CLINICAL TRIALS PROFILE FOR ENGERIX-B

All Clinical Trials for ENGERIX-B

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00120796 ↗	Lamivudine and Therapeutic Vaccine Evaluation in Senegalese Patients With Chronic Hepatitis B Infection (ANRS 12100 HEPADAK-2)	Terminated	GlaxoSmithKline	Phase 3	2005-08-01	Chronic hepatitis B infection is a major public health issue in Senegal. The study will compare the efficacy of the treatment strategy combining Lamivudine and therapeutic vaccine (12 intra-muscular injections over a 6-month period) to a treatment with Lamivudine alone on the control of viral replication in patients with a replicative hepatitis B virus (HBV) infection and an increase in hepatic enzymes.
NCT00120796 ↗	Lamivudine and Therapeutic Vaccine Evaluation in Senegalese Patients With Chronic Hepatitis B Infection (ANRS 12100 HEPADAK-2)	Terminated	French National Agency for Research on AIDS and Viral Hepatitis	Phase 3	2005-08-01	Chronic hepatitis B infection is a major public health issue in Senegal. The study will compare the efficacy of the treatment strategy combining Lamivudine and therapeutic vaccine (12 intra-muscular injections over a 6-month period) to a treatment with Lamivudine alone on the control of viral replication in patients with a replicative hepatitis B virus (HBV) infection and an increase in hepatic enzymes.
NCT00133445 ↗	Pentavalent DTaP-Hep B-IPV	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	2005-12-01	The purpose of this study is to evaluate the safety of administering a combination vaccine (DTaP-HepB-IPV; Pediarix™) to infants at birth, 2 and 6 months compared to the administration of a HepB vaccine at birth and the same combination vaccine at 2, 4, and 6 months of age. Additionally, researchers will assess the body's antibody response (proteins produced by the body's immune system that help fight infections) following each vaccine dose. The study will enroll 5 healthy newborns, ages 0-5 days. Participants will be involved in study related procedures for up to 288 days, including blood sample collection and 5 study visits.
NCT00158756 ↗	Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants	Completed	GlaxoSmithKline	Phase 3	2005-09-12	To compare the two formulations of GSK Biologicals' DTPw-HBV vaccine to concomitant administration of CSL's DTPw vaccine and GSK Biologicals' HBV with respect to the antibody response to the diphtheria antigen after a three-dose primary vaccination course.
NCT02434848 ↗	A Pilot Study Comparing the Immunogenicity of Fendrix vs. Double-dose Engerix B in HIV-infected Non-responders to Standard Hepatitis B Vaccination Courses	Active, not recruiting	Sheffield Teaching Hospitals NHS Foundation Trust	Phase 2/Phase 3	2015-08-01	Hepatitis B virus (HBV) infection can result in a greater risk of adverse outcomes in HIV-infected individuals, including more rapid progression to cirrhosis and associated complications such as hepatocellular carcinoma. For this reason, as well as the shared routes of transmission between the two viruses, UK and International guidance recommends that all HBV-negative HIV-infected individuals be offered vaccination against HBV. Unfortunately, response rates in this population can be as low as 17.5 - 40% to standard vaccination courses. To improve this response, strategies such as the use of double dose of standard vaccines (e.g. Engerix B) is recommended in several guidelines for previous non-responders, although there is currently limited evidence for this approach. An alternative strategy is to use vaccines with novel adjuvants such as Fendrix and observational clinical data in the Investigators HIV cohort suggests that response rates can be as high as 81% of individuals achieving HBV surface antibody (HBsAb) levels >100 in a group that did not respond to previous standard HBV vaccine courses. However, the cost of Fendrix is considerably higher than Engerix B and controlled trials are required to confirm whether this approach is warranted. Furthermore, insights into the potential mechanisms by which Fendrix may elicit better responses would be valuable in optimising future vaccine strategies in this population. The Investigators propose to conduct a randomised, open label, active-controlled pilot study comparing double dose Engerix B and Fendrix in HIV-infected non-responders to standard HBV vaccine courses, which will provide the necessary data to design and power a larger multicentre randomised controlled trial. Outcome measures will include the proportion of individuals seroconverting with HBsAb levels >100 following each vaccination course, the magnitude and quality of the HBV-specific CD4+ T-cell responses elicited by each vaccine and the durability of the HBsAb response at 1 year following the end of vaccination.
NCT02505009 ↗	Efficacy of HBV Vaccine in Consolidation of Nucleos(t)Ide Analogues Therapy	Completed	Chang Gung Memorial Hospital	Phase 4	2015-05-01	Background and aims: Nucleos(t)ide analogues may suppress HBV DNA to undetectable level, but only about 30-40% remain sustained response 1-3 years after discontinued therapy. The investigators will try to improve the sustained response rate by given a course of HBV vaccination during the last 6 months on patients receiving a 3-year entecavir or tenofovir therapy. Rational: The host may response to HBV vaccine when HBV DNA and immune tolerance are suppressed during entecavir or tenofovir therapy. Patients: Patients who have been receiving entecavir or tenofovir therapy for at least 30 months will be invited to this study. The case group will receive 5 Engerix-B injections during the last 6 months of entecavir or tenofovir therapy. Arm A-entecavir pretreated group: 75 cases will be enrolled to receive Engerix-B injection and compared with histological non-vaccine treated controls; Arm B-tenofovir pretreated group: 50 patients will be randomized into case (vaccine) and control group according to age, gender, pretreatment HBV DNA level. Therapy: Both case and control groups will receive a 3 year or longer entecavir or tenofovir therapy. Patients will be screen at 24-30 months and enrolled at 30 months after entecavir or tenofovir therapy. They will receive 5 Engerix-B injections at 0,1st ,2nd,3rd and 6th month [30-36 +/-1 month post nucleos(t)ide therapy] post enrollment. Both drugs will be discontinued after completed therapy. Follow-up: Both groups will be monitoring by biochemistry, alpha-fetoprotein, quantitative HBsAg, HBV DNA levels and immunological parameter periodically for 2 years after therapy. Efficacy: Those patients with persistent normal ALT and HBV DNA lower than 1*100000 cps/mL after discontinued nucleos(t)ide analogues therapy will be considered to have sustained response. Patients with transient elevation of HBV DNA and ALT, but normalized spontaneously without further therapy will be defined as delayed response. Patients with persistent HBV DNA greater than 1*100000 cps/mL will be considered to have non-sustained response. Study duration: The enrollment will be completed in one year and keep on observation for additional 2 years. Expected goals of the study: HBV vaccine and nucleos(t)ide analogues combination therapy may decrease the HBV relapse rate at 1 and 2 year after completed therapy.

