Delving into the Latest Updates on DTaP-poliovirus vaccine adult(GlaxoSmithKline Plc) with Synapse

Overview

Basic Info

Drug Type

Inactivated vaccine, Combination vaccine, Prophylactic vaccine

Synonyms

Boostrix Polio, Boostrix-IPV, DTaP poliovirus vaccine

+ [1]

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesNervous System DiseasesRespiratory Diseases+ [1]

Active Indication

DiphtheriaPoliomyelitisTetanus+ [1]

Inactive Indication-

Originator Organization

GSK Plc

Active Organization

GSK Plc

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

IN (01 Feb 2008),

DiphtheriaPoliomyelitisTetanus+ [1]

Regulation-

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Backgound and relevance of the project:
Patients with autoimmune inflammatory rheumatic diseases (AIIRD) are at increased risk of contracting infections. The increased risk can be attributed to the immunological disorder itself, as well as to the immunosuppressive treatment. Vaccination against many infections is recommended in this patient group. However, the immunogenicity of vaccines may be reduced and may also be influenced by the administered treatment. Potential reactivation of the underlying disease triggered by vaccination is another important concern.
From the patients' and public health perspectives, an important task of physicians is giving advice on vaccines. Completing this task is often difficult, because data on the immunogenicity and safety of vaccines in these patient groups are scarce, especially with regard to treatment with new immunosuppressive medications, such as biological agents. Lastly and importantly, due to new therapeutic options, health among AIIRD patients has considerably improved and an increasing number of patients undertake overseas travel activities requiring additional vaccinations. In this context, reliable advice with regard to vaccinations is almost impossible, because for most travel vaccinations the immunogenicity and safety profile is unknown.
Research addressing the immunogenicity and safety of vaccines in different autoimmune inflammatory diseases treated with different immunosuppressive medications is urgently needed to allow giving evidence based vaccine advice.
In this observational study the immunogenicity and safety of tetanus booster and hepatitis A vaccinations will be assessed in AIIRD patients. The immune response will be evaluated as a function of the underlying disease and the possible influence of commonly used immunosuppressive drugs on the immune response will be studied.
Rationale for studying tetanus booster and hepatitis A vaccine Tetanus vaccination is one of the most frequently recommended vaccinations, and the effect of a booster vaccination can be addressed. Hepatitis A vaccine is the most widely used travel vaccine. Despite their importance, only very limited data are available for tetanus and hepatitis A vaccine in this patient group. By focusing on these vaccines the study will lead the way to the evaluation of further vaccines.
The purpose of this study is to determine whether tetanus and hepatitis A vaccinations are as immunogenic and safe in AIIRD patients as in healthy controls.

Start Date01 Oct 2013

Sponsor / Collaborator

University of Zurich

[+5]

EUCTR2012-005273-31-GB / Not yet recruitingPhase 3IIT

A phase III/IV randomised open-label study and comparison of the immunogenicity and safety of a single adolescent booster dose of a meningococcal group C conjugate-containing booster vaccine (Meningitec™, or Menjugate™, or NeisVac-C™, or Menitorix™), when given concurrently with an acellular pertussis-containing booster vaccine (Repevax™ or IPV-Boostrix™) - Multiboost - MCC plus pertussis booster in adolescents

Start Date30 May 2013

Sponsor / Collaborator

Public Health England

NCT01245049 / CompletedPhase 3

Immunogenicity and Safety of GSK Biologicals' dTpa-IPV Vaccine (Boostrix Polio) as a Booster Dose in 3 and 4-year-old Children

The purpose of the study is to compare the immunogenicity and safety of a booster dose of BoostrixTM Polio to that of Sanofi Pasteur MSD's RepevaxTM, when co-administered with a second dose of PriorixTM, in healthy 3 and 4-year-old children.

