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Engerix-B Kinder
Engerix-B Kinder is a Recombinant hepatitis B vaccine Biologic drug developed by GlaxoSmithKline. It is currently FDA-approved for Active immunization against hepatitis B infection in infants and children. Also known as: HBV vaccine, Engerix™-B.
Engerix-B Kinder is a hepatitis B vaccine that stimulates the immune system to produce antibodies against hepatitis B surface antigen, providing protection against hepatitis B infection.
Engerix-B Kinder is a vaccine used to prevent Hepatitis B. It is administered to adolescents who were previously vaccinated against Hepatitis B as infants.
At a glance
| Generic name | Engerix-B Kinder |
|---|---|
| Also known as | HBV vaccine, Engerix™-B |
| Sponsor | GlaxoSmithKline |
| Drug class | Recombinant hepatitis B vaccine |
| Target | Hepatitis B surface antigen (HBsAg) |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
The vaccine contains recombinant hepatitis B surface antigen (HBsAg) produced in yeast cells. When administered, it triggers both humoral and cellular immune responses, leading to the production of protective antibodies (anti-HBs) and memory B cells. This immunological memory enables rapid immune response upon exposure to the actual hepatitis B virus, preventing infection and disease.
Approved indications
- Active immunization against hepatitis B infection in infants and children
Common side effects
- Injection site pain, redness, or swelling
- Fever
- Irritability
- Fatigue
- Loss of appetite
Key clinical trials
- A Study to Evaluate Persistence of Hepatitis B Antibodies, Immunogenicity and Safety of Engerix™-B Kinder Challenge Dose, in Adolescents Vaccinated With Four Doses of Infanrix™ Hexa During Infancy (PHASE4)
- Persistence of Immunity Against Hepatitis B in 12-13 Year Old Adolescents After Infant Hepatitis B Vaccination (PHASE4)
- Evaluation of the Long-term Persistence of Immunity to Hepatitis B, in Adolescents Vaccinated in Infancy With Engerix™-B Kinder (PHASE4)
- Long-term Persistence of Immunity Against Hepatitis B in 7-8 Years Old Children After Hepatitis B Vaccination. (PHASE4)
- Hepatitis B Antibody Persistence and Immune Response to Hepatitis B Vaccine Challenge in Previously Vaccinated Children (PHASE4)
- This Study Aims to Determine the Long-term Persistence of Antibodies Against Hepatitis B and to Evaluate the Immunogenicity and Safety of Hepatitis B Vaccine in Adolescents Vaccinated in Infancy With Infanrix™ Hexa (PHASE4)
- Persistence of Hepatitis B Antibody Levels & Immune Response to a Hepatitis B Vaccine Challenge (PHASE4)
- Study to Compare Booster Vaccination With Pediacel® to Infanrix® Hexa When Both Are Co-Administered With Prevenar® (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:
- Engerix-B Kinder CI brief — competitive landscape report
- Engerix-B Kinder updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about Engerix-B Kinder
What is Engerix-B Kinder?
How does Engerix-B Kinder work?
What is Engerix-B Kinder used for?
Who makes Engerix-B Kinder?
Is Engerix-B Kinder also known as anything else?
What drug class is Engerix-B Kinder in?
What development phase is Engerix-B Kinder in?
What are the side effects of Engerix-B Kinder?
What does Engerix-B Kinder target?
Related
- Drug class: All Recombinant hepatitis B vaccine drugs
- Target: All drugs targeting Hepatitis B surface antigen (HBsAg)
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Immunology / Infectious Disease
- Indication: Drugs for Active immunization against hepatitis B infection in infants and children
- Also known as: HBV vaccine, Engerix™-B
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing