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-

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.

Drug Highest PhaseApproved

First Approval Date

JP (27 Jul 2012),

DiphtheriaPoliomyelitisTetanus+ [1]

Regulation-

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PURPOSETo investigate postoperative pain variations in vitreoretinal surgeries conducted with combined regional-general anesthesia or general anesthesia.DESIGNSystematic review and meta-analysis.METHODSA systematic search of the PubMed, Embase, and Cochrane Library databases was conducted to identify relevant randomized controlled trials published before December 26, 2023. Studies comparing vitreoretinal surgeries conducted under combined anesthesia to general anesthesia were included, while studies using only regional anesthesia were excluded. The quality of the studies was assessed using the Cochrane Collaboration risk of bias tool, and the results are presented as odds ratios or standardized mean differences (SMDs) with 95% confidence intervals (CIs). I² statistic was calculated to assess heterogeneity. The primary outcomes in our study included the proportions of patients needing as-needed postoperative analgesics, dosage of as-needed postoperative analgesia medications, and time to the first demand for as-needed postoperative analgesia. The secondary outcomes included postoperative pain scores at 0.5, 1, 2, 4, 6, 12, 24 hours (h), duration of surgery and anesthesia, and percentage of patients experiencing postoperative nausea and vomiting.RESULTSA total of 19 randomized controlled trials involving 1314 patients were analyzed. Combined anesthesia was associated with lower proportions of patients needing as-needed postoperative analgesics (odds ratio, 0.218 95% CI, 0.114-0.418, I² = 55.2%), reduced dosage of as-needed postoperative analgesia medications (SMD, -1.429, 95% CI, -2.395 to -0.462, I² = 90.4%), and longer time to the first demand for as-needed postoperative analgesia compared with general anesthesia alone (SMD, 2.650, 95% CI, 1.169-4.132, I² = 96.5%). The effect of additional regional anesthesia lasted for 6 h (0.5 h SMD, -1.471, 95% CI, -2.498 to -0.444, I² = 90.5%; 1 h, -1.507, -2.309 to -0.705, 92.7%; 2 h -1.487, -2.300 to -0.674, 93.2%; 4 h -1.052, -1.708 to -0.396, 89.5%; 6 h -1.053, -1.932 to -0.174, 93.4%; 12 h -0.286, -0.648 to 0.076, 57.1%; 24 h -0.297, -0.624 to 0.029, 64.0%). Combined anesthesia decreased postoperative nausea and vomiting risk without affecting the surgical or anesthesia duration.CONCLUSIONSCombined anesthesia demonstrated additional postoperative analgesic effects versus general anesthesia only. Further research is needed to validate the results of our study and to identify vision-threatening complications.

01 Apr 2024·Vaccine

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 2023·Surgical endoscopy

Epinephrine injection monotherapy shows similar hemostatic efficacy to epinephrine injection combined therapy in high-risk patients (Forrest Ib) with bleeding ulcers.

Article

Author: He, Shan ; Shang, Guanqun ; Shu, Xu ; Wang, Jingsong ; Zhu, Zhenhua ; Lv, Nonghua

BACKGROUNDWhether combination therapy has higher hemostatic efficacy than epinephrine injection monotherapy in different Forrest classifications is not clear. This study aimed to compare hemostatic efficacy between epinephrine injection monotherapy (MT) and combination therapy (CT) based on different Forrest classifications.METHODSWe retrospectively analyzed peptic ulcer bleeding (PUB) patients who underwent endoscopic epinephrine injections or epinephrine injections combined with a second therapy between March 2014 and June 2022 in our center, and the patients were divided into MT group or CT group. Subsequently, a propensity score matching analysis (PSM) was performed and rebleeding rates were calculated according to Forrest classifications via a stratified analysis.RESULTSOverall, 605 patients who met the inclusion criteria were included, and after PSM, 173 patients in each of the CT and MT groups were included. For PUB patients with nonbleeding visible vessels (FIIa), the rebleeding rates by Days 3, 7, 14, and 30 after PSM were 8.8%, 17.5%, 19.3%, and 19.3% in the MT group, respectively, and rates were 0%, 4.1%, 5.5%, and 5.5% in the CT group, respectively, with significant differences observed between the two groups by Days 3, 7, 14, and 30 (P = 0.015, P = 0.011, P = 0.014, and P = 0.014, respectively). However, for PUB patients with oozing bleeding (FIb), the rebleeding rates by Days 3, 7, 14, and 30 after PSM were 14.9%, 16.2%, 17.6%, and 17.6% in the MT group, respectively, and rates were 13.2%, 14.7%, 14.7%, and 16.2% in the CT group, respectively, with no significant differences observed between the two groups by Days 3, 7, 14, and 30 (P = 0.78, P = 0.804, P = 0.644 and P = 0.825).CONCLUSIONCombined therapy has higher hemostatic efficacy than epinephrine injection monotherapy for PUB patients with visible blood vessel (FIIa) ulcers. However, epinephrine injection monotherapy is equally as effective as combined therapy for PUB patients with oozing blood (FIb) ulcers.

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

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R&D Status

Approved

10 top approved records.

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


NCT02140047 (CTgov)	Phase 2	Haemophilus Infections	154	Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate+DPT-IPV (MT-2301-Low)	ddiyqdmoix(hhuecfdigo) = uvuibtoosg rqktdkdsyw (zidgcoibzt, jwniheooqr - ojrxggxzsr) View more	-	19 Sep 2024
				Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate+DPT-IPV (MT-2301-High)	ddiyqdmoix(hhuecfdigo) = wktghgmrbh rqktdkdsyw (zidgcoibzt, qnonwearpp - mktabujtkx) View more
WCLC2019	Not Applicable	Advanced Lung Non-Small Cell Carcinoma Third line	158	S-1 monotherapy	(asxnupolnc) = tqtitelrdr kkcwrsdxjw (uzuvvdfhwe ) View more	Positive	08 Sep 2019
				Combined regimens	(wwwjyamwwr) = mgdvsstuli vmmlcqhjne (vcpgubbvgr )