Delving into the Latest Updates on DTPw-HBV/Hib Kft vaccine(GlaxoSmithKline Plc) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine, Toxoid vaccine

Synonyms

Zilbrix-Hib

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesDigestive System DisordersRespiratory Diseases+ [1]

Active Indication-

Inactive Indication

DiphtheriaHaemophilus InfectionsHepatitis B+ [3]

Originator Organization

GSK Plc

Active Organization-

Inactive Organization

GSK Plc

License Organization-

Drug Highest PhasePendingPhase 3

First Approval Date-

Regulation-

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The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of African Sub-Saharan infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine and oral polio vaccine in children during the first 4 months of life.

Start Date18 Jun 2008

Sponsor / Collaborator

GSK Plc

NCT00473668

/ CompletedPhase 3

Non-inferiority of One Formulation of GSK Biologicals' DTPw-HBV/Hib to 2 Formulations of GSK Biologicals' DTPw-HBV/Hib With Respect to the Immune Response to the PRP Antigen, When Administered to Healthy Infants at 6, 10, 14 Weeks of Age

The purpose of this observer-blind study is to generate immunogenicity data with one formulation of GSK Biologicals' DTPw-HBV/Hib vaccine after the primary vaccination course and to demonstrate non-inferiority of this vaccine as compared to two formulations of GSK Biologicals' DTPw-HBV/Hib vaccine with respect to the anti-PRP antibody response. Additionally to assess the reactogenicity and safety of GSK Biologicals' DTPw-HBV/Hib vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Start Date01 Jun 2007

Sponsor / Collaborator

GSK Plc

NCT00332566

/ CompletedPhase 3

Immunogenicity, Reactogenicity & Safety of a Booster Dose of GSK Biologicals' DTPw-HBV/Hib Kft Vaccine Vs GSK Biologicals' DTPw-HBV/Hib Vaccine, in Infants Who Received a 3-Dose Primary Vaccination Course With the Same Vaccines.

This booster study will assess the immunogenicity, reactogenicity and safety of a booster dose of GSK Biologicals' DTPw-HBV/Hib Kft. vaccine versus DTPw-HBV/Hib vaccine, in healthy children, 18 to 24 months of age, who received the same vaccine for primary vaccination. Prior to the booster dose, this study will also assess the persistence of antibodies to the vaccine antigen components administered in the primary vaccination course. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Start Date01 Jun 2006

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with DTPw-HBV/Hib Kft vaccine(GlaxoSmithKline Plc)

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100 Translational Medicine associated with DTPw-HBV/Hib Kft vaccine(GlaxoSmithKline Plc)

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100 Patents (Medical) associated with DTPw-HBV/Hib Kft vaccine(GlaxoSmithKline Plc)

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9

Literatures (Medical) associated with DTPw-HBV/Hib Kft vaccine(GlaxoSmithKline Plc)

01 May 2012·Human Vaccines & ImmunotherapeuticsQ3 · MEDICINE

Immunogenicity, safety and reactogenicity of the 10-valent pneumococcal non-typeableHaemophilus influenzaeprotein D conjugate vaccine (PHiD-CV) when co-administered with the DTPw-HBV/Hib vaccine in Indian infants: a single-blind, randomized, controlled study

Q3 · MEDICINE

Article

Author: Sukanta Chatterjee ; Shailesh Mehta ; Dorota Borys ; Sanjay Lalwani ; Jugesh Chhatwal ; Valsan P. Verghese ; Marta Moreira ; Lode Schuerman ; Fakrudeen Shafi

In India, pneumococcal diseases are major causes of child mortality, and effective vaccines against Streptococcus pneumoniae are needed. This single-blind, randomized study assessed the immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Hemophilus influenzae (NTHi) protein D conjugate vaccine (PHiD-CV) co-administered with DTPw-HBV/Hib in Indian infants as 3-dose primary vaccination course. A total of 360 infants were randomized (2:1) to receive either PHiD-CV co-administered with DTPw-HBV/Hib (PHiD-CV group) or a Hib vaccine co-administered with DTPw-HBV (control group) at 6, 10, and 14 weeks of age. For each vaccine pneumococcal serotype, the percentage of infants in the PHiD-CV group with antibody concentrations ≥ 0.2 µg/mL one month after the third vaccine dose was at least 98.3%, except for serotypes 6B (77.7%) and 23F (89.5%), and opsonophagocytic activity titers ≥ 8 were measured in at least 95.7% of infants, except for serotypes 1 (90.5%) and 6B (84.5%). In addition, all the infants in the PHiD-CV group were seroprotected against diphtheria, tetanus, Hib, and hepatitis B or seropositive for antibodies against pertussis and NTHi protein D (except one infant). Incidences of solicited local and general symptoms were comparable between groups, except for fever (axillary temperature ≥ 37.5°C), which seemed to occur more frequently in the PHiD-CV group. In conclusion, PHiD-CV was shown to be immunogenic and well-tolerated when co-administered with DTPw-HBV/Hib in Indian infants.

