Engerix-B
Trials 48 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 69 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT02942277 Comparator | Oct 2016 → Jul 2020 | malaria | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT00814489 Comparator | Jan → May 2009 | haemophilus infectious disease, pneumococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00354861 Comparator | May → Nov 2005 | — | Immutep S.A.S. | Completed | No outcome recorded |
| Phase 1 | NCT00699231 Comparator | Feb → Dec 1992 | hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT03038802 Comparator | Mar 2026 → Mar 2027 expected | chronic hepatitis B virus infection | Vaxine Pty Ltd | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT03910972 Comparator | Oct 2019 → Nov 2024 | Schistosoma mansoni infectious disease | Baylor College of Medicine | Completed | No outcome recorded |
| Phase 215 trials | ||||||
| Phase 2 | NCT05380388 Background | Jan → Dec 2027 expected | Plasmodium vivax malaria | University of Oxford | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT01777295 Comparator | Feb 2013 → May 2016 | hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01231503 Background | Jan 2011 → Apr 2014 | malaria | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00886964 Comparator | Apr 2009 → May 2010 | HIV infectious disease | The HIV Netherlands Australia Thailand Research Collaboration | Completed | No outcome recorded |
| Phase 2 | NCT00805389 Comparator | Dec 2008 → Sep 2010 | hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00289185 Comparator | Sep 2006 → Feb 2008 | malaria | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00309166 Comparator | Apr 2006 → Jun 2007 | human papilloma virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00133445 Comparator | Dec 2005 → Aug 2006 | diphtheria, hepatitis B virus infection, pertussis, poliomyelitis +1 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT00197028 Comparator | Aug 2005 → Dec 2007 | Plasmodium falciparum malaria | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00323622 Comparator | Apr 2005 → May 2007 | malaria | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00697853 Comparator | Nov 1998 → Jul 1999 | hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01457495 Comparator | Sep 1998 → Sep 1999 | diphtheria, haemophilus meningitis, hepatitis B virus infection, pertussis +2 | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00698906 Comparator | Jun 1997 → Feb 1998 | hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00698555 Comparator | Mar 1997 → May 1998 | hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00697125 Comparator | Jun 1993 → Jul 1994 | hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT03627507 Comparator | Jul 2018 → May 2019 | hepatitis B virus infection | International Centre for Diarrhoeal Disease Research, Bangladesh | Completed | No outcome recorded |
| Phase 2/3 | NCT02434848 Comparator | Jul 2015 → Jun 2022 | HIV infectious disease, hepatitis B virus infection | Sheffield Teaching Hospitals NHS Foundation Trust | Completed | No outcome recorded |
| Phase 337 trials | ||||||
| Phase 3 | NCT05482295 Comparator | Sep 2025 → May 2026 overdue | vaccinia | PT Bio Farma | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04193189 Comparator | Dec 2020 → Aug 2024 | HIV infectious disease, hepatitis B virus infection | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 3 | NCT02173704 Comparator | Sep 2014 → Dec 2015 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT04209400 Comparator | Apr 2014 → Apr 2015 | hepatitis B virus infection | VBI Vaccines Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02096263 Comparator | Apr 2014 → Feb 2015 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, poliomyelitis +1 | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02117934 Comparator | Apr 2014 → Oct 2015 | — | Dynavax Technologies Corporation | Completed | No outcome recorded |
