Drugs / Hepatitis B vaccine
Hepatitis B vaccine
also known as
HbsAg · Hepatitis B Vaccine (Recombinant) · Engerix B · HBV · Hepatitis B virus vaccine · Recombivax · HB vaccine · hepatitis B antigen peptide · +12 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Refused (EMA) | EU (EMA) | Hexyon | — | 2013-02-22 | europa.eu ↗ |
| Approved | EU (EMA) | Tritanrix HepB | — | 1996-07-19 | europa.eu ↗ |
Trials 54 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 23 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials | ||||||
| Phase 1 | NCT02839161 Comparator | Jan 2017 → Dec 2018 | hookworm infectious disease | Baylor College of Medicine | Completed | No outcome recorded |
| Phase 1 | NCT02126462 Comparator | Nov 2014 → Feb 2016 | hookworm infectious disease | Baylor College of Medicine | Completed | No outcome recorded |
| Phase 1 | NCT02109354 Comparator | Jun 2013 → Feb 2015 | HIV infectious disease | HIV Vaccine Trials Network | Completed | No outcome recorded |
| Phase 1 | NCT01981616 Background | Sep 2011 → May 2012 | inflammatory bowel disease | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00469651 Comparator | Oct 2007 → Aug 2008 | malaria | African Malaria Network Trust | Unknown | No outcome recorded |
| Phase 1 | NCT00452088 Comparator | Apr 2007 → May 2008 | malaria | African Malaria Network Trust | Unknown | No outcome recorded |
| Phase 1 | NCT00426712 Comparator | Jan 2006 → Mar 2008 | hepatitis B virus infection | Dynavax Technologies Corporation | Completed | No outcome recorded |
| Phase 1 | NCT00354861 Background | May → Nov 2005 | — | Immutep S.A.S. | Completed | No outcome recorded |
| Phase 1 | NCT00003434 Background | Jun 1998 → Aug 2002 | malignant pancreatic neoplasm | Duke University | Terminated | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT01356823 Comparator | Mar → Dec 2011 | cervical cancer, cervical intraepithelial neoplasia | Xiamen University | Completed | No outcome recorded |
| Phase 2 | NCT00262002 Background | Sep 2004 → Jul 2005 | meningococcemia | Novartis Vaccines | Completed | No outcome recorded |
| Phase 2 | NCT00107042 Comparator | Feb 2004 → Jul 2008 | hepatitis B virus infection | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 2 | NCT00272493 Comparator | ? → Nov 2007 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT06397768 Background | May 2024 → Sep 2025 | respiratory syncytial virus infectious disease | Sanofi Pasteur, a Sanofi Company | Terminated | No outcome recorded |
| Phase 3 | NCT03691610 Background | Oct 2018 → Oct 2023 | — | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT03673462 Background | Sep 2018 → Mar 2023 | — | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT02750202 Comparator | Jul 2018 → Jul 2025 | anogenital human papillomavirus infection | University of Pretoria | Completed | No outcome recorded |
| Phase 3 | NCT02094833 Comparator | Mar 2014 → Apr 2016 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, pertussis +2 | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT01183611 Comparator | Apr 2007 → Jun 2010 | Hepadnaviridae infectious disease | Jiangsu Province Centers for Disease Control and Prevention | Completed | No outcome recorded |
| Phase 3 | NCT00315055 Comparator | Jul 2006 → Jul 2007 | diphtheria, hepatitis B virus infection, pertussis, poliomyelitis | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT03212911 Comparator | Jul 2017 → Feb 2018 | — | Chiang Mai University | Unknown | No outcome recorded |
| Phase 4 | NCT02429583 Comparator | May 2015 → Nov 2018 | hepatitis C virus infection | Rockefeller University | Terminated | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02444611 Comparator | Mar 2015 → Jun 2016 | — | Murdoch Childrens Research Institute | Completed | No outcome recorded |
Press releases naming this drug 2 releases
| 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 ↗ |
| 2014-05-12 | Alnylam Pharmaceuticals | Alnylam Announces New RNAi Therapeutic Program for the Treatment of Hepatitis B Virus (HBV) Infection and Reports an Up to 2.3 Log10 Reduction of HBV Surface Antigen (HBsAg) in Chronically Infected Chimpanzees alnylam.com ↗ |
Evidence & citations 23 cited values