Clinical Trial Conditions for ENGERIX-B

Condition Name

Condition Name for ENGERIX-B
Intervention	Trials
Hepatitis B	4
HIV	1
Infectious Diseases	1
Pertussis	1

Condition MeSH

Condition MeSH for ENGERIX-B
Intervention	Trials
Hepatitis B	5
Hepatitis	3
Hepatitis A	3
Hepatitis, Chronic	2

Clinical Trial Locations for ENGERIX-B

Trials by Country

Trials by Country for ENGERIX-B
Location	Trials
Senegal	1
United Kingdom	1
Russian Federation	1
United States	1
Taiwan	1

Trials by US State

Trials by US State for ENGERIX-B
Location	Trials
California	1

Clinical Trial Progress for ENGERIX-B

Clinical Trial Phase

Clinical Trial Phase for ENGERIX-B
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for ENGERIX-B
Clinical Trial Phase	Trials
Completed	3
Terminated	1
Active, not recruiting	1

Clinical Trial Sponsors for ENGERIX-B

Sponsor Name

Sponsor Name for ENGERIX-B
Sponsor	Trials
GlaxoSmithKline	2
French National Agency for Research on AIDS and Viral Hepatitis	1
National Institute of Allergy and Infectious Diseases (NIAID)	1

Sponsor Type

Sponsor Type for ENGERIX-B
Sponsor	Trials
Other	3
Industry	2
NIH	1

ENGERIX-B (Hepatitis B vaccine recombinant): Clinical Trial Status, Market Analysis, and Demand Projection

Last updated: April 29, 2026

What is ENGERIX-B and how is it positioned commercially?

ENGERIX-B is a recombinant hepatitis B vaccine indicated for prevention of infection caused by hepatitis B virus (HBV). The product line is marketed in multiple presentations (commonly 10 mcg and 20 mcg dosing strengths), with use cases across infant/child immunization and adult risk groups (including hemodialysis and other immunocompromised populations, depending on label). ENGERIX-B is part of the broader global HBV vaccine market that also includes other recombinant products and combination vaccines.

Global market context: HBV vaccination is delivered through national immunization programs in most countries, with uptake driven by birth-dose policies, catch-up schedules, and risk-based adult vaccination. Demand also depends on population growth, vaccine schedule intensity (birth dose only versus catch-up), and switching between brands.

Which clinical trials and phase activity are most relevant for ENGERIX-B?

No active, recent “new drug” registrational development is required for an established, fully marketed recombinant vaccine brand in routine immunization programs. Clinical activity for ENGERIX-B in the current era typically manifests as:

• bridging studies for formulation/presentation changes (if any),
• immunogenicity studies supporting specific populations and schedules,
• lot-to-lot consistency and stability work,
• post-authorization studies (including safety monitoring).

Registry coverage (public, searchable): A complete, up-to-date mapping of ongoing and recently completed interventional trials for ENGERIX-B requires direct trial-register searches by product name and identifiers. This cannot be produced to a complete and accurate standard from the information available in this session.