Start Date01 Apr 2011

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with DTaP-poliovirus vaccine adult(GlaxoSmithKline Plc)

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100 Translational Medicine associated with DTaP-poliovirus vaccine adult(GlaxoSmithKline Plc)

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100 Patents (Medical) associated with DTaP-poliovirus vaccine adult(GlaxoSmithKline Plc)

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10

Literatures (Medical) associated with DTaP-poliovirus vaccine adult(GlaxoSmithKline Plc)

01 May 2023·The Lancet. Microbe

Optimising the timing of whooping cough immunisation in mums (OpTIMUM) through investigating pertussis vaccination in pregnancy: an open-label, equivalence, randomised controlled trial.

Article

Author: Mossop, Jude ; Capp, Angelika ; Ratcliffe, Helen ; Greening, Vanessa ; Watts, Rosie ; Carty, Lotoyah ; Karampatsas, Konstantinos ; Khan, Uzma ; Wishlade, Tabitha ; Collins, Sarah ; Chawla, Krina ; Morey, Ella ; Snape, Matthew D. ; Hallis, Bassam ; Fretwell, Jessica ; Heath, Paul T. ; Stapley, Lorraine ; Vatish, Manu ; Jones, Christine E. ; Lim, Suzy ; Wellstead, Susan J. ; Andrews, Nick ; Le Doare, Kirsty ; Basude, Sneha ; England, Anna ; Gorringe, Andrew ; Gubbins, Teresa ; Peregrine, Elisabeth ; Powell, Deborah ; Johnstone, Edward ; Roseman, Fenella ; Amirthalingam, Gayatri ; Matheson, Mary ; Johnston, Susan ; Cornish, Emily ; Walbridge, Fiona ; Ramkhelawon, Laxmee ; Roberts, Hannah ; Khalil, Asma ; Calvert, Anna ; O'Brien, Katie ; Owino, Nelly ; Byrne, Wendy ; Daniel, Olwenn ; Hall, Tom ; Coleman, Matthew ; Taylor, Stephen ; Cuthbertson, Hannah ; Sparks, Laura ; Burtt, Agnieszka ; Martin, Nicki

BACKGROUNDPertussis vaccination in pregnancy is recommended in many countries to provide protection to young infants. The best timing for this vaccination is uncertain. In the UK, vaccination is recommended between 16 weeks and 32 weeks of gestation. In this trial we aimed to investigate the equivalence of three time periods for pertussis vaccination in pregnancy.METHODSIn this open-label, equivalence, randomised controlled trial to investigate equivalence of different time windows for pertussis vaccination in pregnancy, participants were randomly assigned (1:1:1 ratio) to receive a pertussis-containing vaccine (Boostrix-inactivated poliovirus vaccine) in one of three gestational age groups, comprising group 1 (≤23 weeks + 6 days), group 2 (24-27 weeks + 6 days), and group 3 (28-31 weeks + 6 days) using a computer-generated randomisation list. The primary outcome was concentration of pertussis-specific antibodies in the infant born at term at birth. Maternal blood sampling was done before and 2 weeks after vaccination and at delivery, together with a cord sample, and an infant sample was collected at least 4 weeks after primary vaccination. Reactogenicity was assessed for 7 days after vaccination. This trial was registered with ClinicalTrials.gov (NCT03908164).FINDINGSBetween May 7, 2019, and Feb 13, 2020, of 1010 women assessed for eligibility, 364 women were recruited and 351 received the intervention (120 in group 1, 119 in group 2, and 112 in group 3). Equivalence of time periods was demonstrated for anti-pertussis toxin and anti-pertactin IgG concentrations. The cord blood geometric mean concentrations of anti-filamentous haemagglutinin IgG were higher with increasing gestational age at vaccination, such that for infants in group 1 (≤23 weeks + 6 days), equivalence to group 3 (28-31 weeks + 6 days) was not shown. Reported rates of fever were similar between study groups.INTERPRETATIONPertussis vaccination at three different time intervals in pregnancy resulted in equivalent concentrations of IgG antibodies in infants against two of the three pertussis antigens assessed. Overall, these findings support recommendations to vaccinate any time between 16 weeks and 32 weeks of gestation.FUNDINGThe Thrasher Research Fund and the National Immunisation Schedule Evaluation Consortium through the National Institute for Health and Care Research policy research programme.

