Data updated: May 30, 2026
Engerix-B (hepatitis b vaccine (recombinant))
Approved 1989-08-27
1
Indication
--
Phase 3 Trials
36
Years on Market
Details
- Status
- Prescription
- First Approved
- 1989-08-27
- Routes
- Intramuscular
- Dosage Forms
- Injection
Companies
Active Ingredient: Hepatitis B Vaccine (Recombinant) , Hepatitis B Vaccine (Recombinant) , Hepatitis B Vaccine (Recombinant) , Hepatitis B Vaccine (Recombinant)
Website: ↗
Engerix-B Approval History
1990
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Original
New Indication
New Form
Label Update
1 FDA actions from 1989 to 1989
Aug 1989 ORIGINAL
Update · CBER biologic (Purple Book)
What Engerix-B Treats
1 FDA approvalsOriginally approved for its first indication in 1989 .
- Other (1)
Other
(1 approval)- • Approved indication (Aug 1989)
GSK's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
EXDENSUR
2025 DEPEMOKIMAB-ULAA
BLENREP
2025 BELANTAMAB MAFODOTIN-BLMF
5 designations
BLUJEPA
2025 GEPOTIDACIN MESYLATE
2 designations
JESDUVROQ
2023 DAPRODUSTAT
1 designation
OJJAARA
2023 MOMELOTINIB DIHYDROCHLORIDE
1 designation
JEMPERLI
2021 DOSTARLIMAB-GXLY
3 designations
BREXAFEMME
2021 IBREXAFUNGERP CITRATE
3 designations
KRINTAFEL
2018 TAFENOQUINE SUCCINATE
3 designations
ZEJULA
2017 NIRAPARIB TOSYLATE
4 designations
📋
Clinical Trial Registry
18 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05272735 | GVI 1028 | Ph 4 | terminated | HBV Vaccination of Healthy Volunteers to Evaluate the Composition of Germinal Centers |
| NCT04193189 BEe-HIVe results posted | ACTG A5379 38569 | Ph 3 | completed | B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B |
| NCT02942277 results posted | 999917006 17-I-N006 | Ph 1 | completed | 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 |
| NCT04072211 | 003-01-19 | Ph 4 | completed | Demonstration Project on Health Care Worker Protection Against Hepatitis B in Kalulushi District |
| NCT00985426 results posted | DV2-HBV-17 2009-015877-11 | Ph 3 | completed | Comparing Safety and Immunogenicity of HEPLISAV-B® to Engerix-B® in Chronic Kidney Disease (CKD) Patients |
| NCT02901951 results posted | 116811 2015-004099-31 | Ph 4 | completed | Long-term Persistence of Immunity to Hepatitis B in Adults Vaccinated With GlaxoSmithKline (GSK) Biologicals' Hepatitis B Vaccine (HBV), Engerix-B |
| NCT02096263 results posted | 117119 2013-004304-19 | Ph 3 | completed | Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants |
| NCT02505009 | 104-3167C | Ph 4 | completed | Efficacy of HBV Vaccine in Consolidation of Nucleos(t)Ide Analogues Therapy |
| NCT01005407 results posted | DV2-HBV-16 | Ph 3 | completed | Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine |
| NCT01195246 | DV2-HBV-18 2010-019633-10 | Ph 3 | completed | Safety and Immunogenicity of HEPLISAV™ a Hepatitis B Virus Vaccine in Adults on Hemodialysis |
| NCT02117934 results posted | DV2-HBV-23 | Ph 3 | completed | Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine |
| NCT01037114 results posted | 112266 | Ph 4 | completed | Long-term Persistence Study in Healthy Adults Previously Vaccinated With Twinrix Adult |
| NCT01000324 results posted | 112267 | Ph 4 | completed | Antibody Persistence & Immune Memory in Healthy Adults Previously Vaccinated With Twinrix Adult |
| NCT00684671 results posted | 111572 | Ph 4 | completed | Evaluation of Immune Memory to Twinrix or Comparator by Challenge Dose Administration 4 Years After Primary Vaccination |
| NCT01231503 results posted | 111315 | Ph 2 | completed | Safety and Immunogenicity of GSK Biologicals' Malaria Vaccine 257049 When Administered on 7 Schedules to African Infants |
| NCT00814489 results posted | 112076 | Ph 1 | completed | Evaluation of Non-typable Haemophilus Influenzae and Pneumococcal Protein Vaccine Formulations in Young Adults |
| NCT00603252 | 111149 | Ph 4 | completed | Study to Show That the Combined Hepatitis A and B Vaccine is Non-inferior to Monovalent Vaccines in Adults |
| NCT01082861 TANGO | LIS144 2010-018459-86 | Ph 4 | terminated | Efficacy and Immunomodulation Study of Simultaneous Human Papillomavirus/ Hepatitis B (HPV/HBV) Vaccination |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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📊
Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
Engerix-B FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.