Delving into the Latest Updates on Diphtheria, tetanus, pertussis and hepatitis-B vaccine(GlaxoSmithKline Plc) with Synapse

Overview

Basic Info

Drug Type

Combination vaccine, Prophylactic vaccine, Toxoid vaccine

Synonyms

DPT + Hepa B vaccine, DTPw-HBV vaccine, Diphtheria tetanus pertussis-hepatitis B vaccine

+ [5]

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesDigestive System DisordersRespiratory Diseases+ [2]

Active Indication-

Inactive Indication

DiphtheriaHaemophilus InfectionsHepatitis B+ [6]

Originator Organization

GSK Plc

Active Organization-

Inactive Organization

GSK PlcGlaxoSmithKline Biologicals SA

Drug Highest PhaseWithdrawn

First Approval Date

European Union (19 Jul 1996),

DiphtheriaHepatitis BTetanus+ [1]

Regulation-

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The aim of the malaria vaccine program of the MVI/GSK partnership is to develop an efficacious malaria vaccine that is deliverable through the existing system, the Expanded Program on Immunization (EPI) of WHO. This study has been designed to:
Investigate the safety and immunogenicity of 7 infant immunization schedules of the experimental malaria vaccine integrated with an EPI regimen.
Investigate how to maximize the antibody response to the experimental malaria vaccine.

Start Date13 Jan 2011

Sponsor / Collaborator

GSK Plc

[+1]

NCT01098474

/ CompletedPhase 2

Safety and Immunogenicity Study of GSK Biologicals' Candidate Tuberculosis Vaccine (692342) When Administered to Healthy Infants

This purpose of the study is to assess the safety and immunogenicity of a GSK Biologicals' candidate tuberculosis vaccine (692342) when administered concomitantly with or after the Expanded Programme of Immunisation vaccines regimen to healthy infants aged between and including 2 and 7 months, living in a tuberculosis endemic region.

Start Date07 Jul 2010

Sponsor / Collaborator

GSK Plc

[+1]

100 Clinical Results associated with Diphtheria, tetanus, pertussis and hepatitis-B vaccine(GlaxoSmithKline Plc)

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100 Translational Medicine associated with Diphtheria, tetanus, pertussis and hepatitis-B vaccine(GlaxoSmithKline Plc)

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100 Patents (Medical) associated with Diphtheria, tetanus, pertussis and hepatitis-B vaccine(GlaxoSmithKline Plc)

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33

Literatures (Medical) associated with Diphtheria, tetanus, pertussis and hepatitis-B vaccine(GlaxoSmithKline Plc)

01 Jan 2020·VaccineQ3 · MEDICINE

Diphteria-tetanus-pertussis vaccine reduces specific IgE, inflammation and remodelling in an animal model of mite-induced respiratory allergy

Q3 · MEDICINE

Article

Author: Giavina-Bianchi, Pedro ; Aun, Marcelo Vivolo ; Saraiva-Romanholo, Beatriz Mangueira ; Arantes-Costa, Fernanda Magalhães ; Martins, Mílton de Arruda ; Kalil, Jorge ; Almeida, Francine Maria de

BACKGROUNDAdjuvants, such as bacterial lipopolysaccharides, have been studied to improve the efficacy of allergen-specific immunotherapy. The Bordetella pertussis (Pw) vaccine has been shown to have a protective role in ovalbumin-induced asthma models. However, its role in allergy to mites is unknown. We evaluated the effects of the diphtheria-tetanus-pertussis (DTPw) vaccine on a murine model of respiratory allergy induced by Dermatophagoides pteronyssinus (Derp).METHODSIn a 30-day protocol, BALB/c mice were immunized subcutaneously with saline or Derp, alone or in combination with diphtheria-tetanus (DT) or DTPw vaccines (days 0, 7 and 14). Subsequently, they underwent a daily intranasal challenge with saline or Derp (days 22-28) and were then sacrificed (day 29). We evaluated serum-specific immunoglobulins, bronchoalveolar lavage (BAL) cellularity, remodelling of the lower airways, density of polymorphonuclear leukocytes (PMNs) and acidic nasal mucus content.RESULTSThe animals sensitized with Derp produced high levels of specific immunoglobulins, increased density of PMNs and nasal mucus content, and elevated BAL cellularity and remodelling. Vaccines led to a reduction in IgE levels, with the Derp-DTPw group being similar to the saline groups. The vaccinated groups had reductions of BAL cellularity and remodelling, with more expressive results in the Derp-DTPw group compared to the Derp-DT group. The DT and DTPw vaccines inhibited the nasal PMN infiltrate, and DTPw modulated the production of acidic nasal mucus.CONCLUSIONSThe DTPw vaccine reduced serum specific IgE, nasal and pulmonary inflammation and remodelling of the lower airways.

