severe adverse events in Japanese children.
authors.affiliation: Department of Microbiology, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan. nishi1@m2.kufm.kagoshima-u.ac.jp
authors.forename: Junichiro
authors.initials: J
authors.lastname: Nishi
authors.forename: Koichi
authors.initials: K
authors.lastname: Tokuda
authors.forename: Naoko
authors.initials: N
authors.lastname: Imuta
authors.forename: Taketsugu
authors.initials: T
authors.lastname: Minami
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Kawano
mesh_terms: D002648:Child; D002675:Child, Preschool; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000473:pathology*; D005260:Female; D018073:Haemophilus Vaccines / Q000008:administration & dosage* / Q000009:adverse effects*; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D006801:Humans; D015994:Incidence; D007223:Infant; D007564:Japan; D008297:Male; D022242:Pneumococcal Vaccines / Q000008:administration & dosage* / Q000009:adverse effects*; D011446:Prospective Studies; D013745:Tetanus Toxoid / Q000008:administration & dosage* / Q000009:adverse effects*
chemical_list: D018073:Haemophilus Vaccines; C055753:Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D022242:Pneumococcal Vaccines; D013745:Tetanus Toxoid