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Live Attenuated H1N1 Influenza Vaccine
Live Attenuated H1N1 Influenza Vaccine is a Live attenuated vaccine Biologic drug developed by University of Rochester. It is currently FDA-approved for Prevention of H1N1 influenza infection in eligible populations. Also known as: Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal.
A live attenuated influenza vaccine that contains weakened H1N1 virus strains to stimulate immune response without causing disease.
A live attenuated influenza vaccine that contains weakened H1N1 virus strains to stimulate immune response without causing disease. Used for Prevention of H1N1 influenza infection in eligible populations.
At a glance
| Generic name | Live Attenuated H1N1 Influenza Vaccine |
|---|---|
| Also known as | Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal |
| Sponsor | University of Rochester |
| Drug class | Live attenuated vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
The vaccine contains temperature-sensitive, attenuated H1N1 influenza virus that replicates in the cooler upper respiratory tract but not in the warmer lower respiratory tract, triggering both humoral and cellular immune responses. This approach induces mucosal and systemic immunity to prevent infection with wild-type H1N1 influenza virus. The attenuated virus is designed to be non-pathogenic while maintaining immunogenicity.
Approved indications
- Prevention of H1N1 influenza infection in eligible populations
Common side effects
- Nasal congestion
- Runny nose
- Sore throat
- Cough
- Fever
- Myalgia
Key clinical trials
- Simultaneous Administration Study of Varicella Attenuated Live Vaccine and Trivalent Inactivated Influenza Vaccine (Split Virion) (PHASE4)
- Intramuscular CodaVax-H1N1 in Healthy Adults (PHASE1)
- Post-marketing Study of Lyophilized Nasal Spray Live Attenuated Influenza Vaccine (PHASE4)
- Safety and Immunogenicity of a Live-attenuated Universal Flu Vaccine Followed by an Inactivated Universal Flu Vaccine (PHASE1)
- Safety Study of Live Attenuated Influenza Vaccine, CodaVax, Delivered Via Intranasal Spray (PHASE1)
- Safety Study of Live Attenuated Influenza Vaccine, CodaVax (PHASE1)
- A Phase III/IV Open-label Study of the Immunogenicity and Safety of a Single Dose of a Live Attenuated Influenza Vaccine (LAIV) (FluenzTM) for Each of Three Successive Years in Children naïve to, or in Previous Receipt of the AS03B Adjuvanted H1N1 (2009) Influenza Vaccine (Pandemrix ™). (PHASE4)
- Safety and Effectiveness of a Seasonal Live Attenuated Influenza Vaccine in a Human Challenge Model of Infection With Wild-type (wt) Influenza A/California/2009 (H1N1)-Like Virus (PHASE1)
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:
- Live Attenuated H1N1 Influenza Vaccine CI brief — competitive landscape report
- Live Attenuated H1N1 Influenza Vaccine updates RSS · CI watch RSS
- University of Rochester portfolio CI
Frequently asked questions about Live Attenuated H1N1 Influenza Vaccine
What is Live Attenuated H1N1 Influenza Vaccine?
How does Live Attenuated H1N1 Influenza Vaccine work?
What is Live Attenuated H1N1 Influenza Vaccine used for?
Who makes Live Attenuated H1N1 Influenza Vaccine?
Is Live Attenuated H1N1 Influenza Vaccine also known as anything else?
What drug class is Live Attenuated H1N1 Influenza Vaccine in?
What development phase is Live Attenuated H1N1 Influenza Vaccine in?
What are the side effects of Live Attenuated H1N1 Influenza Vaccine?
Related
- Drug class: All Live attenuated vaccine drugs
- Manufacturer: University of Rochester — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Prevention of H1N1 influenza infection in eligible populations
- Also known as: Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal
- Compare: Live Attenuated H1N1 Influenza Vaccine vs similar drugs
- Pricing: Live Attenuated H1N1 Influenza Vaccine cost, discount & access