03 Apr 2015·Human Vaccines & ImmunotherapeuticsQ3 · MEDICINE

A comparative clinical study to assess safety and reactogenicity of a DTwP-HepB+Hib vaccine

Q3 · MEDICINE

Article

Author: Prasad S Kulkarni ; Shashank Dalvi ; MA Phadke ; Mohan K Doibale ; CT Deshmukh ; Sanjay K Lalwani ; Dipty Jain ; SS More ; BS Garg ; Mamta Manglani

Hepatitis B and Haemophilus influenzae type b (Hib) infections are major public health problems in developing countries, including India. Hence, combination vaccines containing DTwP, recombinant hepatitis B and Hib conjugate vaccines have been developed. Here, we report a Phase IV study which assessed safety and reactogenicity of a new DTwP-HepB+Hib vaccine. Three doses of DTwP-HepB+Hib vaccine (Pentavac, Serum Institute of India Ltd) or Tritanrix-HB+Hib (GlaxoSmithKline Beecham) were administered to infants at 6, 10 and 14 weeks of age in 2:1 ratio. The subjects were followed till one month after the third dose for safety assessment. Adverse events were captured in structured diaries and physical examinations were performed on each visit. The study was conducted in 1510 infants. Both vaccines caused injection site local and systemic reactions and the incidence was similar in both the groups. The incidence of local solicited reactions was: tenderness 35.9 %-33.6 %; redness 18.1 %-17.2 %; swelling 23.7 %-22.4 %; induration 12.8 % -13.7 %. The percentage of systemic solicited reactions were: diarrhea 2.2 %-2.2 %; drowsiness 3.3 %-3.4 %; fever 14.0 %-11.2 %; irritability 28.1 %-25.4 %; loss of appetite 6.6 %-5.6 %; persistent crying 17.7 %-15.7 %; vomiting 3.5 %-3.0 %. No serious adverse event was caused by the vaccines. The new DTwP-HepB+Hib combination vaccine showed similar safety profile to that of an imported vaccine in Indian infants.

01 Feb 2014·VaccineQ3 · MEDICINE

Interchangeability of Quinvaxem during primary vaccination schedules: Results from a phase IV, single-blind, randomized, controlled, single-center, non-inferiority study

Q3 · MEDICINE

Article

Author: Capeding, Maria Rosario Z ; Alberto, Edison ; Jica, Corina ; Rauscher, Martina ; Macura-Biegun, Anna

Combination vaccines against diphtheria, tetanus and pertussis (DTP) represent the core of childhood vaccination programs. Quinvaxem, a fully-liquid, pentavalent combination vaccine containing inactivated hepatitis B (HepB), Haemophilus influenzae type b (Hib) and whole-cell pertussis (wP) antigens, and tetanus and diphtheria toxoids, has been shown to be suitable for boosting children primed in infancy with another DTwP-HepB-Hib vaccine. This single-blind, randomized, controlled study was designed to demonstrate non-inferiority of a primary vaccination course (6-10-14 week schedule) of Tritanrix HB+Hib (first dose) and Quinvaxem (second/third doses) versus three doses of Quinvaxem with respect to the seroprotection/seroconversion rates for all antigens one month after vaccination course completion. Four hundred healthy subjects eligible for the local Expanded Program on Immunization were enrolled and equally randomized to the two treatment regimens. All subjects achieved seroprotection for tetanus and Hib, all except one for diphtheria, and all except two achieved seroconversion against Bordetella pertussis. Seroprotection against hepatitis B was achieved by 97.4% of Tritanrix HB+Hib followed by Quinvaxem and 94.9% of Quinvaxem subjects. Therefore, one month after vaccination course completion, seroprotection rates (seroconversion rate for B. pertussis) of Tritanrix HB+Hib followed by Quinvaxem were non-inferior to those elicited by Quinvaxem only, thus meeting the primary objective. Adverse events were comparable between the groups and were in line with the safety profile of the vaccines. The switch of vaccine had no apparent effect on safety endpoints. Our results support the use of Quinvaxem interchangeably with Tritanrix HB+Hib in a primary vaccination course and provides further evidence for the interchangeability of pentavalent vaccines (Clinical Trials.gov registry: NCT01357720).

