Engerix-B

ApprovedBiologic

GSK

Engerix-B is one of 311 biologic programs targeting HIV infection. It is currently in Approved.

Indications

Total Trials

Active Trials

310

Competitors

Pipeline

Status by Indication[3][1]

Indication

HIV InfectionActive, not recruiting

Liver TransplantActive, not recruiting

HepatitisActive, not recruiting

MalariaActive, not recruiting

Inflammatory Bowel DiseaseActive, not recruiting

Acute Otitis MediaActive, not recruiting

MemoryActive, not recruiting

Hepatitis BActive, not recruiting

InfluenzaActive, not recruiting

Chronic Kidney DiseaseActive, not recruiting

HIV InfectionApproved

Active, not recruiting

Liver TransplantPhase 3

Active, not recruiting

HepatitisApproved

Active, not recruiting

MalariaPhase 2

Active, not recruiting

Inflammatory Bowel DiseasePreclinical

Active, not recruiting

Acute Otitis MediaPhase 3

Active, not recruiting

MemoryApproved

Active, not recruiting

Hepatitis BPhase 2

Active, not recruiting

InfluenzaPhase 1

Active, not recruiting

Chronic Kidney DiseasePhase 3

Active, not recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

1053 competitors in Influenza

#DrugCompanyPhaseTrials

Engerix-B

GSK

Approved

1 2

Trexall

Alnylam Pharmaceuticals

Preclinical

1 3

Avigan

AAppili Therapeutics Inc.

Preclinical

6 4

Focetria

CChiltern Pesquisa Clinica Ltda

Preclinical

1 5

Influenza A/H5N1

NNational Institute of Allergy and Infectious Diseases (NIAID)

Preclinical

14 6

PD-1/PD-L1 Inhibitors

CChuangzhen Chen

Preclinical

1 7

Fluvirin

Novartis

Preclinical

3 8

TUDCA (tauroursodeoxycholic Acid) Supplementation

TTongji Hospital

Preclinical

1 9

Flulaval

NNational Heart, Lung, and Blood Institute (NHLBI)

Preclinical

1 10

Xuanfei Baidu Granule

PPeking University People's Hospital

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Hepatitis B29 trials

Comparison of Immuno, Reacto and Safety of Recombinant Hepatitis B Vaccine With or Without MPL in Healthy Older Adults

Completed· GSK logo

GSK·Phase 3·NCT00697242·362 enrolled

Study to Compare the Efficacy of GSK Biologicals' Adjuvants in Combination With the Antigen of the Hepatitis B Vaccine

Completed· GSK logo

GSK·Phase 2·NCT00805389·713 enrolled

Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years

Completed· GSK logo

GSK·Phase 3·NCT00383591·120 enrolled

Show 26 more trials

Immune Response to Hepatitis B Vaccine Challenge Dose in Subjects Who Received a Primary Neonatal Hepatitis B Vaccine.

Completed· GSK logo

GSK·Phase 4·NCT00456625·76 enrolled

Demonstration Project on Health Care Worker Protection Against Hepatitis B in Kalulushi District

Completed·CCentre for Infectious Disease Research in Zambia·Phase 4·NCT04072211·641 enrolled

Challenge Dose of Hepatitis B Vaccine in Subjects Who Previously Received Engerix™-B Vaccine

Completed· GSK logo

GSK·Phase 4·NCT00524576·144 enrolled

LT F-up Study 16-20 Yrs After Vaccine Dose of Hepatitis B With/Without HBIg in Newborns to HBeAg+ Mothers

Completed· GSK logo

GSK·Phase 4·NCT00240526·79 enrolled

Comparison of Safety, Immuno- and Reactogenicity of MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B

Completed· GSK logo

GSK·Phase 3·NCT00698087·60 enrolled

Long-term Persistence of Immunity to Hepatitis B in Adults Vaccinated With GlaxoSmithKline (GSK) Biologicals' Hepatitis B Vaccine (HBV), Engerix-B

Completed· GSK logo

GSK·Phase 4·NCT02901951·106 enrolled

Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine

Completed·DDynavax Technologies Corporation·Phase 3·NCT02117934·8,374 enrolled

Safety and Immunogenicity of HEPLISAV™ a Hepatitis B Virus Vaccine in Adults on Hemodialysis