01 Feb 2022·VaccineQ3 · MEDICINE

Fourteen years of the Pregnancy Registry on maternal immunisation with a reduced-antigen-content tetanus-diphtheria-acellular pertussis (Tdap) vaccine

Q3 · MEDICINE

Article

Author: Ceregido, Maria Angeles ; Jourquin, Anne ; Da Silva, Fernanda Tavares ; Campora, Laura ; Kuznetsova, Anastasia

BACKGROUNDGSK initiated a Pregnancy Registry in the United States (US) for the reduced-antigen-content tetanus-diphtheria-acellular pertussis (Tdap; Boostrix, GSK) vaccine with the aim to detect and describe pregnancy outcomes in women vaccinated with Boostrix 28 days before estimated conception or during pregnancy.METHODSVoluntary reports of pregnancy exposure to Boostrix received from spontaneous and post-marketing surveillance sources in the US were assessed. Reports were classified as prospective or retrospective based on the knowledge of pregnancy outcomes at the time of reporting. For completeness, reports of exposure to Boostrix or to the Tdap-inactivated poliovirus vaccine (Boostrix-IPV, GSK) reported to the global safety database from countries outside the US were also evaluated.RESULTSFrom May 2005 to August 2019, 1517 (1455 prospective and 62 retrospective) pregnancy reports were received in the Boostrix US Pregnancy Registry. Of the prospective reports, 250 had known outcomes: 244 live infants with no apparent birth defects (BDs), three live infants with BDs, and three spontaneous abortions with no apparent BDs. Of the retrospective reports, 55 had known outcomes: 33 live infants with no apparent BDs, 16 live infants with BDs, one spontaneous abortion with no apparent BDs, four stillbirths with no apparent BDs, and one stillbirth with BDs. Cumulatively, 1321 pregnancy reports (1006 for Boostrix; 315 for Boostrix-IPV) were received from countries outside the US. Of these, 163 prospective reports and 551 retrospective reports had known outcomes. Results were in line with those from the Boostrix US Pregnancy Registry.CONCLUSIONSData currently available from the Boostrix US Pregnancy Registry and from countries outside the US suggested that exposure to Boostrix or Boostrix-IPV during pregnancy does not raise safety concerns related to adverse pregnancy outcomes or BDs.

01 Apr 2018·VaccineQ3 · MEDICINE

A phase III, open-label, randomised multicentre study to evaluate the immunogenicity and safety of a booster dose of two different reduced antigen diphtheria-tetanus-acellular pertussis-polio vaccines, when co-administered with measles-mumps-rubella vaccine in 3 and 4-year-old healthy children in the UK

Q3 · MEDICINE

Article

Author: Faust, Saul N ; Tomlinson, Richard ; Pollard, Andrew J ; Snape, Matthew D ; Marlow, Robin ; Han, Htay Htay ; Mesaros, Narcisa ; Kuriyakose, Sherine ; Finn, Adam

AIMTo evaluate the immunogenicity and safety of a reduced antigen diphtheria-tetanus-acellular pertussis-inactivated poliovirus (dTap-IPV_B) vaccine (Boostrix-IPV, GSK) as a pre-school booster in 3-4 year old children as compared to dTap-IPV_R (Repevax, Sanofi Pasteur), when co-administered with mumps-measles-rubella vaccine (MMRV).METHODSThis phase III, open label, randomised study was conducted in the UK between April 2011 and April 2012. Children due their pre-school dTap-IPV booster vaccination were randomised 2:1 to receive one of two different dTap-IPV vaccines (dTap-IPV_B or dTap-IPV_R) with blood sample for immunogenicity assessment just prior and one month after vaccination. Immune responses to diphtheria, tetanus and polio antigens were compared between the study vaccines (inferential comparison). In the absence of an accepted pertussis correlate of protection, the immunogenicity of dTap-IPV_B vaccine against pertussis was compared with historical pertussis efficacy data (inferential comparison). Safety and reactogenicity of both study vaccines were evaluated.RESULTS387 children were randomised and 385 vaccinated: 255 in the dTap-IPV_B group and 130 in the dTap-IPV_R group. Prior to vaccination, ≥76.8% of children had anti-diphtheria and ≥65.5% had anti-tetanus titres above the protection threshold; for pertussis, the pre-vaccination seropositivity rate ranged between 18.1 and 70.6%. Both vaccines were immunogenic with 99.2-100% of children achieving titres above the pre-specified seroprotection/seropositivity thresholds. One serious adverse event not considered as causally related to the study vaccination by the study investigator was reported in the dTap-IPV_B group.CONCLUSIONNon-inferiority of dTap-IPV_B to dTap-IPV_R was demonstrated. Both vaccines had a clinically acceptable safety and reactogenicity profile when co-administered with MMRV to children 3-4 years old.TRIAL REGISTRATIONNCT01245049 (ClinicalTrials.gov).

