Last reviewed 2026-04-23 · How we verify

HepavaxGene (thiomersal free)

Crucell Holland BV · Phase 3 active Biologic

HepavaxGene (thiomersal free) is a Recombinant vaccine Biologic drug developed by Crucell Holland BV. It is currently in Phase 3 development for Hepatitis B prevention in infants, children, and adults.

HepavaxGene is a recombinant hepatitis B vaccine that stimulates the immune system to produce antibodies against hepatitis B surface antigen.

HepavaxGene is a recombinant hepatitis B vaccine that stimulates the immune system to produce antibodies against hepatitis B surface antigen. Used for Hepatitis B prevention in infants, children, and adults.

At a glance

Generic name	HepavaxGene (thiomersal free)
Sponsor	Crucell Holland BV
Drug class	Recombinant vaccine
Target	Hepatitis B surface antigen (HBsAg)
Modality	Biologic
Therapeutic area	Immunology / Infectious Disease
Phase	Phase 3

Mechanism of action

HepavaxGene uses recombinant DNA technology to express hepatitis B surface antigen (HBsAg), which is then formulated as a vaccine to elicit both humoral and cellular immune responses. The thiomersal-free formulation removes the mercury-based preservative while maintaining immunogenicity. This approach aims to provide protective immunity against hepatitis B virus infection.

Approved indications

Hepatitis B prevention in infants, children, and adults

Common side effects

Injection site pain or swelling
Fever
Fatigue
Headache

Key clinical trials

Immunogenicity and Safety of the Hepatitis B Vaccine Hepavax-Gene TF and a Comparator Hepatitis B Vaccine in Newborns (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

HepavaxGene (thiomersal free) CI brief — competitive landscape report
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Crucell Holland BV portfolio CI

Frequently asked questions about HepavaxGene (thiomersal free)

What is HepavaxGene (thiomersal free)?

HepavaxGene (thiomersal free) is a Recombinant vaccine drug developed by Crucell Holland BV, indicated for Hepatitis B prevention in infants, children, and adults.

How does HepavaxGene (thiomersal free) work?

HepavaxGene is a recombinant hepatitis B vaccine that stimulates the immune system to produce antibodies against hepatitis B surface antigen.

What is HepavaxGene (thiomersal free) used for?

HepavaxGene (thiomersal free) is indicated for Hepatitis B prevention in infants, children, and adults.

Who makes HepavaxGene (thiomersal free)?

HepavaxGene (thiomersal free) is developed by Crucell Holland BV (see full Crucell Holland BV pipeline at /company/crucell-holland-bv).

What drug class is HepavaxGene (thiomersal free) in?

HepavaxGene (thiomersal free) belongs to the Recombinant vaccine class. See all Recombinant vaccine drugs at /class/recombinant-vaccine.

What development phase is HepavaxGene (thiomersal free) in?

HepavaxGene (thiomersal free) is in Phase 3.

What are the side effects of HepavaxGene (thiomersal free)?

Common side effects of HepavaxGene (thiomersal free) include Injection site pain or swelling, Fever, Fatigue, Headache.

What does HepavaxGene (thiomersal free) target?

HepavaxGene (thiomersal free) targets Hepatitis B surface antigen (HBsAg) and is a Recombinant vaccine.

Drug class: All Recombinant vaccine drugs
Target: All drugs targeting Hepatitis B surface antigen (HBsAg)
Manufacturer: Crucell Holland BV — full pipeline
Therapeutic area: All drugs in Immunology / Infectious Disease
Indication: Drugs for Hepatitis B prevention in infants, children, and adults
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