100 Deals associated with Diphtheria, tetanus, pertussis and hepatitis-B vaccine(GlaxoSmithKline Plc)

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diphtheria	Preclinical	Liechtenstein	GlaxoSmithKline Biologicals SA	19 Jul 1996
Diphtheria	Preclinical	European Union	GlaxoSmithKline Biologicals SA	19 Jul 1996
Diphtheria	Preclinical	Iceland	GlaxoSmithKline Biologicals SA	19 Jul 1996
Diphtheria	Preclinical	Norway	GlaxoSmithKline Biologicals SA	19 Jul 1996
Hepatitis B	Preclinical	Iceland	GlaxoSmithKline Biologicals SA	19 Jul 1996

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01175083 (CTgov)	Phase 3	Streptococcal Infections	300	GSK1024850A (Synflorix)+Tritanrix-HepB/Hib+Polio Sabin (Tritanrix-HepB/Hib+Polio Sabin <6S Group)	msgybquxgq(tmjizzfsjm) = alysgawmvi eafujblscd (blolqkwpbk, urvtgrqfdt - qhlmejpykw) View more	-	06 Jun 2019
				GSK1024850A (Synflorix)+Tritanrix-HepB/Hib+Polio Sabin (Tritanrix-HepB/Hib+Polio Sabin <6NS Group)	msgybquxgq(tmjizzfsjm) = vpqamllqvt eafujblscd (blolqkwpbk, uukkljnkjw - ggrujtbdpw) View more
NCT00547248 (CTgov)	Phase 3	Streptococcal Infections	756	Synflorix+Tritanrix-HepB+Hiberix+Polio Sabin (Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group)	(fwgdhmjsbi) = qprtilzjje zgfzubiihm (sbfeydhsmr, yvdgoabemp - iesvyarvhc) View more	-	14 Jan 2019
				Tritanrix-HepB+Hiberix+Polio Sabin+Prevenar (Wyeth) (Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group)	(fwgdhmjsbi) = tavqgutexg zgfzubiihm (sbfeydhsmr, cdcrnjaklz - cnaknnmcgs) View more
NCT01098474 (CTgov)	Phase 2	Tuberculosis	301	GSK's investigational vaccine 692342 (SB692342 2 Dose Group)	alcvwhllgj(yfuxrlhilh) = sagdxpqbcg usyygunjfr (hadyypiode, gexlumapzr - wymqzrkjui) View more	-	27 Nov 2018
				GSK's investigational vaccine 692342 (SB692342 1 Dose Group)	alcvwhllgj(yfuxrlhilh) = jeiqjallmp usyygunjfr (hadyypiode, ypeoaomhay - xesifowikw) View more
NCT00136604 (CTgov)	Phase 3	Diphtheria \| Hepatitis B \| Meningococcal Infections \| Haemophilus Infections \| Whooping Cough \| Tetanus	617	tritanrix-hepb+Hib-MenAC (ACAC GROUP)	dqvklfmecn(yeiwklvqyg) = wvyuceicfo ebtmibfbkl (pvqufdrcsj, buvbfszhjb - ggnndubhmj) View more	-	17 Sep 2018
				tritanrix-hepb+Hiberix+Meningitec (CC GROUP)	dqvklfmecn(yeiwklvqyg) = rxtexuaids ebtmibfbkl (pvqufdrcsj, ojspjjgvkr - ngwoennhco) View more
NCT00291343 (CTgov)	Phase 3	Meningococcal Infections	296	Hib-MenAC+Tritanrix-HepB+Mencevax ACWY (Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group)	xqzhjgwuuh(imrqujbmie) = fjasneegqk cgxeaifwou (gqtoybcbzr, uzmawjpasv - krpjbzcwfc) View more	-	03 Aug 2017
