Delving into the Latest Updates on DTP-poliovirus vaccine(Kitasato Daiichi Sankyo Vaccine Co., Ltd.) with Synapse

Overview

Basic Info

Drug Type

Combination vaccine, Prophylactic vaccine

Synonyms

4-valent combination DTP-poliovirus vaccine - Kitasato Daiichi Sankyo, DTP-IPV, DTP-IPV vaccine

+ [4]

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesNervous System DiseasesRespiratory Diseases+ [1]

Active Indication

DiphtheriaPoliomyelitisTetanus+ [1]

Inactive Indication-

Originator Organization

Kitasato Daiichi Sankyo Vaccine Co., Ltd.

Active Organization

Kitasato Daiichi Sankyo Vaccine Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

Japan (04 Jul 2014),

DiphtheriaPoliomyelitisTetanus+ [1]

Regulation-

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The purpose of this study is to evaluate the immunogenicity and safety of the diphtheria, tetanus, pertussis and inactivated poliovirus (DPT-IPV) vaccine Squarekids administered with or without the GSK Biologicals' liquid Rotarix (HRV) vaccine, in healthy Japanese infants aged 6 - 12 weeks. GSK Biologicals' liquid HRV vaccine Rotarix is licensed in Japan since 2011. Although the concomitant administration of GSK Biologicals' DTP-IPV vaccine has been evaluated during the clinical development of the HRV vaccine, the vaccine differed in composition and route of administration from the DPT-IPV vaccine Squarekids manufactured in Japan. Hence, as requested by the Japanese regulatory authorities, this post-licensure study will evaluate the immunogenicity of the DPT-IPV vaccine manufactured in Japan when co-administered with the liquid HRV vaccine

Start Date16 Sep 2016

Sponsor / Collaborator

GSK Plc

JPRN-UMIN000022793

/ CompletedPhase 4IIT

A trial for evaluation of effectiveness and safety for dose reduction DTP-IPV vaccination in adult - dose reduction vaccination of DTP-IPV in adult

Start Date01 Apr 2016

Sponsor / Collaborator-

JPRN-UMIN000016740

/ CompletedPhase 3IIT

Randomized controlled trial to evaluate the dose of DTP-IPV vaccine for adult - Randomized controlled study to evaluate the dose of DTP-IPV vaccine for adult

Start Date01 Apr 2015

Sponsor / Collaborator-

100 Clinical Results associated with DTP-poliovirus vaccine(Kitasato Daiichi Sankyo Vaccine Co., Ltd.)

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100 Translational Medicine associated with DTP-poliovirus vaccine(Kitasato Daiichi Sankyo Vaccine Co., Ltd.)

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100 Patents (Medical) associated with DTP-poliovirus vaccine(Kitasato Daiichi Sankyo Vaccine Co., Ltd.)

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17

Literatures (Medical) associated with DTP-poliovirus vaccine(Kitasato Daiichi Sankyo Vaccine Co., Ltd.)

01 Sep 2016·Transactions of The Royal Society of Tropical Medicine and HygieneQ4 · MEDICINE

Sex-differential effects on mortality of BCG and diphtheria-tetanus-pertussis vaccines in a rural area with high vaccination coverage: observational study from Senegal

Q4 · MEDICINE

Article

Author: Aaby, Peter ; Trape, Jean-François ; Nielsen, Jens ; Benn, Christine S

BACKGROUNDDiphtheria-tetanus-pertussis (DTP) may be associated with increased female mortality; the effect of co-administration with BCG is not known.METHODSBetween 1989 and 1997, we examined female and male mortality rates in rural Senegal where 7824 infants received the first dose of DTP and inactivated polio vaccine (DTP-IPV) with BCG. Subsequent doses of DTP-IPV were administered alone. We analysed mortality according to sex and number of doses of DTP-IPV vaccine.RESULTSBCG and DTP-IPV1 simultaneously reduced mortality from 60/1000 person-years in unvaccinated girls to 35/1000 person-years, but mortality increased with subsequent doses of DTP-IPV to 45/1000 person-years. Among boys, BCG and DTP-IPV1 simultaneously reduced mortality from 72/1000 person-years to 60/1000 person-years and mortality decreased further with subsequent doses of DTP-IPV to 34/1000 person-years. In age-adjusted analyses, female-male mortality rate ratios were 0.83(95% CI 0.50-1.40) among unvaccinated children and 0.58 (95% CI 0.35-0.96) among children vaccinated simultaneously with BCG and DTP-IPV1, but increased to 1.17 (95% CI 0.67-2.03) after DTP-IPV2, and 1.63 (95% CI 0.86-3.10) after DTP-IPV3. Difference in vaccination coverage could not explain these sex-differential patterns; girls had significantly better weight-for-age than boys so nutritional status did not explain the increase in female mortality after DTP-IPV3.CONCLUSIONSWhereas BCG co-administered with DTP-IPV was associated with lower female than male mortality, subsequent DTP-IPV vaccinations were associated with an increase in female mortality relative to male mortality.