01 Dec 2010·BMC Infectious DiseasesQ3 · MEDICINE

Primary and booster vaccination in Latin American children with a DTPw-HBV/Hib combination: a randomized controlled trial

Q3 · MEDICINE

ArticleOA

Author: Javier Casellas ; Katia Abarca ; Miguel Tregnaghi ; Jeanne-Marie Jacquet ; Alix Collard ; Inge Lefevre ; Angela Gentile ; Felix Espinoza

AbstractBackgroundDiphtheria-tetanus-whole-cell pertussis (DTPw)-based combination vaccines are an attractive option to rapidly achieve high coverage and protection against other important pathogens, such as hepatitis B virus (HBV) and Haemophilus influenzae type B (Hib). To ensure adequate antigen supply, GlaxoSmithKline Biologicals has introduced a new DTPw antigen source and developed a new DTPw-HBV/Hib combination vaccine containing a reduced amount of Hib polyribosylribitol phosphate (PRP). This study was undertaken to compare the immunogenicity and reactogenicity of this new DTPw-HBV/Hib vaccine with a licensed DTPw-HBV/Hib vaccine (Tritanrix™-HBV/Hib).MethodsThis was a randomized, partially-blind, multicenter study in three countries in Latin America (Argentina, Chile and Nicaragua). Healthy children received either the new DTPw-HBV/Hib vaccine (1 of 3 lots; n = 439; double-blind) or Tritanrix™-HBV/Hib (n = 146; single-blind) co-administered with oral poliovirus vaccine (OPV) at 2, 4 and 6 months, with a booster dose at 18-24 months.ResultsOne month after the end of the 3-dose primary vaccination course, the new DTPw-HBV/Hib vaccine was non-inferior to Tritanrix™-HBV/Hib in terms of seroprotection/vaccine response rates for all component antigens; ≥97.3% and ≥93.9% of subjects in the two groups, respectively, had seroprotective levels of antibodies against diphtheria, tetanus, hepatitis B and Hib and a vaccine response to the pertussis component. Persistence of antibodies against all vaccine antigens was comparable between groups, with marked increases in all antibody concentrations after booster administration in both groups. Both vaccines were generally well-tolerated as primary and booster doses.ConclusionsResults confirm the suitability of this new DTPw-HBV/Hib vaccine comprising antigens from a new source and a reduced PRP content for inclusion into routine childhood vaccination programs.Trial registrationhttp://www.clinicaltrials.gov NCT00332566

01 Dec 2010·BMC Infectious DiseasesQ3 · MEDICINE

The immunogenicity and safety of a reduced PRP-content DTPw-HBV/Hib vaccine when administered according to the accelerated EPI schedule

Q3 · MEDICINE

ArticleOA

Author: Sylvan J Rego ; Sukanta Chatterjee ; Jeanne-Marie Jacquet ; Sanjoy K Datta ; Alix Collard ; Fulton D'Souza ; BD Bhatia