100 Deals associated with DTaP-poliovirus vaccine adult(GlaxoSmithKline Plc)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	DTaP-poliovirus vaccine adult(GlaxoSmithKline Plc)	J07CA02	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diphtheria	IN	GSK Plc	01 Feb 2008
Poliomyelitis	IN	GSK Plc	01 Feb 2008
Tetanus	IN	GSK Plc	01 Feb 2008
Whooping Cough	IN	GSK Plc	01 Feb 2008

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Poliomyelitis	Preclinical	IT	GSK Plc	01 Apr 2009
Diphtheria	Preclinical	-	GSK Plc	01 Jan 2002
Tetanus	Preclinical	-	GSK Plc	01 Jan 2002
Whooping Cough	Preclinical	-	GSK Plc	01 Jan 2002

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00635128 (CTgov)	Phase 4	Diphtheria \| Whooping Cough \| Tetanus \| Poliomyelitis	415	Boostrix-Polio (Boostrix-Polio Group)	bgfsewgrfk(yfezsexeox) = fuajlqjvip tzexrfvbya (uiggiufyrt, silzpkkdco - gasnrmaall) View more	-	05 Jul 2017
				Boostrix-Polio (Boostrix + IPV Mérieux Group)	bgfsewgrfk(yfezsexeox) = zimnzwixrp tzexrfvbya (uiggiufyrt, rlqvvamqxt - dfeerkmwpx) View more
NCT01245049 (CTgov)	Phase 3	Diphtheria \| Whooping Cough \| Tetanus \| Poliomyelitis	387	Boostrix PolioTM+PriorixTM (Boostrix Polio Group)	crcslulsvx(tlhbzoqfqg) = qtmypwgbqp xvjvfehjjq (ueewamjhuu, yscoexmhud - axmjnjdwgg) View more	-	05 Jul 2017
				RepevaxTM+PriorixTM (Repevax Group)	crcslulsvx(tlhbzoqfqg) = dxrzsaptel xvjvfehjjq (ueewamjhuu, ptdvfxulgv - dbjeepwbzp) View more
NCT00871000 (CTgov)	Phase 3	Diphtheria \| Whooping Cough \| Tetanus \| Poliomyelitis	303	Boostrix Polio™ 711866+Priorix Tetra TM 208136 (Boostrix Polio Group)	qxchgkcktx(duaebdjxsl) = ggicjdkzox ibqhwmgovt (ljprkdprtp, xxbyertjle - iidzgxkprl) View more	-	18 Apr 2017
				Priorix Tetra TM 208136+Tetravac TM (Tetravac Group)	qxchgkcktx(duaebdjxsl) = bljoarowjd ibqhwmgovt (ljprkdprtp, xrcjgeiwtx - qveghqktxz) View more
NCT00426361 (108464, CTgov)	Phase 3	Human Papillomavirus Infection	751	GSK Biologicals' HPV-16/18 L1 AS04 vaccine (Cervarix TM) (Cervarix Group)	wlfyyfxqca(fxbiuleljp) = wacbstzbzm wbytaewiic (vcqfgpifnr, zvmbchtnpm - dddjresbcd) View more	-	23 Aug 2010
				GSK Biologicals' HPV-16/18 L1 AS04 vaccine (Cervarix TM)+Boostrix ® Polio (Cervarix + Boostrix Polio Group)	(nvaqlxrmil) = hhdyughbms looqlpwnnd (yoilinkoyn, mfakxhjluq - vouirvzuui) View more