Every value below carries the sentence it was read from. 83 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Hepatitis B vaccine | “Since 2009, the WHO recommends to administer hepatitis B vaccine within 24 hours of birth to prevent MTCT.” NCT04029454 ↗57“There are two vaccines provided in this study: hepatitis B vaccine measles-rubella combined vaccine” NCT03373656 ↗ “Hepatitis B vaccine（Each 1.0ml/HBsAg60 μ g. Shenzhen Kangtai Biological Products Co., Ltd）” NCT05451420 ↗ “three doses of 20 μg of the hepatitis B vaccine, in months 0, 1, 6” NCT04540653 ↗ “HBV (Hepatitis B vaccine)” NCT00262002 ↗ |
| Known as | Combined hepatitis A and hepatitis B vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02445703 ↗ |
| Known as | Engerix B | “Each group received 3 vaccine doses (on days 0, 28 and 56) of either 15 microg of MSP3-LSP, 30 microg of MSP3-LSP or of the Engerix B hepatitis B vaccine.” PMID 19855847 ↗ Oct 20092“children were given one of two different doses of the MSP3 antigen (15 microg or 30 microg) or a control vaccine (Engerix B).” PMID 19607731 ↗ Jul 2009 “ENGERIX-B® (hepatitis B vaccine) at 2 and 6 months of age” NCT03673462 ↗ |
| Known as | GeneVac-B | “hepatitis B vaccine immunotherapy of common warts (GeneVac-B 10 ml vial, Serum Institute of India Ltd., Pune, India)” NCT05326152 ↗ |
| Known as | HABV | “Combined hepatitis A and hepatitis B vaccine (HABV)” NCT02445703 ↗ |
| Known as | HB vaccine | “OBJECTIVE: To compare the safety and immunogenicity of two dosages of recombinant hepatitis B (HB) vaccine administered to infants born to HB-uninfected and HB-infected mothers.” PMID 26144895 ↗ Jul 20151“However, a preponderance of data indicates that the protective efficacy of the HB vaccine can last for at least 5 to 10 years and a booster before 5 years is not necessary.” NCT00172328 ↗ |
| Known as | HbsAg | “hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with IMP321” NCT00354861 ↗ |
| Known as | HBV | “Licensed pediatric HBV vaccine will be administered at birth (Day of Life 0) or delayed to Day of Life 7.” NCT03246230 ↗ |
| Known as | hepatitis B antigen | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00354861 ↗ |
| Known as | hepatitis B antigen peptide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00003434 ↗ |
| Known as | HEPATITIS B SURFACE ANTIGEN | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05028322 ↗ |
| Known as | Hepatitis B Vaccine (Recombinant) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00001119 ↗ |
| Known as | Hepatitis B vaccine, experimental formulation | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00697125 ↗ |
| Known as | Hepatitis B virus vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00272493 ↗ |
| Known as | HepB | “HepB vaccine alone” PMID 32426309 ↗ Apr 2020 |
| Known as | HepB-BD | “hepatitis B birth dose vaccine (HepB-BD)” PMID 34206058 ↗ Jun 2021 |
| Known as | recombinant HB vaccine | “Three doses of 10 or 5 μg recombinant HB vaccine were randomly administered by 1:1 within 24 h after birth, at 1 month and at 6 months.” PMID 26144895 ↗ Jul 2015 |
| Known as | recombinant hepatitis B (HB) vaccine | “OBJECTIVE: To compare the safety and immunogenicity of two dosages of recombinant hepatitis B (HB) vaccine administered to infants born to HB-uninfected and HB-infected mothers.” PMID 26144895 ↗ Jul 2015 |
| Known as | recombinant hepatitis B vaccine | “We conducted a multicenter, randomized, double-blind, parallel-controlled trial including 352 hemodialysis patients who were centrally randomized in a ratio of 1:1 to receive a...” PMID 28803502 ↗ Aug 20171“20 µg recombinant hepatitis B vaccine with one, two or three injections at month 0, months 0, 1 or 0, 1, and 6” NCT05099757 ↗ |
| Known as | recombinant hepatitis B vaccine (Saccharomyces cerevisiae) | “recombinant hepatitis B vaccine (Saccharomyces cerevisiae) (1.0ml/HBsAg 60 per dose)” NCT05451420 ↗ |
| Known as | Recombivax | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00142753 ↗ |
| Modality | Vaccine | “hepatitis B vaccine group” NCT00000745 ↗ |
| Route | Intravenous | “Equal doses of CEA and HBsAg peptide pulsed dendritic cells are administered intravenously over 3 minutes every 4 weeks for a total of 6 doses each.” NCT00003434 ↗ |