Completed·DDynavax Technologies Corporation·Phase 3·NCT01195246·155 enrolled

A Pilot Study Comparing the Immunogenicity of Fendrix vs. Double-dose Engerix B in HIV-infected Non-responders to Standard Hepatitis B Vaccination Courses

Completed·SSheffield Teaching Hospitals NHS Foundation Trust·Phase 2/3·NCT02434848·13 enrolled

Follow-up Study 16-20 Years After Primary Vaccination Against Hepatitis B of Newborns From HBeAg+ & HBsAg+ Mothers

Completed· GSK logo

GSK·Phase 4·NCT00240500·109 enrolled

Does Extra-High Dose Hepatitis B Vaccination Confer Longer Serological Protection in Peritoneal Dialysis Patients?

Completed·—·Phase 4·NCT00125775·130 enrolled

Efficacy and Immunomodulation Study of Simultaneous Human Papillomavirus/ Hepatitis B (HPV/HBV) Vaccination

Terminated·NNational Institute for Public Health and the Environment (RIVM)·Phase 4·NCT01082861

A Randomized Phase I Study of a Hepatitis B Antigen Combined With IMP321

Completed·IImmutep S.A.S.·Phase 1·NCT00354861·48 enrolled

Immunogenicity and Safety of the Hepatitis B Vaccine Hepavax-Gene TF and a Comparator Hepatitis B Vaccine in Newborns

Completed·CCrucell Holland BV·Phase 3·NCT01349283·1,738 enrolled

Comparison of Three Hepatitis B Vaccination Regimens in HIV-Positive Youth

Completed·UUniversity of North Carolina, Chapel Hill·Phase 4·NCT00106964·371 enrolled

Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs

Completed· GSK logo

GSK·Phase 3·NCT00343915·267 enrolled

Safety and Efficacy of HEPLISAV™ Hepatitis B Virus Vaccine Compared With Engerix-B® Vaccine

Completed·DDynavax Technologies Corporation·Phase 3·NCT00435812·2,428 enrolled

Safety, Immunogenicity and Reactogenicity of Recombinant Hepatitis B Vaccine (Adjuvanted & New Formulation) and Engerix™-B

Completed· GSK logo

GSK·Phase 3·NCT00697840·150 enrolled

Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years

Completed· GSK logo

GSK·Phase 3·NCT00383383·141 enrolled

Evaluation of Antibody Persistence and Immune Memory Against the Hepatitis B Antigen in Previously Vaccinated Children

Completed· GSK logo

GSK·Phase 4·NCT01138098·185 enrolled

Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine

Completed·DDynavax Technologies Corporation·Phase 3·NCT01005407·2,452 enrolled

Safety and Immunogenicity of Recombinant Hepatitis B Vaccine Sci-B-Vac® Compared to Engerix-B®

Completed·VVBI Vaccines Inc.·Phase 3·NCT04209400·100 enrolled

Evaluation of Immunogenicity and Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine

Completed· GSK logo

GSK·Phase 3·NCT00697970·321 enrolled

Immunogenicity & Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine With Different Adjuvants

Completed· GSK logo

GSK·Phase 2·NCT00697125·60 enrolled

Immunogenicity and Reactogenicity of MPL Adjuvanted Recombinant Hepatitis B- Vaccine and Engerix™-B in Adult Non-Responders

Completed· GSK logo

GSK·Phase 3·NCT00697931·116 enrolled

Safety and Immunogenicity of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Hepatitis B Vaccine

Completed· GSK logo

GSK·Phase 4·NCT00657657·29 enrolled

Immunogenicity14 trials

Consistency & Immunogenicity Study of 3 Lots of GSK's Hib Conjugate Vaccine Versus ActHIB & Pentacel in Healthy Infants

Completed· GSK logo

GSK·Phase 3·NCT01000974·4,003 enrolled

Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents

Completed· GSK logo

GSK·Phase 4·NCT00534638·34,412 enrolled

Long Term Immunogenicity Study of Engerix-B Vaccine in 10 Year Old Children and the Effect of Booster Injections

Completed·LLaval University·Phase 4·NCT00169858·1,129 enrolled

Show 11 more trials

Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants

Completed· GSK logo

GSK·Phase 3·NCT02096263·585 enrolled

Immunogenicity and Safety of an Adjuvanted HBV Vaccine Compared to Engerix™-B, in a Non-responder Population ≥ 15y

