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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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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container_end_page 3143
container_issue 12
container_start_page 3134
container_title Vaccine
container_volume 42
creator Nakano, Takashi
Hasegawa, Masumi
Endo, Mai
Matsuda, Keiko
Tamai, Hoshio
description •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 
doi_str_mv 10.1016/j.vaccine.2023.03.077
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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 &lt; 43 months using a concomitant vaccination with ActHIB® (Hib) and Tetrabik (DPT-IPV) as a comparator. This study was conducted as a phase 3, multicenter, active controlled, assessor-blinded, randomized, parallel-group study. Participants received a total of 4 subcutaneous doses (3 primary immunization doses and a booster dose) of either the experimental drug (DPT-IPV-Hib) or the active comparator (Hib + DPT-IPV). The primary endpoints were the anti-PRP antibody prevalence rate with ≥ 1 μg/mL, and the antibody prevalence rates against pertussis, diphtheria toxin, tetanus toxin, and attenuated poliovirus after the primary immunization. In 267 randomized participants (133 in the DPT-IPV-Hib group and 134 in the Hib + DPT-IPV group), the antibody prevalence rates after the primary immunization in both groups were 100.0 % and 88.7 % for anti-PRP antibody with ≥ 1 μg/mL, 99.2 % and 98.5 % against diphtheria toxin, and 100.0 % and 99.2 % against tetanus toxin, respectively. The antibody prevalence rates against pertussis and attenuated poliovirus were 100.0 % in both groups. The non-inferiority of the DPT-IPV-Hib group to the Hib + DPT-IPV group was verified for all measured antibodies. In both groups, all the GMTs of antibodies after the primary immunization were higher than those before the first dose, and those after the booster dose were higher than those after the primary immunization. No safety issues were identified. 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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 &lt; 43 months using a concomitant vaccination with ActHIB® (Hib) and Tetrabik (DPT-IPV) as a comparator. This study was conducted as a phase 3, multicenter, active controlled, assessor-blinded, randomized, parallel-group study. Participants received a total of 4 subcutaneous doses (3 primary immunization doses and a booster dose) of either the experimental drug (DPT-IPV-Hib) or the active comparator (Hib + DPT-IPV). The primary endpoints were the anti-PRP antibody prevalence rate with ≥ 1 μg/mL, and the antibody prevalence rates against pertussis, diphtheria toxin, tetanus toxin, and attenuated poliovirus after the primary immunization. In 267 randomized participants (133 in the DPT-IPV-Hib group and 134 in the Hib + DPT-IPV group), the antibody prevalence rates after the primary immunization in both groups were 100.0 % and 88.7 % for anti-PRP antibody with ≥ 1 μg/mL, 99.2 % and 98.5 % against diphtheria toxin, and 100.0 % and 99.2 % against tetanus toxin, respectively. The antibody prevalence rates against pertussis and attenuated poliovirus were 100.0 % in both groups. The non-inferiority of the DPT-IPV-Hib group to the Hib + DPT-IPV group was verified for all measured antibodies. In both groups, all the GMTs of antibodies after the primary immunization were higher than those before the first dose, and those after the booster dose were higher than those after the primary immunization. No safety issues were identified. A single-agent Gobik, the first DPT-IPV-Hib pentavalent vaccine approved in Japan, was confirmed to simultaneously provide primary and booster immunizations against Hib infection, pertussis, diphtheria, tetanus, and poliomyelitis and to have a preventive effect and safety comparable to concomitant vaccination with Hib (ActHIB®) and DPT-IPV quadrivalent vaccine (Tetrabik).</abstract><cop>Netherlands</cop><pub>Elsevier Ltd</pub><pmid>38582691</pmid><doi>10.1016/j.vaccine.2023.03.077</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record>
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identifier ISSN: 0264-410X
ispartof Vaccine, 2024-04, Vol.42 (12), p.3134-3143
issn 0264-410X
1873-2518
language eng
recordid cdi_proquest_miscellaneous_3034246971
source ScienceDirect Freedom Collection 2022-2024
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
title 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
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