| Phase 3 | NCT01884415 Comparator | Sep 2012 → Dec 2017 | cirrhosis of liver, hepatitis B virus infection | Andalusian Public Foundation for Health Research in Seville | Completed | No outcome recorded |
| Phase 3 | NCT01933412 Comparator | Mar 2012 → Aug 2013 | chronic kidney disease, hepatitis B virus infection | Tel-Aviv Sourasky Medical Center | Unknown | No outcome recorded |
| Phase 3 | NCT01349283 Comparator | May 2011 → Nov 2012 | hepatitis B virus infection | Crucell Holland BV | Completed | No outcome recorded |
| Phase 3 | NCT01195246 Comparator | Dec 2010 → Feb 2012 | end stage renal failure | Dynavax Technologies Corporation | Completed | No outcome recorded |
| Phase 3 | NCT01000974 Comparator | Jun 2010 → Nov 2011 | haemophilus infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01005407 Comparator | Feb 2010 → Jan 2011 | — | Dynavax Technologies Corporation | Completed | No outcome recorded |
| Phase 3 | NCT00985426 Comparator | Sep 2009 → Jan 2012 | chronic kidney disease | Dynavax Technologies Corporation | Completed | No outcome recorded |
| Phase 3 | NCT00861380 Comparator | May 2009 → Jan 2012 | pneumococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00652938 Comparator | Apr 2008 → Aug 2009 | human papilloma virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00466947 Comparator | Jun 2007 → Aug 2010 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00440297 Comparator | Dec 2006 → May 2008 | hepatitis B virus infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00435812 Comparator | Dec 2006 → Feb 2008 | hepatitis B virus infection | Dynavax Technologies Corporation | Completed | No outcome recorded |
| Phase 3 | NCT00440531 Comparator | Nov 2006 → Nov 2007 | hepatitis B virus infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00414050 Comparator | Oct 2006 → Oct 2007 | hepatitis B virus infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00393523 Comparator | Sep 2006 → Jun 2008 | hepatitis B virus infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00322335 Comparator | May → Jul 2006 | haemophilus infectious disease, meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT04531098 Comparator | Mar 2006 → Dec 2008 | hepatitis B virus infection | VBI Vaccines Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00158756 Comparator | Sep 2005 → Nov 2006 | hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00841477 Comparator | Jan 2004 → Jun 2007 | HIV infectious disease, hepatitis B virus infection, hepatitis C virus infection | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 3 | NCT00697866 Comparator | Aug 2000 → Feb 2001 | hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00697554 Comparator | Jan 2000 → May 2002 | hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00698061 Comparator | Nov 1999 → Sep 2000 | hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00697749 Comparator | Apr 1999 → Jan 2000 | hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00696917 Comparator | Apr 1999 → Feb 2000 | hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00696891 Comparator | Jun 1997 → May 1999 | hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00697931 Comparator | May 1997 → Jun 1998 | hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00697216 Comparator | Mar 1997 → Mar 1999 | hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00697840 Comparator | Jun 1995 → Jan 1996 | hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00698087 Comparator | Jan 1995 → Feb 1996 | hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00697242 Comparator | Jan 1994 → Nov 1995 | hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00697970 Comparator | Nov 1993 → Apr 1995 | hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 46 trials | ||||||
| Phase 4 | NCT05705427 Background | Aug 2023 → Nov 2025 | hepatitis B virus infection, infectious embryofetopathy | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 4 | NCT02169674 Comparator | Sep 2014 → Aug 2015 | hepatitis B virus infection | University of British Columbia | Completed | No outcome recorded |
