Delving into the Latest Updates on Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio(Sabin strain)Combined Vaccine(Minimum Requirements for Biological Products) with Synapse

Overview

Basic Info

Drug Type

Combination vaccine, Prophylactic vaccine, Multivalent vaccine

Synonyms

Combined vaccine(Biken Techno Corp.), DTP-poliovirus vaccine, テトラビック皮下注シリンジ

+ [6]

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesNervous System DiseasesRespiratory Diseases+ [1]

Active Indication

DiphtheriaPoliomyelitisTetanus+ [1]

Inactive Indication

Meningitis, Bacterial

Originator Organization-

Active Organization

Research Fdn for Microbial Diseases of Osaka University

Inactive Organization

Mitsubishi Tanabe Pharma Corp.

License Organization-

Drug Highest PhaseApproved

First Approval Date

Japan (27 Jul 2012),

DiphtheriaPoliomyelitisTetanus+ [1]

Regulation-

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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

Article

Author: Matsuda, Keiko ; Hasegawa, Masumi ; Tamai, Hoshio ; Nakano, Takashi ; Endo, Mai

OBJECTIVEThis 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 < 43 months using a concomitant vaccination with ActHIB® (Hib) and Tetrabik (DPT-IPV) as a comparator.METHODSThis 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.RESULTSIn 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.CONCLUSIONA 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).

01 Sep 2011·Nihon rinsho. Japanese journal of clinical medicine

[Inactivated poliovirus vaccine].

Review

Author: Shimizu, Hiroyuki

During the final stage of global polio eradication program, universal use of inactivated poliovirus vaccine (IPV) is the most feasible option to minimize the inherent risk of oral poliovirus vaccine (OPV), such as vaccine-associated paralytic poliomyelitis (VAPP) and polio outbreaks due to vaccine-derived polioviruses. Introduction of diphtheria, pertussis, tetanus, IPV (DPT-IPV) products, instead of OPV, to routine polio immunization should be seriously and urgently considered to minimize ongoing risk of VAPP in Japan. Accordingly, a further polio immunization strategy, including the immunization schedule using DPT-IPV, interchangeability of different DPT-IPV products, intensified polio surveillance activities, and appropriate polio vaccine stockpile, should be developed to maintain polio-free status in Japan prior to the introduction of DPT-IPV.

01 Feb 1999·VaccineQ3 · MEDICINE

A comparative study of PENTA™ vaccine booster doses given at 12, 15 or 18 months of age

Q3 · MEDICINE

Article

Author: David W Scheifele ; Pierre Lavigne ; Roland Guasparini

For infants immunized with Haemophilus influenzae type b conjugate vaccines, booster immunization is usually recommended in the second year of life, typically between 12 and 18 months. This study assessed the effect of age at booster immunization on pre-immunization antibody trough levels and on subsequent responses, for a PRP-T conjugate vaccine. Subjects were healthy children who had received PENTA vaccine (DPT-IPV/PRP-T combination) as infants. They were enrolled and given measles-mumps-rubella vaccine (MMR) at 12 months of age, then randomly assigned to receive PENTA vaccine concurrently with MMR or at 15 or 18 months of age. Parents were asked to note any adverse effects after PENTA vaccination. Blood samples were obtained prior to PENTA vaccination and 4 weeks later, and tested for antibodies to each antigen. In total 253 children received PENTA vaccine: 86 at 12 months, 85 at 15 months and 82 at 18 months. Injection site redness and swelling were least extensive in the youngest group (p < 0.001) but their rates of occurrence did not differ with age. Anti-PRP levels were similar in each age group prior to immunization; post-booster geometric mean concentrations (GMCs) ranged from 13.0 microg/ml in the youngest to 33.9 microg/ml in the oldest subjects (p < 0.0001). For each of the other antigens examined, booster responses were strongest at 18 months. We conclude that anti-PRP levels are stable between 12 and 18 months in children previously given PRP-T vaccine. PENTA boosters given at 12 months appear to cause milder injection site morbidity whereas those given at 18 months result in stronger responses to virtually every constituent antigen, although each age group responded satisfactorily.

100 Deals associated with Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio(Sabin strain)Combined Vaccine(Minimum Requirements for Biological Products)

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diphtheria	Japan	Research Fdn for Microbial Diseases of Osaka University	27 Jul 2012
Poliomyelitis	Japan	Research Fdn for Microbial Diseases of Osaka University	27 Jul 2012
Tetanus	Japan	Research Fdn for Microbial Diseases of Osaka University	27 Jul 2012
Whooping Cough	Japan	Research Fdn for Microbial Diseases of Osaka University	27 Jul 2012

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Meningitis, Bacterial	Discovery	Japan	Mitsubishi Tanabe Pharma Corp.	01 Apr 2019

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02992925 (CTgov)	Phase 3	Vaccination	370	DPT-IPV-Hib-High (BK1310-High)	bxtuoqmoac(oxnfxzgzms) = jnfjcplzan jnpxoqsxia (xdrfebwbfh, qicqwrszdb - jjvofbksaj) View more	-	07 Jan 2025
				DPT-IPV-Hib (BK1310-Low)	bxtuoqmoac(oxnfxzgzms) = jigpvhmpjd jnpxoqsxia (xdrfebwbfh, azrqyvbynw - qmxoucmyqq) View more
NCT02140047 (CTgov)	Phase 2	Haemophilus Infections	154	Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate+DPT-IPV (MT-2301-Low)	wbzytzczpj(wyjjuuqqxf) = kfpsaqyoxo mofxnvxgcs (weenngunpa, zsqhsxelma - iphmbidtnh) View more	-	19 Sep 2024
				Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate+DPT-IPV (MT-2301-High)	wbzytzczpj(wyjjuuqqxf) = mxampnyfiv mofxnvxgcs (weenngunpa, yrssfffzcu - wdkarrjmjk) View more
WCLC2019	Not Applicable	Advanced Lung Non-Small Cell Carcinoma Third line	158	S-1 monotherapy	(xoxajcvmyj) = qwhirzmxug jncjibhtey (kyybmbpjuk ) View more	Positive	08 Sep 2019
				Combined regimens	(aknvlqwqcz) = ohzauxhckc sfzqpffafm (trmbwccftx )