AbstractBackgroundCombination vaccines improve coverage, compliance and effectively introduce new antigens to mass vaccination programmes. This was a phase III, observer-blind, randomized study of GSK Biologicals diphtheria-tetanus-whole cell pertussis vaccine combined with hepatitis B and Haemophilus influenzae type b vaccines, containing a reduced amount of polyribosyl-ribitol-phosphate (PRP) and a DTPw component manufactured at a different site (DTPw-HBV/Hib2.5 [Kft]). The primary aim of this study was to demonstrate that DTPw-HBV/Hib2.5 [Kft] was not inferior to the licensed DTPw-HBV/Hib (Tritanrix(tm)-HepB/Hiberix(tm)) vaccine or the DTPw-HBV/Hib2.5 vaccine, also containing a reduced amount of PRP, with respect to the immune response to the PRP antigen, when administered to healthy infants, according to the Expanded Programme for Immunization (EPI) schedule at 6, 10 and 14 weeks of age.Methods299 healthy infants were randomised to receive either DTPw-HBV/Hib2.5 [Kft] DTPw-HBV/Hib2.5 or DTPw-HBV/Hib according to the 6-10-14 week EPI schedule. Blood samples were analysed prior to the first dose of study vaccine and one month after the third vaccine dose for the analysis of immune responses. Solicited local and general symptoms such as pain, redness and swelling at the injection site and drowsiness and fever, unsolicited symptoms (defined as any additional adverse event) and serious adverse events (SAEs) were recorded up to 20 weeks of age.ResultsOne month after the third vaccine dose, 100% of subjects receiving DTPw-HBV/Hib2.5 [Kft] or DTPw-HBV/Hib and 98.8% of subjects receiving DTPw-HBV/Hib2.5 vaccine had seroprotective levels of anti-PRP antibodies (defined as anti-PRP antibody concentration ≥0.15 μg/ml). Seroprotective antibody concentrations were attained in over 98.9% of subjects for diphtheria, tetanus and hepatitis B. The vaccine response rate to pertussis antigen was at least 97.8% in each group. Overall, the DTPw-HBV/Hib2.5 [Kft] vaccine was well tolerated in healthy infants; no SAEs were reported in any group.ConclusionsThe DTPw-HBV/Hib2.5 [Kft] vaccine was immunogenic and well-tolerated when administered according to the EPI schedule to Indian infants.Trial registrationhttp://www.clinicaltrials.gov NCT00473668

100 Deals associated with DTPw-HBV/Hib Kft vaccine(GlaxoSmithKline Plc)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diphtheria	Phase 3	Nicaragua	GSK Plc	01 Jun 2006
Diphtheria	Phase 3	Argentina	GSK Plc	01 Jun 2006
Haemophilus Infections	Phase 3	Argentina	GSK Plc	01 Jun 2006
Haemophilus Infections	Phase 3	Nicaragua	GSK Plc	01 Jun 2006
Hepatitis B	Phase 3	Nicaragua	GSK Plc	01 Jun 2006
Hepatitis B	Phase 3	Argentina	GSK Plc	01 Jun 2006
Tetanus	Phase 3	Argentina	GSK Plc	01 Jun 2006
Tetanus	Phase 3	Nicaragua	GSK Plc	01 Jun 2006
Whooping Cough	Phase 3	Nicaragua	GSK Plc	01 Jun 2006
Whooping Cough	Phase 3	Argentina	GSK Plc	01 Jun 2006

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00678301 (CTgov)	Phase 3	Streptococcal Infections	365	GSK Biologicals' Synflorix™+GSK Biologicals' Polio Sabin™+GSK Biologicals' Zilbrix™ Hib (Synflorix™ + Zilbrix™ Hib + Polio Sabin™)	ilpmmivzdk(adlwrhshoe) = tyyestsvjk dhujygiaqb (dmqyrglvet, mwsfwkjtep - adsdifsoao) View more	-	27 Oct 2017
				GSK Biologicals' Polio Sabin™+GSK Biologicals' Zilbrix™ Hib (Zilbrix™ Hib + Polio Sabin™)	ilpmmivzdk(adlwrhshoe) = nngkkxrtxa dhujygiaqb (dmqyrglvet, qnnniscudz - ybqjwesnem) View more
NCT00473668 (CTgov)	Phase 3	Diphtheria \| Hepatitis B \| Haemophilus Infections \| Whooping Cough \| Tetanus	300	Zilbrix-Hib (Tritanrix-HepB/Hiberix Kft. Group)	uownavsura(aewxyqszzl) = bmnspvboga aswocofmsa (vgmsxtpvlr, htotfpfngs - qahmnmvsnr) View more	-	18 Aug 2017
				Tritanrix™-HepB+Hiberix™ (Tritanrix-HepB/Hiberix LD Group)	uownavsura(aewxyqszzl) = wvvybbvrmy aswocofmsa (vgmsxtpvlr, jribnpxkyi - wtmrzqhjyf) View more
NCT00473668 (Pubmed \| BMC Infect Dis)	Phase 3	Diphtheria \| Hepatitis B \| Haemophilus Infections \| Whooping Cough \| Tetanus	299	DTPw-HBV/Hib vaccine (DTPw-HBV/Hib2.5 [Kft])	rpdtwykpzv(qqerypnfjh) = qfabqeuuhy ktzxrobvmu (stgbgzlail ) View more	Positive	15 Oct 2010
				DTPw-HBV/Hib vaccine (DTPw-HBV/Hib)	rpdtwykpzv(qqerypnfjh) = allhftyars ktzxrobvmu (stgbgzlail ) View more