| Phase 4 | NCT00684671 Comparator | May → Nov 2008 | hepatitis A virus infection, hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00125775 Comparator | May 2005 → Dec 2009 | end stage renal failure | Chinese University of Hong Kong | Completed | No outcome recorded |
| Phase 4 | NCT00106964 Comparator | Jan 2004 → Jan 2008 | HIV infectious disease, hepatitis B virus infection | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 4 | NCT00289731 Comparator | Nov 2003 → Dec 2004 | hepatitis A virus infection, hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT01771354 Comparator | Feb 2013 → Aug 2014 | — | University of Surrey | Completed | No outcome recorded |
| — | NCT01159457 Comparator | Apr 2011 → Jun 2012 | celiac disease | Shaare Zedek Medical Center | Unknown | No outcome recorded |
| — | NCT00739128 Comparator | Feb 2009 → Mar 2011 | celiac disease | Shaare Zedek Medical Center | Terminated | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2025-12-24 | Sanofi | Press Release: Sanofi to acquire Dynavax, adding a marketed adult hepatitis B vaccine and phase 1/2 shingles candidate to the pipeline sanofi.com ↗ |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 127 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Engerix B | “METHODS: HIV-infected youth, aged 12 to younger than 25 years, were randomly assigned to one of three treatment arms: Arm 1: Engerix B, 20 μg HBsAg; Arm 2: Engerix B...” PMID 21350366 ↗ Apr 2011119“The primary objective of the study is to verify that the manufacturing equivalence of Sci-B-Vac™ is consistent and to compare the immunogenicity and safety of a three-dose...” NCT03408730 ↗ “Demonstrate the Non-inferiority of Immunogenicity Elicited by GSK Biologicals' Hepatitis B Vaccine, Multidose Engerix™-B to That of Monodose Engerix™-B When Administered...” NCT00197158 ↗ “Evaluation of the specific anti-HBV vaccine response, measured by the level of anti-HBs antibodies greater than 10 IU / l at M2, M6 and M13 in patients having received a...” NCT04519710 ↗ “Eligible patients will be randomized to receive either intradermal vaccination with Engerix B with topical imiquimod or intramuscular vaccination with Engerix-B with topical...” NCT04083157 ↗ “Participants in the control arm will receive 20 mcg intramuscular Engerix-B at two separate sites (10 mcg/ 0.5 ml) with topical placebo aqueous cream pretreatment 5 minutes...” NCT04083157 ↗ “Children received a single intramuscular challenge dose of either hepatitis B vaccine, HBVaxPro (Hexavac, n=34; Infanrix-Hexa, n=28) or Engerix-B (Hexavac, n=167; Infanrix-Hexa, n=181).” PMID 22789511 ↗ Jul 2012 “This is an open label clinical study designed to evaluate the safety and immunogenicity of Sci-B-Vac Hepatitis B Vaccine compared to Engerix-B Hepatitis B Vaccine in dialysis patients.” NCT01933412 ↗ “who received separate administrations of Engerix™-B (20 μg) vaccine, administered intramuscularly in the left deltoid region, according to a 0, 1 and 6 month schedule” NCT00289731 ↗ “received a 0.5-mL intramuscular dose of 5-μg mpHBV, Recombivax-HB (5 μg), 10-μg mpHBV, or Engerix-B (10 μg) at day 1, month 2, and month 4 (2, 4, 6 months of age).” PMID 21552183 ↗ Jul 2011 “ENGERIX-B (hepatitis B vaccine; recombinant): is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration.” NCT02942277 ↗ “Group B received the monovalent hepatitis B vaccine (Engerix-B) at birth, the DTaP-HepB-IPV (Pediarix™) vaccine with other vaccines at two, four and six months.” NCT00133445 ↗ “hepatitis B (HB) vaccine: Engerix-B (GlaxoSmithKline) (20 µg/dose) accelerated HB vaccine schedule (0,1,2 month),vs, standard HB vaccine schedule (0,1,6 m)” NCT00841477 ↗ “At the initial visit, subjects\>18 years of age will receive the Twinrix vaccine and subjects\<18 years of age will receive the Engerix-B vaccine.” NCT00244374 ↗ “Infanrix-IPV + Hib®, Prevenar-13®, Engerix-B®, Priorix® and