Immunogenicity and safety of adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain)-Haemophilus type b conjugate combined vaccine (DPT-IPV-Hib) in healthy Japanese Infants ≥ 2 and < 43 months of Age: A phase III, multicenter, active controlled, assessor-blinded, randomized, parallel-group study

•The development of 5-combined vaccine and others is of high priority in Japan.•The first vaccination of DPT-IPV should be given concomitantly with the Hib vaccine.•Gobik is the first DPT-IPV-Hib pentavalent vaccine approved in Japan.•Gobik simultaneously provide primary and booster immunizations as...

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Bibliographic Details
Published in:Vaccine 2024-04, Vol.42 (12), p.3134-3143
Main Authors: Nakano, Takashi, Hasegawa, Masumi, Endo, Mai, Matsuda, Keiko, Tamai, Hoshio
Format: Article
Language:English
Subjects:
Active control
Adsorbed Diphtheria-Purified Pertussis-Tetanus-Inactivated Polio Combined Vaccine
Antibodies
Antigens
Combined vaccines
Comparators
Diphtheria
Diphtheria toxin
DPT-IPV
DPT-IPV-Hib
Drug dosages
Guardians
Haemophilus influenzae type b
Hib
Immune system
Immunization
Immunogenicity
Infants
Pertussis
Poliomyelitis
Public health
Safety
Tetanus
Tetanus toxin
Toxins
Vaccines
Whooping cough
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Summary:•The development of 5-combined vaccine and others is of high priority in Japan.•The first vaccination of DPT-IPV should be given concomitantly with the Hib vaccine.•Gobik is the first DPT-IPV-Hib pentavalent vaccine approved in Japan.•Gobik simultaneously provide primary and booster immunizations as a single agent. This study investigated the immunogenicity and safety of a pentavalent vaccine Gobik (DPT-IPV-Haemophilus influenzae type b [Hib]) in healthy Japanese infants aged ≥ 2 and 
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2023.03.077