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Engerix TM
Engerix-B is a recombinant hepatitis B vaccine that stimulates the immune system to produce antibodies against hepatitis B surface antigen (HBsAg).
Engerix-B is a recombinant hepatitis B vaccine that stimulates the immune system to produce antibodies against hepatitis B surface antigen (HBsAg). Used for Prevention of hepatitis B infection in infants, children, and adults, Post-exposure prophylaxis for hepatitis B.
At a glance
| Generic name | Engerix TM |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Recombinant vaccine |
| Target | Hepatitis B surface antigen (HBsAg) |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
The vaccine contains recombinant hepatitis B surface antigen produced in yeast cells, which is adsorbed onto aluminum hydroxide as an adjuvant. Upon administration, it triggers both humoral and cellular immune responses, leading to the production of protective antibodies (anti-HBs) and memory B cells that provide long-term immunity against hepatitis B virus infection.
Approved indications
- Prevention of hepatitis B infection in infants, children, and adults
- Post-exposure prophylaxis for hepatitis B
Common side effects
- Injection site soreness or swelling
- Fatigue
- Headache
- Fever (low-grade)
- Myalgia
Key clinical trials
- A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection (PHASE1, PHASE2)
- Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage
- Impact on Carriage, Acute Otitis Media, Immuno & Safety of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A (PHASE3)
- Evaluation of Effectiveness of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A Against Invasive Disease (PHASE3)
- Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,6 Month Schedule (PHASE3)
- Evaluation of Immunogenicity and Safety of Human Papillomavirus (HPV) Vaccine Co-administered With Another Vaccine in Healthy Female Subjects (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 |