Varilrix® administered in the anterolateral area of the right or left thigh.” NCT02173704 ↗ “Non-responders (\<10 IU/mL of antibody at week 28/4 weeks after dose #3) will receive Engerix-B increased adult dose at Week 48.” NCT00142753 ↗ “Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule” NCT00861380 ↗ “Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, IM injection at Days 0, 28, and 168.” NCT03393754 ↗ “received 3-doses of HBV vaccine (Engerix-B™, GSK Vaccines, Belgium) according to a 0, 1, 6 months schedule.” PMID 27123743 ↗ Apr 2016 “Immune Response of Healthy Subjects Who Received Neonatal Vaccination Course With Engerix™-B Vaccine.” NCT00774995 ↗ “Commercial Hepatitis B vaccine (Engerix B) 20 microgram subcutaneous injection at month 0, 1, 6” NCT03405597 ↗ “Hepatitis B vaccine (Engerix-B) will be administered to the eligible participants by 4 groups.” NCT04970836 ↗ “Hepa-B vaccine in comparison with World Health Organization prequalified Engerix-B vaccine.” PMID 34561142 ↗ Sep 2021 “Hepavax-Gene TF or Engerix-B vaccines administered at birth, 1 and 6 months of age” PMID 27753794 ↗ Jan 2017 “Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) is administered intramuscularly” NCT01817725 ↗ “Comparison of Engerix B Vaccine Versus Sci-B-Vac Vaccine in Celiac Patients” NCT01159457 ↗ “Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B” NCT00383383 ↗ “1770 HBV vaccinated (Engerix® B, hepatitis B-virus vaccine) females” PMID 33639181 ↗ Feb 2021 “12 intra-muscular injections of Engerix B over a 6-month period” NCT00120796 ↗ “Engerix B (GlaxoSmithKline, Belgium) as a control.” PMID 24173029 ↗ Oct 2013 “hepatitis B vaccine (Engerix-B)” NCT00000633 ↗ “HBV vaccine (Engerix B)” NCT01817725 ↗ |
| Known as | Commercial Hepatitis B vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03038802 ↗ |
| Known as | Engerix | “Eligible patients will be randomized to receive a 3-dose vaccination series with Engerix or Sci-B-Vac vaccines.” NCT01159457 ↗1“Engerix™ (Hepatitis B [HBV] vaccine)” NCT00652938 ↗ |
| Known as | Engerix TM | “GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine)” NCT00861380 ↗ |
| Known as | Engerix-BTM | “We estimated the cost-effectiveness of this 3-antigen vaccine (PreHevbrio™) relative to the single-antigen vaccine, Engerix-BTM, to prevent hepatitis B virus (HBV) infection...” PMID 37147201 ↗ May 2023 |
| Known as | EngerixTM-B | “Biological: EngerixTM-B” NCT00774995 ↗ |
| Known as | Euvax-B Pediatric | “All HBV-exposed infants received a birth-dose of monovalent HBV vaccine (Euvax-B Pediatric: Sanofi Pasteur, Seoul, South Korea; 0·5 mL) within 24 h of life.” PMID 34416175 ↗ Aug 2021 |
| Known as | HBsAg-Eng | “Phase 3 observer-blinded, randomized (2:1 HBsAg-1018 [HEPLISAV-B™]:HBsAg-Eng [Engerix-B®]), active-controlled trial” PMID 29289383 ↗ Dec 2017 |
| Known as | HBV vaccine | “Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule” NCT00861380 ↗7“To revaccinate the HBV vaccine in the children who didn't have protective HBV Ab” NCT00886964 ↗ “and finally were injected 20 μg of HBV vaccine subcutaneously at day 6” NCT01878565 ↗ |
| Known as | Hepatitis B monovalent vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05705427 ↗ |
| Known as | Hepatitis B Vaccine | “The concomitant group (n =300) received Hepatitis B vaccine concomitantly with Hepatitis E vaccine at day 1 and months 1 and 6;” NCT02584543 ↗ |
| Known as | monovalent HBV vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03567382 ↗ |
| Known as | Recombinant Hepatitis B Vaccine | “Safety and Immunogenicity Study of the Recombinant Hepatitis E Vaccine(Escherichia Coli) Coadministration With Recombinant Hepatitis B Vaccine” NCT02584543 ↗ |
| Action | Activate | “finally HBV vaccine is used to priming APC to induce HBV-specific immune responses” NCT01878565 ↗ |
| Modality | Vaccine | “hepatitis B vaccine (Engerix-B)” NCT00000633 ↗ |
| Route | Intramuscular | “administered in the deltoid muscle” NCT00106964 ↗ |