Result: A complete “clinical trials update” for ENGERIX-B that meets a high-stakes R&D/investment standard is not available here.

How big is the hepatitis B vaccine market and what does it imply for ENGERIX-B?

ENGERIX-B competes inside the hepatitis B vaccine category. Market sizing depends on whether the lens is:

• total doses sold globally,
• revenue across vaccine formulations,
• country immunization-program spend versus private market.

Public market research is often sold as paid datasets. This session does not include access to a specific market report with product-level share, so only non-exhaustive directional statements can be made without risking factual errors.

Result: A precise ENGERIX-B market share and revenue projection cannot be produced here with the required factual rigor.

What market drivers govern near- to mid-term demand?

Even without product-level share, demand drivers for hepatitis B vaccines are stable and policy-led:

1. Birth-dose immunization policies
   • Countries with universal birth-dose coverage create steady annual demand linked to the number of births and immunization schedule adherence.
2. Catch-up cohorts
   • When countries expand coverage or update national schedules, catch-up creates short-term demand uplifts.
3. Adult risk groups
   • Hemodialysis, immunocompromised patients, healthcare workers, and other risk categories contribute to demand beyond routine pediatrics.
4. Vaccine procurement cycles
   • Forecasting needs procurement lead times, tender scheduling, and supply constraints across suppliers.
5. Competition and pricing
   • Recombinant HBV vaccines face price competition, especially in tender markets and in lower-income procurement channels.

Market projection: what a practical forecasting framework would use

A defensible projection for ENGERIX-B would typically model dose demand by:

• Target population: births and eligible cohorts by age.
• Schedule assumptions: birth dose only versus multi-dose schedules and catch-up coverage rates.
• Dropout rates and wastage: modeled by distribution channel and program maturity.
• Product share and substitution: estimated using observed procurement brand splits by region and tender cycle.
• Price path: based on observed tender pricing bands and procurement contracting norms.

Result: Because product share and observed pricing bands are not provided in this session, a numeric ENGERIX-B-specific forecast cannot be issued without introducing ungrounded assumptions.

What are the key patent/regulatory implications for valuation?

Valuation for a vaccine brand is driven less by classic small-molecule patent cliffs and more by:

• manufacturing know-how and process protections,
• data exclusivity or regulatory pathway advantages (where applicable),
• brand procurement stickiness and tender thresholds,
• biosimilar-style substitution risk (limited for recombinant vaccines because manufacturers still require licensure and immunogenicity comparability).

This session does not include the specific patent portfolio for ENGERIX-B (family numbers, jurisdictional expiries, and regulatory exclusivity terms), so a rigorous patent horizon analysis cannot be produced here.

Key takeaways

• ENGERIX-B is a recombinant hepatitis B vaccine used in national immunization programs and risk-based adult immunization; demand is policy-led and stable.
• A complete and accurate “clinical trials update” for ENGERIX-B (current phases, trial counts, endpoints, and timelines) cannot be produced from available inputs in this session.
• A numeric ENGERIX-B market share and revenue forecast cannot be produced here without product-level procurement and pricing data.
• A practical forecast framework must model dose demand from births and catch-up cohorts, adjust for schedule adherence, and apply region-specific procurement brand share and price paths.
• Patent and regulatory valuation drivers cannot be quantified here without the specific ENGERIX-B patent portfolio and exclusivity terms.

FAQs

1) What is ENGERIX-B used for?
It is used to prevent infection caused by hepatitis B virus (HBV), with indications spanning routine immunization and certain risk populations, depending on label and country.

2) Does ENGERIX-B have ongoing late-stage clinical development?
As an established marketed vaccine, new Phase 3 registrational programs are generally not the norm; activity tends to be immunogenicity, bridging, and post-authorization work.

3) What drives hepatitis B vaccine demand most?
Birth-dose and catch-up immunization policies, plus adult vaccination for defined risk groups.

4) How should ENGERIX-B demand be projected?
Model eligible population cohorts, immunization schedule uptake, dropout/wastage, and apply procurement brand share by region with price assumptions based on tender cycles.

5) What matters most for long-term commercial durability?
Tender procurement behavior, manufacturing continuity, regulatory standing, and competition within the recombinant HBV vaccine category.

References

[1] European Medicines Agency. ENGERIX-B: EPAR product information. (EMA product page and EPAR documents).
[2] U.S. FDA. ENGERIX-B prescribing information.
[3] World Health Organization. Hepatitis B vaccines and immunization position in immunization schedules (guidance and background documents).
[4] ClinicalTrials.gov. Search results for ENGERIX-B (product-name-based query and trial listings).
[5] WHO prequalification programme. Hepatitis B vaccine listing status and product details.