				Tritanrix-HepB+Hiberix+Mencevax ACWY (Tritanrix-HepB/Hiberix+Mencevax ACWY Group)	xqzhjgwuuh(imrqujbmie) = rytnritzog cgxeaifwou (gqtoybcbzr, rejofbxviz - qkyfpjkoxl) View more
NCT00158756 (CTgov)	Phase 3	Hepatitis B	308	Tritanrix™-HepB+Rotarix™ (Tritanrix™-HepB+Rotarix™ Group)	njdefrkllg(zdfmcsyfgk) = zsvmqkswat bgzuncnujt (sdrpveyzsw, gbfkmswbah - zwnnhrjvsz) View more	-	12 Jul 2017
				Placebo+Tritanrix™-HepB (Tritanrix™-HepB+Placebo Group)	njdefrkllg(zdfmcsyfgk) = likqqsoenl bgzuncnujt (sdrpveyzsw, kdhchopqiy - namttqsnwr) View more
NCT00317109 (CTgov)	Phase 3	Meningococcal Infections	168	Tritanrix-HepB+Hiberix (Tritanrix-HepB/Hiberix Group)	fyjrjbxnwv(ryjlpmesas) = bksxkxizvd yzcwlpkybq (nyixnqgmwl, tnlpwblyia - qalvxqthcm) View more	-	01 Mar 2017
				Hiberix-Mencevax AC+Tritanrix-HepB (Tritanrix-HepB/Hiberix-Mencevax AC Group)	fyjrjbxnwv(ryjlpmesas) = fzkkgcbxwe yzcwlpkybq (nyixnqgmwl, ovkhiyjehy - iddewsqqqp) View more
NCT00169442 (CTgov)	Phase 3	Diphtheria \| Hepatitis B \| Haemophilus Infections \| Whooping Cough \| Tetanus	745	Polyribosil-Ribitol-Phosphate (PRP) vaccine+Tritanrix™-HepB Kft+Hiberix (PRP Tritanrix-HepB Kft. Mix Group)	tfgqbvttbg(rucqpzmlmf) = qguyebhzon otvvqwsfeo (kkkuzcqnmz, enjsfptfbq - abgfcrhjrr) View more	-	28 Feb 2017
				Polyribosil-Ribitol-Phosphate (PRP) vaccine+Tritanrix™-HepB Kft+Hiberix (PRP Tritanrix-HepB Kft. Ref Group)	tfgqbvttbg(rucqpzmlmf) = ohtbrazoee otvvqwsfeo (kkkuzcqnmz, yfyaparehl - mlybnjrlou) View more
NCT01231503 (CTgov)	Phase 2	Malaria	480	Rouvax+Tritanrix HepB Hib+BCG+OPV+GSK Biological's Investigational Malaria Vaccine 257049 (RTS,S Neo-10-14 Group)	abxkvxmxjb(tqsaemvbet) = kpgldqehht fweamlensm (afthlwvfgu, ifzbdqhawm - bbwywfsujp) View more	-	20 May 2015
				Rouvax+Tritanrix HepB Hib+BCG+OPV+GSK Biological's Investigational Malaria Vaccine 257049 (RTS,S Neo-10-26 Group)	abxkvxmxjb(tqsaemvbet) = ojqlopdbio fweamlensm (afthlwvfgu, ibjumbloyp - fkqxwvdmxc) View more
NCT00436007 (CTgov)	Phase 2	Yellow Fever \| Malaria \| Measles	511	Rouvax™+Tritanrix+Hiberix+Stamaril™+Polio Sabin™+GSK 257049 (GSK 257049 1 Group)	aqfirwposu(lpuchvbhtm) = zmyflyajnk igyuzpicdm (kxdozexvqp, mhxfaofxzh - yiiuzkkdhg) View more	-	27 May 2013
				Rouvax™+Tritanrix+Hiberix+Stamaril™+Polio Sabin™+GSK 257049 (GSK 257049 2 Group)	aqfirwposu(lpuchvbhtm) = ygxwdokeic igyuzpicdm (kxdozexvqp, rfgnejhpum - qfegawuuuu) View more