Completed· GSK logo

GSK·Phase 3·NCT00698061·145 enrolled

Immunogenicity & Reactogenicity of HBV-MPL Vaccine and Engerix™-B in Healthy Adults Following 2 Different Schedules

Completed· GSK logo

GSK·Phase 2·NCT00697229·99 enrolled

Safety and Immunogenicity of 3 Lots of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Volunteers ≥ 15y

Completed· GSK logo

GSK·Phase 3·NCT00696917·1,303 enrolled

Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 18-40 y

Completed· GSK logo

GSK·Phase 2·NCT00698555·163 enrolled

Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Healthy Volunteers Positive for the HLA-DQ2 Genotype

Completed· GSK logo

GSK·Phase 3·NCT00697749·230 enrolled

Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Adults (15-40 Yrs).

Completed· GSK logo

GSK·Phase 3·NCT00697216·340 enrolled

Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 19-40 y

Completed· GSK logo

GSK·Phase 2·NCT00698906·160 enrolled

Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Bios' HBV-MPL Vaccine With That of Engerix™-B in Adults

Completed· GSK logo

GSK·Phase 3·NCT00696891·380 enrolled

Safety and Immunogenicity of GSK Bio's Candidate HBV-MPL Vaccines Compared to Engerix™-B, in Healthy Adolescents

Completed· GSK logo

GSK·Phase 2·NCT00697775·200 enrolled

Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine (2 Doses), and of Engerix™-B (3 Doses) in Healthy Adults

Completed· GSK logo

GSK·Phase 2·NCT00697853·200 enrolled

Memory3 trials

Antibody Persistence & Immune Memory in Healthy Adults Previously Vaccinated With Twinrix Adult

Completed· GSK logo

GSK·Phase 4·NCT01000324·44 enrolled

Evaluation of Immune Memory to Twinrix or Comparator by Challenge Dose Administration 4 Years After Primary Vaccination

Completed· GSK logo

GSK·Phase 4·NCT00684671·506 enrolled

Immunologic Memory (Supp. of ATN 024)

Completed·UUniversity of North Carolina, Chapel Hill·Phase 4·NCT00142753·95 enrolled

Malaria3 trials

Safety and Immunogenicity of GSK Biologicals' Malaria Vaccine 257049 When Administered on 7 Schedules to African Infants

Completed· GSK logo

GSK·Phase 2·NCT01231503·480 enrolled

Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine in Tanzanian Infants

Completed· GSK logo

GSK·Phase 2·NCT00289185·340 enrolled

Examine Safety and Immune Responses of GSK 257049 Vaccine When Administered to Infants Living in a Malaria-endemic Region

Completed· GSK logo

GSK·Phase 2·NCT00197028·214 enrolled

Hepatitis2 trials

Effect of Risk Factors Likely to Influence Immuno of Combined Hepatitis A & B Vacc vs Monovalent Hepatitis A & B Vacc

Completed· GSK logo

GSK·Phase 4·NCT00289731·596 enrolled

Study to Show That the Combined Hepatitis A and B Vaccine is Non-inferior to Monovalent Vaccines in Adults

Completed· GSK logo

GSK·Phase 4·NCT00603252·213 enrolled

18 more indications

Vaccine2 trials

Consistency of 3 Consecutive Lots of a Novel HBV Vaccine With Single-blind Safety Evaluation Using Engerix™-B as Control

Completed· GSK logo

GSK·Phase 3·NCT00697866·951 enrolled

Non Inferiority Trial of Locally Manufactured 'Hepa-B' Vaccine in Bangladesh.

Completed·IInternational Centre for Diarrhoeal Disease Research, Bangladesh·Phase 2/3·NCT03627507·158 enrolled

Adult2 trials

Long-term Persistence Study in Healthy Adults Previously Vaccinated With Twinrix Adult

Completed· GSK logo

GSK·Phase 4·NCT01037114·50 enrolled

A Bridging Study: Comparing Two Lots of Sci-B-Vac™ and Engerix-B in Healthy Adults

Completed·VVBI Vaccines Inc.·Phase 3·NCT04531098·402 enrolled

Chronic Kidney Disease2 trials

Long-Term Study on Safety and Immunogenicity of HEPLISAV™ and Engerix-B® in Adults With Chronic Kidney Disease

