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Hepatitis A vaccine AVAXIM 80U
Hepatitis A vaccine AVAXIM 80U is a Inactivated viral vaccine Biologic drug developed by Sanofi Pasteur, a Sanofi Company. It is currently in Phase 3 development for Prevention of hepatitis A infection in susceptible individuals, Post-exposure prophylaxis for hepatitis A. Also known as: AVAXIM 80U Pediatric vaccine.
AVAXIM 80U is an inactivated hepatitis A vaccine that stimulates the immune system to produce antibodies against hepatitis A virus.
AVAXIM 80U is an inactivated hepatitis A vaccine that stimulates the immune system to produce antibodies against hepatitis A virus. Used for Prevention of hepatitis A infection in susceptible individuals, Post-exposure prophylaxis for hepatitis A.
At a glance
| Generic name | Hepatitis A vaccine AVAXIM 80U |
|---|---|
| Also known as | AVAXIM 80U Pediatric vaccine |
| Sponsor | Sanofi Pasteur, a Sanofi Company |
| Drug class | Inactivated viral vaccine |
| Target | Hepatitis A virus antigen |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
The vaccine contains inactivated (killed) hepatitis A virus antigen that triggers both humoral and cellular immune responses, leading to the production of protective antibodies (anti-HAV IgG) and immunological memory. This prevents infection and disease upon exposure to wild-type hepatitis A virus. The 80U designation refers to the antigen content (80 units) per dose.
Approved indications
- Prevention of hepatitis A infection in susceptible individuals
- Post-exposure prophylaxis for hepatitis A
Common side effects
- Injection site pain or soreness
- Headache
- Fatigue
- Myalgia
- Low-grade fever
Key clinical trials
- Safety of Two Doses of Avaxim® 80U Pediatric (Inactivated Hepatitis A Vaccine) in Toddlers, Children and Adolescents (PHASE4)
- Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines (PHASE3)
- Immunogenicity and Safety of Hepatitis A Vaccine Given at the Same Time of Measles, Mumps, Rubella Combined Vaccine (PHASE4)
- Immunogenicity and Safety of Sanofi Pasteur's AVAXIM 80U Pediatric Vaccine Followed by Booster Dose (PHASE3)
- A Study of Dengue Vaccine in Healthy Toddlers Aged 12 to 15 Months in the Philippines (PHASE2)
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:
- Hepatitis A vaccine AVAXIM 80U CI brief — competitive landscape report
- Hepatitis A vaccine AVAXIM 80U updates RSS · CI watch RSS
- Sanofi Pasteur, a Sanofi Company portfolio CI
Frequently asked questions about Hepatitis A vaccine AVAXIM 80U
What is Hepatitis A vaccine AVAXIM 80U?
How does Hepatitis A vaccine AVAXIM 80U work?
What is Hepatitis A vaccine AVAXIM 80U used for?
Who makes Hepatitis A vaccine AVAXIM 80U?
Is Hepatitis A vaccine AVAXIM 80U also known as anything else?
What drug class is Hepatitis A vaccine AVAXIM 80U in?
What development phase is Hepatitis A vaccine AVAXIM 80U in?
What are the side effects of Hepatitis A vaccine AVAXIM 80U?
What does Hepatitis A vaccine AVAXIM 80U target?
Related
- Drug class: All Inactivated viral vaccine drugs
- Target: All drugs targeting Hepatitis A virus antigen
- Manufacturer: Sanofi Pasteur, a Sanofi Company — full pipeline
- Therapeutic area: All drugs in Immunology / Infectious Disease
- Indication: Drugs for Prevention of hepatitis A infection in susceptible individuals
- Indication: Drugs for Post-exposure prophylaxis for hepatitis A
- Also known as: AVAXIM 80U Pediatric vaccine
- Compare: Hepatitis A vaccine AVAXIM 80U vs similar drugs
- Pricing: Hepatitis A vaccine AVAXIM 80U cost, discount & access