01 Dec 2015·BMC Infectious DiseasesQ3 · MEDICINE

Gender-specific mortality in DTP-IPV- and MMR ± MenC-eligible age groups to determine possible sex-differential effects of vaccination: an observational study

Q3 · MEDICINE

ArticleOA

Author: Schurink-van't Klooster, Tessa M ; Knol, Mirjam J ; de Melker, Hester E ; van der Sande, Marianne A B

BACKGROUNDSeveral studies suggested that vaccines could have non-specific effects on mortality depending on the type of vaccine. Non-specific effects seem to be different in boys and girls. In this study we want to investigate whether there are differences in gender-specific mortality among Dutch children according to the last vaccination received. We tested the hypothesis that the mortality rate ratio for girls versus boys is more favourable for girls following MMR±MenC vaccination (from 14 months of age) compared with the ratio following DTP-IPV vaccination (2-13 months of age). Secondarily, we investigated whether there were gender-specific changes in mortality following booster vaccination at 4 years of age.METHODSThis observational study included all Dutch children aged 0-11 years from 2000 until 2011. Age groups were classified according to the last vaccination offered. The mortality rates for all natural causes of death were calculated by gender and age group. Incidence rate ratios (IRRs) were computed using a multivariable Poisson analysis to compare mortality in boys and girls across different age groups.RESULTSThe study population consisted of 6,261,472 children. During the study period, 14,038 children (0.22%) died, 91% of which were attributed to a known natural cause of death. The mortality rate for natural causes was higher among boys than girls in all age groups. Adjusted IRRs for girls compared with boys ranged between 0.81 (95% CI 0.74-0.89) and 0.91 (95% CI 0.77-1.07) over the age groups. The IRR did not significantly differ between all vaccine-related age groups (p=0.723), between children 2-13 months (following DTP-IPV vaccination) and 14 months-3 years (following MMR±MenC vaccination) (p=0.493) and between children 14 months-3 years and 4-8 years old (following DTP-IPV vaccination) (p=0.868).CONCLUSIONSIn the Netherlands, a high income country, no differences in gender-specific mortality related to the type of last vaccination received were observed in DTP-IPV- and MMR ± MenC eligible age groups. The inability to detect this effect indicates that when non-specific effects were present the effects were not reflected in changes in the differences in mortality between boys and girls. The findings in this large population-based study are reassuring for the continued trust in the safety of the national vaccination programme.

01 Jan 2009·European Journal of Pediatrics

Discolored leg syndrome after vaccination—descriptive epidemiology

Article

Author: Patricia E. Vermeer-de Bondt ; Jeanet M. Kemmeren ; Nicoline A. T. van der Maas

Discoloration of the leg following vaccination is a relatively unknown entity. We carried out a study of discolored leg syndrome (DLS) during a 10-year consecutive period with the objective of characterizing DLS in infants following vaccination received in the Dutch National Vaccination Program as well as its occurrence and association with different vaccines. Discolored leg syndrome was defined as an even or patchy red, blue or purple discoloration of the leg(s) and/or leg petechiae with or without swelling. All reports of adverse events following immunization that were made to the passive surveillance system between 1994 and 2003 were included-a total of 1162 identified cases. Red, blue, purple discoloration and isolated petechiae were reported in 39, 19, 27 and 14% of these cases, respectively. Of these 1162 cases, 1105 were considered to be related to the vaccination, based on a predefined risk window with symptom onset after vaccination (48 h for discolorations and 2 weeks for petechiae). Of the 1105 cases, about 50% occurred after DTP-IPV+Hib1 vaccinations, and 30% occurred after DTP-IPV+Hib2 vaccinations. Discolored leg syndrome was frequently accompanied by fierce crying (78%). The median time interval between vaccination and the occurrence of DLS was 3.8 +/- 46.7 h, and the median duration was short (2 +/- 61.7 h). Advancing the vaccination schedule from 3 to 2 months of age caused a small increase in DLS. Discolored leg syndrome manifested mainly after the first and/or second vaccination. In addition to dose, the occurrence of DLS may be slightly age-dependent and self-limiting. The pathophysiology is unknown but may be the result of a vasomotor reaction. Future studies should elucidate the recurrence rate, identify risk factors and assess late outcomes.

100 Deals associated with DTP-poliovirus vaccine(Kitasato Daiichi Sankyo Vaccine Co., Ltd.)

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Diphtheria	Japan	-	04 Jul 2014
Poliomyelitis	Japan	-	04 Jul 2014
Tetanus	Japan	-	04 Jul 2014
Whooping Cough	Japan	-	04 Jul 2014

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02907216 (CTgov)	Phase 4	Diphtheria \| Rotavirus Infections \| Whooping Cough \| Tetanus	292	Squarekids+Rotarix (Co-administration Group)	nmjnzszmhf(xnhbgjlrgs) = oehesurjij rfrmzmuthj (hgnnwrbxzq, zpzljvelum - oqgnwrdwma) View more	-	23 Jan 2019
				Squarekids+Rotarix (Staggered Group)	nmjnzszmhf(xnhbgjlrgs) = staohbvcqm rfrmzmuthj (hgnnwrbxzq, afiybsuxas - augngkjnhe) View more