Completed·DDynavax Technologies Corporation··NCT01282762·147 enrolled

Comparing Safety and Immunogenicity of HEPLISAV-B® to Engerix-B® in Chronic Kidney Disease (CKD) Patients

Completed·DDynavax Technologies Corporation·Phase 3·NCT00985426·521 enrolled

Prospective1 trial

A Prospective Study of HBV Immunity and HBV Vaccination in Patients With NAFLD in Canada

Completed·UUniversity of Calgary··NCT02985450·82 enrolled

HIV infection1 trial

Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection

Unknown status·NNational Taiwan University Hospital·Phase 4·NCT03854630·575 enrolled

ALS1 trial

Long-term Persistence Study to Assess a Booster Dose of GSK Biologicals' Hib-MenC

Completed· GSK logo

GSK·Phase 3·NCT00322335·230 enrolled

Acute otitis media1 trial

COMPAS (Clinical Otitis Media & Pneumonia Study): Pneumonia & Acute Otitis Media (AOM ) Efficacy Study of the Pneumococcal Conjugate Vaccine

Completed· GSK logo

GSK·Phase 3·NCT00466947·23,802 enrolled

Efficacy1 trial

Efficacy of HBV Vaccine in Consolidation of Nucleos(t)Ide Analogues Therapy

Completed·—·Phase 4·NCT02505009·116 enrolled

Rotavirus Vaccine1 trial

Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants

Completed· GSK logo

GSK·Phase 3·NCT00158756·308 enrolled

Dialysis Patients1 trial

Evaluation of Immunogenicity, Reactogenicity and Safety of HBV-MPL Vaccine vs Engerix™-B, in Haemodialysis Patients

Completed· GSK logo

GSK·Phase 1·NCT00699231·30 enrolled

Inflammatory Bowel Disease1 trial

Hepatitis B Vaccine in Patients With Inflammatory Bowel Disease

Completed·SSoroka University Medical Center·N/A·NCT01531075·91 enrolled

Liver Transplant1 trial

Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Pre-liver Transplant Patients 18 Years of Age

Completed· GSK logo

GSK·Phase 3·NCT00697554·93 enrolled

Plasmodium Falciparum1 trial

Safety and Immunogenicity of Pfs25M-EPA/AS01 and Pfs230D1M-EPA/AS01 Vaccines, Transmission Blocking Vaccines Against Plasmodium Falciparum, at Full and Fractional Dosing in Adults in Mali

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT02942277·301 enrolled

Long-term Follow-up1 trial

Long-Term Follow-up of Children for a 2-Year Period to Confirm the Safety and Immunogenicity of GSK 257049 Vaccine

Completed· GSK logo

GSK·Phase 2·NCT00323622·1,737 enrolled

Vaccination1 trial

B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT04193189·638 enrolled

Papilloma1 trial

Evaluation of Immunogenicity and Safety of Human Papillomavirus (HPV) Vaccine Co-administered With Another Vaccine in Healthy Female Subjects

Completed· GSK logo

GSK·Phase 3·NCT00652938·744 enrolled

Influenza1 trial

Evaluation of Non-typable Haemophilus Influenzae and Pneumococcal Protein Vaccine Formulations in Young Adults

Completed· GSK logo

GSK·Phase 1·NCT00814489·40 enrolled

Immunity1 trial

Preservation and Transfer of HBV Immunity After Allogeneic HSCT for SCD

Unknown status·—·N/A·NCT05200338·30 enrolled

Sources

References

[1]
ClinicalTrials.gov — 72 trial records for Engerix-B. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Engerix-B compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Engerix-B. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — GSK company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Biologic[2]
Highest Phase: Approved[1]
Company: GSK

Engerix-B

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Hepatitis B29 trials

Immunogenicity14 trials

Memory3 trials

Malaria3 trials

Hepatitis2 trials

Vaccine2 trials

Adult2 trials

Chronic Kidney Disease2 trials

Prospective1 trial

HIV infection1 trial

ALS1 trial

Acute otitis media1 trial

Efficacy1 trial

Rotavirus Vaccine1 trial

Dialysis Patients1 trial

Inflammatory Bowel Disease1 trial

Liver Transplant1 trial

Plasmodium Falciparum1 trial

Long-term Follow-up1 trial

Vaccination1 trial

Papilloma1 trial

Influenza1 trial

Immunity1 trial

References

Drug Info

Quick Facts

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