TY - JOUR
T1 - Prospective safety monitoring of Haemophilus influenzae type b and heptavalent pneumococcal conjugate vaccines in Kagoshima, Japan
AU - Nishi, Junichiro
AU - Tokuda, Koichi
AU - Imuta, Naoko
AU - Minami, Taketsugu
AU - Kawano, Yoshifumi
N1 - Copyright:
Copyright 2014 Elsevier B.V., All rights reserved.
PY - 2013
Y1 - 2013
N2 - 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 399C within 2 days after inoculation, and other complications requiring hospitalization. The incidences of these events for PRP-T and PCV7 administration were 0.68z (76/11,197) and 0.92z (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, 0.55z (31/5,662) versus 0.81z (45/5,535; P = 0.11); PCV7, 0.88z (11/1,247) versus 0.94z (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.
AB - 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 399C within 2 days after inoculation, and other complications requiring hospitalization. The incidences of these events for PRP-T and PCV7 administration were 0.68z (76/11,197) and 0.92z (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, 0.55z (31/5,662) versus 0.81z (45/5,535; P = 0.11); PCV7, 0.88z (11/1,247) versus 0.94z (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.
KW - Haemophilus influenzae type b conjugate vaccine
KW - Pneumococcal conjugate vaccine
KW - Vaccine safety
UR - http://www.scopus.com/inward/record.url?scp=84878119082&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84878119082&partnerID=8YFLogxK
U2 - 10.7883/yoken.66.235
DO - 10.7883/yoken.66.235
M3 - Article
C2 - 23698486
AN - SCOPUS:84878119082
VL - 66
SP - 235
EP - 237
JO - Japanese medical journal
JF - Japanese medical journal
SN - 1344-6304
IS - 3
ER -